Rules of Agency Practice and Procedure Concerning Occupational Safety and Health Administration Access to Employee Medical Records, 45780-45793 [2020-15562]

Download as PDF 45780 Federal Register / Vol. 85, No. 147 / Thursday, July 30, 2020 / Rules and Regulations Inspecting a harness takes about 0.25 work-hour, for an estimated cost of $21 per harness. If required, replacing a harness takes about 1 work-hour and parts cost about $1,050 for an estimated replacement cost of $1,135 per harness. Authority for This Rulemaking Regulatory Findings This AD will not have federalism implications under Executive Order 13132. This AD will not have a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government. For the reasons discussed above, I certify that this AD: 1. Is not a ‘‘significant regulatory action’’ under Executive Order 12866, 2. Will not affect intrastate aviation in Alaska, and 3. Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act. khammond on DSKJM1Z7X2PROD with RULES List of Subjects in 14 CFR Part 39 Air transportation, Aircraft, Aviation safety, Incorporation by reference, Safety. Adoption of the Amendment Accordingly, under the authority delegated to me by the Administrator, the FAA amends 14 CFR part 39 as follows: 16:01 Jul 29, 2020 Jkt 250001 certificate holding district office, before operating any aircraft complying with this AD through an AMOC. 1. The authority citation for part 39 continues to read as follows: (g) Related Information Bell Helicopter Textron Alert Service Bulletin 204B–15–70 for Model 204B helicopters, Bell ASB 205–15–113 for Model 205A and 205A–1 helicopters, Bell ASB 205B–15–66 for Model 205B helicopters, Bell ASB 212–15–156 for Model 212 helicopters, Bell ASB 412–15–170 for Model 412 and 412EP helicopters, and Bell ASB 412CF–15– 60 for Model 412CF helicopters, all dated January 20, 2016, and Bell ASB 214–15–76, dated January 11, 2016, for Model 214B and 214B–1 helicopters, all of which are not incorporated by reference, contain additional information about the subject of this AD. For service information identified in this AD, contact Bell Textron Inc., P.O. Box 482, Fort Worth, TX 76101; telephone 817–280–3391; fax 817–280–6466; or at https:// www.bellcustomer.com. You may view a copy of the information at the FAA, Office of the Regional Counsel, Southwest Region, 10101 Hillwood Pkwy., Room 6N–321, Fort Worth, TX 76177. ■ Authority: 49 U.S.C. 106(g), 40113, 44701. § 39.13 [Amended] 2. The FAA amends § 39.13 by adding the following new airworthiness directive (AD): ■ Title 49 of the United States Code specifies the FAA’s authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. Subtitle VII: Aviation Programs, describes in more detail the scope of the Agency’s authority. The FAA is issuing this rulemaking under the authority described in Subtitle VII, Part A, Subpart III, Section 44701: General requirements. Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on helicopters identified in this rulemaking action. VerDate Sep<11>2014 PART 39—AIRWORTHINESS DIRECTIVES 2020–16–10 Bell Textron Inc. (Type Certificate Previously Held by Bell Helicopter Textron Inc.): Amendment 39–21194; Docket No. FAA–2018–0598; Product Identifier 2018–SW–030–AD. (a) Applicability This AD applies to Bell Textron Inc. (Bell) Model 204B, 205A, 205A–1, 205B, 212, 214B, 214B–1, 412, 412CF, and 412EP helicopters, certificated in any category, with a shoulder harness seat belt comfort clip (comfort clip) part numbers (P/Ns) D7LZ–6560286–A, D7LZ–6560286–B, or 504636–401, installed. (b) Unsafe Condition This AD defines the unsafe condition as a comfort clip interfering with the seat belt inertia reel. The FAA is issuing this AD to prevent the seat belt from locking. This condition could result in injury to the occupant during an emergency landing. (c) Effective Date This AD becomes effective September 3, 2020. (d) Compliance You are responsible for performing each action required by this AD within the specified compliance time unless it has already been accomplished prior to that time. (e) Required Actions (1) Within 50 hours time-in-service: (i) Remove from service each comfort clip P/Ns D7LZ–6560286–A, D7LZ–6560286–B, or 504636–401 from the shoulder harness seat belt (harness). (ii) Inspect each harness for a rip and an abrasion. If there is a rip or any abrasion, before further flight, remove from service the harness. (2) After the effective date of this AD, do not install comfort clip P/Ns D7LZ–6560286– A, D7LZ–6560286–B, or 504636–401 on any helicopter. (f) Alternative Methods of Compliance (AMOCs) (1) The Manager, DSCO Branch, FAA, may approve AMOCs for this AD. Send your proposal to: Kuethe Harmon, Safety Management Program Manager, DSCO Branch, FAA, 10101 Hillwood Pkwy., Fort Worth, TX 76177; telephone 817–222–5198; fax: 817–222–4960; email: kuethe.harmon@ faa.gov. (2) For operations conducted under a 14 CFR part 119 operating certificate or under 14 CFR part 91, subpart K, the FAA suggests that you notify your principal inspector, or lacking a principal inspector, the manager of the local flight standards district office or PO 00000 Frm 00020 Fmt 4700 Sfmt 4700 (h) Subject Joint Aircraft Service Component (JASC) Code: 2500, Cabin Equipment/Furnishings. Issued on July 24, 2020. Gaetano A. Sciortino, Deputy Director for Strategic Initiatives, Compliance & Airworthiness Division, Aircraft Certification Service. [FR Doc. 2020–16490 Filed 7–29–20; 8:45 am] BILLING CODE 4910–13–P DEPARTMENT OF LABOR Occupational Safety and Health Administration 29 CFR Part 1913 [Docket No. OSHA–2020–0005] RIN 1218–AC95 Rules of Agency Practice and Procedure Concerning Occupational Safety and Health Administration Access to Employee Medical Records Occupational Safety and Health Administration (OSHA); Labor. ACTION: Final rule. AGENCY: OSHA is issuing a final rule to amend the regulation addressing the rules of agency practice and procedure concerning OSHA access to employee medical records. The final rule transfers the approval of written medical access orders (MAO) from the Assistant Secretary for Occupational Safety and Health (Assistant Secretary) to the OSHA Medical Records Officer (MRO) and makes the MRO responsible for making determinations regarding inter- SUMMARY: E:\FR\FM\30JYR1.SGM 30JYR1 Federal Register / Vol. 85, No. 147 / Thursday, July 30, 2020 / Rules and Regulations agency transfer and public disclosure of personally identifiable medical information in OSHA’s possession. DATES: This final rule is effective on July 30, 2020. ADDRESSES: In accordance with 29 U.S.C. 2112(a)(2), OSHA designates, Mr. Edmund C. Baird, Associate Solicitor of Labor for Occupational Safety and Health, Office of the Solicitor, Room S– 4004, U.S. Department of Labor, 200 Constitution Avenue NW, Washington, DC 20210, to receive petitions for review of the final rule. FOR FURTHER INFORMATION CONTACT: Press inquiries: Mr. Frank Meilinger, OSHA, Office of Communications; telephone: (202) 693–1999; email: Meilinger.francis2@dol.gov. General and technical information: Dr. Michael Hodgson, Director, OSHA Office of Occupational Medicine and Nursing; telephone: (202) 693–1768; email: hodgson.michael@dol.gov. SUPPLEMENTARY INFORMATION: The final rule also amends § 1913.10 to clarify that a written MAO does not constitute an administrative subpoena, eliminates outdated requirements for the removal of direct personal identifiers when OSHA personnel review medical information away from a worksite, and establishes new procedures for the access and safeguarding of personally identifiable employee medical information in electronic form. The revisions to § 1913.10 in the final rule will increase employee privacy and enhance OSHA’s ability to safeguard personally identifiable medical information. Table of Contents I. Background II. Legal Authority III. Summary and Explanation of the Final Rule IV. State Plans V. Regulatory Flexibility Certification VI. Environmental Impact Analysis VII. Federalism VIII. Unfunded Mandates IX. Consultation and Coordination With Indian Tribal Governments X. Office of Management and Budget Review Under the Paperwork Reduction Act of 1995 khammond on DSKJM1Z7X2PROD with RULES I. Background A. Introduction In order to carry out its statutory obligations, OSHA often reviews employee medical records. For example, OSHA may need to review employee medical records during a compliance inspection to determine whether an employer is in compliance with OSHA standards and regulations, or to verify that an employer has taken steps to VerDate Sep<11>2014 16:01 Jul 29, 2020 Jkt 250001 correct existing violations. Access to employee medical records may also be necessary during inspections to determine the effectiveness of voluntary employer safety and health programs. OSHA also reviews medical records when gathering information during agency rulemaking to develop or revise occupational safety and health standards. Several OSHA standards and regulations mandate medical records access, including 29 CFR 1910.1020, Access to Employee Exposure and Medical Records, which sets forth procedures by which exposure and medical records can be accessed by employees, their designated representatives, and OSHA. This regulation, which applies to employers with employees exposed to toxic substances and harmful physical agents, provides OSHA representatives with prompt access to employee exposure and medical records and to analysis thereof using exposure or medical records. See 29 CFR 1910.1020(e)(3). In addition, several of OSHA’s substancespecific standards include provisions for OSHA access to employee medical records. (e.g., 29 CFR 1910.25(n)(4) (Lead), and 29 CFR 1910.1028(k) (Benzene)). In many instances, OSHA must examine and copy employee medical information in personally identifiable form. Personally identifiable employee medical information as defined by 29 CFR 1913.10(b)(2) means employee medical information accompanied by either direct identifiers (name, address, social security number, payroll number) or by information which could reasonably be used in particular circumstances indirectly to identify specific employees (e.g., date of birth, race, sex, date of initial employment, job title). An employee medical record may include individual health histories as well as medical opinions and evaluations generated during diagnosis, physical examinations, or medical treatment by a health care professional. Because of the substantial personal privacy interests involved, OSHA authority to access personally identifiable employee medical information is exercised only after the agency has made a careful determination of the need for the information, and only when appropriate safeguards are in place to prevent unauthorized access. Once this information is accessed, OSHA examination and use is limited to only that information needed to accomplish a relevant statutory purpose. Also, personally identifiable employee medical information is retained by PO 00000 Frm 00021 Fmt 4700 Sfmt 4700 45781 OSHA only for so long as needed to accomplish the purpose for access, is kept secured while being used, and is not disclosed to other agencies or members of the public except in narrowly defined circumstances. In addition, the examination and use of personally identifiable employee medical information is limited to only OSHA personnel with a need to review such information. This rule is not an Executive Order (E.O.) 13771 regulatory action because this rule is not significant under E.O. 12866. Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.), the Office of Information and Regulatory Affairs designated this rule not a ‘major rule’, as defined by 5 U.S.C. 804(2). B. OSHA’s Regulation at 29 CFR 1913.10 On May 25, 1980, OSHA issued a final rule entitled Rules of Agency Practice and Procedure Concerning OSHA Access to Employee Medical Records (45 FR 35284). The final rule was developed and published in concert with the promulgation of 29 CFR 1910.1020, Access to Employee Exposure and Medical Records (45 FR 35212). During the rulemaking, there was universal agreement that if OSHA obtained access to employee medical records, the access should be accompanied by stringent internal agency procedures to preclude abuse of personally identifiable medical information. Provided these procedures were established, many participants in the rulemaking endorsed OSHA access to employee medical records without the consent of the employee for occupational safety and health purposes (see 45 FR 35218). Except as provided in 29 CFR 1913.10(b)(3) through (6), the rules of agency practice and procedure apply to all requests by OSHA personnel to obtain access to records to examine and copy personally identifiable employee medical information, whether or not access is mandated by 29 CFR 1910.1020. Among other things, the regulation at 29 CFR 1913.10 establishes certain responsibilities for specific OSHA officials when the agency accesses personally identifiable employee medical information. The regulation also includes provisions addressing the internal use of employee medical records by agency personnel, as well as requirements for inter-agency transfer and public disclosure of such records. The regulation includes security procedures for the use and storage of employee medical records while in the agency’s possession. Finally, the regulation sets forth internal E:\FR\FM\30JYR1.SGM 30JYR1 khammond on DSKJM1Z7X2PROD with RULES 45782 Federal Register / Vol. 85, No. 147 / Thursday, July 30, 2020 / Rules and Regulations agency requirements for the retention and destruction of records. A key provision set forth in § 1913.10 is that, with few exceptions, each request by an OSHA representative to examine or copy personally identifiable employee medical information must be made pursuant to a written access order. The written access order is an authorization for specific OSHA personnel to examine or copy personally identifiable employee medical information contained in records held by an employer or other record holder. The rules of agency practice and procedure in § 1913.10 make clear that each written access order must state the statutory purpose for which access is sought, a general description of the type of employee medical information that will be examined and why there is a need to examine personally identifiable information, whether the medical information will be examined on-site, what type of information will be copied and removed off-site, and the anticipated time during which OSHA expects to retain the employee medical information in personally identifiable form. In order to enhance employee privacy, and clarify certain provisions, OSHA has determined that it is necessary to revise its regulation at § 1913.10. For example, OSHA’s previous regulation at § 1913.10 used the term ‘‘written access order.’’ However, this final rule revises the regulatory text to include the more commonly used term ‘‘medical access order’’ or ‘‘MAO.’’ The final rule also amends the regulation at 29 CFR 1913.10 to transfer certain responsibilities from the Assistant Secretary to the OSHA Medical Records Officer (MRO). Specifically, the MRO will now be responsible for the overall administration and implementation of the procedures contained in § 1913.10. These new responsibilities include making determinations regarding (1) OSHA access to personally identifiable employee medical information pursuant to a MAO, and (2) inter-agency transfer and public disclosure of personally identifiable employee medical information. The final rule also transfers responsibility from the Assistant Secretary to the MRO for issuing written directives that authorize OSHA compliance personnel to review certain information without obtaining a MAO. The final rule clarifies that a MAO does not constitute an administrative subpoena, and eliminates requirements for the removal of direct personal identifiers when OSHA personnel review medical information away from VerDate Sep<11>2014 16:01 Jul 29, 2020 Jkt 250001 a workplace. The deletion of requirements for the removal of direct personal identifiers will be offset by new provisions designed to strengthen employee privacy. Finally, the final rule establishes new internal OSHA requirements, based on existing agency policy, for the access and safeguarding of personally identifiable employee medical information maintained in electronic form. The procedures set forth in § 1913.10 are internal agency procedures and do not affect employer compliance with OSHA requirements. Employers and employees will benefit from the revisions to § 1913.10 in several ways. First, since the process for determining whether there is a need for OSHA to review employee medical information will be more efficient, employers will know sooner if such a review is authorized at their worksite. Second, the elimination of the outdated requirement to remove direct personal identifiers before taking medical information offsite for review will reduce the amount of an employer’s time and physical space needed by OSHA personnel when they visit a specific workplace. Third, the revisions will benefit employees because the procedures in § 1913.10 to protect the security and privacy of employee medical records will be strengthened, especially with regard to medical information in electronic form. Fourth, the elimination of the requirement to remove direct personal identifiers before taking medical information off-site will enhance employee privacy because the removal process always carries with it the possibility that medical information will be misidentified or mislabeled, which could result in unauthorized staff mistakenly reviewing that information. Finally, deletion of the time-consuming de-identification procedures will mean that authorized OSHA personnel can conduct follow-up consultations with employees about their health more quickly. The notice and comment rulemaking procedures of 5 U.S.C. 553 of the Administrative Procedure Act (APA) do not apply to ‘‘interpretive rules, general statements of policy, or rules of agency organization, procedure, or practice.’’ 5 U.S.C. 553(b)(A). The provisions in 29 CFR 1913.10 are rules of agency procedure and practice within the meaning of section 553(b)(A) of the APA. Therefore, publication in the Federal Register of a notice of proposed rulemaking and request for comments is not required. Furthermore, because this rule is procedural rather than substantive, the normal requirement of 5 U.S.C. 553(d) that a rule not be PO 00000 Frm 00022 Fmt 4700 Sfmt 4700 effective until at least 30 days after publication in the Federal Register is inapplicable. OSHA also finds good cause to provide an immediate effective date for this rule, because it imposes no obligations on parties outside the federal government and therefore no advance notice is required to enable employers or other private parties to come into compliance. II. Legal Authority The Occupational Safety and Health Act of 1970, 29 U.S.C. 651 et seq. (OSH Act) authorizes the Secretary to issue two types of occupational safety and health rules: Standards and regulations. Standards, which are authorized by section 6 of the Act, specify remedial measures to be taken to prevent and control employee exposure to identified occupational safety and health hazards, while regulations are the means to effectuate other statutory purposes, including the maintaining of records. For example, the OSHA requirements at 29 CFR 1910.95 are a ‘‘standard’’ because they include remedial measures to address the specific and already identified hazard of employee exposure to occupational noise. In contrast, a ‘‘regulation’’ is a purely administrative effort designed to uncover violations of the Act and discover unknown dangers. The procedural regulations in 29 CFR 1913.10 are necessary to enable the use of employee medical records by OSHA consistent with the employee’s right of privacy. In section 2(b) of the OSH Act, Congress declared the overriding purpose of the Act is ‘‘to assure so far as possible every working man and woman in the Nation safe and healthful working conditions.’’ (29 U.S.C. 651.) Congress also explicitly declared that this must be accomplished, among other ways, ‘‘by providing an effective enforcement program . . .’’ (29 U.S.C. 651(b)(10)). For the Secretary of Labor to conduct an effective enforcement program, he or she must determine whether occupational safety and health hazards exist in the workplace. To that end, the OSH Act authorizes the Secretary to enter and inspect workplaces and to conduct reasonable investigations into working conditions. Section 8(a) of the OSH Act authorizes OSHA to enter, inspect, and investigate places of employment, and section 8(b) permits OSHA to subpoena both witnesses and evidence when conducting inspections and investigations. (29 U.S.C. 657(a) and (b)). As noted above, in some instances, it may be necessary for OSHA to examine personally identifiable employee medical information. Section E:\FR\FM\30JYR1.SGM 30JYR1 Federal Register / Vol. 85, No. 147 / Thursday, July 30, 2020 / Rules and Regulations 8 of the OSH Act recognizes OSHA’s right of access to medical records, and records access is mandated by OSHA standards and regulations, including 29 CFR 1910.1020(e)(3) (access to employee exposure and medical records). OSHA relies on administrative subpoenas to compel production of medical records by employers and other record holders. OSHA is issuing the final rule pursuant to authority expressly granted in section 8 of the OSH Act. Section 8(c)(1) requires each employer to ‘‘make, keep, preserve, and make available to the Secretary [of Labor] or the Secretary of Health and Human Services, such records regarding his activities relating to this Act as the Secretary, in cooperation with the Secretary of Health and Human Services, may prescribe by regulation as necessary or appropriate for the enforcement of this Act or for developing information regarding the causes and prevention of occupational accidents and illnesses’’ (29 U.S.C. 657(c)(1)). Employee medical records are included within the type of records addressed by this provision. Section 8(g)(1) of the OSH Act provides that the Secretary and Secretary of Health and Human Services are authorized to compile, analyze, and publish, either in summary or detailed from, all records or information obtained under this section (29 U.S.C. 657(g)(1)). Section 8(g)(2) is the general rulemaking authority of the OSH Act and provides that the Secretary and the Secretary of Health and Human Services shall prescribe such rules and regulations as he may deem necessary to carry out their responsibilities under this Act, including rules and regulations dealing with the inspection of an employer’s establishment. khammond on DSKJM1Z7X2PROD with RULES III. Summary and Explanation of the Final Rule Section 1913.10(b)—Scope and Application OSHA’s regulation at 29 CFR 1913.10(b), Scope and application, defines the circumstances under which the procedural regulations in § 1913.10 will apply. Except as provided in paragraphs (b)(3) through (6), the policies and procedures in § 1913.10 apply to all requests by OSHA personnel to access personally identifiable employee medical information. In general, 29 CFR 1913.10 requires OSHA personnel to obtain a MAO (previously ‘‘written access order,’’ but referred to in this section as ‘‘MAO’’ as it is in the final rule) when accessing personally identifiable employee VerDate Sep<11>2014 16:01 Jul 29, 2020 Jkt 250001 medical information. However, under certain circumstances, the regulation states that OSHA access may be accomplished without obtaining a MAO. For example, § 1913.10(d)(4)(i) provides that a MAO is not needed when an employee gives specific written consent for OSHA to access their medical records. Also, § 1913.10(b)(3) through (5) include several categories of records that are not subject to § 1913.10 and therefore may be accessed without obtaining a MAO. These categories of records include medical information that is not in personally identifiable form, injury and illness records required by 29 CFR part 1904, death certificates, employee exposure records, and medical information obtained in the course of litigation. In addition, previous § 1913.10(b)(6) provided that the policies and procedures in § 1913.10 do not apply when a written directive by the Assistant Secretary authorizes appropriately qualified personnel to conduct limited review of specific medical information mandated by an OSHA standard or of specific biological monitoring test results. This final rule amends § 1913.10(b)(6) to state that the MRO is now responsible for issuing these written authorization directives. OSHA Directive CPL 02–02–072, Rules of agency practice and procedure concerning OSHA access to employee medical records, August 22, 2007, includes authorization for review of three categories of information based on the provisions in § 1913.10(b)(6). The directive authorizes OSHA compliance personnel to review (1) medical opinions mandated by OSHA standards, (2) information required by a medical surveillance program, and (3) certain information used to verify compliance with the injury and illness recordkeeping requirements in 29 CFR part 1904. OSHA personnel do not need a MAO when they access the information at a workplace pursuant to a written directive under § 1913.10(b)(6). Instead, OSHA personnel follow the procedures set forth in the written directive. The 2007 directive includes provisions on how OSHA personnel may access the specific types of information and how the information should be protected once in the agency’s possession. OSHA believes the MRO is in the best position to make determinations regarding written authorization under § 1913.10(b)(6). Section 1913.10(c)(2) already provides that the MRO must have experience or training in the evaluation, use, and privacy protection of medical records, and, as discussed below in this preamble, paragraph (c) of PO 00000 Frm 00023 Fmt 4700 Sfmt 4700 45783 § 1913.10 has been amended to provide that the MRO is now responsible for the overall administration of the policies and procedures in § 1913.10. Also, as part of the final rule, paragraph (c) now states that the MRO is specifically responsible for making determinations regarding the approval of MAOs, interagency transfer, and public disclosure of identifiable employee medical records. Given all the new MRO responsibilities set forth in paragraph (c), as well as the existing duties in the other paragraphs of the regulation, it is appropriate to also make the MRO responsible for written authorization under paragraph (b)(6). Accordingly, final § 1913.10(b)(6) states that the provisions of 29 CFR 1913.10 do not apply where a written directive by the MRO authorizes appropriately qualified personnel to conduct limited review of specific medical information mandated by an occupational safety and health standard or of specific biological monitoring test results. OSHA will also amend Directive CPL 02–02–072 to reflect the new regulatory text in paragraph (b)(6). Section 1913.10(c)—Responsible Persons OSHA’s regulation at 29 CFR 1913.10(c) establishes certain responsibilities for OSHA personnel when the agency accesses personally identifiable employee medical information. Paragraph (c) is largely a summary of duties established by other paragraphs in § 1913.10 and sets forth specific responsibilities for the Assistant Secretary, MRO, and Principal OSHA Investigator. The final rule amends several provisions in paragraph (c) to emphasize the responsibilities of the MRO. Under the previous regulation, paragraph (c)(1) provided that the OSHA Assistant Secretary was responsible for the overall administration and implementation of the policies and procedures in § 1913.10. This responsibility included making determinations regarding (1) OSHA access to personally identifiable employee medical information and (2) interagency transfer or public disclosure of personally identifiable employee medical information. Also under the previous regulation, § 1913.10(d)(1) provided that each request by an OSHA representative to access information through a written access order must be approved by the Assistant Secretary upon the recommendation of the MRO. Section 1913.10(c)(2) of the previous regulation provided that the Assistant Secretary was responsible for designating an OSHA official with experience or training in the evaluation, E:\FR\FM\30JYR1.SGM 30JYR1 khammond on DSKJM1Z7X2PROD with RULES 45784 Federal Register / Vol. 85, No. 147 / Thursday, July 30, 2020 / Rules and Regulations use, and privacy protection of medical records to be the MRO. The MRO, who reported directly to the Assistant Secretary on matters related to § 1913.10, was responsible for making recommendations to the Assistant Secretary on whether to approve or deny written access orders, and served as the central reviewer of the sufficiency and justification of these documents. The MRO was also responsible for responding to employee, collective bargaining agent, and employer objections to written access orders. In addition, § 1913.10(c)(2) of the previous regulation stated that the MRO was responsible for controlling the use of direct personal identifiers; controlling internal agency use and security of personally identifiable employee medical information; assuring that the results of agency analysis of personally identifiable employee medical information are, where appropriate, communicated to employees; preparing an annual report for the Assistant Secretary on OSHA’s experience with respect to § 1913.10; and assuring that adequate notice is given of intended inter-agency transfers or public disclosures of personally identifiable employee medical information. The other OSHA official with important responsibilities when the agency accesses employee medical information is the Principal OSHA Investigator. Section 1913.10(c)(3) provides that the Principal OSHA Investigator is the OSHA employee designated on the MAO who is primarily responsible for ensuring that OSHA examination and use of employee medical information is in accordance with the provisions of the MAO and § 1913.10. In most instances, the Principal OSHA Investigator named on a MAO is an employee from an OSHA Regional or Area Office and determines how and when employee medical information will be accessed during an OSHA inspection or investigation. In practice, the Principal OSHA Investigator is responsible for ensuring that the provisions of the MAO and § 1913.10 are followed by OSHA personnel when medical information is accessed at a specific workplace. As provided in § 1913.10(c)(3), the Principal OSHA Investigator must be professionally trained in medicine, public health, or similar fields (epidemiology, toxicology, industrial hygiene, biostatistics, environmental health) when access is made pursuant to a MAO. The provisions in § 1913.10(c)(3) concerning the Principal OSHA Investigator are unchanged by the final rule. VerDate Sep<11>2014 16:01 Jul 29, 2020 Jkt 250001 The final rule retains the Assistant Secretary’s responsibility to designate an OSHA official as MRO. However, this responsibility is now set forth in § 1913.10(c)(1). Like the previous regulation, § 1913.10(c)(1) of the final rule states that the Assistant Secretary shall designate an OSHA official with experience or training in the evaluation, use, and privacy protection of medical records to be the OSHA Medical Records Officer. The final rule also states that the Assistant Secretary may change the designation of the MRO at will. The final rule includes several changes to paragraph (c)(2), OSHA Medical Records Officer. Some of these changes transfer specific responsibilities from the Assistant Secretary to the MRO while other responsibilities assigned to the MRO in § 1913.10(c)(2) are carried over from the previous regulation. The final rule amends paragraph (c)(2) to provide that the MRO is now responsible for the overall administration and implementation of the procedures contained in § 1913.10. OSHA believes there are two central principles that form the basis of the procedural requirements in § 1913.10: (1) There should be a thorough review of all efforts to examine or copy personally identifiable employee medical information before the information is obtained and (2) personally identifiable information must be carefully protected once obtained. OSHA also believes the MRO is in the best position to ensure that the central principles of § 1913.10 are carried out by the agency. As already noted, paragraph (c)(1) of the final rule, like the previous regulation, provides that the MRO must have experience and training in the evaluation, use, and privacy protection of medical records. Historically, a physician from OSHA’s Office of Occupational Medicine and Nursing (OOMN) has been designated as MRO, and, in most cases, the person designated has been the Director of OOMN. As a result, the MRO has had an extensive background in both medicine and administration. Additionally, under the previous regulation, the MRO was already responsible for ensuring the sufficiency and justification of MAOs and making recommendations to the Assistant Secretary on whether to approve or deny such documents. The MRO also has several duties set forth throughout the other paragraphs in § 1913.10 and therefore has a good understanding of the day-to-day implementation of the regulation. PO 00000 Frm 00024 Fmt 4700 Sfmt 4700 Under the final rule, the MRO will now be responsible for making determinations regarding whether to approve or deny MAOs, any interagency transfer, and public disclosures of personally identifiable employee medical information, as well as whether to issue written directives authorizing OSHA personnel to conduct limited review of certain medical information without an MAO. Accordingly, the extensive medical and administrative experience, the responsibilities under the previous regulation, and the new responsibilities assigned by this final rule make the MRO the logical OSHA official to have responsibility for the overall administration and implementation of the procedures in § 1913.10. While the final rule limits the role of the Assistant Secretary in the day-to-day implementation of § 1913.10, the Assistant Secretary still maintains an important oversight responsibility. As in the previous regulation, the Assistant Secretary retains the responsibility for naming an OSHA official as MRO, with the ability to replace the MRO at will, and the MRO must still report to the Assistant Secretary on matters related to § 1913.10. In practice, the MRO will continue to consult with the Assistant Secretary on MAO approval, interagency transfers, and public disclosures of personally identifiable employee medical information. In addition, paragraph (l) requires the MRO to prepare an annual report for the Assistant Secretary on matters related to the approval and purpose of MAOs, objections to MAOs, and inter-agency transfers and public disclosures during the previous year. The responsibility to designate an OSHA official as MRO, continued consultation, and receiving reports from the MRO will keep the Assistant Secretary informed about OSHA’s overall implementation of § 1913.10. Accordingly, like the previous regulation, the final rule at paragraph (c)(2) provides that the MRO is responsible for reporting directly to the Assistant Secretary on matters concerning § 1913.10. Under the final rule, the MRO is also now responsible for making determinations concerning (1) access to personally identifiable employee medical information and (2) interagency transfer or public disclosure of personally identifiable employee medical information. These two responsibilities had been assigned to the Assistant Secretary in previous § 1913.10(c)(1). Section 1913.10(c)(2)(i) of the final rule states that the MRO is responsible for making determinations concerning E:\FR\FM\30JYR1.SGM 30JYR1 khammond on DSKJM1Z7X2PROD with RULES Federal Register / Vol. 85, No. 147 / Thursday, July 30, 2020 / Rules and Regulations OSHA access to personally identifiable employee medical information under § 1913.10(d). Paragraph (d) addresses OSHA access to personally identifiable employee medical information by MAO. With the exception of two circumstances described at the end of paragraph (d), each request by OSHA to examine or copy personally identifiable employee medical information is made pursuant to an MAO. Paragraph (d)(2) sets criteria the agency must follow when it seeks access to identifiable medical information, and paragraph (d)(3) sets forth the content to be included in the MAO. In order to be valid, an MAO must be approved by the MRO using the criteria in paragraph (d)(2). First, the MRO must consider whether the information to be examined or copied is relevant to a statutory purpose and whether there is a need to gain access to the information. The MRO has the responsibility, on a caseby-case basis, to ensure that access is sought only where there is a genuine need to do so. OSHA believes that a finding of relevance and need by the MRO is a significant safeguard against excessive use of the agency’s authority to access personally identifiable employee medical information. Paragraph (d)(2) next states that consideration must be given to whether the personally identifiable employee medical information subject to the MAO is limited to only that information needed to accomplish the purpose for access. This provision is aimed at preventing OSHA access to extraneous medical information unrelated to the purpose for access. Lastly, paragraph (d)(2) states that the MRO must determine that the personnel authorized to review the medical information are limited to those who have a need for access and have appropriate professional qualifications. The limiting of personnel that can review and analyze information to only those who have a need for access and who have appropriate professional qualifications is important for maintaining the confidentiality of employee medical records. OSHA believes the MRO is in the best position to evaluate the criteria in paragraph (d) and make determinations on whether to approve or deny MAOs. Typically, the MRO has extensive subject-matter clinical experience and expertise in occupational medicine. This allows the MRO to evaluate whether, and to what extent, employee medical information needs to be accessed by OSHA. Accordingly, paragraph (d)(2) has been amended to state that, before approving an MAO, the MRO must determine that the VerDate Sep<11>2014 16:01 Jul 29, 2020 Jkt 250001 documents meet the criteria in that paragraph. For similar reasons, the MRO is also now responsible for making determinations concerning inter-agency transfer and public disclosure of personally identifiable employee medical information. Section 1913.10(m) describes the circumstances under which personally identifiable employee medical information can be transferred to another agency or disclosed to the public. The requirements in paragraph (m) remain unchanged from the previous regulation. However, the provisions in paragraph (m), as well as paragraph (c)(2), are amended by the final rule to provide that the MRO, not the Assistant Secretary, is now responsible for making determinations regarding inter-agency transfer and public disclosure of personally identifiable employee medical information. The individual provisions in paragraph (m) are amended to cross reference with the new MRO responsibility established in § 1913.10(c)(2)(vii). The following discussion of the individual provisions in paragraph (m) clarifies the MRO’s new responsibility for making determinations concerning inter-agency transfer and public disclosure set forth in § 1913.10(c)(2). The previous regulation at § 1913.10(m)(1) stated that personally identifiable employee medical information shall not be transferred to another agency or office outside of OSHA (other than the Office of the Solicitor of Labor) or disclosed to the public (other than to the affected employee or the original recordholder) except when required by law or when approved by the Assistant Secretary. The final rule amends paragraph (c)(2)(vii) to make clear that the MRO is now responsible for making these determinations. The final rule also amends paragraph (m) to provide that the MRO must follow specific criteria when making determinations concerning inter-agency transfer and public disclosure of personally identifiable employee medical information. OSHA’s longstanding position is that inter-agency transfer and public disclosure of personally identifiable employee medical information should be carefully considered, and paragraph (m) addresses these issues. Inter-agency transfer and public disclosure of personally identifiable employee medical information are not categorically prohibited by the regulation for two reasons. OSHA believes (1) it cannot legally make such a commitment and (2) situations arise PO 00000 Frm 00025 Fmt 4700 Sfmt 4700 45785 where transfer or disclosure is appropriate. Under certain circumstances, as a matter of law, OSHA is compelled to transfer information to another agency or disclose it to a nongovernmental individual. For example, OSHA might be required to provide the information in response to a lawful subpoena. In other circumstances, disclosure may also be appropriate. For example, in order to resolve a public health problem, OSHA may need to transfer employee medical information to another federal or state agency. In such situations, the transfer of employee medical information may be critical in identifying an emerging health issue, compiling data on worker fatalities from specific exposure, or evaluating the effectiveness of workplace controls designed to prevent occupational illness at manufacturing facilities. OSHA notes that inter-agency transfer and public disclosure of personally identifiable employee medical information is not a common occurrence. In the last five years, the agency has made only three inter-agency transfers of personally identifiable employee medical information to another federal or state agency. OSHA also notes that inter-agency transfer and public disclosure of employee medical information not in personally identifiable form is not subject to provisions in § 1913.10. Paragraph (m) of § 1913.10 includes strict limitations on inter-agency sharing and public disclosure of employee medical information. Except when required by law, all inter-agency transfer or public disclosure of personally identifiable employee medical information must be approved by the MRO in accordance with the criteria in paragraph (m). Paragraph (m)(2) states that, except as provided for in paragraph (m)(3), the MRO shall not approve a request for an inter-agency transfer, which has not been consented to by the affected employee, unless the request is by a public health agency. Under this provision, transfer of medical information is permitted only to a public health agency for a substantial public health purpose. The regulation goes on to state that the MRO can approve the transfer only if the public health agency (1) needs the information for substantial public health purposes, (2) will not use the information to make individual determinations concerning affected employees which could be to their detriment, (3) has regulations or written established procedures providing protection for personally identifiable medical information substantially equivalent to § 1913.10, E:\FR\FM\30JYR1.SGM 30JYR1 khammond on DSKJM1Z7X2PROD with RULES 45786 Federal Register / Vol. 85, No. 147 / Thursday, July 30, 2020 / Rules and Regulations and (4) satisfies an exemption to the Privacy Act to the extent the Privacy Act applies to the requested information. Because OSHA collects medical information only for a public health purpose, OSHA believes it is appropriate to restrict all subsequent discretionary transfers to those agencies with an equivalent public health purpose. The MRO must review each request for a transfer on a case-by-case basis by taking into account each of the listed criteria in paragraph (m)(2). Most importantly, in order to protect individual privacy, the MRO must be satisfied that the recipient agency’s privacy protections are equivalent to OSHA’s. Paragraph (m)(3) contains two exceptions to the requirements of paragraph (m)(2). First, upon the approval of the MRO, personally identifiable employee medical information can be shared with the National Institute for Occupational Safety and Health (NIOSH). Like OSHA, NIOSH is a public health agency and its research activities complement OSHA’s regulatory responsibilities. OSHA’s ability to analyze employee medical records is often improved by gaining NIOSH assistance, and medical information collected by OSHA may have major research value for NIOSH. Also, because of its frequent use of medical information, and sensitivity to individual privacy, NIOSH has procedures in place that provide for the protection of personally identifiable medical information that are substantially equivalent to § 1913.10. As a result, employee medical information may be transferred to NIOSH if approved by the MRO without further inquiry into the sufficiency of its programs for protecting medical records. Paragraph (m)(3) also permits, upon the approval of the MRO, the interagency transfer of personally identifiable employee medical information to the U.S. Department of Justice when necessary with respect to a specific action under the OSH Act. For example, the Justice Department prosecutes criminal violations under the OSH Act, as well as civil penalty collection actions. The Justice Department also represents OSHA in Freedom of Information Act (FOIA) lawsuits. Personally identifiable employee medical information may be relevant in these legal actions, and OSHA must be able to share information in these circumstances. Paragraphs (m)(4) and (5) address public disclosure of personally identifiable employee medical information which has not been consented to by the affected employee. VerDate Sep<11>2014 16:01 Jul 29, 2020 Jkt 250001 Paragraph (m)(4) provides that the MRO shall not approve a request for public disclosure of employee medical information containing personal identifiers unless there are compelling circumstances affecting the health or safety of an individual. Also, paragraph (m)(5) states that the MRO shall not approve a request for public disclosure of employee medical information which contains information which could reasonably be used indirectly to identify specific employees when the disclosure would constitute a clearly unwarranted invasion of personal privacy. Finally, paragraph (m)(6) retains the provision from the previous regulation that, except as to inter-agency transfer to NIOSH or the Department of Justice, the MRO shall ensure that advance notice is provided to any collective bargaining agent representing affected employees and to the employer on each occasion OSHA intends to transfer personally identifiable employee medical information to another agency or disclose it to a member of the public other than to an affected employee. When feasible, the MRO must take reasonable steps to assure that advance notice is provided to affected employees when the employees’ medical information to be transferred or disclosed contains direct personal identifiers. Finally, the final rule at § 1913.10(c)(2) retains several provisions from the previous regulation. Specifically, paragraph (c)(2)(iii) continues to provide that the MRO is responsible for responding to MAO objections, and paragraph (c)(2)(iv) continues to provide that the MRO is responsible for overseeing the internal use and security of personally identifiable employee medical information. Two other MRO responsibilities in paragraph (c)(2) have been retained from the previous regulation but have been renumbered under the final rule. Paragraph (c)(2)(v), formerly paragraph (c)(2)(vi), continues to provide that the MRO is responsible for assuring that the results of agency analyses of personally identifiable medical information are, where appropriate, communicated to employees. Paragraph (c)(2)(vi), formerly paragraph (c)(2)(vii), retains the provision that the MRO is responsible for preparing an annual report of OSHA’s experience under § 1913.10. Section 1913.10(d)(1)—Requirements for Medical Access Orders OSHA’s previous regulation at § 1913.10(d)(1) stated that, except as provided in paragraph (d)(4), each PO 00000 Frm 00026 Fmt 4700 Sfmt 4700 request by an OSHA representative to examine or copy personally identifiable employee medical information contained in a record held by an employer or other record holder shall be made pursuant to a written access order which has been approved by the Assistant Secretary upon the recommendation of the OSHA Medical Records Officer. Paragraph (d)(1) went on to state that, if deemed appropriate, a written access order may constitute, or be accompanied by, an administrative subpoena. As explained above, the MRO is now responsible for the approval or denial of MAOs, and paragraph (d)(1) has been revised to reflect this change. The final rule also amends paragraph (d)(1) to make clear that a MAO does not constitute an administrative subpoena. An administrative subpoena is a written order issued by OSHA to require an employer, or any other person, to produce listed records, documents, testimony and/or other supporting evidence relevant to an inspection or investigation under the OSH Act. If the person served with a subpoena refuses to honor (or only partially honors) the order, the subpoena is subject to judicial review and enforcement by a U.S. District Court. OSHA Regional Administrators have authority to issue administrative subpoenas and are also authorized to delegate to Area Directors the authority to issue routine administrative subpoenas. OSHA’s policies and procedures for issuing an administrative subpoena are set forth in OSHA Instruction ADM 01–00–002, August 19, 1991. In contrast, a MAO is an authorization for specified OSHA personnel to examine or copy personally identifiable employee medical information contained in a record held by an employer or some other record holder. Since an MAO relates to internal OSHA procedures, it cannot be used to compel the production of records, nor be enforced in a U.S. District Court. Historically, OSHA has not treated an MAO as equivalent to an administrative subpoena. OSHA’s longstanding practice has been to rely on an administrative subpoena to compel production of medical records by employers. See OSHA’s August 22, 2007, Instruction CPL 02–02–072, Rules of agency practice and procedure concerning OSHA access to employee medical records. MAOs set forth internal OSHA procedure for assuring appropriate confidentiality of medical records is observed by OSHA personnel. As a result, except when reasonably certain that the employer will grant access to employee medical E:\FR\FM\30JYR1.SGM 30JYR1 Federal Register / Vol. 85, No. 147 / Thursday, July 30, 2020 / Rules and Regulations khammond on DSKJM1Z7X2PROD with RULES information, OSHA personnel present an administrative subpoena to the employer concurrently with an MAO. The final rule amends § 1913.10(d)(1) to state that except as provided in paragraph (d)(4), each request by an OSHA representative to examine or copy personally identifiable employee medical information contained in a record held by an employer or other recordholder shall be made pursuant to a written medical access order which has been approved by the OSHA Medical Records Officer. A medical access order does not constitute an administrative subpoena. Section 1913.10(g)—Removal of Direct Personal Identifiers OSHA’s previous regulation at § 1913.10(g) provided that all direct personal identifiers (e.g., name, address, Social Security Number, payroll number) must be removed by OSHA personnel whenever employee medical information obtained pursuant to a written access order is taken off-site, unless otherwise directed by the MRO. The regulation also required the Principal OSHA Investigator to code the medical information and the list of direct personal identifiers with a unique identifying number for each employee and then hand deliver or mail the list of identifiers to the MRO. The MRO thereafter controlled the use and distribution of the list of coded identifiers to those with a need to know its contents. In addition, the numerical coded medical information was to be used and kept secured as though still in a directly identifiable form. Paragraph (g) was originally promulgated by OSHA when the rules of agency practice and procedure were issued in 1980. At that time, electronic medical records did not exist, and the employee records that did exist were maintained almost entirely in paper form. Since 1980, the number of medical records maintained by employers and other record holders has substantially increased, and the majority of these records are now maintained in electronic form. The final rule revises § 1913.10 by deleting the outdated procedures set forth in paragraph (g). OSHA is eliminating this internal requirement for several reasons. First, existing access and safeguarding requirements in § 1913.10 already address privacy concerns when OSHA takes medical information away from a workplace for off-site review. Specifically, paragraph (h) of § 1913.10 provides that only authorized personnel may examine or copy personally identifiable employee medical information. As explained VerDate Sep<11>2014 16:01 Jul 29, 2020 Jkt 250001 below, OSHA experience is that this process can result in coding and recoding errors in individual employee medical records. Likewise, it provides that, unless an exception applies, OSHA personnel and contractors are authorized to use information only for the purpose for which it was obtained. In addition, paragraph (h)(5) states that, whenever practicable, the examination of personally identifiable employee medical information shall be conducted on-site with a minimum of medical information taken off-site in a personally identifiable form. Additionally, paragraph (i) of § 1913.10 includes security procedures for handling personally identifiable employee medical information. For example, paragraph (i)(1) provides that files containing personally identifiable employee medical information shall be segregated from other agency files and, when not in active use, must be kept in a locked cabinet or vault. In practice, the locking requirement extends to when medical information is transported from the workplace, as OSHA personnel place records in a locked trunk during transport by automobile. Second, paragraph (n) of this final rule establishes new requirements for the access and safeguarding of personally identifiable employee medical information in electronic form. As discussed more extensively below, paragraph (n) of the final rule provides that the Principal OSHA Investigator is responsible for preventing any careless, accidental, or unintentional disclosure of, modification to, or destruction of electronic medical records. Paragraph (n)(3) of the final rule provides that the transfer and/or duplication of medical records in electronic form must be kept to the minimum necessary to accomplish the purpose for which it was obtained. Also, paragraph (n)(4) states that electronic files containing personally identifiable employee medical information shall be downloaded only to a computer hard drive or laptop that is secured (e.g., password protected). Paragraph (n)(4) now includes the Government standards that address secure access to Government systems and the data they contain: Federal Information Processing Standards (FIPS) 201–2, ‘‘Personal Identity Verification (PIV) of Federal Employees and Contractors’’; and HSPD–12, ‘‘Homeland Security Presidential Directive 12: Policy for a Common Identification Standard for Federal Employees and Contractors (HSPD–12).’’ In addition, paragraph (n)(5) provides that electronic files containing PO 00000 Frm 00027 Fmt 4700 Sfmt 4700 45787 personally identifiable employee medical information must be encrypted before transferred to authorized individuals. OSHA believes the safeguards for electronic medical records established by this final rule, which are based on existing OSHA practices and policy, enhance privacy protection and reduces the need to remove direct personal identifiers when OSHA personnel take personally identifiable employee medical information off-site. OSHA’s experience is that deidentification increases the risk of mislabeling or misidentifying employee medical records and places a burden on agency resources by requiring additional OSHA staff time to accurately conduct de-identification and copying of employee medical records. In some cases, depending on the number of employees at a specific facility, OSHA employees may spend several hours finding and removing each direct personal identifier within each affected employee’s medical record. The deletion of paragraph (g) will reduce the amount of time and physical space needed by OSHA personnel at a worksite. Finally, the deletion of deidentification procedures in paragraph (g) will simplify follow-up communication from authorized OSHA personnel with individual employees after evaluation of their medical information. For example, by not having to complete a potentially extensive deidentification process, critical medical information about an employee will be reviewed by an OSHA physician sooner, and this will allow the physician to conduct follow-up consultation with the employee in a timely manner. Also, because personally-identifiable information will remain in the medical records taken from a workplace for offsite review, it will make it easier for the OSHA physician to identify employees, compare associated records, and contact individual employees. For all of the above reasons, OSHA has concluded that the removal of direct personal identifier requirements in paragraph (g) should be deleted. Section 1913.10(n)—Medical Records Maintained in Electronic Form In many cases, employers and other record holders maintain personally identifiable employee medical information in electronic form. OSHA’s regulation at 29 CFR 1910.1020 provides that a ‘‘record’’ includes any item, collection, or grouping of information regardless of the form or process by which it is maintained (e.g., paper, document, microfilm, X-ray film, or E:\FR\FM\30JYR1.SGM 30JYR1 khammond on DSKJM1Z7X2PROD with RULES 45788 Federal Register / Vol. 85, No. 147 / Thursday, July 30, 2020 / Rules and Regulations automated data processing). Medical records may also be maintained on media such as magnetic tape, computer disks, USB storage devices (e.g., thumb drives), and online computer storage. Historically, OSHA personnel have followed the requirements in 29 CFR 1913.10 when accessing personally identifiable employee medical information maintained in electronic form. However, the regulation did not include provisions that specifically addressed electronic medical records. The final rule establishes new internal policies and procedures in paragraph (n) to § 1913.10 that specifically address OSHA access, use, and safeguarding of personally identifiable employee medical information maintained in electronic form. Since the rules of agency practice and procedure were first issued in 1980, medical professionals have increasingly relied on the use and storage of medical records in electronic form. These records tend to improve the quality of health care and have several practical advantages over paper records. For example, electronic medical records can be accessed by health care professionals at any time from any given location. Legible records can also lead to more accurate diagnosis, treatment, and drug prescription. Electronic medical records are cost-effective because they take up less storage space and can be stored indefinitely. However, because they are in electronic form, these records also present unique challenges to security, privacy, and data integrity. OSHA believes the best way to protect the security and confidentiality of personally identifiable employee medical information in electronic form is to prevent unauthorized access to such information. Several effective administrative, technological, and physical measures can be taken to protect electronic medical information from unauthorized access, use, disclosure, disruption, modification, or destruction. These methods include establishing specific security roles and responsibilities for OSHA officials, technology safeguards such as encryption or firewalls to protect against electronic breaches, ID/password protection for devices and information systems, and the use of anti-virus and intrusion detection software. The establishment of new internal OSHA policies and procedures in paragraph (n) of this final rule will effectively protect the security, privacy, and data integrity of employee medical information in electronic form. Section 1913.10(n)(1) of the final rule provides that, in general, when accessing and/or copying personally VerDate Sep<11>2014 16:01 Jul 29, 2020 Jkt 250001 identifiable employee medical information in electronic form, OSHA personnel shall follow the requirements set forth in 29 CFR 1913.10. As noted above, OSHA personnel have historically followed the rules of agency practice and procedure in § 1913.10 when accessing employee medical information in electronic form, and many of the provisions in § 1913.10 are applicable regardless of the format used to maintain information. As a result, unless specifically addressed in paragraph (n), OSHA personnel should continue to follow the rules of agency practice and procedure in paragraphs (a) through (m) when accessing and safeguarding electronic employee medical information. Section (n)(2) of the final rule includes responsibilities for the Principal OSHA Investigator when OSHA personnel access personally identifiable employee medical information in electronic form. Specifically, paragraph (n)(2) states that when personally identifiable employee medical information in electronic form is taken off-site, the Principal OSHA Investigator is primarily responsible for ensuring that such information is properly used and kept secured. This provision is based on the requirement in paragraph (h)(1) of § 1913.10, which provides that the Principal OSHA Investigator is responsible for ensuring that medical information is used and kept secured in accordance with § 1913.10. Other specific responsibilities assigned to the Principal OSHA Investigator in paragraph (n)(2) include preventing any accidental or unintentional disclosure of, modification to, or destruction of personally identifiable employee medical information in electronic form (paragraph (n)(2)(i)); controlling the flow of data into, through, and from agency computer operations (paragraph (n)(2)(ii)); and ensuring that distribution and review of medical information in electronic form is limited to only those OSHA personnel and contractors with a need for access (paragraph (n)(2)(iii)). The requirement in paragraph (n)(2)(iii) is derived from § 1913.10(d)(2)(iii), which provides that, before approving a MAO, the MRO must determine that personnel authorized to review and analyze personally identifiable employee medical information are limited to those who have a need for access and have appropriate qualifications. As discussed above, the Principal OSHA Investigator is the OSHA employee in the field with primary responsibility for ensuring that the examination and use of employee PO 00000 Frm 00028 Fmt 4700 Sfmt 4700 medical information is in accordance with § 1913.10. As such, the Principal OSHA Investigator is responsible for ensuring that the provisions in paragraph (n) are followed by OSHA personnel when electronic medical information is accessed from a specific workplace. For example, this would include ensuring that access to personally identifiable employee medical records in electronic form is limited to only authorized personnel with a need to review the information, ensuring that employee medical information is only downloaded to a secured device (e.g., password protected), and verifying that medical information is deleted or destroyed when no longer needed by the agency. Section 1913.10(n)(3) of the final rule provides that the transfer and/or duplication of medical information in electronic form shall be kept to the minimum necessary to accomplish the purpose for which it was obtained. This provision is similar to paragraph (i)(3) of § 1913.10, which states that the photocopying or other duplication of personally identifiable employee medical information shall be kept to the minimum necessary to accomplish the purpose for which the information was obtained. In some cases, personally identifiable employee medical information in electronic form needs to be transferred or duplicated to facilitate internal OSHA review. For example, in order to conduct a proper workplace inspection or investigation, it may be necessary for OSHA personnel to transfer employee medical records to another OSHA employee with expertise on a specific occupational health hazard. Paragraph (n)(3) of the final rule permits the transfer and duplication of electronic medical information but only to authorized individuals with a need to review the information. Transfer and duplication are also limited to the minimum necessary to accomplish the purpose for which it was obtained. An example of this limitation might include the review of a medical record to determine whether an employee has sustained a work-related injury or illness. In such cases, review of a medical record would extend only to information about the employee’s injury or illness. In this example, the transfer and/or duplication of electronic medical information unrelated to the injury or illness would not be permitted. Additionally, OSHA believes the likelihood that medical information in electronic form will be lost, altered, or destroyed increases during transfer or duplication. The duplication of electronic medical information can also E:\FR\FM\30JYR1.SGM 30JYR1 khammond on DSKJM1Z7X2PROD with RULES Federal Register / Vol. 85, No. 147 / Thursday, July 30, 2020 / Rules and Regulations raise concern about data integrity. For example, the copying or deleting of employee medical information from one document to another raises concern about the accuracy of the information. Accordingly, personally identifiable electronic medical information should be transferred only to authorized individuals with a need to know the information and should be duplicated only to facilitate authorized internal agency review. Consistent with existing OSHA policy, § 1913.10(n)(4) of the final rule states that electronic files containing personally identifiable employee medical information shall be downloaded only to a computer hard drive or laptop that is in accordance with Federal Information Processing Standard (FIPS) 201–2, ‘‘Personal Identity Verification (PIV) of Federal Employees and Contractors,’’ and ‘‘Homeland Security Presidential Directive 12: Policy for Common Identification Standard for Federal Employees and Contractors (HSPD– 12).’’ The use of secured technology when downloading medical records will help to ensure that information is (1) accessed only by authorized individuals with a need-to-know and (2) not modified or deleted. In accordance with current OSHA and Federal Government policy, the use of password protection is easy to implement, cost-effective, and a reliable method for securing electronic information. By downloading employee medical information to a secured hard drive or laptop, OSHA personnel will be able to ensure that only individuals that know the password can open a document and read its content. This practice also provides a level of protection that goes with the document no matter where it is stored or sent. Finally, because tampering with a secured device takes time and effort, providing this level of protection acts as a deterrent to accessing document content by unauthorized individuals. Additionally, it is important for OSHA personnel to follow proper security practices when using password protected devices containing personally identifiable employee medical information. Authorized individuals must not share their ID with others, should log-off when leaving a terminal, and use their own ID to access employee medical records. Also, authorized individuals should not keep written facsimiles of passwords or access codes. Other security measures, such as the use of firewalls, anti-virus software, and intrusion detection software should also be used to protect data integrity. Again, the Principal OSHA Investigator is VerDate Sep<11>2014 16:01 Jul 29, 2020 Jkt 250001 responsible for ensuring that proper security measures are in place in the field to protect the confidentiality of personally identifiable employee medical records in electronic form. Moreover, it is critically important that mobile devices be encrypted or use password protection when used to download, transfer, or store electronic medical information. Mobile devices are for individual use, and are not designed for centralized IT management. These devices can easily be manipulated, damaged, or stolen. By encryption, OSHA means the process of changing plain text into cypher text for the purpose of security. The use of encryption results in the encoding of information in such a way so that only authorized individuals can access the information. Section 1913.10(n)(5) of the final rule states that electronic files containing personally identifiable employee medical information shall not be transferred to authorized personnel through email attachment unless appropriately encrypted. The transfer of employee medical information by email attachment increases the risk that such information will be sent to an unauthorized individual. The transfer of personally identifiable employee medical information in electronic form must be made through secured means. See § 1913.10(n)(4), discussed above (‘‘Electronic files containing personally identifiable employee medical information shall only be downloaded to a computer hard drive or laptop that is secured.’’). Appropriate methods for the transfer of personally identifiable employee medical information in electronic form may include the use of password protected or encrypted files on a secured agency website designed for confidential information, the mailing of encrypted computer disks or USB drives, the emailing of password protected medical records (Adobe secured), and the printing and hand delivery of paper records. Paragraph (n)(6) provides that when an employer or other record holder(s) provides access to employee medical information through a properly encrypted email attachment, the attachment shall be downloaded to a secured hard drive or laptop. After the attachment is downloaded, the email shall be permanently deleted. In some cases, employers and other record holders provide OSHA with access to employee medical information through an encrypted email attachment. As noted above, the use of email attachments to transfer medical records makes it more likely that the information will be sent to unauthorized PO 00000 Frm 00029 Fmt 4700 Sfmt 4700 45789 individuals. Paragraph (n)(6) ensures that medical information received in an encrypted email attachment is downloaded to a secured device. After downloading the attachment from the employer or other record holder, the email must be permanently deleted to prevent transfer to unauthorized individuals. By permanently deleted, OSHA means that the email should be deleted so that it cannot be retrieved. Some email programs automatically delete trashed emails after a certain amount of time. Other programs retain emails until the user runs out of space. However, the intent of this provision is that, once the attachment is downloaded, OSHA personnel should immediately and permanently delete the incoming email. Most email programs have a ‘‘delete forever’’ function that allows the user to select emails in the trash folder for permanent deletion. Section 1913.10(n)(7) of the final rule states that personally identifiable employee medical information in electronic form shall be secured when not in use. This provision is based on paragraph (i)(1) of § 1913.10, which states that agency files containing personally identifiable employee medical information shall be segregated from other agency files, and when not in active use, files containing this information shall be kept secured in a locked cabinet or vault. Paragraph (n)(7) is intended to prevent unauthorized access or modification to employee medical information in electronic form. In addition to all of the procedures in paragraph (n) addressing the use of electronic information by OSHA personnel, when not in use, such information must be stored in a secured manner. For example, when not in use, personally identifiable employee medical information should be stored on a password protected hard drive or laptop. Another example might be the storing of information on a password protected agency website designed to store confidential information. Also, if employee medical records are kept on computer disk or other electronic storage media, when not in use, the disk or media should be stored under lock and key. Paragraph (n)(7)(i) of the final rule also emphasizes the importance of proper storage by specifically stating that medical information in electronic form shall only be maintained or stored where facilities and conditions are designed to prevent unauthorized access. Paragraph (n)(7)(ii) provides that personally identifiable employee medical information in electronic form shall be maintained only for so long as E:\FR\FM\30JYR1.SGM 30JYR1 khammond on DSKJM1Z7X2PROD with RULES 45790 Federal Register / Vol. 85, No. 147 / Thursday, July 30, 2020 / Rules and Regulations needed to accomplish the purpose for access. This provision is derived from paragraph (j)(1) of § 1913.10, which provides that consistent with OSHA records disposition programs, personally identifiable employee medical information shall be destroyed or returned to the original record holder when no longer needed for the purposes for which they were obtained. In OSHA’s view, maintaining medical records only for so long as needed helps to ensure that such information will not be accessed by unauthorized individuals. In some cases, after its initial use by the agency, personally identifiable employee medical information may not be used again until sometime in the future. For example, medical information used as the basis for an OSHA citation may be used during the hearing stage of an enforcement case before the Occupational Safety and Health Review Commission. The medical information may not be used while the case is on appeal, but there may be a need for the information if the case is remanded for further judicial proceedings. Similarly, an investigation of an apparently new health hazard may produce uncertain results. Before completely closing out this investigation, it may be appropriate to await the outcome of an ongoing research study or parallel investigation elsewhere in the country. In these cases, § 1913.10(j) provides that the medical information should be transferred to the MRO. Also, under § 1913.10(l)(2), the MRO must conduct an annual review of all centrally-held information to determine which information is no longer needed for the purposes for which it was obtained. These requirements apply equally to personally identifiable employee medical information stored in electronic form. Paragraph (n)(7)(iii) of the final rules states that when no longer needed, the Principal OSHA Investigator shall ensure that all personally identifiable employee medical information on electric files has been deleted, destroyed, or returned to the original record holder. The requirement in paragraph (n)(7)(iii) is intended to ensure that the Principal OSHA Investigator is responsible for OSHA access and use of electronic medical information from beginning to end. When no longer needed, the Principal OSHA Investigator must make sure that authorized OSHA personnel follow proper procedures for the deletion, destruction and disposal of personally identifiable employee medical information. In practice, the Principal VerDate Sep<11>2014 16:01 Jul 29, 2020 Jkt 250001 OSHA Investigator must ensure that media containing employee medical information is sanitized or destroyed before disposal or release for reuse in accordance with approved methods. In addition, if electronic medical records are returned to the original record holder, the Principal OSHA Investigator must ensure that all data is returned, and no data remains in the possession of OSHA personnel. Paragraph (n)(7)(iv) states that the disposal of personally identifiable employee medical information maintained in electronic form shall be accomplished in such a manner as to make the data unattainable by unauthorized personnel. When no longer needed, electronic media must be handled and sanitized appropriately to prevent unauthorized disclosure or modification of personally identifiable employee medical information. OSHA personnel use several types of electronic media to access, use, and maintain personally identifiable employee medical information, including hard drives, laptops, USB storage drives (e.g., thumb drives), CDs, DVDs, and digital storage cards such as camera cards. In order to meet the requirement in paragraph (n)(7)(iv), and depending on the type of electronic media used, OSHA personnel may need to re-use, recycle, or destroy the electronic media containing medical information. Also, when employee medical information in electronic form is no longer needed, it is important to ensure that deleted data is not easily recoverable. Residual data may allow unauthorized individuals to reconstruct data and thereby gain access to personally identifiable employee medical information. Sanitization is one method that can be used to ensure that deleted data cannot be reconstructed. Sanitization is the general process of removing data from storage media, such that there is reasonable assurance that the data may not be easily retrieved and reconstructed. There are different types of sanitization for each type of media, including cleaning, purging, and destroying. Cleaning is the removal of data from devices in such a way that there is assurance that the data cannot be reconstructed using normal system functions or software file/data recovery utilities. For example, cleaning may include using software or hardware products to overwhelm media with nonsensitive data. Purging is generally done before releasing media beyond control, such as before discarding old media, and includes degaussing or exposing media to a strong magnetic field in order to disrupt recorded magnetic domains. PO 00000 Frm 00030 Fmt 4700 Sfmt 4700 Destruction of media is the ultimate form of sanitization. In some cases, OSHA personnel maintain employee medical information on media that may not be able to be reused such as computer disks and camera cards. In these situations, when no longer needed, electronic media containing personally identifiable employee medical information should be disposed of using approved secure data destruction. Several methods exist to dispose of electronic media containing medical information. For example, computer disks can be rendered unusable by shredding, incinerating, or pulverizing. Many OSHA Regional and Area Offices already have equipment that can shred or burn disks. Other offices contract with private companies to perform this task in a secure manner. As a reminder, in order to address security and privacy concerns, disposal operations should be conducted in accordance with approved DOL or OSHA methods. In addition, OSHA is responsible for the management of records pursuant to the Federal Records Act of 1950, as amended (44 U.S.C. Chapters 21, 29, 31, 33). The retention and destruction of Federal records must be conducted in accordance with the procedures described in the Federal Records Act. Finally, in the future, OSHA personnel will be using media types not specifically mentioned in this preamble. The processes mentioned in this document should guide media sanitization and disposal decisions regardless of the type of media in use. In the future, OSHA will issue guidance to agency staff as new technology is developed. IV. State Plans The 28 states and U.S. territories with their own OSHA-approved occupational safety and health plans are encouraged, but not required, to adopt these rules of agency practice and procedure concerning employee medical record access that Federal OSHA is promulgating to 29 CFR 1913.10 in this final rule. The states and U.S. territories with OSHA-approved occupational safety and health plans covering private employees and state and local government employees are Alaska, Arizona, California, Hawaii, Indiana, Iowa, Kentucky, Maryland, Michigan, Minnesota, Nevada, New Mexico, North Carolina, Oregon, Puerto Rico, South Carolina, Tennessee, Utah, Vermont, Virginia, Washington, and Wyoming. In addition, six states and U.S. territories have OSHA-approved state Plans that apply to state and local government employees only: Connecticut, Illinois, E:\FR\FM\30JYR1.SGM 30JYR1 Federal Register / Vol. 85, No. 147 / Thursday, July 30, 2020 / Rules and Regulations khammond on DSKJM1Z7X2PROD with RULES Maine, New Jersey, New York, and the Virgin Islands. This final rule describes a Federal program change for which State Plan adoption is not required. However, State Plans are required to have standards, and an enforcement program, that are ‘‘at least as effective in providing safe and healthful employment’’ as those of Federal OSHA. In order to be ‘‘at least as effective’’ as Federal OSHA, a State Plan must appropriately utilize its authority for access to medical records, and must have effective procedures to assure that the privacy of those records is protected in a manner consistent with applicable state and federal privacy laws. Therefore, although adoption of this rule is not required, State Plans must have procedures covering this issue that are at least as effective as those of Federal OSHA and are encouraged to adopt requirements comparable to those in 29 CFR 1913.10. Within 60 days of the effective date of this final rule, a State Plan must submit a notice of intent indicating whether they already have a similar policy in place, intend to adopt new policies and procedures, or do not intend to adopt this final rule. If a State Plan does not adopt at first, but at some later point decides to adopt this final rule or an at least as effective version of this final rule, the State Plan must notify OSHA of this change in intent. Within 60 days of adoption, the State Plan must provide an electronic copy of the regulation or policy, or a link to where their policy is posted on the State Plan’s website. The State Plan must also provide the date of adoption and identify differences, if any, between their policy and this final rule. OSHA will provide summary information on the State Plan responses to this instruction on its website at: www.osha.gov/dcsp/osp/ index.html. V. Regulatory Flexibility Certification The notice and comment procedures of section 553 of the APA do not apply ‘‘to interpretative rules, general statements of policy, or rules of agency organization, procedure, or practice.’’ 5 U.S.C. 553(b)(A). Rules that are exempt from APA notice and comment requirements are also exempt from the Regulatory Flexibility Act (RFA). See SBA Office of Advocacy, A Guide for Government Agencies: How to Comply with the Regulatory Flexibility Act (August 2017); also found at https:// www.sba.gov/sites/default/files/rfaguide 5F05125F0.pdf. This is a rule of agency procedure, practice, and interpretation within the meaning of that section; and therefore, is exempt from both the notice and comment rulemaking VerDate Sep<11>2014 16:01 Jul 29, 2020 Jkt 250001 procedures of the APA and the requirements of the RFA. VI. Environmental Impact Analysis In accordance with the requirements of the National Environmental Policy Act (NEPA) (42 U.S.C. 4231 et seq.), Council on Environmental Quality NEPA regulations (40 CFR parts 1500 through 1518), and the Department of Labor NEPA regulations (29 CFR part 11), OSHA has determined that this final rule will not have a significant impact on the external environment. VII. Federalism OSHA reviewed this final rule in accordance with the most recent Executive order on federalism (Executive Order 13132, 64 FR 43255, August 10, 1999). This Executive order requires Federal agencies, to the extent possible, to refrain from limiting state policy options, consult with states prior to taking any action that would restrict state policy options, and take such actions only when clear constitutional authority exists and the problem is national in scope. This rule does not have ‘‘federalism implications.’’ The rule does not have ‘‘substantial direct effects on the States, on the relationship between the National Government and the States, or on the distribution of power and responsibilities among the various levels of government’’ and therefore is not subject to Executive Order 13132 (Federalism). VIII. Unfunded Mandates The Department has concluded that this rule is not a ‘‘significant regulatory action’’ within the meaning of Executive Order 12866, reaffirmed by Executive Order 13563, because it is not likely to (1) have an annual effect on the economy of $100 million or more or adversely affect in a material way the economy, a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or state, local, or Tribal governments or communities; (2) create a serious inconsistency or otherwise interfere with an action taken or planned by another agency; (3) materially alter the budgetary impact of entitlements, grants, user fees, or loan programs or the rights and obligations of recipients thereof; or (4) raise novel legal or policy issues arising out of legal mandates, the President’s priorities, or the principles set forth in Executive Order 12866. Therefore, no economic impact analysis under section 6(a)(3)(C) of Executive Order 12866 has been prepared. For the same reason, and because no notice of proposed rulemaking was published, no PO 00000 Frm 00031 Fmt 4700 Sfmt 4700 45791 statement is required under section 202 of the Unfunded Mandates Reform Act of 1995, 2 U.S.C. 1532. In any event, this rulemaking is procedural and interpretive in nature and is thus not expected to have a significant economic impact. IX. Consultation and Coordination With Indian Tribal Governments OSHA reviewed this rule in accordance with Executive Order 13175 (65 FR 67249, November 6, 2000) and determined that it does not have ‘‘tribal implications’’ as defined in that order. The rule does not have substantial direct effects on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes. X. Office of Management and Budget Review Under the Paperwork Reduction Act of 1995 The Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501 et seq.) and OMB regulations (5 CFR part 1320) require agencies to obtain approval from OMB before conducting any collection of information. The PRA defines a ‘‘collection of information’’ as ‘‘the obtaining, causing to be obtained, soliciting, or requiring the disclosure to third parties or the public of facts or opinions by or for an agency regardless of form or format’’ (44 U.S.C. 3502(3)(A)). The PRA does not apply to this final rule because it amends existing internal agency procedures and does not impose any new recordkeeping or information collection requirements that require OMB approval. Authority and Signature This document was prepared under the direction of Loren Sweatt, Principal Deputy Assistant Secretary for Occupational Safety and Health. It is issued under Section 8 of the Occupational Safety and Health Act (29 U.S.C. 657), 5 U.S.C. 553, 5 U.S.C. 552a(e), 5 U.S.C. 301, and Secretary of Labor’s Order No. 5–2012 (77 FR 3912). Signed at Washington, DC, on July 14, 2020. Loren Sweatt, Principal Deputy Assistant Secretary of Labor for Occupational Safety and Health. Final Rule Part 1913 of title 29 of the Code of Federal Regulations is hereby amended as follows: E:\FR\FM\30JYR1.SGM 30JYR1 45792 Federal Register / Vol. 85, No. 147 / Thursday, July 30, 2020 / Rules and Regulations PART 1913—[AMENDED] 1. The authority citation for part 1913 is revised to read as follows: ■ Authority: 29 U.S.C. 657; 5 U.S.C. 553; 5 U.S.C. 301; Secretary of Labor’s Order No. 8– 76 (41 FR 25059), 5–2002 (67 FR 65008), or 1–2012 (77 FR 3912) as applicable. 2. Amend § 1913.10 by: a. Revising paragraphs (b)(6), (c)(1) and (2), and (d)(1) and (2); ■ b. Removing and reserving paragraph (g); ■ c. Revising paragraph (m); and ■ d. Adding paragraph (n). The revisions and addition read as follows: ■ ■ § 1913.10 Rules of agency practice and procedure concerning OSHA access to employee medical records. khammond on DSKJM1Z7X2PROD with RULES * * * * * (b) * * * (6) This section does not apply where a written directive by the OSHA Medical Records Officer authorizes appropriately qualified personnel to conduct limited reviews of specific medical information mandated by an occupational safety and health standard, or of specific biological monitoring test results. * * * * * (c) * * * (1) Assistant Secretary. The Assistant Secretary of Labor for Occupational Safety and Health (Assistant Secretary) shall designate an OSHA official with experience or training in the evaluation, use, and privacy protection of medical records to be the OSHA Medical Records Officer. The Assistant Secretary may change the designation of the OSHA Medical Records Officer at will. (2) OSHA Medical Records Officer. The OSHA Medical Records Officer shall be responsible for the overall administration and implementation of the procedures contained in this section. The OSHA Medical Records Officer shall report directly to the Assistant Secretary on matters concerning this section and be responsible for: (i) Making final determinations concerning the approval or denial of medical access orders (paragraph (d) of this section); (ii) Assuring that medical access orders meet the requirements of paragraphs (d)(2) and (3) of this section; (iii) Responding to objections concerning medical access orders (paragraph (f) of this section); (iv) Overseeing internal agency use and security of personally identifiable employee medical information (paragraphs (g) through (j) of this section); VerDate Sep<11>2014 16:01 Jul 29, 2020 Jkt 250001 (v) Assuring that the results of agency analyses of personally identifiable medical information are, where appropriate, communicated to employees (paragraph (k) of this section); (vi) Preparing an annual report of OSHA’s experience under this section (paragraph (l) of this section); and (vii) Making final determinations concerning inter-agency transfer or public disclosure of personally identifiable employee medical information (paragraph (m) of this section). The Medical Records Officer shall also assure that advance notice is given of intended inter-agency transfers or public disclosures. * * * * * (d) * * * (1) Requirement for medical access order. Except as provided in paragraph (d)(4) of this section, each request by an OSHA representative to examine or copy personally identifiable employee medical information contained in a record held by an employer or other recordholder shall be made pursuant to a written medical access order which has been approved by the OSHA Medical Records Officer. A medical access order does not constitute an administrative subpoena. (2) Approval criteria for medical access order. Before approving a medical access order, the OSHA Medical Records Officer shall determine that: (i) The medical information to be examined or copied is relevant to a statutory purpose and there is a need to gain access to this personally identifiable information; (ii) The personally identifiable medical information to be examined or copied is limited to only that information needed to accomplish the purpose for access; and (iii) The personnel authorized to review and analyze the personally identifiable medical information are limited to those who have a need for access and have appropriate professional qualifications. * * * * * (m) Inter-agency transfer and public disclosure. (1) Personally identifiable employee medical information shall not be transferred to another agency or office outside of OSHA (other than to the Office of the Solicitor of Labor) or disclosed to the public (other than to the affected employee or the original recordholder) except when required by law or when approved by the OSHA Medical Records Officer. (2) Except as provided in paragraph (m)(3) of this section, the OSHA PO 00000 Frm 00032 Fmt 4700 Sfmt 4700 Medical Records Officer shall not approve a request for an inter-agency transfer of personally identifiable employee medical information, which has not been consented to by the affected employees, unless the request is by a public health agency which: (i) Needs the requested information in a personally identifiable form for a substantial public health purpose; (ii) Will not use the requested information to make individual determinations concerning affected employees which could be to their detriment; (iii) Has regulations or established written procedures providing protection for personally identifiable medical information substantially equivalent to that of this section; and (iv) Satisfies an exemption to the Privacy Act to the extent that the Privacy Act applies to the requested information (see 5 U.S.C. 552a(b); 29 CFR 70a.3). (3) Upon the approval of the OSHA Medical Records Officer, personally identifiable employee medical information may be transferred to: (i) The National Institute for Occupational Safety and Health (NIOSH); and (ii) The Department of Justice when necessary with respect to a specific action under the Occupational Safety and Health Act. (4) The OSHA Medical Records Officer shall not approve a request for public disclosure of employee medical information containing direct personal identifiers unless there are compelling circumstances affecting the health or safety of an individual. (5) The OSHA Medical Records Officer shall not approve a request for public disclosure of employee medical information which contains information which could reasonably be used indirectly to identify specific employees when the disclosure would constitute a clearly unwarranted invasion of personal privacy (see 5 U.S.C. 552(b)(6); 29 CFR 70.26). (6) Except as to inter-agency transfers to NIOSH or the Department of Justice, the OSHA Medical Records Officer shall ensure that advance notice is provided to any collective bargaining agent representing affected employees and to the employer on each occasion that OSHA intends to either transfer personally identifiable employee medical information to another agency or disclose it to a member of the public other than to an affected employee. When feasible, the OSHA Medical Records Officer shall take reasonable steps to assure that advance notice is provided to affected employees when E:\FR\FM\30JYR1.SGM 30JYR1 khammond on DSKJM1Z7X2PROD with RULES Federal Register / Vol. 85, No. 147 / Thursday, July 30, 2020 / Rules and Regulations the employee medical information to be transferred or disclosed contains direct personal identifiers. (n) Medical records maintained in electronic form. (1) In general, when accessing and/or copying personally identifiable employee medical information in electronic form, OSHA personnel shall follow all of the requirements set forth in this section. (2) When personally identifiable employee medical information in electronic form is taken off-site, the Principal OSHA Investigator is primarily responsible for ensuring that such information is properly used and kept secured. (i) The Principal OSHA Investigator is responsible for preventing any accidental or unintentional disclosure of, modification to, or destruction of personally identifiable employee medical information in electronic form. (ii) The Principal OSHA Investigator is responsible for controlling the flow of data into, through, and from agency computer operations. (iii) The Principal OSHA Investigator shall ensure the distribution and review of medical information in electronic form is limited to only those OSHA personnel and contractors with a need for access. (3) The transfer and/or duplication of medical information in electronic form shall be kept to the minimum necessary to accomplish the purpose for which it was obtained. (4) Electronic files containing personally identifiable employee medical information shall be downloaded only to a computer hard drive or laptop that is secured in accordance with Federal Information Processing Standard (FIPS) 201–2 ‘‘Personal Identity Verification (PIV) of Federal Employees and Contractors’’ and ‘‘Homeland Security Presidential Directive 12: Policy for a Common Identification Standard for Federal Employees and Contractors (HSPD– 12).’’ (5) Electronic files containing personally identifiable employee medical information shall not be transferred to authorized personnel through email attachment unless appropriately encrypted. (6) When an employer or other record holder(s) provides access to employee medical information through a properly encrypted email attachment, the attachment shall be downloaded to a secured hard drive or laptop. After the attachment is downloaded, the email shall be permanently deleted. (7) Personally identifiable employee medical information in electronic form shall be secured when not in use. VerDate Sep<11>2014 16:01 Jul 29, 2020 Jkt 250001 (i) Medical information in electronic form shall only be maintained or stored where facilities and conditions are designed to prevent unauthorized access. (ii) Personally identifiable employee medical information in electronic form shall be maintained only for so long as needed to accomplish the purpose for access. (iii) When no longer needed, the Principal OSHA Investigator shall ensure that all personally identifiable employee medical information on electronic files has been deleted, destroyed, or returned to the original record holder. (iv) The disposal of personally identifiable employee medical information maintained in electronic form shall be accomplished in such a manner as to make the data unattainable by unauthorized personnel. [FR Doc. 2020–15562 Filed 7–29–20; 8:45 am] BILLING CODE 4510–26–P FEDERAL COMMUNICATIONS COMMISSION 47 CFR Part 54 [WC Docket Nos. 18–143, 10–90, 14–58; FCC 19–95; FRS 16955] The Uniendo a Puerto Rico Fund and the Connect USVI Fund, Connect America Fund, ETC Annual Reports and Certifications Federal Communications Commission. ACTION: Final rule; announcement of effective date. AGENCY: In this document, the Federal Communications Commission (Commission) announces that the Office of Management and Budget (OMB) has approved, for a period of three years, an information collection associated with the rules for the Connect America Fund contained in the Commission’s Uniendo a Puerto Rico Fund and Connect USVI Fund Order, FCC 19–95. This document is consistent with the Uniendo a Puerto Rico Fund and Connect USVI Fund Order, which stated that the Commission would publish a document in the Federal Register announcing the effective date of the new information collection requirements. DATES: The amendments to §§ 54.1505, 54.1508 and 54.1515 published at 84 FR 59937, November 7, 2019 are effective July 30, 2020. FOR FURTHER INFORMATION CONTACT: Alexander Minard, Wireline Competition Bureau at (202) 418–7400 SUMMARY: PO 00000 Frm 00033 Fmt 4700 Sfmt 4700 45793 or TTY (202) 418–0484. For additional information concerning the Paperwork Reduction Act information collection requirements contact Nicole Ongele at (202) 418–2991 or via email: Nicole.Ongele@fcc.gov. SUPPLEMENTARY INFORMATION: The Commission submitted revised information collection requirements for review and approval by OMB, as required by the Paperwork Reduction Act (PRA) of 1995, on May 20, 2020, which were approved by OMB on July 9, 2020. The information collection requirements are contained in the Commission’s Uniendo a Puerto Rico Fund and Connect USVI Fund Order, FCC 19–95 published at 84 FR 59937, November 7, 2019. The OMB Control Number is 3060–1274. If you have any comments on the burden estimates listed in the following, or how the Commission can improve the collections and reduce any burdens caused thereby, please contact Nicole Ongele, Federal Communications Commission, Room 1–A620, 445 12th Street SW, Washington, DC 20554. Please include the OMB Control Number, 3060–1274, in your correspondence. The Commission will also accept your comments via email at PRA@fcc.gov. To request materials in accessible formats for people with disabilities (Braille, large print, electronic files, audio format), send an email to fcc504@ fcc.gov or call the Consumer and Governmental Affairs Bureau at (202) 418–0530 (voice), (202) 418–0432 (TTY). Synopsis As required by the Paperwork Reduction Act of 1995 (44 U.S.C. 3507), the Commission is notifying the public that it received OMB approval on July 9, 2020, for the information collection requirements contained in 47 CFR 54.1505, 54.1508 and 54.1515 published at 84 FR 59937, November 7, 2019. Under 5 CFR part 1320, an agency may not conduct or sponsor a collection of information unless it displays a current, valid OMB Control Number. No person shall be subject to any penalty for failing to comply with a collection of information subject to the Paperwork Reduction Act that does not display a current, valid OMB Control Number. The OMB Control Number is 3060–1274. The foregoing notice is required by the Paperwork Reduction Act of 1995, Public Law 104–13, October 1, 1995, and 44 U.S.C. 3507. The total annual reporting burdens and costs for the respondents are as follows: E:\FR\FM\30JYR1.SGM 30JYR1

Agencies

[Federal Register Volume 85, Number 147 (Thursday, July 30, 2020)]
[Rules and Regulations]
[Pages 45780-45793]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-15562]


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DEPARTMENT OF LABOR

Occupational Safety and Health Administration

29 CFR Part 1913

[Docket No. OSHA-2020-0005]
RIN 1218-AC95


Rules of Agency Practice and Procedure Concerning Occupational 
Safety and Health Administration Access to Employee Medical Records

AGENCY: Occupational Safety and Health Administration (OSHA); Labor.

ACTION: Final rule.

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SUMMARY: OSHA is issuing a final rule to amend the regulation 
addressing the rules of agency practice and procedure concerning OSHA 
access to employee medical records. The final rule transfers the 
approval of written medical access orders (MAO) from the Assistant 
Secretary for Occupational Safety and Health (Assistant Secretary) to 
the OSHA Medical Records Officer (MRO) and makes the MRO responsible 
for making determinations regarding inter-

[[Page 45781]]

agency transfer and public disclosure of personally identifiable 
medical information in OSHA's possession.

DATES: This final rule is effective on July 30, 2020.

ADDRESSES: In accordance with 29 U.S.C. 2112(a)(2), OSHA designates, 
Mr. Edmund C. Baird, Associate Solicitor of Labor for Occupational 
Safety and Health, Office of the Solicitor, Room S-4004, U.S. 
Department of Labor, 200 Constitution Avenue NW, Washington, DC 20210, 
to receive petitions for review of the final rule.

FOR FURTHER INFORMATION CONTACT: 
    Press inquiries: Mr. Frank Meilinger, OSHA, Office of 
Communications; telephone: (202) 693-1999; email: 
[email protected].
    General and technical information: Dr. Michael Hodgson, Director, 
OSHA Office of Occupational Medicine and Nursing; telephone: (202) 693-
1768; email: [email protected].

SUPPLEMENTARY INFORMATION: The final rule also amends Sec.  1913.10 to 
clarify that a written MAO does not constitute an administrative 
subpoena, eliminates outdated requirements for the removal of direct 
personal identifiers when OSHA personnel review medical information 
away from a worksite, and establishes new procedures for the access and 
safeguarding of personally identifiable employee medical information in 
electronic form. The revisions to Sec.  1913.10 in the final rule will 
increase employee privacy and enhance OSHA's ability to safeguard 
personally identifiable medical information.

Table of Contents

I. Background
II. Legal Authority
III. Summary and Explanation of the Final Rule
IV. State Plans
V. Regulatory Flexibility Certification
VI. Environmental Impact Analysis
VII. Federalism
VIII. Unfunded Mandates
IX. Consultation and Coordination With Indian Tribal Governments
X. Office of Management and Budget Review Under the Paperwork 
Reduction Act of 1995

I. Background

A. Introduction

    In order to carry out its statutory obligations, OSHA often reviews 
employee medical records. For example, OSHA may need to review employee 
medical records during a compliance inspection to determine whether an 
employer is in compliance with OSHA standards and regulations, or to 
verify that an employer has taken steps to correct existing violations. 
Access to employee medical records may also be necessary during 
inspections to determine the effectiveness of voluntary employer safety 
and health programs. OSHA also reviews medical records when gathering 
information during agency rulemaking to develop or revise occupational 
safety and health standards.
    Several OSHA standards and regulations mandate medical records 
access, including 29 CFR 1910.1020, Access to Employee Exposure and 
Medical Records, which sets forth procedures by which exposure and 
medical records can be accessed by employees, their designated 
representatives, and OSHA. This regulation, which applies to employers 
with employees exposed to toxic substances and harmful physical agents, 
provides OSHA representatives with prompt access to employee exposure 
and medical records and to analysis thereof using exposure or medical 
records. See 29 CFR 1910.1020(e)(3). In addition, several of OSHA's 
substance-specific standards include provisions for OSHA access to 
employee medical records. (e.g., 29 CFR 1910.25(n)(4) (Lead), and 29 
CFR 1910.1028(k) (Benzene)).
    In many instances, OSHA must examine and copy employee medical 
information in personally identifiable form. Personally identifiable 
employee medical information as defined by 29 CFR 1913.10(b)(2) means 
employee medical information accompanied by either direct identifiers 
(name, address, social security number, payroll number) or by 
information which could reasonably be used in particular circumstances 
indirectly to identify specific employees (e.g., date of birth, race, 
sex, date of initial employment, job title). An employee medical record 
may include individual health histories as well as medical opinions and 
evaluations generated during diagnosis, physical examinations, or 
medical treatment by a health care professional.
    Because of the substantial personal privacy interests involved, 
OSHA authority to access personally identifiable employee medical 
information is exercised only after the agency has made a careful 
determination of the need for the information, and only when 
appropriate safeguards are in place to prevent unauthorized access. 
Once this information is accessed, OSHA examination and use is limited 
to only that information needed to accomplish a relevant statutory 
purpose. Also, personally identifiable employee medical information is 
retained by OSHA only for so long as needed to accomplish the purpose 
for access, is kept secured while being used, and is not disclosed to 
other agencies or members of the public except in narrowly defined 
circumstances. In addition, the examination and use of personally 
identifiable employee medical information is limited to only OSHA 
personnel with a need to review such information.
    This rule is not an Executive Order (E.O.) 13771 regulatory action 
because this rule is not significant under E.O. 12866. Pursuant to the 
Congressional Review Act (5 U.S.C. 801 et seq.), the Office of 
Information and Regulatory Affairs designated this rule not a `major 
rule', as defined by 5 U.S.C. 804(2).

B. OSHA's Regulation at 29 CFR 1913.10

    On May 25, 1980, OSHA issued a final rule entitled Rules of Agency 
Practice and Procedure Concerning OSHA Access to Employee Medical 
Records (45 FR 35284). The final rule was developed and published in 
concert with the promulgation of 29 CFR 1910.1020, Access to Employee 
Exposure and Medical Records (45 FR 35212). During the rulemaking, 
there was universal agreement that if OSHA obtained access to employee 
medical records, the access should be accompanied by stringent internal 
agency procedures to preclude abuse of personally identifiable medical 
information. Provided these procedures were established, many 
participants in the rulemaking endorsed OSHA access to employee medical 
records without the consent of the employee for occupational safety and 
health purposes (see 45 FR 35218).
    Except as provided in 29 CFR 1913.10(b)(3) through (6), the rules 
of agency practice and procedure apply to all requests by OSHA 
personnel to obtain access to records to examine and copy personally 
identifiable employee medical information, whether or not access is 
mandated by 29 CFR 1910.1020. Among other things, the regulation at 29 
CFR 1913.10 establishes certain responsibilities for specific OSHA 
officials when the agency accesses personally identifiable employee 
medical information. The regulation also includes provisions addressing 
the internal use of employee medical records by agency personnel, as 
well as requirements for inter-agency transfer and public disclosure of 
such records. The regulation includes security procedures for the use 
and storage of employee medical records while in the agency's 
possession. Finally, the regulation sets forth internal

[[Page 45782]]

agency requirements for the retention and destruction of records.
    A key provision set forth in Sec.  1913.10 is that, with few 
exceptions, each request by an OSHA representative to examine or copy 
personally identifiable employee medical information must be made 
pursuant to a written access order. The written access order is an 
authorization for specific OSHA personnel to examine or copy personally 
identifiable employee medical information contained in records held by 
an employer or other record holder. The rules of agency practice and 
procedure in Sec.  1913.10 make clear that each written access order 
must state the statutory purpose for which access is sought, a general 
description of the type of employee medical information that will be 
examined and why there is a need to examine personally identifiable 
information, whether the medical information will be examined on-site, 
what type of information will be copied and removed off-site, and the 
anticipated time during which OSHA expects to retain the employee 
medical information in personally identifiable form.
    In order to enhance employee privacy, and clarify certain 
provisions, OSHA has determined that it is necessary to revise its 
regulation at Sec.  1913.10. For example, OSHA's previous regulation at 
Sec.  1913.10 used the term ``written access order.'' However, this 
final rule revises the regulatory text to include the more commonly 
used term ``medical access order'' or ``MAO.''
    The final rule also amends the regulation at 29 CFR 1913.10 to 
transfer certain responsibilities from the Assistant Secretary to the 
OSHA Medical Records Officer (MRO). Specifically, the MRO will now be 
responsible for the overall administration and implementation of the 
procedures contained in Sec.  1913.10. These new responsibilities 
include making determinations regarding (1) OSHA access to personally 
identifiable employee medical information pursuant to a MAO, and (2) 
inter-agency transfer and public disclosure of personally identifiable 
employee medical information. The final rule also transfers 
responsibility from the Assistant Secretary to the MRO for issuing 
written directives that authorize OSHA compliance personnel to review 
certain information without obtaining a MAO.
    The final rule clarifies that a MAO does not constitute an 
administrative subpoena, and eliminates requirements for the removal of 
direct personal identifiers when OSHA personnel review medical 
information away from a workplace. The deletion of requirements for the 
removal of direct personal identifiers will be offset by new provisions 
designed to strengthen employee privacy. Finally, the final rule 
establishes new internal OSHA requirements, based on existing agency 
policy, for the access and safeguarding of personally identifiable 
employee medical information maintained in electronic form.
    The procedures set forth in Sec.  1913.10 are internal agency 
procedures and do not affect employer compliance with OSHA 
requirements. Employers and employees will benefit from the revisions 
to Sec.  1913.10 in several ways. First, since the process for 
determining whether there is a need for OSHA to review employee medical 
information will be more efficient, employers will know sooner if such 
a review is authorized at their worksite. Second, the elimination of 
the outdated requirement to remove direct personal identifiers before 
taking medical information off-site for review will reduce the amount 
of an employer's time and physical space needed by OSHA personnel when 
they visit a specific workplace. Third, the revisions will benefit 
employees because the procedures in Sec.  1913.10 to protect the 
security and privacy of employee medical records will be strengthened, 
especially with regard to medical information in electronic form. 
Fourth, the elimination of the requirement to remove direct personal 
identifiers before taking medical information off-site will enhance 
employee privacy because the removal process always carries with it the 
possibility that medical information will be misidentified or 
mislabeled, which could result in unauthorized staff mistakenly 
reviewing that information. Finally, deletion of the time-consuming de-
identification procedures will mean that authorized OSHA personnel can 
conduct follow-up consultations with employees about their health more 
quickly.
    The notice and comment rulemaking procedures of 5 U.S.C. 553 of the 
Administrative Procedure Act (APA) do not apply to ``interpretive 
rules, general statements of policy, or rules of agency organization, 
procedure, or practice.'' 5 U.S.C. 553(b)(A). The provisions in 29 CFR 
1913.10 are rules of agency procedure and practice within the meaning 
of section 553(b)(A) of the APA. Therefore, publication in the Federal 
Register of a notice of proposed rulemaking and request for comments is 
not required. Furthermore, because this rule is procedural rather than 
substantive, the normal requirement of 5 U.S.C. 553(d) that a rule not 
be effective until at least 30 days after publication in the Federal 
Register is inapplicable. OSHA also finds good cause to provide an 
immediate effective date for this rule, because it imposes no 
obligations on parties outside the federal government and therefore no 
advance notice is required to enable employers or other private parties 
to come into compliance.

II. Legal Authority

    The Occupational Safety and Health Act of 1970, 29 U.S.C. 651 et 
seq. (OSH Act) authorizes the Secretary to issue two types of 
occupational safety and health rules: Standards and regulations. 
Standards, which are authorized by section 6 of the Act, specify 
remedial measures to be taken to prevent and control employee exposure 
to identified occupational safety and health hazards, while regulations 
are the means to effectuate other statutory purposes, including the 
maintaining of records. For example, the OSHA requirements at 29 CFR 
1910.95 are a ``standard'' because they include remedial measures to 
address the specific and already identified hazard of employee exposure 
to occupational noise. In contrast, a ``regulation'' is a purely 
administrative effort designed to uncover violations of the Act and 
discover unknown dangers. The procedural regulations in 29 CFR 1913.10 
are necessary to enable the use of employee medical records by OSHA 
consistent with the employee's right of privacy.
    In section 2(b) of the OSH Act, Congress declared the overriding 
purpose of the Act is ``to assure so far as possible every working man 
and woman in the Nation safe and healthful working conditions.'' (29 
U.S.C. 651.) Congress also explicitly declared that this must be 
accomplished, among other ways, ``by providing an effective enforcement 
program . . .'' (29 U.S.C. 651(b)(10)). For the Secretary of Labor to 
conduct an effective enforcement program, he or she must determine 
whether occupational safety and health hazards exist in the workplace. 
To that end, the OSH Act authorizes the Secretary to enter and inspect 
workplaces and to conduct reasonable investigations into working 
conditions.
    Section 8(a) of the OSH Act authorizes OSHA to enter, inspect, and 
investigate places of employment, and section 8(b) permits OSHA to 
subpoena both witnesses and evidence when conducting inspections and 
investigations. (29 U.S.C. 657(a) and (b)). As noted above, in some 
instances, it may be necessary for OSHA to examine personally 
identifiable employee medical information. Section

[[Page 45783]]

8 of the OSH Act recognizes OSHA's right of access to medical records, 
and records access is mandated by OSHA standards and regulations, 
including 29 CFR 1910.1020(e)(3) (access to employee exposure and 
medical records). OSHA relies on administrative subpoenas to compel 
production of medical records by employers and other record holders.
    OSHA is issuing the final rule pursuant to authority expressly 
granted in section 8 of the OSH Act. Section 8(c)(1) requires each 
employer to ``make, keep, preserve, and make available to the Secretary 
[of Labor] or the Secretary of Health and Human Services, such records 
regarding his activities relating to this Act as the Secretary, in 
cooperation with the Secretary of Health and Human Services, may 
prescribe by regulation as necessary or appropriate for the enforcement 
of this Act or for developing information regarding the causes and 
prevention of occupational accidents and illnesses'' (29 U.S.C. 
657(c)(1)). Employee medical records are included within the type of 
records addressed by this provision.
    Section 8(g)(1) of the OSH Act provides that the Secretary and 
Secretary of Health and Human Services are authorized to compile, 
analyze, and publish, either in summary or detailed from, all records 
or information obtained under this section (29 U.S.C. 657(g)(1)). 
Section 8(g)(2) is the general rulemaking authority of the OSH Act and 
provides that the Secretary and the Secretary of Health and Human 
Services shall prescribe such rules and regulations as he may deem 
necessary to carry out their responsibilities under this Act, including 
rules and regulations dealing with the inspection of an employer's 
establishment.

III. Summary and Explanation of the Final Rule

Section 1913.10(b)--Scope and Application

    OSHA's regulation at 29 CFR 1913.10(b), Scope and application, 
defines the circumstances under which the procedural regulations in 
Sec.  1913.10 will apply. Except as provided in paragraphs (b)(3) 
through (6), the policies and procedures in Sec.  1913.10 apply to all 
requests by OSHA personnel to access personally identifiable employee 
medical information.
    In general, 29 CFR 1913.10 requires OSHA personnel to obtain a MAO 
(previously ``written access order,'' but referred to in this section 
as ``MAO'' as it is in the final rule) when accessing personally 
identifiable employee medical information. However, under certain 
circumstances, the regulation states that OSHA access may be 
accomplished without obtaining a MAO. For example, Sec.  
1913.10(d)(4)(i) provides that a MAO is not needed when an employee 
gives specific written consent for OSHA to access their medical 
records. Also, Sec.  1913.10(b)(3) through (5) include several 
categories of records that are not subject to Sec.  1913.10 and 
therefore may be accessed without obtaining a MAO. These categories of 
records include medical information that is not in personally 
identifiable form, injury and illness records required by 29 CFR part 
1904, death certificates, employee exposure records, and medical 
information obtained in the course of litigation. In addition, previous 
Sec.  1913.10(b)(6) provided that the policies and procedures in Sec.  
1913.10 do not apply when a written directive by the Assistant 
Secretary authorizes appropriately qualified personnel to conduct 
limited review of specific medical information mandated by an OSHA 
standard or of specific biological monitoring test results. This final 
rule amends Sec.  1913.10(b)(6) to state that the MRO is now 
responsible for issuing these written authorization directives.
    OSHA Directive CPL 02-02-072, Rules of agency practice and 
procedure concerning OSHA access to employee medical records, August 
22, 2007, includes authorization for review of three categories of 
information based on the provisions in Sec.  1913.10(b)(6). The 
directive authorizes OSHA compliance personnel to review (1) medical 
opinions mandated by OSHA standards, (2) information required by a 
medical surveillance program, and (3) certain information used to 
verify compliance with the injury and illness recordkeeping 
requirements in 29 CFR part 1904. OSHA personnel do not need a MAO when 
they access the information at a workplace pursuant to a written 
directive under Sec.  1913.10(b)(6). Instead, OSHA personnel follow the 
procedures set forth in the written directive. The 2007 directive 
includes provisions on how OSHA personnel may access the specific types 
of information and how the information should be protected once in the 
agency's possession.
    OSHA believes the MRO is in the best position to make 
determinations regarding written authorization under Sec.  
1913.10(b)(6). Section 1913.10(c)(2) already provides that the MRO must 
have experience or training in the evaluation, use, and privacy 
protection of medical records, and, as discussed below in this 
preamble, paragraph (c) of Sec.  1913.10 has been amended to provide 
that the MRO is now responsible for the overall administration of the 
policies and procedures in Sec.  1913.10. Also, as part of the final 
rule, paragraph (c) now states that the MRO is specifically responsible 
for making determinations regarding the approval of MAOs, inter-agency 
transfer, and public disclosure of identifiable employee medical 
records. Given all the new MRO responsibilities set forth in paragraph 
(c), as well as the existing duties in the other paragraphs of the 
regulation, it is appropriate to also make the MRO responsible for 
written authorization under paragraph (b)(6). Accordingly, final Sec.  
1913.10(b)(6) states that the provisions of 29 CFR 1913.10 do not apply 
where a written directive by the MRO authorizes appropriately qualified 
personnel to conduct limited review of specific medical information 
mandated by an occupational safety and health standard or of specific 
biological monitoring test results. OSHA will also amend Directive CPL 
02-02-072 to reflect the new regulatory text in paragraph (b)(6).

Section 1913.10(c)--Responsible Persons

    OSHA's regulation at 29 CFR 1913.10(c) establishes certain 
responsibilities for OSHA personnel when the agency accesses personally 
identifiable employee medical information. Paragraph (c) is largely a 
summary of duties established by other paragraphs in Sec.  1913.10 and 
sets forth specific responsibilities for the Assistant Secretary, MRO, 
and Principal OSHA Investigator. The final rule amends several 
provisions in paragraph (c) to emphasize the responsibilities of the 
MRO.
    Under the previous regulation, paragraph (c)(1) provided that the 
OSHA Assistant Secretary was responsible for the overall administration 
and implementation of the policies and procedures in Sec.  1913.10. 
This responsibility included making determinations regarding (1) OSHA 
access to personally identifiable employee medical information and (2) 
interagency transfer or public disclosure of personally identifiable 
employee medical information. Also under the previous regulation, Sec.  
1913.10(d)(1) provided that each request by an OSHA representative to 
access information through a written access order must be approved by 
the Assistant Secretary upon the recommendation of the MRO.
    Section 1913.10(c)(2) of the previous regulation provided that the 
Assistant Secretary was responsible for designating an OSHA official 
with experience or training in the evaluation,

[[Page 45784]]

use, and privacy protection of medical records to be the MRO. The MRO, 
who reported directly to the Assistant Secretary on matters related to 
Sec.  1913.10, was responsible for making recommendations to the 
Assistant Secretary on whether to approve or deny written access 
orders, and served as the central reviewer of the sufficiency and 
justification of these documents. The MRO was also responsible for 
responding to employee, collective bargaining agent, and employer 
objections to written access orders. In addition, Sec.  1913.10(c)(2) 
of the previous regulation stated that the MRO was responsible for 
controlling the use of direct personal identifiers; controlling 
internal agency use and security of personally identifiable employee 
medical information; assuring that the results of agency analysis of 
personally identifiable employee medical information are, where 
appropriate, communicated to employees; preparing an annual report for 
the Assistant Secretary on OSHA's experience with respect to Sec.  
1913.10; and assuring that adequate notice is given of intended inter-
agency transfers or public disclosures of personally identifiable 
employee medical information.
    The other OSHA official with important responsibilities when the 
agency accesses employee medical information is the Principal OSHA 
Investigator. Section 1913.10(c)(3) provides that the Principal OSHA 
Investigator is the OSHA employee designated on the MAO who is 
primarily responsible for ensuring that OSHA examination and use of 
employee medical information is in accordance with the provisions of 
the MAO and Sec.  1913.10. In most instances, the Principal OSHA 
Investigator named on a MAO is an employee from an OSHA Regional or 
Area Office and determines how and when employee medical information 
will be accessed during an OSHA inspection or investigation. In 
practice, the Principal OSHA Investigator is responsible for ensuring 
that the provisions of the MAO and Sec.  1913.10 are followed by OSHA 
personnel when medical information is accessed at a specific workplace. 
As provided in Sec.  1913.10(c)(3), the Principal OSHA Investigator 
must be professionally trained in medicine, public health, or similar 
fields (epidemiology, toxicology, industrial hygiene, biostatistics, 
environmental health) when access is made pursuant to a MAO. The 
provisions in Sec.  1913.10(c)(3) concerning the Principal OSHA 
Investigator are unchanged by the final rule.
    The final rule retains the Assistant Secretary's responsibility to 
designate an OSHA official as MRO. However, this responsibility is now 
set forth in Sec.  1913.10(c)(1). Like the previous regulation, Sec.  
1913.10(c)(1) of the final rule states that the Assistant Secretary 
shall designate an OSHA official with experience or training in the 
evaluation, use, and privacy protection of medical records to be the 
OSHA Medical Records Officer. The final rule also states that the 
Assistant Secretary may change the designation of the MRO at will.
    The final rule includes several changes to paragraph (c)(2), OSHA 
Medical Records Officer. Some of these changes transfer specific 
responsibilities from the Assistant Secretary to the MRO while other 
responsibilities assigned to the MRO in Sec.  1913.10(c)(2) are carried 
over from the previous regulation.
    The final rule amends paragraph (c)(2) to provide that the MRO is 
now responsible for the overall administration and implementation of 
the procedures contained in Sec.  1913.10. OSHA believes there are two 
central principles that form the basis of the procedural requirements 
in Sec.  1913.10: (1) There should be a thorough review of all efforts 
to examine or copy personally identifiable employee medical information 
before the information is obtained and (2) personally identifiable 
information must be carefully protected once obtained. OSHA also 
believes the MRO is in the best position to ensure that the central 
principles of Sec.  1913.10 are carried out by the agency.
    As already noted, paragraph (c)(1) of the final rule, like the 
previous regulation, provides that the MRO must have experience and 
training in the evaluation, use, and privacy protection of medical 
records. Historically, a physician from OSHA's Office of Occupational 
Medicine and Nursing (OOMN) has been designated as MRO, and, in most 
cases, the person designated has been the Director of OOMN. As a 
result, the MRO has had an extensive background in both medicine and 
administration.
    Additionally, under the previous regulation, the MRO was already 
responsible for ensuring the sufficiency and justification of MAOs and 
making recommendations to the Assistant Secretary on whether to approve 
or deny such documents. The MRO also has several duties set forth 
throughout the other paragraphs in Sec.  1913.10 and therefore has a 
good understanding of the day-to-day implementation of the regulation.
    Under the final rule, the MRO will now be responsible for making 
determinations regarding whether to approve or deny MAOs, any inter-
agency transfer, and public disclosures of personally identifiable 
employee medical information, as well as whether to issue written 
directives authorizing OSHA personnel to conduct limited review of 
certain medical information without an MAO. Accordingly, the extensive 
medical and administrative experience, the responsibilities under the 
previous regulation, and the new responsibilities assigned by this 
final rule make the MRO the logical OSHA official to have 
responsibility for the overall administration and implementation of the 
procedures in Sec.  1913.10.
    While the final rule limits the role of the Assistant Secretary in 
the day-to-day implementation of Sec.  1913.10, the Assistant Secretary 
still maintains an important oversight responsibility. As in the 
previous regulation, the Assistant Secretary retains the responsibility 
for naming an OSHA official as MRO, with the ability to replace the MRO 
at will, and the MRO must still report to the Assistant Secretary on 
matters related to Sec.  1913.10. In practice, the MRO will continue to 
consult with the Assistant Secretary on MAO approval, inter-agency 
transfers, and public disclosures of personally identifiable employee 
medical information. In addition, paragraph (l) requires the MRO to 
prepare an annual report for the Assistant Secretary on matters related 
to the approval and purpose of MAOs, objections to MAOs, and inter-
agency transfers and public disclosures during the previous year. The 
responsibility to designate an OSHA official as MRO, continued 
consultation, and receiving reports from the MRO will keep the 
Assistant Secretary informed about OSHA's overall implementation of 
Sec.  1913.10. Accordingly, like the previous regulation, the final 
rule at paragraph (c)(2) provides that the MRO is responsible for 
reporting directly to the Assistant Secretary on matters concerning 
Sec.  1913.10.
    Under the final rule, the MRO is also now responsible for making 
determinations concerning (1) access to personally identifiable 
employee medical information and (2) interagency transfer or public 
disclosure of personally identifiable employee medical information. 
These two responsibilities had been assigned to the Assistant Secretary 
in previous Sec.  1913.10(c)(1).
    Section 1913.10(c)(2)(i) of the final rule states that the MRO is 
responsible for making determinations concerning

[[Page 45785]]

OSHA access to personally identifiable employee medical information 
under Sec.  1913.10(d). Paragraph (d) addresses OSHA access to 
personally identifiable employee medical information by MAO.
    With the exception of two circumstances described at the end of 
paragraph (d), each request by OSHA to examine or copy personally 
identifiable employee medical information is made pursuant to an MAO. 
Paragraph (d)(2) sets criteria the agency must follow when it seeks 
access to identifiable medical information, and paragraph (d)(3) sets 
forth the content to be included in the MAO. In order to be valid, an 
MAO must be approved by the MRO using the criteria in paragraph (d)(2). 
First, the MRO must consider whether the information to be examined or 
copied is relevant to a statutory purpose and whether there is a need 
to gain access to the information. The MRO has the responsibility, on a 
case-by-case basis, to ensure that access is sought only where there is 
a genuine need to do so. OSHA believes that a finding of relevance and 
need by the MRO is a significant safeguard against excessive use of the 
agency's authority to access personally identifiable employee medical 
information.
    Paragraph (d)(2) next states that consideration must be given to 
whether the personally identifiable employee medical information 
subject to the MAO is limited to only that information needed to 
accomplish the purpose for access. This provision is aimed at 
preventing OSHA access to extraneous medical information unrelated to 
the purpose for access. Lastly, paragraph (d)(2) states that the MRO 
must determine that the personnel authorized to review the medical 
information are limited to those who have a need for access and have 
appropriate professional qualifications. The limiting of personnel that 
can review and analyze information to only those who have a need for 
access and who have appropriate professional qualifications is 
important for maintaining the confidentiality of employee medical 
records.
    OSHA believes the MRO is in the best position to evaluate the 
criteria in paragraph (d) and make determinations on whether to approve 
or deny MAOs. Typically, the MRO has extensive subject-matter clinical 
experience and expertise in occupational medicine. This allows the MRO 
to evaluate whether, and to what extent, employee medical information 
needs to be accessed by OSHA. Accordingly, paragraph (d)(2) has been 
amended to state that, before approving an MAO, the MRO must determine 
that the documents meet the criteria in that paragraph.
    For similar reasons, the MRO is also now responsible for making 
determinations concerning inter-agency transfer and public disclosure 
of personally identifiable employee medical information. Section 
1913.10(m) describes the circumstances under which personally 
identifiable employee medical information can be transferred to another 
agency or disclosed to the public. The requirements in paragraph (m) 
remain unchanged from the previous regulation. However, the provisions 
in paragraph (m), as well as paragraph (c)(2), are amended by the final 
rule to provide that the MRO, not the Assistant Secretary, is now 
responsible for making determinations regarding inter-agency transfer 
and public disclosure of personally identifiable employee medical 
information. The individual provisions in paragraph (m) are amended to 
cross reference with the new MRO responsibility established in Sec.  
1913.10(c)(2)(vii).
    The following discussion of the individual provisions in paragraph 
(m) clarifies the MRO's new responsibility for making determinations 
concerning inter-agency transfer and public disclosure set forth in 
Sec.  1913.10(c)(2). The previous regulation at Sec.  1913.10(m)(1) 
stated that personally identifiable employee medical information shall 
not be transferred to another agency or office outside of OSHA (other 
than the Office of the Solicitor of Labor) or disclosed to the public 
(other than to the affected employee or the original recordholder) 
except when required by law or when approved by the Assistant 
Secretary. The final rule amends paragraph (c)(2)(vii) to make clear 
that the MRO is now responsible for making these determinations. The 
final rule also amends paragraph (m) to provide that the MRO must 
follow specific criteria when making determinations concerning inter-
agency transfer and public disclosure of personally identifiable 
employee medical information.
    OSHA's longstanding position is that inter-agency transfer and 
public disclosure of personally identifiable employee medical 
information should be carefully considered, and paragraph (m) addresses 
these issues. Inter-agency transfer and public disclosure of personally 
identifiable employee medical information are not categorically 
prohibited by the regulation for two reasons. OSHA believes (1) it 
cannot legally make such a commitment and (2) situations arise where 
transfer or disclosure is appropriate. Under certain circumstances, as 
a matter of law, OSHA is compelled to transfer information to another 
agency or disclose it to a non-governmental individual. For example, 
OSHA might be required to provide the information in response to a 
lawful subpoena. In other circumstances, disclosure may also be 
appropriate. For example, in order to resolve a public health problem, 
OSHA may need to transfer employee medical information to another 
federal or state agency. In such situations, the transfer of employee 
medical information may be critical in identifying an emerging health 
issue, compiling data on worker fatalities from specific exposure, or 
evaluating the effectiveness of workplace controls designed to prevent 
occupational illness at manufacturing facilities.
    OSHA notes that inter-agency transfer and public disclosure of 
personally identifiable employee medical information is not a common 
occurrence. In the last five years, the agency has made only three 
inter-agency transfers of personally identifiable employee medical 
information to another federal or state agency. OSHA also notes that 
inter-agency transfer and public disclosure of employee medical 
information not in personally identifiable form is not subject to 
provisions in Sec.  1913.10.
    Paragraph (m) of Sec.  1913.10 includes strict limitations on 
inter-agency sharing and public disclosure of employee medical 
information. Except when required by law, all inter-agency transfer or 
public disclosure of personally identifiable employee medical 
information must be approved by the MRO in accordance with the criteria 
in paragraph (m).
    Paragraph (m)(2) states that, except as provided for in paragraph 
(m)(3), the MRO shall not approve a request for an inter-agency 
transfer, which has not been consented to by the affected employee, 
unless the request is by a public health agency. Under this provision, 
transfer of medical information is permitted only to a public health 
agency for a substantial public health purpose. The regulation goes on 
to state that the MRO can approve the transfer only if the public 
health agency (1) needs the information for substantial public health 
purposes, (2) will not use the information to make individual 
determinations concerning affected employees which could be to their 
detriment, (3) has regulations or written established procedures 
providing protection for personally identifiable medical information 
substantially equivalent to Sec.  1913.10,

[[Page 45786]]

and (4) satisfies an exemption to the Privacy Act to the extent the 
Privacy Act applies to the requested information.
    Because OSHA collects medical information only for a public health 
purpose, OSHA believes it is appropriate to restrict all subsequent 
discretionary transfers to those agencies with an equivalent public 
health purpose. The MRO must review each request for a transfer on a 
case-by-case basis by taking into account each of the listed criteria 
in paragraph (m)(2). Most importantly, in order to protect individual 
privacy, the MRO must be satisfied that the recipient agency's privacy 
protections are equivalent to OSHA's.
    Paragraph (m)(3) contains two exceptions to the requirements of 
paragraph (m)(2). First, upon the approval of the MRO, personally 
identifiable employee medical information can be shared with the 
National Institute for Occupational Safety and Health (NIOSH). Like 
OSHA, NIOSH is a public health agency and its research activities 
complement OSHA's regulatory responsibilities. OSHA's ability to 
analyze employee medical records is often improved by gaining NIOSH 
assistance, and medical information collected by OSHA may have major 
research value for NIOSH. Also, because of its frequent use of medical 
information, and sensitivity to individual privacy, NIOSH has 
procedures in place that provide for the protection of personally 
identifiable medical information that are substantially equivalent to 
Sec.  1913.10. As a result, employee medical information may be 
transferred to NIOSH if approved by the MRO without further inquiry 
into the sufficiency of its programs for protecting medical records.
    Paragraph (m)(3) also permits, upon the approval of the MRO, the 
inter-agency transfer of personally identifiable employee medical 
information to the U.S. Department of Justice when necessary with 
respect to a specific action under the OSH Act. For example, the 
Justice Department prosecutes criminal violations under the OSH Act, as 
well as civil penalty collection actions. The Justice Department also 
represents OSHA in Freedom of Information Act (FOIA) lawsuits. 
Personally identifiable employee medical information may be relevant in 
these legal actions, and OSHA must be able to share information in 
these circumstances.
    Paragraphs (m)(4) and (5) address public disclosure of personally 
identifiable employee medical information which has not been consented 
to by the affected employee. Paragraph (m)(4) provides that the MRO 
shall not approve a request for public disclosure of employee medical 
information containing personal identifiers unless there are compelling 
circumstances affecting the health or safety of an individual. Also, 
paragraph (m)(5) states that the MRO shall not approve a request for 
public disclosure of employee medical information which contains 
information which could reasonably be used indirectly to identify 
specific employees when the disclosure would constitute a clearly 
unwarranted invasion of personal privacy. Finally, paragraph (m)(6) 
retains the provision from the previous regulation that, except as to 
inter-agency transfer to NIOSH or the Department of Justice, the MRO 
shall ensure that advance notice is provided to any collective 
bargaining agent representing affected employees and to the employer on 
each occasion OSHA intends to transfer personally identifiable employee 
medical information to another agency or disclose it to a member of the 
public other than to an affected employee. When feasible, the MRO must 
take reasonable steps to assure that advance notice is provided to 
affected employees when the employees' medical information to be 
transferred or disclosed contains direct personal identifiers.
    Finally, the final rule at Sec.  1913.10(c)(2) retains several 
provisions from the previous regulation. Specifically, paragraph 
(c)(2)(iii) continues to provide that the MRO is responsible for 
responding to MAO objections, and paragraph (c)(2)(iv) continues to 
provide that the MRO is responsible for overseeing the internal use and 
security of personally identifiable employee medical information. Two 
other MRO responsibilities in paragraph (c)(2) have been retained from 
the previous regulation but have been renumbered under the final rule. 
Paragraph (c)(2)(v), formerly paragraph (c)(2)(vi), continues to 
provide that the MRO is responsible for assuring that the results of 
agency analyses of personally identifiable medical information are, 
where appropriate, communicated to employees. Paragraph (c)(2)(vi), 
formerly paragraph (c)(2)(vii), retains the provision that the MRO is 
responsible for preparing an annual report of OSHA's experience under 
Sec.  1913.10.

Section 1913.10(d)(1)--Requirements for Medical Access Orders

    OSHA's previous regulation at Sec.  1913.10(d)(1) stated that, 
except as provided in paragraph (d)(4), each request by an OSHA 
representative to examine or copy personally identifiable employee 
medical information contained in a record held by an employer or other 
record holder shall be made pursuant to a written access order which 
has been approved by the Assistant Secretary upon the recommendation of 
the OSHA Medical Records Officer. Paragraph (d)(1) went on to state 
that, if deemed appropriate, a written access order may constitute, or 
be accompanied by, an administrative subpoena.
    As explained above, the MRO is now responsible for the approval or 
denial of MAOs, and paragraph (d)(1) has been revised to reflect this 
change. The final rule also amends paragraph (d)(1) to make clear that 
a MAO does not constitute an administrative subpoena.
    An administrative subpoena is a written order issued by OSHA to 
require an employer, or any other person, to produce listed records, 
documents, testimony and/or other supporting evidence relevant to an 
inspection or investigation under the OSH Act. If the person served 
with a subpoena refuses to honor (or only partially honors) the order, 
the subpoena is subject to judicial review and enforcement by a U.S. 
District Court. OSHA Regional Administrators have authority to issue 
administrative subpoenas and are also authorized to delegate to Area 
Directors the authority to issue routine administrative subpoenas. 
OSHA's policies and procedures for issuing an administrative subpoena 
are set forth in OSHA Instruction ADM 01-00-002, August 19, 1991.
    In contrast, a MAO is an authorization for specified OSHA personnel 
to examine or copy personally identifiable employee medical information 
contained in a record held by an employer or some other record holder. 
Since an MAO relates to internal OSHA procedures, it cannot be used to 
compel the production of records, nor be enforced in a U.S. District 
Court. Historically, OSHA has not treated an MAO as equivalent to an 
administrative subpoena. OSHA's longstanding practice has been to rely 
on an administrative subpoena to compel production of medical records 
by employers. See OSHA's August 22, 2007, Instruction CPL 02-02-072, 
Rules of agency practice and procedure concerning OSHA access to 
employee medical records. MAOs set forth internal OSHA procedure for 
assuring appropriate confidentiality of medical records is observed by 
OSHA personnel. As a result, except when reasonably certain that the 
employer will grant access to employee medical

[[Page 45787]]

information, OSHA personnel present an administrative subpoena to the 
employer concurrently with an MAO.
    The final rule amends Sec.  1913.10(d)(1) to state that except as 
provided in paragraph (d)(4), each request by an OSHA representative to 
examine or copy personally identifiable employee medical information 
contained in a record held by an employer or other recordholder shall 
be made pursuant to a written medical access order which has been 
approved by the OSHA Medical Records Officer. A medical access order 
does not constitute an administrative subpoena.

Section 1913.10(g)--Removal of Direct Personal Identifiers

    OSHA's previous regulation at Sec.  1913.10(g) provided that all 
direct personal identifiers (e.g., name, address, Social Security 
Number, payroll number) must be removed by OSHA personnel whenever 
employee medical information obtained pursuant to a written access 
order is taken off-site, unless otherwise directed by the MRO. The 
regulation also required the Principal OSHA Investigator to code the 
medical information and the list of direct personal identifiers with a 
unique identifying number for each employee and then hand deliver or 
mail the list of identifiers to the MRO. The MRO thereafter controlled 
the use and distribution of the list of coded identifiers to those with 
a need to know its contents. In addition, the numerical coded medical 
information was to be used and kept secured as though still in a 
directly identifiable form.
    Paragraph (g) was originally promulgated by OSHA when the rules of 
agency practice and procedure were issued in 1980. At that time, 
electronic medical records did not exist, and the employee records that 
did exist were maintained almost entirely in paper form. Since 1980, 
the number of medical records maintained by employers and other record 
holders has substantially increased, and the majority of these records 
are now maintained in electronic form.
    The final rule revises Sec.  1913.10 by deleting the outdated 
procedures set forth in paragraph (g). OSHA is eliminating this 
internal requirement for several reasons. First, existing access and 
safeguarding requirements in Sec.  1913.10 already address privacy 
concerns when OSHA takes medical information away from a workplace for 
off-site review. Specifically, paragraph (h) of Sec.  1913.10 provides 
that only authorized personnel may examine or copy personally 
identifiable employee medical information. As explained below, OSHA 
experience is that this process can result in coding and re-coding 
errors in individual employee medical records. Likewise, it provides 
that, unless an exception applies, OSHA personnel and contractors are 
authorized to use information only for the purpose for which it was 
obtained. In addition, paragraph (h)(5) states that, whenever 
practicable, the examination of personally identifiable employee 
medical information shall be conducted on-site with a minimum of 
medical information taken off-site in a personally identifiable form.
    Additionally, paragraph (i) of Sec.  1913.10 includes security 
procedures for handling personally identifiable employee medical 
information. For example, paragraph (i)(1) provides that files 
containing personally identifiable employee medical information shall 
be segregated from other agency files and, when not in active use, must 
be kept in a locked cabinet or vault. In practice, the locking 
requirement extends to when medical information is transported from the 
workplace, as OSHA personnel place records in a locked trunk during 
transport by automobile.
    Second, paragraph (n) of this final rule establishes new 
requirements for the access and safeguarding of personally identifiable 
employee medical information in electronic form. As discussed more 
extensively below, paragraph (n) of the final rule provides that the 
Principal OSHA Investigator is responsible for preventing any careless, 
accidental, or unintentional disclosure of, modification to, or 
destruction of electronic medical records. Paragraph (n)(3) of the 
final rule provides that the transfer and/or duplication of medical 
records in electronic form must be kept to the minimum necessary to 
accomplish the purpose for which it was obtained. Also, paragraph 
(n)(4) states that electronic files containing personally identifiable 
employee medical information shall be downloaded only to a computer 
hard drive or laptop that is secured (e.g., password protected). 
Paragraph (n)(4) now includes the Government standards that address 
secure access to Government systems and the data they contain: Federal 
Information Processing Standards (FIPS) 201-2, ``Personal Identity 
Verification (PIV) of Federal Employees and Contractors''; and HSPD-12, 
``Homeland Security Presidential Directive 12: Policy for a Common 
Identification Standard for Federal Employees and Contractors (HSPD-
12).''
    In addition, paragraph (n)(5) provides that electronic files 
containing personally identifiable employee medical information must be 
encrypted before transferred to authorized individuals. OSHA believes 
the safeguards for electronic medical records established by this final 
rule, which are based on existing OSHA practices and policy, enhance 
privacy protection and reduces the need to remove direct personal 
identifiers when OSHA personnel take personally identifiable employee 
medical information off-site.
    OSHA's experience is that de-identification increases the risk of 
mislabeling or misidentifying employee medical records and places a 
burden on agency resources by requiring additional OSHA staff time to 
accurately conduct de-identification and copying of employee medical 
records. In some cases, depending on the number of employees at a 
specific facility, OSHA employees may spend several hours finding and 
removing each direct personal identifier within each affected 
employee's medical record. The deletion of paragraph (g) will reduce 
the amount of time and physical space needed by OSHA personnel at a 
worksite.
    Finally, the deletion of de-identification procedures in paragraph 
(g) will simplify follow-up communication from authorized OSHA 
personnel with individual employees after evaluation of their medical 
information. For example, by not having to complete a potentially 
extensive de-identification process, critical medical information about 
an employee will be reviewed by an OSHA physician sooner, and this will 
allow the physician to conduct follow-up consultation with the employee 
in a timely manner. Also, because personally-identifiable information 
will remain in the medical records taken from a workplace for off-site 
review, it will make it easier for the OSHA physician to identify 
employees, compare associated records, and contact individual 
employees.
    For all of the above reasons, OSHA has concluded that the removal 
of direct personal identifier requirements in paragraph (g) should be 
deleted.

Section 1913.10(n)--Medical Records Maintained in Electronic Form

    In many cases, employers and other record holders maintain 
personally identifiable employee medical information in electronic 
form. OSHA's regulation at 29 CFR 1910.1020 provides that a ``record'' 
includes any item, collection, or grouping of information regardless of 
the form or process by which it is maintained (e.g., paper, document, 
microfilm, X-ray film, or

[[Page 45788]]

automated data processing). Medical records may also be maintained on 
media such as magnetic tape, computer disks, USB storage devices (e.g., 
thumb drives), and online computer storage. Historically, OSHA 
personnel have followed the requirements in 29 CFR 1913.10 when 
accessing personally identifiable employee medical information 
maintained in electronic form. However, the regulation did not include 
provisions that specifically addressed electronic medical records. The 
final rule establishes new internal policies and procedures in 
paragraph (n) to Sec.  1913.10 that specifically address OSHA access, 
use, and safeguarding of personally identifiable employee medical 
information maintained in electronic form.
    Since the rules of agency practice and procedure were first issued 
in 1980, medical professionals have increasingly relied on the use and 
storage of medical records in electronic form. These records tend to 
improve the quality of health care and have several practical 
advantages over paper records. For example, electronic medical records 
can be accessed by health care professionals at any time from any given 
location. Legible records can also lead to more accurate diagnosis, 
treatment, and drug prescription. Electronic medical records are cost-
effective because they take up less storage space and can be stored 
indefinitely. However, because they are in electronic form, these 
records also present unique challenges to security, privacy, and data 
integrity.
    OSHA believes the best way to protect the security and 
confidentiality of personally identifiable employee medical information 
in electronic form is to prevent unauthorized access to such 
information. Several effective administrative, technological, and 
physical measures can be taken to protect electronic medical 
information from unauthorized access, use, disclosure, disruption, 
modification, or destruction. These methods include establishing 
specific security roles and responsibilities for OSHA officials, 
technology safeguards such as encryption or firewalls to protect 
against electronic breaches, ID/password protection for devices and 
information systems, and the use of anti-virus and intrusion detection 
software. The establishment of new internal OSHA policies and 
procedures in paragraph (n) of this final rule will effectively protect 
the security, privacy, and data integrity of employee medical 
information in electronic form.
    Section 1913.10(n)(1) of the final rule provides that, in general, 
when accessing and/or copying personally identifiable employee medical 
information in electronic form, OSHA personnel shall follow the 
requirements set forth in 29 CFR 1913.10. As noted above, OSHA 
personnel have historically followed the rules of agency practice and 
procedure in Sec.  1913.10 when accessing employee medical information 
in electronic form, and many of the provisions in Sec.  1913.10 are 
applicable regardless of the format used to maintain information. As a 
result, unless specifically addressed in paragraph (n), OSHA personnel 
should continue to follow the rules of agency practice and procedure in 
paragraphs (a) through (m) when accessing and safeguarding electronic 
employee medical information.
    Section (n)(2) of the final rule includes responsibilities for the 
Principal OSHA Investigator when OSHA personnel access personally 
identifiable employee medical information in electronic form. 
Specifically, paragraph (n)(2) states that when personally identifiable 
employee medical information in electronic form is taken off-site, the 
Principal OSHA Investigator is primarily responsible for ensuring that 
such information is properly used and kept secured. This provision is 
based on the requirement in paragraph (h)(1) of Sec.  1913.10, which 
provides that the Principal OSHA Investigator is responsible for 
ensuring that medical information is used and kept secured in 
accordance with Sec.  1913.10. Other specific responsibilities assigned 
to the Principal OSHA Investigator in paragraph (n)(2) include 
preventing any accidental or unintentional disclosure of, modification 
to, or destruction of personally identifiable employee medical 
information in electronic form (paragraph (n)(2)(i)); controlling the 
flow of data into, through, and from agency computer operations 
(paragraph (n)(2)(ii)); and ensuring that distribution and review of 
medical information in electronic form is limited to only those OSHA 
personnel and contractors with a need for access (paragraph 
(n)(2)(iii)). The requirement in paragraph (n)(2)(iii) is derived from 
Sec.  1913.10(d)(2)(iii), which provides that, before approving a MAO, 
the MRO must determine that personnel authorized to review and analyze 
personally identifiable employee medical information are limited to 
those who have a need for access and have appropriate qualifications.
    As discussed above, the Principal OSHA Investigator is the OSHA 
employee in the field with primary responsibility for ensuring that the 
examination and use of employee medical information is in accordance 
with Sec.  1913.10. As such, the Principal OSHA Investigator is 
responsible for ensuring that the provisions in paragraph (n) are 
followed by OSHA personnel when electronic medical information is 
accessed from a specific workplace. For example, this would include 
ensuring that access to personally identifiable employee medical 
records in electronic form is limited to only authorized personnel with 
a need to review the information, ensuring that employee medical 
information is only downloaded to a secured device (e.g., password 
protected), and verifying that medical information is deleted or 
destroyed when no longer needed by the agency.
    Section 1913.10(n)(3) of the final rule provides that the transfer 
and/or duplication of medical information in electronic form shall be 
kept to the minimum necessary to accomplish the purpose for which it 
was obtained. This provision is similar to paragraph (i)(3) of Sec.  
1913.10, which states that the photocopying or other duplication of 
personally identifiable employee medical information shall be kept to 
the minimum necessary to accomplish the purpose for which the 
information was obtained.
    In some cases, personally identifiable employee medical information 
in electronic form needs to be transferred or duplicated to facilitate 
internal OSHA review. For example, in order to conduct a proper 
workplace inspection or investigation, it may be necessary for OSHA 
personnel to transfer employee medical records to another OSHA employee 
with expertise on a specific occupational health hazard. Paragraph 
(n)(3) of the final rule permits the transfer and duplication of 
electronic medical information but only to authorized individuals with 
a need to review the information. Transfer and duplication are also 
limited to the minimum necessary to accomplish the purpose for which it 
was obtained. An example of this limitation might include the review of 
a medical record to determine whether an employee has sustained a work-
related injury or illness. In such cases, review of a medical record 
would extend only to information about the employee's injury or 
illness. In this example, the transfer and/or duplication of electronic 
medical information unrelated to the injury or illness would not be 
permitted.
    Additionally, OSHA believes the likelihood that medical information 
in electronic form will be lost, altered, or destroyed increases during 
transfer or duplication. The duplication of electronic medical 
information can also

[[Page 45789]]

raise concern about data integrity. For example, the copying or 
deleting of employee medical information from one document to another 
raises concern about the accuracy of the information. Accordingly, 
personally identifiable electronic medical information should be 
transferred only to authorized individuals with a need to know the 
information and should be duplicated only to facilitate authorized 
internal agency review.
    Consistent with existing OSHA policy, Sec.  1913.10(n)(4) of the 
final rule states that electronic files containing personally 
identifiable employee medical information shall be downloaded only to a 
computer hard drive or laptop that is in accordance with Federal 
Information Processing Standard (FIPS) 201-2, ``Personal Identity 
Verification (PIV) of Federal Employees and Contractors,'' and 
``Homeland Security Presidential Directive 12: Policy for Common 
Identification Standard for Federal Employees and Contractors (HSPD-
12).'' The use of secured technology when downloading medical records 
will help to ensure that information is (1) accessed only by authorized 
individuals with a need-to-know and (2) not modified or deleted.
    In accordance with current OSHA and Federal Government policy, the 
use of password protection is easy to implement, cost-effective, and a 
reliable method for securing electronic information. By downloading 
employee medical information to a secured hard drive or laptop, OSHA 
personnel will be able to ensure that only individuals that know the 
password can open a document and read its content. This practice also 
provides a level of protection that goes with the document no matter 
where it is stored or sent. Finally, because tampering with a secured 
device takes time and effort, providing this level of protection acts 
as a deterrent to accessing document content by unauthorized 
individuals.
    Additionally, it is important for OSHA personnel to follow proper 
security practices when using password protected devices containing 
personally identifiable employee medical information. Authorized 
individuals must not share their ID with others, should log-off when 
leaving a terminal, and use their own ID to access employee medical 
records. Also, authorized individuals should not keep written 
facsimiles of passwords or access codes. Other security measures, such 
as the use of firewalls, anti-virus software, and intrusion detection 
software should also be used to protect data integrity. Again, the 
Principal OSHA Investigator is responsible for ensuring that proper 
security measures are in place in the field to protect the 
confidentiality of personally identifiable employee medical records in 
electronic form.
    Moreover, it is critically important that mobile devices be 
encrypted or use password protection when used to download, transfer, 
or store electronic medical information. Mobile devices are for 
individual use, and are not designed for centralized IT management. 
These devices can easily be manipulated, damaged, or stolen. By 
encryption, OSHA means the process of changing plain text into cypher 
text for the purpose of security. The use of encryption results in the 
encoding of information in such a way so that only authorized 
individuals can access the information.
    Section 1913.10(n)(5) of the final rule states that electronic 
files containing personally identifiable employee medical information 
shall not be transferred to authorized personnel through email 
attachment unless appropriately encrypted. The transfer of employee 
medical information by email attachment increases the risk that such 
information will be sent to an unauthorized individual. The transfer of 
personally identifiable employee medical information in electronic form 
must be made through secured means. See Sec.  1913.10(n)(4), discussed 
above (``Electronic files containing personally identifiable employee 
medical information shall only be downloaded to a computer hard drive 
or laptop that is secured.''). Appropriate methods for the transfer of 
personally identifiable employee medical information in electronic form 
may include the use of password protected or encrypted files on a 
secured agency website designed for confidential information, the 
mailing of encrypted computer disks or USB drives, the emailing of 
password protected medical records (Adobe secured), and the printing 
and hand delivery of paper records.
    Paragraph (n)(6) provides that when an employer or other record 
holder(s) provides access to employee medical information through a 
properly encrypted email attachment, the attachment shall be downloaded 
to a secured hard drive or laptop. After the attachment is downloaded, 
the email shall be permanently deleted.
    In some cases, employers and other record holders provide OSHA with 
access to employee medical information through an encrypted email 
attachment. As noted above, the use of email attachments to transfer 
medical records makes it more likely that the information will be sent 
to unauthorized individuals. Paragraph (n)(6) ensures that medical 
information received in an encrypted email attachment is downloaded to 
a secured device.
    After downloading the attachment from the employer or other record 
holder, the email must be permanently deleted to prevent transfer to 
unauthorized individuals. By permanently deleted, OSHA means that the 
email should be deleted so that it cannot be retrieved. Some email 
programs automatically delete trashed emails after a certain amount of 
time. Other programs retain emails until the user runs out of space. 
However, the intent of this provision is that, once the attachment is 
downloaded, OSHA personnel should immediately and permanently delete 
the incoming email. Most email programs have a ``delete forever'' 
function that allows the user to select emails in the trash folder for 
permanent deletion.
    Section 1913.10(n)(7) of the final rule states that personally 
identifiable employee medical information in electronic form shall be 
secured when not in use. This provision is based on paragraph (i)(1) of 
Sec.  1913.10, which states that agency files containing personally 
identifiable employee medical information shall be segregated from 
other agency files, and when not in active use, files containing this 
information shall be kept secured in a locked cabinet or vault. 
Paragraph (n)(7) is intended to prevent unauthorized access or 
modification to employee medical information in electronic form. In 
addition to all of the procedures in paragraph (n) addressing the use 
of electronic information by OSHA personnel, when not in use, such 
information must be stored in a secured manner. For example, when not 
in use, personally identifiable employee medical information should be 
stored on a password protected hard drive or laptop. Another example 
might be the storing of information on a password protected agency 
website designed to store confidential information. Also, if employee 
medical records are kept on computer disk or other electronic storage 
media, when not in use, the disk or media should be stored under lock 
and key. Paragraph (n)(7)(i) of the final rule also emphasizes the 
importance of proper storage by specifically stating that medical 
information in electronic form shall only be maintained or stored where 
facilities and conditions are designed to prevent unauthorized access.
    Paragraph (n)(7)(ii) provides that personally identifiable employee 
medical information in electronic form shall be maintained only for so 
long as

[[Page 45790]]

needed to accomplish the purpose for access. This provision is derived 
from paragraph (j)(1) of Sec.  1913.10, which provides that consistent 
with OSHA records disposition programs, personally identifiable 
employee medical information shall be destroyed or returned to the 
original record holder when no longer needed for the purposes for which 
they were obtained. In OSHA's view, maintaining medical records only 
for so long as needed helps to ensure that such information will not be 
accessed by unauthorized individuals.
    In some cases, after its initial use by the agency, personally 
identifiable employee medical information may not be used again until 
sometime in the future. For example, medical information used as the 
basis for an OSHA citation may be used during the hearing stage of an 
enforcement case before the Occupational Safety and Health Review 
Commission. The medical information may not be used while the case is 
on appeal, but there may be a need for the information if the case is 
remanded for further judicial proceedings. Similarly, an investigation 
of an apparently new health hazard may produce uncertain results. 
Before completely closing out this investigation, it may be appropriate 
to await the outcome of an ongoing research study or parallel 
investigation elsewhere in the country. In these cases, Sec.  
1913.10(j) provides that the medical information should be transferred 
to the MRO. Also, under Sec.  1913.10(l)(2), the MRO must conduct an 
annual review of all centrally-held information to determine which 
information is no longer needed for the purposes for which it was 
obtained. These requirements apply equally to personally identifiable 
employee medical information stored in electronic form.
    Paragraph (n)(7)(iii) of the final rules states that when no longer 
needed, the Principal OSHA Investigator shall ensure that all 
personally identifiable employee medical information on electric files 
has been deleted, destroyed, or returned to the original record holder. 
The requirement in paragraph (n)(7)(iii) is intended to ensure that the 
Principal OSHA Investigator is responsible for OSHA access and use of 
electronic medical information from beginning to end. When no longer 
needed, the Principal OSHA Investigator must make sure that authorized 
OSHA personnel follow proper procedures for the deletion, destruction 
and disposal of personally identifiable employee medical information. 
In practice, the Principal OSHA Investigator must ensure that media 
containing employee medical information is sanitized or destroyed 
before disposal or release for reuse in accordance with approved 
methods. In addition, if electronic medical records are returned to the 
original record holder, the Principal OSHA Investigator must ensure 
that all data is returned, and no data remains in the possession of 
OSHA personnel.
    Paragraph (n)(7)(iv) states that the disposal of personally 
identifiable employee medical information maintained in electronic form 
shall be accomplished in such a manner as to make the data unattainable 
by unauthorized personnel. When no longer needed, electronic media must 
be handled and sanitized appropriately to prevent unauthorized 
disclosure or modification of personally identifiable employee medical 
information.
    OSHA personnel use several types of electronic media to access, 
use, and maintain personally identifiable employee medical information, 
including hard drives, laptops, USB storage drives (e.g., thumb 
drives), CDs, DVDs, and digital storage cards such as camera cards. In 
order to meet the requirement in paragraph (n)(7)(iv), and depending on 
the type of electronic media used, OSHA personnel may need to re-use, 
recycle, or destroy the electronic media containing medical 
information. Also, when employee medical information in electronic form 
is no longer needed, it is important to ensure that deleted data is not 
easily recoverable. Residual data may allow unauthorized individuals to 
reconstruct data and thereby gain access to personally identifiable 
employee medical information. Sanitization is one method that can be 
used to ensure that deleted data cannot be reconstructed.
    Sanitization is the general process of removing data from storage 
media, such that there is reasonable assurance that the data may not be 
easily retrieved and reconstructed. There are different types of 
sanitization for each type of media, including cleaning, purging, and 
destroying. Cleaning is the removal of data from devices in such a way 
that there is assurance that the data cannot be reconstructed using 
normal system functions or software file/data recovery utilities. For 
example, cleaning may include using software or hardware products to 
overwhelm media with non-sensitive data. Purging is generally done 
before releasing media beyond control, such as before discarding old 
media, and includes degaussing or exposing media to a strong magnetic 
field in order to disrupt recorded magnetic domains. Destruction of 
media is the ultimate form of sanitization.
    In some cases, OSHA personnel maintain employee medical information 
on media that may not be able to be reused such as computer disks and 
camera cards. In these situations, when no longer needed, electronic 
media containing personally identifiable employee medical information 
should be disposed of using approved secure data destruction. Several 
methods exist to dispose of electronic media containing medical 
information. For example, computer disks can be rendered unusable by 
shredding, incinerating, or pulverizing. Many OSHA Regional and Area 
Offices already have equipment that can shred or burn disks. Other 
offices contract with private companies to perform this task in a 
secure manner. As a reminder, in order to address security and privacy 
concerns, disposal operations should be conducted in accordance with 
approved DOL or OSHA methods. In addition, OSHA is responsible for the 
management of records pursuant to the Federal Records Act of 1950, as 
amended (44 U.S.C. Chapters 21, 29, 31, 33). The retention and 
destruction of Federal records must be conducted in accordance with the 
procedures described in the Federal Records Act.
    Finally, in the future, OSHA personnel will be using media types 
not specifically mentioned in this preamble. The processes mentioned in 
this document should guide media sanitization and disposal decisions 
regardless of the type of media in use. In the future, OSHA will issue 
guidance to agency staff as new technology is developed.

IV. State Plans

    The 28 states and U.S. territories with their own OSHA-approved 
occupational safety and health plans are encouraged, but not required, 
to adopt these rules of agency practice and procedure concerning 
employee medical record access that Federal OSHA is promulgating to 29 
CFR 1913.10 in this final rule. The states and U.S. territories with 
OSHA-approved occupational safety and health plans covering private 
employees and state and local government employees are Alaska, Arizona, 
California, Hawaii, Indiana, Iowa, Kentucky, Maryland, Michigan, 
Minnesota, Nevada, New Mexico, North Carolina, Oregon, Puerto Rico, 
South Carolina, Tennessee, Utah, Vermont, Virginia, Washington, and 
Wyoming. In addition, six states and U.S. territories have OSHA-
approved state Plans that apply to state and local government employees 
only: Connecticut, Illinois,

[[Page 45791]]

Maine, New Jersey, New York, and the Virgin Islands.
    This final rule describes a Federal program change for which State 
Plan adoption is not required. However, State Plans are required to 
have standards, and an enforcement program, that are ``at least as 
effective in providing safe and healthful employment'' as those of 
Federal OSHA. In order to be ``at least as effective'' as Federal OSHA, 
a State Plan must appropriately utilize its authority for access to 
medical records, and must have effective procedures to assure that the 
privacy of those records is protected in a manner consistent with 
applicable state and federal privacy laws. Therefore, although adoption 
of this rule is not required, State Plans must have procedures covering 
this issue that are at least as effective as those of Federal OSHA and 
are encouraged to adopt requirements comparable to those in 29 CFR 
1913.10.
    Within 60 days of the effective date of this final rule, a State 
Plan must submit a notice of intent indicating whether they already 
have a similar policy in place, intend to adopt new policies and 
procedures, or do not intend to adopt this final rule. If a State Plan 
does not adopt at first, but at some later point decides to adopt this 
final rule or an at least as effective version of this final rule, the 
State Plan must notify OSHA of this change in intent. Within 60 days of 
adoption, the State Plan must provide an electronic copy of the 
regulation or policy, or a link to where their policy is posted on the 
State Plan's website. The State Plan must also provide the date of 
adoption and identify differences, if any, between their policy and 
this final rule. OSHA will provide summary information on the State 
Plan responses to this instruction on its website at: www.osha.gov/dcsp/osp/.

V. Regulatory Flexibility Certification

    The notice and comment procedures of section 553 of the APA do not 
apply ``to interpretative rules, general statements of policy, or rules 
of agency organization, procedure, or practice.'' 5 U.S.C. 553(b)(A). 
Rules that are exempt from APA notice and comment requirements are also 
exempt from the Regulatory Flexibility Act (RFA). See SBA Office of 
Advocacy, A Guide for Government Agencies: How to Comply with the 
Regulatory Flexibility Act (August 2017); also found at https://www.sba.gov/sites/default/files/rfaguide5F05125F0.pdf. This is a rule 
of agency procedure, practice, and interpretation within the meaning of 
that section; and therefore, is exempt from both the notice and comment 
rulemaking procedures of the APA and the requirements of the RFA.

VI. Environmental Impact Analysis

    In accordance with the requirements of the National Environmental 
Policy Act (NEPA) (42 U.S.C. 4231 et seq.), Council on Environmental 
Quality NEPA regulations (40 CFR parts 1500 through 1518), and the 
Department of Labor NEPA regulations (29 CFR part 11), OSHA has 
determined that this final rule will not have a significant impact on 
the external environment.

VII. Federalism

    OSHA reviewed this final rule in accordance with the most recent 
Executive order on federalism (Executive Order 13132, 64 FR 43255, 
August 10, 1999). This Executive order requires Federal agencies, to 
the extent possible, to refrain from limiting state policy options, 
consult with states prior to taking any action that would restrict 
state policy options, and take such actions only when clear 
constitutional authority exists and the problem is national in scope.
    This rule does not have ``federalism implications.'' The rule does 
not have ``substantial direct effects on the States, on the 
relationship between the National Government and the States, or on the 
distribution of power and responsibilities among the various levels of 
government'' and therefore is not subject to Executive Order 13132 
(Federalism).

VIII. Unfunded Mandates

    The Department has concluded that this rule is not a ``significant 
regulatory action'' within the meaning of Executive Order 12866, 
reaffirmed by Executive Order 13563, because it is not likely to (1) 
have an annual effect on the economy of $100 million or more or 
adversely affect in a material way the economy, a sector of the 
economy, productivity, competition, jobs, the environment, public 
health or safety, or state, local, or Tribal governments or 
communities; (2) create a serious inconsistency or otherwise interfere 
with an action taken or planned by another agency; (3) materially alter 
the budgetary impact of entitlements, grants, user fees, or loan 
programs or the rights and obligations of recipients thereof; or (4) 
raise novel legal or policy issues arising out of legal mandates, the 
President's priorities, or the principles set forth in Executive Order 
12866. Therefore, no economic impact analysis under section 6(a)(3)(C) 
of Executive Order 12866 has been prepared. For the same reason, and 
because no notice of proposed rulemaking was published, no statement is 
required under section 202 of the Unfunded Mandates Reform Act of 1995, 
2 U.S.C. 1532. In any event, this rulemaking is procedural and 
interpretive in nature and is thus not expected to have a significant 
economic impact.

IX. Consultation and Coordination With Indian Tribal Governments

    OSHA reviewed this rule in accordance with Executive Order 13175 
(65 FR 67249, November 6, 2000) and determined that it does not have 
``tribal implications'' as defined in that order. The rule does not 
have substantial direct effects on one or more Indian tribes, on the 
relationship between the Federal Government and Indian tribes, or on 
the distribution of power and responsibilities between the Federal 
Government and Indian tribes.

X. Office of Management and Budget Review Under the Paperwork Reduction 
Act of 1995

    The Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501 et seq.) 
and OMB regulations (5 CFR part 1320) require agencies to obtain 
approval from OMB before conducting any collection of information. The 
PRA defines a ``collection of information'' as ``the obtaining, causing 
to be obtained, soliciting, or requiring the disclosure to third 
parties or the public of facts or opinions by or for an agency 
regardless of form or format'' (44 U.S.C. 3502(3)(A)). The PRA does not 
apply to this final rule because it amends existing internal agency 
procedures and does not impose any new recordkeeping or information 
collection requirements that require OMB approval.

Authority and Signature

    This document was prepared under the direction of Loren Sweatt, 
Principal Deputy Assistant Secretary for Occupational Safety and 
Health. It is issued under Section 8 of the Occupational Safety and 
Health Act (29 U.S.C. 657), 5 U.S.C. 553, 5 U.S.C. 552a(e), 5 U.S.C. 
301, and Secretary of Labor's Order No. 5-2012 (77 FR 3912).

    Signed at Washington, DC, on July 14, 2020.
Loren Sweatt,
Principal Deputy Assistant Secretary of Labor for Occupational Safety 
and Health.

Final Rule

    Part 1913 of title 29 of the Code of Federal Regulations is hereby 
amended as follows:

[[Page 45792]]

PART 1913--[AMENDED]

0
1. The authority citation for part 1913 is revised to read as follows:

    Authority:  29 U.S.C. 657; 5 U.S.C. 553; 5 U.S.C. 301; Secretary 
of Labor's Order No. 8-76 (41 FR 25059), 5-2002 (67 FR 65008), or 1-
2012 (77 FR 3912) as applicable.


0
2. Amend Sec.  1913.10 by:
0
a. Revising paragraphs (b)(6), (c)(1) and (2), and (d)(1) and (2);
0
b. Removing and reserving paragraph (g);
0
c. Revising paragraph (m); and
0
d. Adding paragraph (n).
    The revisions and addition read as follows:


Sec.  1913.10   Rules of agency practice and procedure concerning OSHA 
access to employee medical records.

* * * * *
    (b) * * *
    (6) This section does not apply where a written directive by the 
OSHA Medical Records Officer authorizes appropriately qualified 
personnel to conduct limited reviews of specific medical information 
mandated by an occupational safety and health standard, or of specific 
biological monitoring test results.
* * * * *
    (c) * * *
    (1) Assistant Secretary. The Assistant Secretary of Labor for 
Occupational Safety and Health (Assistant Secretary) shall designate an 
OSHA official with experience or training in the evaluation, use, and 
privacy protection of medical records to be the OSHA Medical Records 
Officer. The Assistant Secretary may change the designation of the OSHA 
Medical Records Officer at will.
    (2) OSHA Medical Records Officer. The OSHA Medical Records Officer 
shall be responsible for the overall administration and implementation 
of the procedures contained in this section. The OSHA Medical Records 
Officer shall report directly to the Assistant Secretary on matters 
concerning this section and be responsible for:
    (i) Making final determinations concerning the approval or denial 
of medical access orders (paragraph (d) of this section);
    (ii) Assuring that medical access orders meet the requirements of 
paragraphs (d)(2) and (3) of this section;
    (iii) Responding to objections concerning medical access orders 
(paragraph (f) of this section);
    (iv) Overseeing internal agency use and security of personally 
identifiable employee medical information (paragraphs (g) through (j) 
of this section);
    (v) Assuring that the results of agency analyses of personally 
identifiable medical information are, where appropriate, communicated 
to employees (paragraph (k) of this section);
    (vi) Preparing an annual report of OSHA's experience under this 
section (paragraph (l) of this section); and
    (vii) Making final determinations concerning inter-agency transfer 
or public disclosure of personally identifiable employee medical 
information (paragraph (m) of this section). The Medical Records 
Officer shall also assure that advance notice is given of intended 
inter-agency transfers or public disclosures.
* * * * *
    (d) * * *
    (1) Requirement for medical access order. Except as provided in 
paragraph (d)(4) of this section, each request by an OSHA 
representative to examine or copy personally identifiable employee 
medical information contained in a record held by an employer or other 
recordholder shall be made pursuant to a written medical access order 
which has been approved by the OSHA Medical Records Officer. A medical 
access order does not constitute an administrative subpoena.
    (2) Approval criteria for medical access order. Before approving a 
medical access order, the OSHA Medical Records Officer shall determine 
that:
    (i) The medical information to be examined or copied is relevant to 
a statutory purpose and there is a need to gain access to this 
personally identifiable information;
    (ii) The personally identifiable medical information to be examined 
or copied is limited to only that information needed to accomplish the 
purpose for access; and
    (iii) The personnel authorized to review and analyze the personally 
identifiable medical information are limited to those who have a need 
for access and have appropriate professional qualifications.
* * * * *
    (m) Inter-agency transfer and public disclosure. (1) Personally 
identifiable employee medical information shall not be transferred to 
another agency or office outside of OSHA (other than to the Office of 
the Solicitor of Labor) or disclosed to the public (other than to the 
affected employee or the original recordholder) except when required by 
law or when approved by the OSHA Medical Records Officer.
    (2) Except as provided in paragraph (m)(3) of this section, the 
OSHA Medical Records Officer shall not approve a request for an inter-
agency transfer of personally identifiable employee medical 
information, which has not been consented to by the affected employees, 
unless the request is by a public health agency which:
    (i) Needs the requested information in a personally identifiable 
form for a substantial public health purpose;
    (ii) Will not use the requested information to make individual 
determinations concerning affected employees which could be to their 
detriment;
    (iii) Has regulations or established written procedures providing 
protection for personally identifiable medical information 
substantially equivalent to that of this section; and
    (iv) Satisfies an exemption to the Privacy Act to the extent that 
the Privacy Act applies to the requested information (see 5 U.S.C. 
552a(b); 29 CFR 70a.3).
    (3) Upon the approval of the OSHA Medical Records Officer, 
personally identifiable employee medical information may be transferred 
to:
    (i) The National Institute for Occupational Safety and Health 
(NIOSH); and
    (ii) The Department of Justice when necessary with respect to a 
specific action under the Occupational Safety and Health Act.
    (4) The OSHA Medical Records Officer shall not approve a request 
for public disclosure of employee medical information containing direct 
personal identifiers unless there are compelling circumstances 
affecting the health or safety of an individual.
    (5) The OSHA Medical Records Officer shall not approve a request 
for public disclosure of employee medical information which contains 
information which could reasonably be used indirectly to identify 
specific employees when the disclosure would constitute a clearly 
unwarranted invasion of personal privacy (see 5 U.S.C. 552(b)(6); 29 
CFR 70.26).
    (6) Except as to inter-agency transfers to NIOSH or the Department 
of Justice, the OSHA Medical Records Officer shall ensure that advance 
notice is provided to any collective bargaining agent representing 
affected employees and to the employer on each occasion that OSHA 
intends to either transfer personally identifiable employee medical 
information to another agency or disclose it to a member of the public 
other than to an affected employee. When feasible, the OSHA Medical 
Records Officer shall take reasonable steps to assure that advance 
notice is provided to affected employees when

[[Page 45793]]

the employee medical information to be transferred or disclosed 
contains direct personal identifiers.
    (n) Medical records maintained in electronic form. (1) In general, 
when accessing and/or copying personally identifiable employee medical 
information in electronic form, OSHA personnel shall follow all of the 
requirements set forth in this section.
    (2) When personally identifiable employee medical information in 
electronic form is taken off-site, the Principal OSHA Investigator is 
primarily responsible for ensuring that such information is properly 
used and kept secured.
    (i) The Principal OSHA Investigator is responsible for preventing 
any accidental or unintentional disclosure of, modification to, or 
destruction of personally identifiable employee medical information in 
electronic form.
    (ii) The Principal OSHA Investigator is responsible for controlling 
the flow of data into, through, and from agency computer operations.
    (iii) The Principal OSHA Investigator shall ensure the distribution 
and review of medical information in electronic form is limited to only 
those OSHA personnel and contractors with a need for access.
    (3) The transfer and/or duplication of medical information in 
electronic form shall be kept to the minimum necessary to accomplish 
the purpose for which it was obtained.
    (4) Electronic files containing personally identifiable employee 
medical information shall be downloaded only to a computer hard drive 
or laptop that is secured in accordance with Federal Information 
Processing Standard (FIPS) 201-2 ``Personal Identity Verification (PIV) 
of Federal Employees and Contractors'' and ``Homeland Security 
Presidential Directive 12: Policy for a Common Identification Standard 
for Federal Employees and Contractors (HSPD-12).''
    (5) Electronic files containing personally identifiable employee 
medical information shall not be transferred to authorized personnel 
through email attachment unless appropriately encrypted.
    (6) When an employer or other record holder(s) provides access to 
employee medical information through a properly encrypted email 
attachment, the attachment shall be downloaded to a secured hard drive 
or laptop. After the attachment is downloaded, the email shall be 
permanently deleted.
    (7) Personally identifiable employee medical information in 
electronic form shall be secured when not in use.
    (i) Medical information in electronic form shall only be maintained 
or stored where facilities and conditions are designed to prevent 
unauthorized access.
    (ii) Personally identifiable employee medical information in 
electronic form shall be maintained only for so long as needed to 
accomplish the purpose for access.
    (iii) When no longer needed, the Principal OSHA Investigator shall 
ensure that all personally identifiable employee medical information on 
electronic files has been deleted, destroyed, or returned to the 
original record holder.
    (iv) The disposal of personally identifiable employee medical 
information maintained in electronic form shall be accomplished in such 
a manner as to make the data unattainable by unauthorized personnel.

[FR Doc. 2020-15562 Filed 7-29-20; 8:45 am]
BILLING CODE 4510-26-P


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