Notice of Availability: Secretarial Recognition of Certain Healthcare Information Technology Standards Panel (HITSP) Interoperability Specifications as Interoperability Standards for Health Information Technology, 3973-3977 [08-234]
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Federal Register / Vol. 73, No. 15 / Wednesday, January 23, 2008 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institute for Occupational
Safety and Health
Office of the Secretary
Findings of Scientific Misconduct
Final Effect of Designation of a Class
of Employees for Addition to the
Special Exposure Cohort
National Institute for
Occupational Safety and Health
(NIOSH), Department of Health and
Human Services (HHS).
AGENCY:
ACTION:
Notice.
SUMMARY: 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 Nuclear Materials and
Equipment Corporation (NUMEC) in
Apollo, Pennsylvania, as an addition to
the Special Exposure Cohort (SEC)
under the Energy Employees
Occupational Illness Compensation
Program Act of 2000. On November 29,
2007, 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:
Atomic Weapons Employer (AWE)
employees who were monitored or should
have been monitored for exposure to ionizing
radiation while working at the Nuclear
Materials and Equipment Corporation
(NUMEC) in Apollo, Pennsylvania from
January 1, 1957, through December 31, 1983,
for a number of work days aggregating at least
250 work days or in combination with work
days within the parameters established for
one or more other classes of employees in the
Special Exposure Cohort.
This designation became effective on
December 29, 2007, as provided for
under 42 U.S.C. 7384l(14)(C). Hence,
beginning on December 29, 2007,
members of this class of employees,
defined as reported in this notice,
became members of the Special
Exposure Cohort.
FOR FURTHER INFORMATION CONTACT:
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Larry Elliott, Director, Office of
Compensation Analysis and Support,
National Institute for Occupational
Safety and Health, 4676 Columbia
Parkway, MS C–46, Cincinnati, OH
45226, Telephone 513–533–6800 (this is
not a toll-free number). Information
requests can also be submitted by e-mail
to OCAS@CDC.GOV.
Dated: January 15, 2008.
John Howard,
Director, National Institute for Occupational
Safety and Health.
[FR Doc. E8–1018 Filed 1–22–08; 8:45 am]
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Office of the Secretary, HHS.
Notice.
AGENCY:
ACTION:
SUMMARY: Notice is hereby given that
the Office of Research Integrity (ORI)
and the Assistant Secretary for Health
have taken final action in the following
case:
Scott E. Monte, Huntington Memorial
Hospital: Based on the findings of an
investigation conducted by Huntington
Memorial Hospital (HMH) and
information obtained by the Office of
Research Integrity (ORI) during its
oversight review, the U.S. Public Health
Service (PHS) found that Scott E. Monte,
L.V.N., former Clinical Research
Associate, HMH, engaged in scientific
misconduct by knowingly and
intentionally falsifying and fabricating
clinical research records in HMH cancer
prevention and treatment protocols
supported by National Cancer Institute
(NCI), National Institutes of Health
(NIH), awards U10 CA69651, U10
CA12027, U10 CA32012, and U10
CA86004.
Specifically, Mr. Monte knowingly
and intentionally:
(1) Entered falsified and fabricated
laboratory data or physical examination
results on five (5) research protocol case
report forms (CRFs);
(2) Falsified a gynecological
examination report in a physician’s
progress note and entered the falsified
document in the patient’s research
chart; and
(3) Fabricated progress notes for four
patients and a case report form for one
of these patients.
ORI has implemented the following
administrative actions for a period of
three (3) years, beginning on January 7,
2008:
(1) Dr. Monte is debarred from any
contracting or subcontracting with any
agency of the United States Government
and from eligibility or involvement in
nonprocurement programs of the United
States Government pursuant to HHS’
implementation of the OMB Guidelines
to Agencies on Governmentwide
Debarment and Suspension at 2 CFR
Part 376; and
(2) Dr. Monte is prohibited from
serving in any advisory capacity to PHS,
including but not limited to service on
any PHS advisory committee, board,
and/or peer review committee, or as a
consultant.
FOR FURTHER INFORMATION CONTACT:
Director, Division of Investigative
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3973
Oversight, Office of Research Integrity,
1101 Wootton Parkway, Suite 750,
Rockville, MD 20852, (240) 453–8800.
Chris B. Pascal,
Director, Office of Research Integrity.
[FR Doc. E8–1024 Filed 1–22–08; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Office of the National Coordinator for
Health Information Technology (ONC),
DHHS
Notice of Availability: Secretarial
Recognition of Certain Healthcare
Information Technology Standards
Panel (HITSP) Interoperability
Specifications as Interoperability
Standards for Health Information
Technology
Office of the National
Coordinator for Health Information
Technology (ONC), DHHS.
Authority: Executive Order 13335
(‘‘Incentives for the Use of Health
Information Technology and
Establishing the Position of the National
Health Information Technology
Coordinator’’), Executive Order 13410
(‘‘Promoting Quality and Efficient
Health Care in Federal Government
Administered or Sponsored Health Care
Programs’’), Public Law 110–161,
(‘‘Consolidated Appropriations Act,
2008’’), 42 U.S.C.1395nn(b)(4), 42 U.S.C.
1302(a), and 42 CFR 411.357(w).
SUMMARY: By publication of this
document, we are informing the public
of the Secretary’s recognition of certain
Healthcare Information Technology
Standards Panel (HITSP)
‘‘Interoperability Specifications’’ as
interoperability standards for health
information technology. The Secretary
accepted these HITSP ‘‘Interoperability
Specifications’’, Version 1.2, in
December of 2006, and hereby
recognizes them as interoperability
standards in updated versions in
January of 2008. The list of recognized
interoperability standards is provided
below and is available at https://
www.hitsp.org; click on ‘‘HITSP
Interoperability Specifications HERE’’
box.
AGENCY:
The
Healthcare Information Technology
Standards Panel (HITSP) was created in
2005 to serve as a cooperative
partnership between the public and
private sectors for the purpose of
achieving a widely accepted and useful
set of standards specifically to enable
and support widespread interoperability
SUPPLEMENTARY INFORMATION:
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among healthcare software systems, as
they will interact in a local, regional,
and the Nationwide Health Information
Network in the United States.
Under a contract with the Department
of Health and Human Services, the
American National Standards Institute
(ANSI) established HITSP, following a
neutral and inclusive governance
model. The process was built by
vendors, standards development
organizations (SDOs), consumers,
payers, providers, etc. HITSP is a multistakeholder organization involving more
than 600 different healthcare industry
organizations and technical experts
whose activities to date on these
Interoperability Specifications represent
more than 20,000 volunteer hours of
effort.
In March of 2006, HITSP was given
three initial priority areas (use cases):
Consumer Empowerment,
Biosurveillance, and Laboratory
Electronic Health Record
Interoperability. HITSP converted those
use cases into detailed requirements
documents and examined more than
700 standards that would meet those
requirements and assessed their
readiness and appropriateness. From
those 700 standards, HITSP identified
30 named standards, and produced
detailed implementation guidance,
‘‘constructs,’’ that describe the specific
transactions and use of these named
standards. The Secretary therefore is
recognizing the ‘‘constructs’’ associated
with the as interoperability standards to
clarify the intended use and application
of the ‘‘named standards’’.
On October 31, 2006, HITSP
presented to the American Health
Information Community (AHIC) three
sets of Interoperability Specifications.
The AHIC is a Federal Advisory
Committee Act (FACA) advisory body,
chartered in 2005 to make
recommendations to the Secretary on
methods for accelerating the
development and adoption of health
information technology. At the October
31, 2006, AHIC meeting, the members
discussed the HITSP Interoperability
Specifications and made the consensus
recommendation that the
Interoperability Specifications be
recognized by the Secretary. Secretary
Leavitt accepted these Interoperability
Specifications in December 2006 with
the intent to recognize them one year
later, presuming that any changes would
be minimal, reflecting public comment
and/or of a minor and technical nature.
On March 1, 2007, the Department
published a Notice in the Federal
Register (72 FR 9339) announcing the
Secretary’s acceptance and planned
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recognition of certain interoperability
specifications.
The HITSP Panel approved the
subsequent version of the
interoperability specifications on May
11, 2007. No additional constructs or
standards were added as a result of
implementation testing feedback. All
changes were minor or of a technical
nature to the implementation guidance.
On June 12, 2007, HIC presented to
Secretary Leavitt these completed
Interoperability Specifications,
including 28 of 30 completely balloted
named standards and implementation
guidance in the form of constructs. As
detailed below, in December 2007, one
of the two outstanding named standards
passed ballot by its SDO; after the
designated 6-month waiting period, this
named standard and two associated
constructs will achieve full recognition
status by the Secretary in June 2008 by
the Secretary. The final standard is still
under ballot.
The three high level groupings of
these interoperability standards are as
follows.
I. Electronic Health Record (EHR)
Laboratory Results Reporting
The purpose of the EHR
interoperability specification is to allow
ordering clinicians to electronically
access laboratory results, and to allow
non-ordering authorized clinicians to
electronically access historical and
other laboratory results for clinical care.
The recognized version of the standard
addresses the lack of harmonization
among data interoperability standards
including vocabulary and laboratory
and other messaging standards; it also
accommodates both laboratory message
transaction and document-sharing
paradigms. In addition, a laboratory
message implementation guide has been
completed to meet AHIC use case
requirements. The EHR specification is
complete and includes all of the
implementation guidance necessary to
implement and the final balloted work
products of all the standards
development organizations involved,
with one caveat. The messaging
standard for laboratories, HL–7 2.5.1,
passed ballot in December 2007, with
final implementation guidance to be
incorporated into the HITSP
specifications. This standard, along with
an associated construct, the Lab Result
Message Component (C36) will achieve
full recognition status by the Secretary
in June 2008.
The interoperability standards—
Interoperability Specification including
Constructs (Components, Transactions,
and Transaction Packages) and Named
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Standards associated with EHR are
listed below.
Interoperability Specification
Constructs (Components (C),
Transactions (T), and Transaction
Packages (TP)) for EHR
• EHR Lab Reporting Interoperability
Specification (HITSP V2.1 2007 IS01).
• Lab Result Terminology Component
(HITSP V2.0 2007 C35).
• Lab Report Document Component
(HITSP V2.0 2007 C37).
• Secure Web Connection Component
(HITSP V2.0 2007 C44).
• View Lab Result From Web App
Transaction (HITSP V2.0 2007 T18).
• Patient Demographics Query
Transaction (HITSP V2.0 2007 T23).
• Notification of Document
Availability Transaction (HITSP V2.0
2007 T29).
• Manage Sharing of Documents
Transaction Package (HITSP V2.2 2007
TP13).
• Send Lab Result Message
Transaction Package (HITSP V2.1 2007
TP14).
• Patient ID Cross-Referencing
Transaction Package (HITSP V2.0 2007
TP22).
Named Standards for EHR
• Portions of the Clinical Laboratory
Improvement Amendments (CLIA) of
1988 (42 CFR part 493).
• Portions of the Health Insurance
Portability and Accountability Act of
1996 (HIPAA)—Administrative
Simplification.
• Health Level Seven (HL7) Version
2.5.
• Health Level Seven (HL7) Version
2.5/2.5.1.
• Health Level Seven (HL7) Version
3.0 Clinical Document Architecture
(CDA/CDA R2).
• Hypertext Transfer Protocol Secure
(HTTPS) 443/tcp.
• Integrating the Healthcare
Enterprise (IHE) IT Infrastructure
Technical Framework (ITI–TF) Revision
3.0.
• Integrating the Healthcare
Enterprise (IHE) IT Infrastructure
Technical Framework (ITI–TF) Revision
4.0.
• Integrating the Healthcare
Enterprise (IHE) IT Infrastructure
Technical Framework (ITI–TF) Revision
4.0—Registry Stored Query Transaction
for XDS Profile Supplement.
• Integrating the Healthcare
Enterprise (IHE) IT Infrastructure
Technical Framework (ITI–TF) Revision
4.0 XCA Supplement.
• Integrating the Healthcare
Enterprise (IHE) IT Infrastructure
Technical Framework (TF)
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Supplement—ITI–25 Notification of
Document Availability (NAV) June 28,
2005.
• Integrating the Healthcare
Enterprise (IHE) Laboratory Technical
Framework Supplement 2006–2007
Revision 1.0.
• International Health Terminology
Standards Development Organisation
(IHTSDO) Systematized Nomenclature
of Medicine Clinical Terms (SNOMED
CT).
• International Organization for
Standardization (ISO) Electronic
business eXtensible Markup Language
(ebXML), Technical Specification #
15000—Part 4: Registry services
specification (ebRS), May, 2004.
• Logical Observation Identifiers
Names and Codes (LOINC).
• Unified Code for Units of Measure
(UCUM).
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II. Biosurveillance (BIO)
The purpose of the BIO
interoperability specification is to
transmit essential ambulatory care and
emergency department visit, utilization,
and laboratory result data from
electronically enabled healthcare
delivery and public health systems in
standardized and anonymized format to
authorized Public Health Agencies with
less than one day lag time. The BIO
specification is complete and includes
all of the implementation guidance
necessary to implement and the final
balloted work products of all the
standards development organizations
involved, with two exceptions. The
messaging standard for laboratories,
HL–7 2.5.1, passed ballot in December
2007, with final implementation
guidance to be incorporated into the
HITSP specifications. This standard,
along with two associated constructs,
the Lab Result Message Component
(C36) and the Resource Utilization
Component (C47), will achieve full
recognition status by the Secretary in
June 2008. The Hospital Availability
Exchange Standard (HAVE) is still
under the SDO ballot process.
The interoperability standards—
Interoperability Specification including
Constructs (Components, Transactions,
and Transaction Packages) and Named
Standards associated with BIO are listed
below.
Interoperability Specification Constructs
(Components (C), Transactions (T), and
Transaction Packages (TP)) for BIO
• Biosurveillance Interoperability
Specification (HITSP V2.1 2007 IS02).
• Anonymize Component (HITSP
V2.1 2007 C25).
• Lab Result Terminology Component
(HITSP V2.0 2007 C35).
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• Lab Report Document Component
(HITSP V2.0 2007 C37).
• Encounter Message Component
(HITSP V2.0 2007 C39).
• Radiology Result Message
Component (HITSP V2.0 2007 C41).
• Encounter Document Component
(HITSP V2.1 2007 C48).
• Pseudonymize Transaction (HITSP
V2.1 2007 T24).
• Notification of Document
Availability Transaction (HITSP V2.0
2007 T29).
• Manage Sharing of Documents
Transaction Package (HITSP V2.2 2007
TP13).
• Patient ID Cross-Referencing
Transaction Package (HITSP V2.0 2007
TP22).
• Sharing Radiology Results
Transaction Package (HITSP V2.0 2007
TP49).
• Retrieve Form for Data Capture
Transaction Package (HITSP V2.1 2007
TP50).
Named Standards for BIO:
• American Medical Association
(AMA) Current Procedural Terminology
(CPT) Fourth Edition (CPT–4).
• Clinical Care Classification (CCC)
Version 2.0 [formerly known as the
Home Healthcare Classification (HHCC)
System].
• Portions of the Clinical Laboratory
Improvement Amendments (CLIA) of
1988 (42 CFR part 493).
• Digital Imaging and
Communications in Medicine (DICOM)
Attribute Level Confidentiality
Supplement: # 55.
• Federal Information Processing
Standards (FIPS) Codes for the
Identification of the States, the District
of Columbia and the Outlying Areas of
the United States, and Associated Areas
Publication # 5–2, May, 1987.
• Portions of the Health Insurance
Portability and Accountability Act of
1996 (HIPAA)—Administrative
Simplification.
• Health Level Seven (HL7) Version
2.5.
• Health Level Seven (HL7) Version
2.5/2.5.1.
• Health Level Seven (HL7) Version
3.0.
• Health Level Seven (HL7) Version
3.0 Clinical Document Architecture
(CDA/CDA R2).
• Healthcare Common Procedure
Coding System (HCPCS) Level II Code
Set.
• Integrating the Healthcare
Enterprise (IHE) IT Infrastructure
Technical Framework (ITI–TF) Revision
3.0.
• Integrating the Healthcare
Enterprise (IHE) IT Infrastructure
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Technical Framework (ITI–TF) Revision
4.0.
• Integrating the Healthcare
Enterprise (IHE) IT Infrastructure
Technical Framework (ITI–TF) Revision
4.0—Registry Stored Query Transaction
for XDS Profile Supplement.
• Integrating the Healthcare
Enterprise (IHE) IT Infrastructure
Technical Framework (ITI–TF) Revision
4.0 XCA Supplement.
• Integrating the Healthcare
Enterprise (IHE) IT Infrastructure
Technical Framework (TF)
Supplement—ITI–25 Notification of
Document Availability (NAV) June 28,
2005.
• Integrating the Healthcare
Enterprise (IHE) IT Infrastructure
Technical Framework (TF)
Supplement—Retrieve Form for Data
Capture (RFD) Sept 25, 2006.
• Integrating the Healthcare
Enterprise (IHE) Laboratory Technical
Framework Supplement 2006–2007
Revision 1.0.
• Integrating the Healthcare
Enterprise (IHE) Patient Care
Coordination (PCC) Technical
Framework Revision 3.0.
• Integrating the Healthcare
Enterprise (IHE) Radiology Technical
Framework Revision 7.0.
• International Classification of
Diseases, 10th Revision, Procedure
Coding System (ICD–10–CS).
• International Classification of
Diseases, 10th Revision, Related Health
Problems (ICD–10–CM).
• International Classification of
Diseases, 9th Revision, Clinical
Modifications (ICD–9–CM).
• International Health Terminology
Standards Development Organisation
(IHTSDO) Systematized Nomenclature
of Medicine Clinical Terms (SNOMED
CT).
• International Organization for
Standardization (ISO) Health
informatics—Pseudonymization,
Unpublished Technical Specification
# 25237.
• International Organization for
Standardization (ISO) Electronic
business eXtensible Markup Language
(ebXML), Technical Specification
# 15000—Part 4: Registry services
specification (ebRS), May, 2004.
• Logical Observation Identifiers
Names and Codes (LOINC ).
• National Library of Medicine (NLM)
Unified Medical Language System
(UMLS) RxNorm.
• National Uniform Billing
Committee (NUBC) Uniform Bill
Version 1992 (UB–92) Current UB Data
Specification Manual Field 22, Patient
Discharge Status, Codes.
• Organization for the Advancement
of Structured Information Standards
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(OASIS) Emergency Data Exchange
Language (EDXL) Distribution Element
(DE).
• Unified Code for Units of Measure
(UCUM).
III. Consumer Empowerment (CE)
The purpose of the CE interoperability
specification is to allow consumers to
establish and manage permissions
access, rights, and informed consent for
authorized and secure exchange,
viewing, and querying of their linked
patient registration summaries and
medication histories between
designated caregivers and other health
professionals. The CE specification is
complete and includes all of the
implementation guidance necessary to
implement and the final balloted work
products of all the standards
development organizations involved.
The interoperability standards—
Interoperability Specification including
Constructs (Components, Transactions,
and Transaction Packages) and Named
Standards associated with CE are listed
below.
Interoperability Specification Constructs
(Components (C), Transactions (T), and
Transaction Packages (TP)) for CE
• Consumer Empowerment
Interoperability Specification (HITSP
V2.1 2007 IS03).
• Summary Documents Using CCD
Component (HITSP V2.1 2007 C32).
• Patient Demographics Query
Transaction (HITSP V2.0 2007 T23).
• Manage Sharing of Documents
Transaction Package (HITSP V2.2 2007
TP13).
• Patient ID Cross-Referencing
Transaction Package (HITSP V2.0 2007
TP22).
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Named Standards for CE
• Accredited Standards Committee
(ASC) X12 Insurance Subcommittee
(X12N) Implementation Guides Version
004010 plus Addenda 004010A1.
• Accredited Standards Committee
(ASC) X12 Standards Release 004010.
• American Society for Testing and
Materials (ASTM) Standard
Specification for Coded Values Used in
the Electronic Health Record: # E1633–
02.
• American Society for Testing and
Materials (ASTM) Standard
Specification for Continuity of Care
Record (CCR): # E2369–05.
• CDC Race and Ethnicity Code Sets.
• Council for Affordable Quality
Health Care (CAQH) Committee on
Operating Rules for Information
Exchange (CORE) Phase I Operating
Rules.
• Federal Medication Terminologies.
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• Health Care Provider Taxonomy.
• Health Level Seven (HL7) EHR
System Functional Model Draft
Standard for Trial Use (DSTU).
• Health Level Seven (HL7) Version
2.5.
• Health Level Seven (HL7) Version
2.5/2.5.1.
• Health Level Seven (HL7) Version
3.0.
• Health Level Seven (HL7) Version
3.0 Clinical Document Architecture
(CDA/CDA R2).
• HL7 Implementation Guide: CDA
Release 2—Continuity of Care
Document (CCD), Release 1.0, April 1,
2007.
• Integrating the Healthcare
Enterprise (IHE) IT Infrastructure
Technical Framework (ITI–TF) Revision
3.0.
• Integrating the Healthcare
Enterprise (IHE) IT Infrastructure
Technical Framework (ITI–TF) Revision
4.0.
• Integrating the Healthcare
Enterprise (IHE) IT Infrastructure
Technical Framework (ITI–TF) Revision
4.0—Registry Stored Query Transaction
for XDS Profile Supplement.
• Integrating the Healthcare
Enterprise (IHE) IT Infrastructure
Technical Framework (ITI–TF) Revision
4.0 XCA Supplement.
• Integrating the Healthcare
Enterprise (IHE) Patient Care
Coordination (PCC) Technical
Framework Revision 3.0.
• International Organization for
Standardization (ISO) Electronic
business eXtensible Markup Language
(ebXML), Technical Specification
# 15000—Part 4: Registry services
specification (ebRS), May, 2004.
• Logical Observation Identifiers
Names and Codes (LOINC ).
• National Council for Prescription
Drug Programs (NCPDP) SCRIPT
Standard Version 8.1.
• Revisions to the Standards for the
Classification of Federal Data on Race
and Ethnicity.
We recognize that certain legal
obligations may flow from the
recognition of these interoperability
standards. First, pursuant to Executive
Order 13410 (EO 13410) dated August
22, 2006, recognition of interoperability
standards would require each Federal
health agency, as it implements,
acquires, or upgrades health information
technology systems used for the direct
exchange of health information between
agencies and with non-Federal entities,
to ‘‘utilize, where available, health
information technology systems and
products that meet interoperability
standards recognized by the Secretary.’’
Therefore, Federal agencies would be
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required to appropriately consider
health information technology systems
and products that comply with these
Interoperability Specifications when
purchasing, implementing, or upgrading
such items.
Similarly, the EO 13410 directs
Federal agencies to contractually
require, to the extent permitted by law,
certain entities with whom they do
business, to use, where available, health
information technology systems and
products that meet recognized
interoperability standards.
In addition, the regulations
promulgated on August 8, 2006 (see 71
FR 45140 and 71 FR 45110) established
exceptions and safe harbors to the
physician self-referral law and the antikickback statute, respectively, for
certain arrangements involving the
donation of electronic prescribing and
electronic health records (EHR)
technology and services. The EHR
exception and safe harbor require that
the software be ‘‘interoperable’’ as
defined in the regulations. The rules
also provide that certain software will
be deemed to be ‘‘interoperable’’ if that
software has been certified by a
certifying body recognized by the
Secretary within 12 months prior to the
donation. Under the interim guidance
for the recognition of certifying bodies
published by the ONC (‘‘Office of the
National Coordinator for Health
Information Technology (ONC) Interim
Guidance Regarding the Recognition of
Certification Bodies’’), for an
organization to be recognized as a
recognized certifying body (RCB), the
organization must:
Have in place a demonstrated process
for and experience in certifying
products to be in compliance with
criteria recognized by the Secretary;
Have a method by which they can
incorporate all applicable standards
and certification criteria recognized
by the Secretary into their
certification processes; and
Have the ability to adapt their processes
to emerging certification criteria
recognized by the Secretary.
The RCBs would therefore have to
certify such products in conformity
with, among other provisions, these
interoperability specifications for the
certified products to meet the
interoperability deeming provisions of
the physician self-referral exception and
anti-kickback safe harbor, respectively.
The Secretary is mindful that the
ability of software to be interoperable
evolves as technology develops.
Consequently, if an enforcement action
is initiated for an allegedly improper
donation of EHR non-certified software,
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the Secretary would review whether the
software was interoperable, as defined
in the regulations. The Secretary would
consider the prevailing state of
technology at the time the items or
services were provided to the recipient.
As explained in the regulations, the
Secretary understands that parties
should have a reasonable basis for
determining whether the EHR software
is interoperable. We therefore indicated
that ‘‘it would be appropriate—and,
indeed, advisable—for parties to consult
any standards and criteria related to
interoperability recognized by the
Department.’’
Compliance with these standards and
criteria, as we explained in the
regulations, ‘‘will provide greater
certainty to donors and recipients that
products meet the interoperability
requirement, and may be relevant in an
enforcement action.’’
Based on the changing nature of
technological development noted above,
the Secretary has accepted and
recognized these Interoperability
Specifications. He has also delegated
authority to ONC to coordinate and
oversee the incorporation of these
Interoperability Specifications in
relevant activities among Federal
agencies and other partner
organizations, as appropriate.
FOR FURTHER INFORMATION CONTACT:
Judith Sparrow at (202) 690–7151.
Dated: January 17, 2008.
Robert M. Kolodner,
National Coordinator for Health Information
Technology, Office of the National
Coordinator for Health Information
Technology.
[FR Doc. 08–234 Filed 1–17–08; 1:18pm]
BILLING CODE 4150–45–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[30Day–08–05CZ]
Agency Forms Undergoing Paperwork
Reduction Act Review
The Centers for Disease Control and
Prevention (CDC) publishes a list of
information collection requests under
review by the Office of Management and
Budget (OMB) in compliance with the
Paperwork Reduction Act (44 U.S.C.
Chapter 35). To request a copy of these
requests, call the CDC Reports Clearance
Officer at (404) 639–5960 or send an email to omb@cdc.gov. Send written
comments to CDC Desk Officer, Office of
Management and Budget, Washington,
DC or by fax to (202) 395–6974. Written
comments should be received within 30
days of this notice.
Proposed Project
Assessing the Diabetes Detection
Initiative for Policy Decisions—New—
National Center for Chronic Disease
Prevention and Health Promotion
(NCCDPHP), Centers for Disease Control
and Prevention (CDC).
Background and Brief Description
Type II diabetes is a chronic disease
that affects more than 18 million
Americans, approximately 5 million of
whom do not know that they have the
disease. As the disease progresses, it
often causes severe complications,
including heart disease, blindness,
lower extremity arterial disease, and
kidney failure. American Indians,
African Americans, Latino Americans,
and some Asian Americans and Pacific
Islanders are disproportionately affected
by diabetes. Identifying persons who
have undiagnosed diabetes and treating
them could prevent or delay diabetes
complications.
In November 2003 the Diabetes
Detection Initiative (DDI) was launched
in 10 regional locations around the U.S.
to identify a portion of the estimated 5
million people with undiagnosed Type
II diabetes. The DDI was designed to
refer persons at increased risk of Type
II diabetes to diagnostic testing, and if
appropriate, to follow-up treatment.
Whether or not the DDI should be
expanded to other communities
depends on the health benefit and costs
of the program. The CDC plans to
conduct a one-year study to provide this
critical information.
The planned information collection
will assess the resources used, the cost
per case detected, and the perceived
benefit of the DDI to patients.
Information for the assessment will be
obtained by conducting the following
surveys: (1) A health clinic leadership
survey will be completed by the clinic
director or representative of each of the
43 clinics that participated in the DDI.
The survey will obtain information on
all activities and resources used at the
clinic level related to diabetes
screening, detection, and outreach
services. Approximately 30 of the 43
eligible clinics are expected to
participate in the survey. (2) A patient
survey will be administered to a sample
of 600 patients from the participating
clinics. The survey will collect
information about each patient’s
background and out-of-pocket medical
and non-medical direct health care costs
(e.g., co-payments, transportation costs,
and the value of the patient’s time
associated with clinic visits). The DDI
Patient Survey will include a computerassisted personal interview (CAPI)
module to collect information about
each patient’s stated preferences with
respect to diabetes screening options.
The results of the study will also
provide information needed for
evaluating the long-term costeffectiveness of screening for
undiagnosed diabetes in the United
States.
There are no costs to the respondents
other than their time. The total
estimated annualized burden hours are
263.
ESTIMATED ANNUALIZED BURDEN HOURS
Form name
DDI Clinic Representatives .................
Patients at DDI Clinics ........................
ebenthall on PROD1PC69 with NOTICES
Type of
respondents
DDI Health Clinic Leadership Survey ..............................
Screening Questions for the DDI Patient Survey ............
DDI Patient Survey ...........................................................
VerDate Aug<31>2005
15:17 Jan 22, 2008
Jkt 214001
PO 00000
Frm 00057
Fmt 4703
Sfmt 4703
Number of
respondents
E:\FR\FM\23JAN1.SGM
30
1,000
600
23JAN1
Number of
responses
per
respondent
Average
burden
(in hours)
1
1
1
1
2/60
20/60
]]>Agencies
[Federal Register Volume 73, Number 15 (Wednesday, January 23, 2008)]
[Notices]
[Pages 3973-3977]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 08-234]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Office of the National Coordinator for Health Information
Technology (ONC), DHHS
Notice of Availability: Secretarial Recognition of Certain
Healthcare Information Technology Standards Panel (HITSP)
Interoperability Specifications as Interoperability Standards for
Health Information Technology
AGENCY: Office of the National Coordinator for Health Information
Technology (ONC), DHHS.
Authority: Executive Order 13335 (``Incentives for the Use of
Health Information Technology and Establishing the Position of the
National Health Information Technology Coordinator''), Executive Order
13410 (``Promoting Quality and Efficient Health Care in Federal
Government Administered or Sponsored Health Care Programs''), Public
Law 110-161, (``Consolidated Appropriations Act, 2008''), 42
U.S.C.1395nn(b)(4), 42 U.S.C. 1302(a), and 42 CFR 411.357(w).
SUMMARY: By publication of this document, we are informing the public
of the Secretary's recognition of certain Healthcare Information
Technology Standards Panel (HITSP) ``Interoperability Specifications''
as interoperability standards for health information technology. The
Secretary accepted these HITSP ``Interoperability Specifications'',
Version 1.2, in December of 2006, and hereby recognizes them as
interoperability standards in updated versions in January of 2008. The
list of recognized interoperability standards is provided below and is
available at https://www.hitsp.org; click on ``HITSP Interoperability
Specifications HERE'' box.
SUPPLEMENTARY INFORMATION: The Healthcare Information Technology
Standards Panel (HITSP) was created in 2005 to serve as a cooperative
partnership between the public and private sectors for the purpose of
achieving a widely accepted and useful set of standards specifically to
enable and support widespread interoperability
[[Page 3974]]
among healthcare software systems, as they will interact in a local,
regional, and the Nationwide Health Information Network in the United
States.
Under a contract with the Department of Health and Human Services,
the American National Standards Institute (ANSI) established HITSP,
following a neutral and inclusive governance model. The process was
built by vendors, standards development organizations (SDOs),
consumers, payers, providers, etc. HITSP is a multi-stakeholder
organization involving more than 600 different healthcare industry
organizations and technical experts whose activities to date on these
Interoperability Specifications represent more than 20,000 volunteer
hours of effort.
In March of 2006, HITSP was given three initial priority areas (use
cases): Consumer Empowerment, Biosurveillance, and Laboratory
Electronic Health Record Interoperability. HITSP converted those use
cases into detailed requirements documents and examined more than 700
standards that would meet those requirements and assessed their
readiness and appropriateness. From those 700 standards, HITSP
identified 30 named standards, and produced detailed implementation
guidance, ``constructs,'' that describe the specific transactions and
use of these named standards. The Secretary therefore is recognizing
the ``constructs'' associated with the as interoperability standards to
clarify the intended use and application of the ``named standards''.
On October 31, 2006, HITSP presented to the American Health
Information Community (AHIC) three sets of Interoperability
Specifications. The AHIC is a Federal Advisory Committee Act (FACA)
advisory body, chartered in 2005 to make recommendations to the
Secretary on methods for accelerating the development and adoption of
health information technology. At the October 31, 2006, AHIC meeting,
the members discussed the HITSP Interoperability Specifications and
made the consensus recommendation that the Interoperability
Specifications be recognized by the Secretary. Secretary Leavitt
accepted these Interoperability Specifications in December 2006 with
the intent to recognize them one year later, presuming that any changes
would be minimal, reflecting public comment and/or of a minor and
technical nature. On March 1, 2007, the Department published a Notice
in the Federal Register (72 FR 9339) announcing the Secretary's
acceptance and planned recognition of certain interoperability
specifications.
The HITSP Panel approved the subsequent version of the
interoperability specifications on May 11, 2007. No additional
constructs or standards were added as a result of implementation
testing feedback. All changes were minor or of a technical nature to
the implementation guidance. On June 12, 2007, HIC presented to
Secretary Leavitt these completed Interoperability Specifications,
including 28 of 30 completely balloted named standards and
implementation guidance in the form of constructs. As detailed below,
in December 2007, one of the two outstanding named standards passed
ballot by its SDO; after the designated 6-month waiting period, this
named standard and two associated constructs will achieve full
recognition status by the Secretary in June 2008 by the Secretary. The
final standard is still under ballot.
The three high level groupings of these interoperability standards
are as follows.
I. Electronic Health Record (EHR) Laboratory Results Reporting
The purpose of the EHR interoperability specification is to allow
ordering clinicians to electronically access laboratory results, and to
allow non-ordering authorized clinicians to electronically access
historical and other laboratory results for clinical care. The
recognized version of the standard addresses the lack of harmonization
among data interoperability standards including vocabulary and
laboratory and other messaging standards; it also accommodates both
laboratory message transaction and document-sharing paradigms. In
addition, a laboratory message implementation guide has been completed
to meet AHIC use case requirements. The EHR specification is complete
and includes all of the implementation guidance necessary to implement
and the final balloted work products of all the standards development
organizations involved, with one caveat. The messaging standard for
laboratories, HL-7 2.5.1, passed ballot in December 2007, with final
implementation guidance to be incorporated into the HITSP
specifications. This standard, along with an associated construct, the
Lab Result Message Component (C36) will achieve full recognition status
by the Secretary in June 2008.
The interoperability standards--Interoperability Specification
including Constructs (Components, Transactions, and Transaction
Packages) and Named Standards associated with EHR are listed below.
Interoperability Specification Constructs (Components (C), Transactions
(T), and Transaction Packages (TP)) for EHR
EHR Lab Reporting Interoperability Specification (HITSP
V2.1 2007 IS01).
Lab Result Terminology Component (HITSP V2.0 2007 C35).
Lab Report Document Component (HITSP V2.0 2007 C37).
Secure Web Connection Component (HITSP V2.0 2007 C44).
View Lab Result From Web App Transaction (HITSP V2.0 2007
T18).
Patient Demographics Query Transaction (HITSP V2.0 2007
T23).
Notification of Document Availability Transaction (HITSP
V2.0 2007 T29).
Manage Sharing of Documents Transaction Package (HITSP
V2.2 2007 TP13).
Send Lab Result Message Transaction Package (HITSP V2.1
2007 TP14).
Patient ID Cross-Referencing Transaction Package (HITSP
V2.0 2007 TP22).
Named Standards for EHR
Portions of the Clinical Laboratory Improvement Amendments
(CLIA) of 1988 (42 CFR part 493).
Portions of the Health Insurance Portability and
Accountability Act of 1996 (HIPAA)--Administrative Simplification.
Health Level Seven (HL7) Version 2.5.
Health Level Seven (HL7) Version 2.5/2.5.1.
Health Level Seven (HL7) Version 3.0 Clinical Document
Architecture (CDA/CDA R2).
Hypertext Transfer Protocol Secure (HTTPS) 443/tcp.
Integrating the Healthcare Enterprise (IHE) IT
Infrastructure Technical Framework (ITI-TF) Revision 3.0.
Integrating the Healthcare Enterprise (IHE) IT
Infrastructure Technical Framework (ITI-TF) Revision 4.0.
Integrating the Healthcare Enterprise (IHE) IT
Infrastructure Technical Framework (ITI-TF) Revision 4.0--Registry
Stored Query Transaction for XDS Profile Supplement.
Integrating the Healthcare Enterprise (IHE) IT
Infrastructure Technical Framework (ITI-TF) Revision 4.0 XCA
Supplement.
Integrating the Healthcare Enterprise (IHE) IT
Infrastructure Technical Framework (TF)
[[Page 3975]]
Supplement--ITI-25 Notification of Document Availability (NAV) June 28,
2005.
Integrating the Healthcare Enterprise (IHE) Laboratory
Technical Framework Supplement 2006-2007 Revision 1.0.
International Health Terminology Standards Development
Organisation (IHTSDO) Systematized Nomenclature of Medicine Clinical
Terms (SNOMED CT[supreg]).
International Organization for Standardization (ISO)
Electronic business eXtensible Markup Language (ebXML), Technical
Specification 15000--Part 4: Registry services specification
(ebRS), May, 2004.
Logical Observation Identifiers Names and Codes
(LOINC[supreg]).
Unified Code for Units of Measure (UCUM).
II. Biosurveillance (BIO)
The purpose of the BIO interoperability specification is to
transmit essential ambulatory care and emergency department visit,
utilization, and laboratory result data from electronically enabled
healthcare delivery and public health systems in standardized and
anonymized format to authorized Public Health Agencies with less than
one day lag time. The BIO specification is complete and includes all of
the implementation guidance necessary to implement and the final
balloted work products of all the standards development organizations
involved, with two exceptions. The messaging standard for laboratories,
HL-7 2.5.1, passed ballot in December 2007, with final implementation
guidance to be incorporated into the HITSP specifications. This
standard, along with two associated constructs, the Lab Result Message
Component (C36) and the Resource Utilization Component (C47), will
achieve full recognition status by the Secretary in June 2008. The
Hospital Availability Exchange Standard (HAVE) is still under the SDO
ballot process.
The interoperability standards--Interoperability Specification
including Constructs (Components, Transactions, and Transaction
Packages) and Named Standards associated with BIO are listed below.
Interoperability Specification Constructs (Components (C), Transactions
(T), and Transaction Packages (TP)) for BIO
Biosurveillance Interoperability Specification (HITSP V2.1
2007 IS02).
Anonymize Component (HITSP V2.1 2007 C25).
Lab Result Terminology Component (HITSP V2.0 2007 C35).
Lab Report Document Component (HITSP V2.0 2007 C37).
Encounter Message Component (HITSP V2.0 2007 C39).
Radiology Result Message Component (HITSP V2.0 2007 C41).
Encounter Document Component (HITSP V2.1 2007 C48).
Pseudonymize Transaction (HITSP V2.1 2007 T24).
Notification of Document Availability Transaction (HITSP
V2.0 2007 T29).
Manage Sharing of Documents Transaction Package (HITSP
V2.2 2007 TP13).
Patient ID Cross-Referencing Transaction Package (HITSP
V2.0 2007 TP22).
Sharing Radiology Results Transaction Package (HITSP V2.0
2007 TP49).
Retrieve Form for Data Capture Transaction Package (HITSP
V2.1 2007 TP50).
Named Standards for BIO:
American Medical Association (AMA) Current Procedural
Terminology (CPT[supreg]) Fourth Edition (CPT-4).
Clinical Care Classification (CCC) Version 2.0 [formerly
known as the Home Healthcare Classification (HHCC) System].
Portions of the Clinical Laboratory Improvement Amendments
(CLIA) of 1988 (42 CFR part 493).
Digital Imaging and Communications in Medicine (DICOM)
Attribute Level Confidentiality Supplement: 55.
Federal Information Processing Standards (FIPS) Codes for
the Identification of the States, the District of Columbia and the
Outlying Areas of the United States, and Associated Areas Publication
5-2, May, 1987.
Portions of the Health Insurance Portability and
Accountability Act of 1996 (HIPAA)--Administrative Simplification.
Health Level Seven (HL7) Version 2.5.
Health Level Seven (HL7) Version 2.5/2.5.1.
Health Level Seven (HL7) Version 3.0.
Health Level Seven (HL7) Version 3.0 Clinical Document
Architecture (CDA/CDA R2).
Healthcare Common Procedure Coding System (HCPCS) Level II
Code Set.
Integrating the Healthcare Enterprise (IHE) IT
Infrastructure Technical Framework (ITI-TF) Revision 3.0.
Integrating the Healthcare Enterprise (IHE) IT
Infrastructure Technical Framework (ITI-TF) Revision 4.0.
Integrating the Healthcare Enterprise (IHE) IT
Infrastructure Technical Framework (ITI-TF) Revision 4.0--Registry
Stored Query Transaction for XDS Profile Supplement.
Integrating the Healthcare Enterprise (IHE) IT
Infrastructure Technical Framework (ITI-TF) Revision 4.0 XCA
Supplement.
Integrating the Healthcare Enterprise (IHE) IT
Infrastructure Technical Framework (TF) Supplement--ITI-25 Notification
of Document Availability (NAV) June 28, 2005.
Integrating the Healthcare Enterprise (IHE) IT
Infrastructure Technical Framework (TF) Supplement--Retrieve Form for
Data Capture (RFD) Sept 25, 2006.
Integrating the Healthcare Enterprise (IHE) Laboratory
Technical Framework Supplement 2006-2007 Revision 1.0.
Integrating the Healthcare Enterprise (IHE) Patient Care
Coordination (PCC) Technical Framework Revision 3.0.
Integrating the Healthcare Enterprise (IHE) Radiology
Technical Framework Revision 7.0.
International Classification of Diseases, 10th Revision,
Procedure Coding System (ICD-10-CS).
International Classification of Diseases, 10th Revision,
Related Health Problems (ICD-10-CM).
International Classification of Diseases, 9th Revision,
Clinical Modifications (ICD-9-CM).
International Health Terminology Standards Development
Organisation (IHTSDO) Systematized Nomenclature of Medicine Clinical
Terms (SNOMED CT[supreg]).
International Organization for Standardization (ISO)
Health informatics--Pseudonymization, Unpublished Technical
Specification 25237.
International Organization for Standardization (ISO)
Electronic business eXtensible Markup Language (ebXML), Technical
Specification 15000--Part 4: Registry services specification
(ebRS), May, 2004.
Logical Observation Identifiers Names and Codes (LOINC
[supreg]).
National Library of Medicine (NLM) Unified Medical
Language System (UMLS) RxNorm.
National Uniform Billing Committee (NUBC) Uniform Bill
Version 1992 (UB-92) Current UB Data Specification Manual Field 22,
Patient Discharge Status, Codes.
Organization for the Advancement of Structured Information
Standards
[[Page 3976]]
(OASIS) Emergency Data Exchange Language (EDXL) Distribution Element
(DE).
Unified Code for Units of Measure (UCUM).
III. Consumer Empowerment (CE)
The purpose of the CE interoperability specification is to allow
consumers to establish and manage permissions access, rights, and
informed consent for authorized and secure exchange, viewing, and
querying of their linked patient registration summaries and medication
histories between designated caregivers and other health professionals.
The CE specification is complete and includes all of the implementation
guidance necessary to implement and the final balloted work products of
all the standards development organizations involved.
The interoperability standards--Interoperability Specification
including Constructs (Components, Transactions, and Transaction
Packages) and Named Standards associated with CE are listed below.
Interoperability Specification Constructs (Components (C), Transactions
(T), and Transaction Packages (TP)) for CE
Consumer Empowerment Interoperability Specification (HITSP
V2.1 2007 IS03).
Summary Documents Using CCD Component (HITSP V2.1 2007
C32).
Patient Demographics Query Transaction (HITSP V2.0 2007
T23).
Manage Sharing of Documents Transaction Package (HITSP
V2.2 2007 TP13).
Patient ID Cross-Referencing Transaction Package (HITSP
V2.0 2007 TP22).
Named Standards for CE
Accredited Standards Committee (ASC) X12 Insurance
Subcommittee (X12N) Implementation Guides Version 004010 plus Addenda
004010A1.
Accredited Standards Committee (ASC) X12 Standards Release
004010.
American Society for Testing and Materials (ASTM) Standard
Specification for Coded Values Used in the Electronic Health Record:
E1633-02.
American Society for Testing and Materials (ASTM) Standard
Specification for Continuity of Care Record (CCR): E2369-05.
CDC Race and Ethnicity Code Sets.
Council for Affordable Quality Health Care (CAQH)
Committee on Operating Rules for Information Exchange (CORE) Phase I
Operating Rules.
Federal Medication Terminologies.
Health Care Provider Taxonomy.
Health Level Seven (HL7) EHR System Functional Model Draft
Standard for Trial Use (DSTU).
Health Level Seven (HL7) Version 2.5.
Health Level Seven (HL7) Version 2.5/2.5.1.
Health Level Seven (HL7) Version 3.0.
Health Level Seven (HL7) Version 3.0 Clinical Document
Architecture (CDA/CDA R2).
HL7 Implementation Guide: CDA Release 2--Continuity of
Care Document (CCD), Release 1.0, April 1, 2007.
Integrating the Healthcare Enterprise (IHE) IT
Infrastructure Technical Framework (ITI-TF) Revision 3.0.
Integrating the Healthcare Enterprise (IHE) IT
Infrastructure Technical Framework (ITI-TF) Revision 4.0.
Integrating the Healthcare Enterprise (IHE) IT
Infrastructure Technical Framework (ITI-TF) Revision 4.0--Registry
Stored Query Transaction for XDS Profile Supplement.
Integrating the Healthcare Enterprise (IHE) IT
Infrastructure Technical Framework (ITI-TF) Revision 4.0 XCA
Supplement.
Integrating the Healthcare Enterprise (IHE) Patient Care
Coordination (PCC) Technical Framework Revision 3.0.
International Organization for Standardization (ISO)
Electronic business eXtensible Markup Language (ebXML), Technical
Specification 15000--Part 4: Registry services specification
(ebRS), May, 2004.
Logical Observation Identifiers Names and Codes (LOINC
[supreg]).
National Council for Prescription Drug Programs (NCPDP)
SCRIPT Standard Version 8.1.
Revisions to the Standards for the Classification of
Federal Data on Race and Ethnicity.
We recognize that certain legal obligations may flow from the
recognition of these interoperability standards. First, pursuant to
Executive Order 13410 (EO 13410) dated August 22, 2006, recognition of
interoperability standards would require each Federal health agency, as
it implements, acquires, or upgrades health information technology
systems used for the direct exchange of health information between
agencies and with non-Federal entities, to ``utilize, where available,
health information technology systems and products that meet
interoperability standards recognized by the Secretary.'' Therefore,
Federal agencies would be required to appropriately consider health
information technology systems and products that comply with these
Interoperability Specifications when purchasing, implementing, or
upgrading such items.
Similarly, the EO 13410 directs Federal agencies to contractually
require, to the extent permitted by law, certain entities with whom
they do business, to use, where available, health information
technology systems and products that meet recognized interoperability
standards.
In addition, the regulations promulgated on August 8, 2006 (see 71
FR 45140 and 71 FR 45110) established exceptions and safe harbors to
the physician self-referral law and the anti-kickback statute,
respectively, for certain arrangements involving the donation of
electronic prescribing and electronic health records (EHR) technology
and services. The EHR exception and safe harbor require that the
software be ``interoperable'' as defined in the regulations. The rules
also provide that certain software will be deemed to be
``interoperable'' if that software has been certified by a certifying
body recognized by the Secretary within 12 months prior to the
donation. Under the interim guidance for the recognition of certifying
bodies published by the ONC (``Office of the National Coordinator for
Health Information Technology (ONC) Interim Guidance Regarding the
Recognition of Certification Bodies''), for an organization to be
recognized as a recognized certifying body (RCB), the organization
must:
Have in place a demonstrated process for and experience in certifying
products to be in compliance with criteria recognized by the Secretary;
Have a method by which they can incorporate all applicable standards
and certification criteria recognized by the Secretary into their
certification processes; and
Have the ability to adapt their processes to emerging certification
criteria recognized by the Secretary.
The RCBs would therefore have to certify such products in
conformity with, among other provisions, these interoperability
specifications for the certified products to meet the interoperability
deeming provisions of the physician self-referral exception and anti-
kickback safe harbor, respectively.
The Secretary is mindful that the ability of software to be
interoperable evolves as technology develops. Consequently, if an
enforcement action is initiated for an allegedly improper donation of
EHR non-certified software,
[[Page 3977]]
the Secretary would review whether the software was interoperable, as
defined in the regulations. The Secretary would consider the prevailing
state of technology at the time the items or services were provided to
the recipient. As explained in the regulations, the Secretary
understands that parties should have a reasonable basis for determining
whether the EHR software is interoperable. We therefore indicated that
``it would be appropriate--and, indeed, advisable--for parties to
consult any standards and criteria related to interoperability
recognized by the Department.''
Compliance with these standards and criteria, as we explained in
the regulations, ``will provide greater certainty to donors and
recipients that products meet the interoperability requirement, and may
be relevant in an enforcement action.''
Based on the changing nature of technological development noted
above, the Secretary has accepted and recognized these Interoperability
Specifications. He has also delegated authority to ONC to coordinate
and oversee the incorporation of these Interoperability Specifications
in relevant activities among Federal agencies and other partner
organizations, as appropriate.
FOR FURTHER INFORMATION CONTACT: Judith Sparrow at (202) 690-7151.
Dated: January 17, 2008.
Robert M. Kolodner,
National Coordinator for Health Information Technology, Office of the
National Coordinator for Health Information Technology.
[FR Doc. 08-234 Filed 1-17-08; 1:18pm]
BILLING CODE 4150-45-P
