Department of Health and Human Services August 4, 2006 – Federal Register Recent Federal Regulation Documents
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Notice of Availability: Secretarial Recognition of Certain Certification Commission for Healthcare Information Technology (CCHIT) Functionality, Interoperability, Security and Reliability Criteria for Ambulatory Electronic Health Records
By this document we are informing the public of the Secretary's recognition of certain Certification Commission for Healthcare Information Technology (CCHIT) criteria for ambulatory EHR functionality, interoperability, security and reliability standards. This list of recognized criteria is available by clicking the applicable link at https://www.hhs.gov/healthit. The CCHIT was created in 2004 by an industry coalition of the American Health Information Management Association (AHIMA), the Health Information and Management Systems Society (HIMSS) and the National Alliance for Health Information Technology. CCHIT's mission is to accelerate the adoption of HIT by creating an efficient, credible and sustainable product certification program. During the three comment cycles that generated the ambulatory EHR criteria that the Secretary has recognized, CCHIT received over 1500 comments from a wide range of stakeholders. Further outreach was achieved through the establishment of several large Town Hall presentations with attendances in the range of 500-1000 at Healthcare Information Management Systems Society (HIMSS) conferences as well as at more than thirty smaller presentations to a variety of associations, organizations and the press gatherings. CCHIT grouped its ambulatory EHR certification criteria recommendations into three groups, ``functionality,'' ``interoperability'' and ``security/reliability.'' For ease of understanding, the Secretary broke the security and reliability recommendations into separate categories. Definitions of these categories, and an example that illuminates the various functions of each category are as follows: 1. Functionality criteria identify minimum required and provisional product features for documenting and managing a typical patient encounter. For example, a physician needs to be able to access his/her patient's laboratory test results, so an example of a functional requirement is that an EHR would need to provide the capability of displaying laboratory test results. 2. Interoperability criteria establish standards for how products interact with other products within and across care settings. For example, to ensure interoperability, the physician EHR noted above would need to be able to receive laboratory test results from another physician's (within care settings) as well as from laboratory systems (across care settings). 3. Security and reliability criteria are designed to help the security inspector assess a product's ability to protect, manage and audit access to sensitive patient data. For clarity, we have broken these criteria into the two separate categories, security and reliability. a. Security \1\ addresses the appropriate access to data by appropriate parties and the protection of data from improper manipulation. For example, laboratory test results should be accessible to a treating physician, but inaccessible to a clerical employee who does not need such access to accomplish their job. Security also involves ensuring that data have not been altered or tampered with.
Notice of Availability: Office of the National Coordinator for Health Information Technology (ONC) Interim Guidance Regarding the Recognition of Certification Bodies
This notice provides the public with information about the availability of a Certification Guidance Document (CGD) at https:// www.hhs.gov/healthit. The CGD explains the factors that ONC will use to determine whether or not to recommend to the Secretary of the Department of Health and Human Services (the Secretary) that he recognize a body for certification. Once recognized, that body will have Recognized Certification Body (RCB) status. The CGD will serve as guide for ONC as it evaluates applications for RCB status and seeks to provide all of the information a body would need to apply for and obtain such status. By publishing the CGD, HHS will ensure a transparent and open process as a basis for these recommendations. To encourage a more widespread adoption of interoperable health information technology, the Department of Health and Human Services (HHS) published two final rules in August 2006 regarding certain arrangements involving the donation of interoperable electronic health records (EHR) technology to physicians and other health care practitioners or entities. The first, published by the Centers for Medicare & Medicaid Services (CMS), promulgated an exception to the physician self-referral prohibition. The second, published by the Office of Inspector General (OIG), established a safe harbor under the anti-kickback statute. In order for the donation of EHR technology to be protected under the exception and safe harbor provisions of these rules, the technology must be interoperable. The exception and safe harbor provide that EHR software will be ``deemed to be interoperable if a certifying body recognized by the Secretary has certified the software no more than 12 months prior to the date it is provided to the [physician/recipient].'' Both rules become effective 60 days after publication. The Department will utilize notice and comment rulemaking to formalize and finalize the policies and procedures that will govern whether ONC will recommend to the Secretary a body for RCB status. In the meantime, this guidance document identifies the factors to be considered by the Secretary in granting such recognition. In addition, the guidance sets forth an interim procedure that certifying bodies should follow in obtaining recognition by the Secretary. Until such time as the Department formalizes the procedure, a certifying body will be considered ``recognized by the Secretary'' if it has become an RCB in accordance with the interim guidance. The guidance document seeks to reduce uncertainty about key aspects of the certification body recognition process.
Final Effect of Designation of a Class of Employees for Addition to the Special Exposure Cohort
The Department of Health and Human Services (HHS) gives notice concerning the final effect of the HHS decision to designate a class of employees at the Nevada Test Site (NTS), Mercury, Nevada, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000. On June 26, 2006, as provided for under 42 U.S.C. 7384q(b), the Secretary of HHS designated the following class of employees as an addition to the SEC:
Decision To Evaluate and Petition To Designate a Class of Employees at Harshaw Chemical Company (Also Known as Uranium Refinery and/or Harshaw Filtrol Partners), Cleveland, OH, To Be Included in the Special Exposure Cohort
The Department of Health and Human Services (HHS) gives notice as required by 42 CFR 83.12(e) of a decision to evaluate a petition to designate a class of employees at Harshaw Chemical Company (also known as Uranium Refinery and/or Harshaw Filtrol Partners), to be included in the Special Exposure Cohort under the Energy Employees Occupational Illness Compensation Program Act of 2000. The initial proposed definition for the class being evaluated, subject to revision as warranted by the evaluation, is as follows: Facility: Harshaw Chemical Company. Location: Cleveland, Ohio. Job Titles and/or Job Duties: All workers at Harshaw Chemical Company plant and the laboratories of the separate facility located at 1945 East 97th Street. Period of Employment: January 1, 1942 through November 30, 1949.
Decision To Evaluate a Petition To Designate a Class of Employees at General Atomics (Also Known as GA, and/or Division of General Dynamics, and/or John Jay Hopkins Laboratory for Pure and Applied Science), La Jolla, Laboratory for Pure and Applied Science), La Jolla, California, To Be Included in the Special Exposure Cohort
The Department of Health and Human Services (HHS) gives notice as required by 42 CFR 83.12(e) of a decision to evaluate a petition to designate a class of employees at General Atomics (also known as GA, and/or Division of General Dynamics, and/or John Jay Hopkins Laboratory for Pure and Applied Science), to be included in the Special Exposure Cohort under the Energy Employees Occupational Illness Compensation Program Act of 2000. The initial proposed definition for the class being evaluated, subject to revision as warranted by the evaluation, is as follows: Facility: General Atomics. Location: La Jolla, California. Job Titles and/or Job Duties: Potentially worked in the locations: [cir] Building 2 (Science laboratories A, B, and C). [cir] Building 9 (Experimental Building). [cir] Building 10 (Maintenance). [cir] Building 11 (Service Building). [cir] Building 21. [cir] Building 22. [cir] Building 23 (Hot Cell Facility). [cir] Building 25. [cir] Building 26. [cir] Building 27 (Experimental Area Building 1). [cir] Building 27-1 (Experimental Area Building 1). [cir] Building 30 (LINAC Complex). [cir] Building 31 (HTGR-TCF). [cir] Building 33 (Fusion Building). [cir] Building 34 (Fusion Doublet III). [cir] Building 37 (SV-A). [cir] Building 39 (SV-B). [cir] SV-D. Period of Employment: January 1, 1960 through December 31, 1969.
Final Effect of Designation of a Class of Employees for Addition to the Special Exposure Cohort
The Department of Health and Human Services (HHS) gives notice concerning the final effect of the HHS decision to designate a class of employees at the Pacific Proving Grounds, Enewetak Atoll, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000. On June 26, 2006, as provided for under 42 U.S.C. 7384q(b), the Secretary of HHS designated the following class of employees as an addition to the SEC:
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