21 January 2009
[Federal Register: January 21, 2009 (Volume 74, Number 12)]
[Notices]
[Page 3599-3608]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr21ja09-81]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Office of the National Coordinator for Health Information
Technology (ONC), HHS; Notice of Availability: Secretarial Recognition
of Certain Healthcare Information Technology Standards Panel (HITSP)
Interoperability Specifications and the Standards They Contain as
Interoperability Standards for Health Information Technology
AGENCY: Office of the National Coordinator for Health Information
Technology (ONC), HHS.
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''), continued by Public Law 110-329 (``Consolidated Security,
Disaster Assistance, and Continuing Appropriations Act, 2009''), 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) ``HITSP Interoperability
Specifications'' and the standards they contain as ``Interoperability
Standards'' for health information technology. The Secretary accepted
these Interoperability Standards in January of 2008, and hereby
recognizes them in updated versions one year later, effective January
16, 2009. The lists of recognized Interoperability Standards are
provided below and are available at http://www.hitsp.org; click on the
``View by Status'' tab.
SUPPLEMENTARY INFORMATION: The American Health Information
[[Page 3600]]
Community (the ``Community'') was a Federal advisory committee that was
formed in 2005 to advise the Secretary concerning efforts to develop
information technology standards and achieve interoperability of health
IT, and to serve as a forum for a broad range of stakeholders to
provide input on achieving widespread adoption of interoperable health
IT. The final meeting of the Community was held on November 12, 2008. A
successor to the Community has been established in the private sector,
and it held its first Board meeting on November 13, 2008.
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 harmonizing and
integrating standards that will meet clinical and business needs for
sharing information among organizations and systems. 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 HITSP standards harmonization process
was built by vendors, standards development organizations (SDOs),
consumers, payers, providers, and other sectors of the industry. HITSP
is a multi-stakeholder organization involving more than 600 different
healthcare industry organizations and technical experts whose
activities to date on these HITSP Interoperability Specifications
represent more than 23,000 volunteer hours of effort.
The HITSP Interoperability Specifications are developed through a
voluntary consensus-based process as a means to advance the national
agenda for secure interoperable health information systems. The HITSP
Interoperability Specifications are based on priorities previously
recommended by the Community to the Secretary, who in turn considered
the Community's advice and directed the advancement of Use Cases to
further the priorities he adopted. A Use Case provides a description of
the activity of persons or things (actors), a sequence of their
actions, and technical specifications for systems and technologies
involved when the actors engage in responding or participating in a
priority area or scenario.
The HITSP Harmonization Framework defines a set of artifacts, known
as ``Constructs,'' which specify how to integrate and constrain
designated standards to meet the business needs of a Use Case; and
determines how best to adopt and use emerging standards and to
harmonize overlapping standards. A brief description of the Construct
types and the relationships among them follows. Additional information
on the HITSP Harmonization Framework may be found at http://
www.hitsp.org.
HITSP Construct types, in decreasing breadth of scope, include
``Interoperability Specifications,'' ``Transaction Packages,''
``Transactions,'' and ``Components.'' Interoperability Specifications
describe the integration of all other Constructs used to meet the
business needs of a Use Case. Transaction Packages contain a logical
grouping of Transactions. Transactions provide a logical grouping of
actions that use Components and/or composite standards to realize the
actions. Components are logical groupings of base standards that work
together, such as message and terminology standards. Specific rules
exist for each type of Construct, defining what the Construct type can
be used for and how the Construct types can be nested. A Construct may
contain other Constructs or Construct types that are less inclusive in
scope. A Construct may constrain another Construct or standard that it
contains; conversely, a Construct may be constrained by a Construct
that contains it. Each Construct is a candidate for reuse and
repurposing, if a new set of requirements and context can be fulfilled
by the Construct without impacting existing uses of the Construct. Each
Construct is uniquely identified and version controlled.
Named Standards are major terminologies, technologies, and
messaging formats referenced and/or incorporated in the HITSP
Interoperability Specifications, and fall into three categories:
Selected Standards, Informative Reference Standards, and Federally
Adopted Standards. Selected Standards are those Named Standards that
HITSP has determined to be necessary for interoperability and to be
used to meet information exchange requirements of associated
Constructs. They are ``selected'' for use in a Construct within the
context of the specific Use Case requirements, and their selection for
one particular Construct does not necessarily reflect selection in
other contexts. Informative Reference Standards are Named Standards
that provide additional background information or guidance, and are not
required for interoperability or to implement the referencing
Construct. Frequently, Informative Reference Standards simply provide
illustrative examples that are intended to assist entities in
implementing relevant HITSP Interoperability Specifications. The last
category of Named Standards, Federally Adopted Standards, are those
standards that HITSP has identified in Constructs, which have been
adopted by federal regulation or are otherwise required by federal law.
All ``HITSP Interoperability Specifications'' and their components
include language that defers to Federally Adopted Standards, wherever
they apply.
The term ``HITSP Interoperability Specifications'' is used here
both broadly and inclusively to refer to the specific Use-Case-derived
Interoperability Specifications, the Constructs, implementation
guidance, and the Selected Standards. Informative Reference Standards
are intended solely to provide greater clarity and guidance for
implementing the HITSP Interoperability Specifications. Similarly,
HITSP Technical Notes, which are used to give additional guidance and
direction to the HITSP analysis process as well as background
information for implementers, are intended solely for guidance.
The HITSP presented to the Community the following: Three updated
sets of HITSP Interoperability Specifications and three sets of new
HITSP Interoperability Specifications, along with all of the Selected
Standards and Constructs associated with each, as approved by the HITSP
and described in the following paragraphs. The Community subsequently
recommended that the updated and new HITSP Interoperability
Specifications, which include Constructs, and Named Standards,
initially be accepted by the Secretary as ``Interoperability
Standards'' as of January 2008 and then be recognized by the Secretary
one year later in January 2009. HITSP indicated that it would, in
conjunction with the public and private sectors that will be
implementing these standards, be refining the components over the
course of this year, and that any refinements would consist solely of
changes that are minor and of a technical nature. The Secretary has
since considered and adopted the Community's recommendations, and in
turn, accepted the HITSP Interoperability Specifications in January
2008 while indicating his intention to recognize them one year later,
in January 2009, presuming that any changes would be minimal,
reflecting public comment and/or of a minor and technical nature.
The updated HITSP Interoperability Specification recommended for
acceptance in January 2008 and recognition in January 2009 is IS03
Consumer Empowerment and Access to Clinical Information via Networks
(v3).
[[Page 3601]]
The new HITSP Interoperability Specifications recommended for
acceptance and recognition include IS04 Emergency Responder Electronic
Health Record (v1), IS05 Consumer Empowerment and Access to Clinical
Information via Portable Media (v1), and IS06 Quality (v1).
The IS04 Emergency Responder Electronic Health Record (v1) and
related standards address the deployment of standardized, widely
available and secure solutions for accessing and exchanging current and
historical patient-specific health information in both small- and
large-scale emergency care incidents. Both of the Consumer Empowerment
Interoperability Specifications and related standards address the
support of consumer interactions to reconcile identifiers and access,
view, and share registration summaries and clinical information with
personal health records; they are distinguished by the modes of
exchange, via networks (IS03 v3) or portable media (IS05 v1). The IS06
Quality (v1) and related standards enable interoperable, electronic
quality monitoring and improvement.
A series of Constructs referenced in the HITSP Security and Privacy
Technical Note (TN900) supports existing and developing polices for the
security of electronic health information by providing an initial
infrastructure of standards and implementation guidance that can be
used with a variety of different methodologies and approaches that are
currently employed. These data and technical standards do not define
policies, but provide an infrastructure that can support policy
implementation. The Constructs referenced in TN900 have been integrated
into all of the accepted HITSP Interoperability Specifications, as well
as into all existing Interoperability Standards, and will continue to
be reused for future use cases. The updated Interoperability Standards
previously recognized in January 2008 now incorporate the security and
privacy constructs from TN900. These include IS01 Electronic Health
Records Laboratory Results Reporting (v3) and IS02 Biosurveillance
(v3), as well as the previously mentioned IS03 Consumer Empowerment and
Access to Clinical Information via Networks (v3).
The Interoperability Standards associated with the HITSP
Biosurveillance Interoperability Specification (HITSP v2 2007 IS02), or
``BIO,'' were recognized by the Secretary in December 2007. The
Hospital Availability Exchange Standard (HAVE), which was referenced in
the HITSP Interoperability Specification, was not ready for secretarial
recognition in June 2008 as anticipated, but since its content has been
previously included in the accepted HITSP Interoperability
Specifications and it has achieved final ballot by the Standards
Development Organization, it is being recognized.
Over the course of the year between ``acceptance'' and
``recognition,'' all refinements to the HITSP Interoperability
Specifications have been solely of a minor and technical nature. In
addition, further mappings of existing policies were conducted to
ensure that there were no issues or conflicts.
Inserted below are lists of the HITSP Interoperability
Specifications, including the Constructs and Selected Standards
referenced by each Construct, which the Secretary is recognizing,
effective January 16, 2009. For the newly recognized Interoperability
Standards (i.e., IS04, IS05, and IS06), all Constructs and Selected
Standards are listed. For the previously recognized Interoperability
Standards that have been updated, only the minor, technical changes are
listed for clarity and convenience. The full text of the HITSP
Interoperability Specifications, Constructs, and references to the
Selected Standards, along with the related Use Cases can be found at
http://www.hitsp.org.
IS01--Electronic Health Records Laboratory Results Reporting V3
Below is a list of the HITSP constructs that have been added as
referenced by this HITSP Interoperability Specification since
previously recognized.
HITSP/C19 Entity Identity Assertion Component (V1)
HITSP/T14 Send Laboratory Result Message Transaction (V2)
HITSP/T15 Collect and Communicate Security Audit Trail
Transaction (V1)
HITSP/T16 Consistent Time Transaction (V1)
HITSP/T17 Secured Communication Channel Transaction (V1)
HITSP/TP20 Access Control Transaction Package (V1)
HITSP/TP30 Manage Consent Directives Transaction Package
(V1)
Below is a list of Selected Standards that have been added for this
HITSP Interoperability Specification since previously recognized.
Health Level Seven (HL7) U.S. Realm--Interoperability
Specification: Lab Result Message to EHR (ORU-R01) (HL7 Version 2.5.1)
September, 2007
Health Level Seven (HL7) V3 RBAC, R1-2008, HL7 Version 3
Standard: Role Based Access Control (RBAC) Healthcare Permissions
Catalog, Release 1, February 2008
Health Level Seven (HL7) Version 2.3.1
Health Level Seven (HL7) Version 2.5.1
Health Level Seven (HL7) Version 3.0 Privacy Consent
related specifications RCMR--RM010001--Data Consent
Integrating the Healthcare Enterprise (IHE) IT
Infrastructure Technical Framework (ITI-TF) Volume 2 Supplement 2007-
2008 Cross-Enterprise User Assertion (XUA)
Integrating the Healthcare Enterprise (IHE) IT
Infrastructure Technical Framework (ITI-TF) Revision 4.0, Audit Trail
and Node Authentication (ATNA) Integration Profile
Integrating the Healthcare Enterprise (IHE) IT
Infrastructure Technical Framework (ITI-TF) Revision 4.0, Consistent
Time (CT) Integration Profile
Integrating the Healthcare Enterprise (IHE) IT
Infrastructure Technical Framework (ITI-TF) Revision 4.0, Patient
Demographics Query (PDQ) Integration Profile
Integrating the Healthcare Enterprise (IHE) IT
Infrastructure Technical Framework (TF) Supplement--ITI-25 Notification
of Document Availability (NAV) Jun 28, 2005
Integrating the Healthcare Enterprise (IHE) IT
Infrastructure Technical Framework (ITI-TF) Revision 4.0, Section 10
Cross-Enterprise Document Sharing (XDS.a)
Integrating the Healthcare Enterprise (IHE) IT
Infrastructure Technical Framework (ITI-TF) Volume 2 Supplement 2007-
2008 Cross-Enterprise Document Sharing-B (XDS.b)
Integrating the Healthcare Enterprise (IHE) IT
Infrastructure Technical Framework (ITI-TF) Supplement 2007-2008 Basic
Patient Privacy Consents (BPPC)--Trial Implementation
Integrating the Healthcare Enterprise (IHE) IT
Infrastructure Technical Framework Supplement 2008-2009, Pediatric
Demographics, Draft for Trial Implementation (August 22, 2008)
Integrating the Healthcare Enterprise (IHE) IT
Infrastructure Technical Framework (ITI-TF) Revision 4.0, Patient
Identifier Cross-Referencing Integration Profile (PIX)
Integrating the Healthcare Enterprise (IHE) Laboratory
Technical Framework Volume 3 (LAB TF-3) Document-based Transactions,
Revision
[[Page 3602]]
2.0--For Trial Implementation, August 16, 2007
Internet Engineering Task Force (IETF) Hypertext Transfer
Protocol (HTTP) over Transport Layer Security (TLS) (RFC)
2818, May 2000
Internet Engineering Task Force (IETF) Network Time
Protocol (Version 3) Specification, Implementation and Analysis,
``Request for Comment'' (RFC) 1305, March, 1992
Internet Engineering Task Force (IETF) Simple Network Time
Protocol (SNTP) Version 4, ``Request for Comment'' (RFC)
2030, October, 1996
Organization for the Advancement of Structured Information
Standards (OASIS) Security Assertion Markup Language (SAML) v2.0 OASIS
Standard; ITU-T X.1141
Organization for the Advancement of Structured Information
Standards (OASIS) WS-Federation Web Services Federation Language (WS-
Federation), Version 1.1, December 2006
Organization for the Advancement of Structured Information
Standards (OASIS) WS-Trust Version 1.3, March 2007
Organization for the Advancement of Structured Information
Standards (OASIS) eXtensible Access Control Markup Language (XACML),
ITU-T Recommendation X.1142, February 2005
Below is a list of standards that have been removed, re-
categorized, or expanded on for this HITSP Interoperability
Specification since previously recognized.
Clinical Laboratory Improvement Amendments (CLIA) of 1988
[cir] Designated as Federally Adopted Standards
Health Insurance Portability and Accountability Act
(HIPAA)--Administrative Simplification
[cir] Designated as Federally Adopted Standards
Hypertext Transfer Protocol Secure (HTTPS) 443/tcp
[cir] Removed from Interoperability Specification
Integrating the Healthcare Enterprise (IHE) IT
Infrastructure Technical Framework (ITI-TF) Revision 3.0
[cir] Has been expanded upon to add more detail/clarity
Health Level Seven (HL7) Version 2.5/2.5.1
[cir] Has been expanded upon to add more detail/clarity
Integrating the Healthcare Enterprise (IHE) IT
Infrastructure Technical Framework (ITI-TF) Revision 4.0
[cir] Has been expanded upon to add more detail/clarity
Integrating the Healthcare Enterprise (IHE) IT
Infrastructure Technical Framework (TF) Supplement
[cir] Has been expanded upon to add more detail/clarity
Integrating the Healthcare Enterprise (IHE) Laboratory
Technical Framework Supplement 2006-2007 Revision 1.0
[cir] Removed from Interoperability Specification
International Organization for Standardization (ISO)
Electronic business eXtensible Markup Language (ebXML), Technical
Specification 15000--Part 4: Registry services specification
(ebRS), May, 2004
[cir] Removed from Interoperability Specification
IS02--Biosurveillance V3
Below is a list of the HITSP constructs that have been added as
referenced by this HITSP Interoperability Specification since
previously recognized.
HITSP/C19 Entity Identity Assertion Component (V1)
HITSP/C26 Nonrepudiation of Origin Component (V1)
HITSP/T15 Collect and Communicate Security Audit Trail
Transaction (V1)
HITSP/T16 Consistent Time Transaction (V1)
HITSP/T17 Secured Communication Channel Transaction (V1)
HITSP/TP20 Access Control Transaction Package (V1)
HITSP/TP30 Manage Consent Directives Transaction Package
(V1)
Below is a list of Selected Standards that have been added for this
HITSP Interoperability Specification since previously recognized.
American Society for Testing and Materials (ASTM) Standard
Guide for Electronic Authentication of Health Care Information:
E1762-95(2003)
European Telecommunications Standards Institute (ETSI)
Technical Specification TS 101 903: XML Advanced Electronic Signatures
(XadES)
Health Level Seven (HL7) U.S. Realm--Interoperability
Specification: Lab Result Message to EHR (ORU[caret]R01) (HL7 Version
2.5.1) September, 2007
Health Level Seven (HL7) V3 RBAC, R1-2008, HL7 Version 3
Standard: Role Based Access Control (RBAC) Healthcare Permissions
Catalog, Release 1, February 2008
Health Level Seven (HL7) Version 2.3.1
Health Level Seven (HL7) Version 2.5.1
Health Level Seven (HL7) Version 3.0 Privacy Consent
related specifications RCMR--RM010001--Data Consent
Integrating the Healthcare Enterprise (IHE) IT
Infrastructure Technical Framework (ITI-TF) Revision 4.0, Audit Trail
and Node Authentication (ATNA) Integration Profile
Integrating the Healthcare Enterprise (IHE) IT
Infrastructure Technical Framework (ITI-TF) Revision 4.0, Consistent
Time (CT) Integration Profile
Integrating the Healthcare Enterprise (IHE) IT
Infrastructure Technical Framework (ITI-TF) Revision 4.0, Section 10
Cross-Enterprise Document Sharing (XDS.a)
Integrating the Healthcare Enterprise (IHE) IT
Infrastructure Technical Framework (TF) Supplement--ITI-25 Notification
of Document Availability (NAV) Jun 28, 2005
Integrating the Healthcare Enterprise (IHE) IT
Infrastructure Technical Framework (ITI-TF) Volume 2 Supplement 2007-
2008 Cross-Enterprise User Assertion (XUA)
Integrating the Healthcare Enterprise (IHE) IT
Infrastructure Technical Framework (ITI-TF) Volume 2 Supplement 2007-
2008 Cross-Enterprise Document Sharing-B (XDS.b)
Integrating the Healthcare Enterprise (IHE) IT
Infrastructure Technical Framework (ITI-TF) Supplement 2007-2008 Basic
Patient Privacy Consents (BPPC)--Trial Implementation
Integrating the Healthcare Enterprise (IHE) IT
Infrastructure Technical Framework (TF) Supplement Volume 3--Document
Digital Signature (DSG) Content Profile
Integrating the Healthcare Enterprise (IHE) IT
Infrastructure Technical Framework (TF) 2007-2008 Supplement, Retrieve
Form for Data Capture (RFD)
Integrating the Healthcare Enterprise (IHE) IT
Infrastructure Technical Framework Supplement 2008-2009, Pediatric
Demographics, Draft for Trial Implementation (August 22, 2008)
Integrating the Healthcare Enterprise (IHE) IT
Infrastructure Technical Framework (ITI-TF) Revision 4.0, Patient
Identifier Cross-Referencing Integration Profile (PIX)
Integrating the Healthcare Enterprise (IHE) Laboratory
Technical Framework Volume 3 (LAB TF-3) Document-based Transactions,
Revision 2.0--For Trial Implementation, August 16, 2007
Integrating the Healthcare Enterprise (IHE) Patient Care
[[Page 3603]]
Coordination (PCC), Revision 3.0, 2007-2008, Cross-Enterprise Sharing
of Medical Summaries (XDS-MS) Integration Profile
Integrating the Healthcare Enterprise (IHE) Radiology
Technical Framework Revision 8.0
Internet Engineering Task Force (IETF) Network Time
Protocol (Version 3) Specification, Implementation and Analysis,
``Request for Comment'' (RFC) 1305, March, 1992
Internet Engineering Task Force (IETF) Simple Network Time
Protocol (SNTP) Version 4, ``Request for Comment'' (RFC) 2030,
October, 1996
Organization for the Advancement of Structured Information
Standards (OASIS) Security Assertion Markup Language (SAML) v2.0 OASIS
Standard; ITU-T X.1141
Organization for the Advancement of Structured Information
Standards (OASIS) WS-Federation Web Services Federation Language (WS-
Federation), Version 1.1, December 2006
Organization for the Advancement of Structured Information
Standards (OASIS) WS-Trust Version 1.3, March 2007
Organization for the Advancement of Structured Information
Standards (OASIS) eXtensible Access Control Markup Language (XACML),
ITU-T Recommendation X.1142, February 2005
Below is a list of standards that have been removed, re-
categorized, or expanded on for this HITSP Interoperability
Specification since previously recognized.
Clinical Care Classification (CCC) Version 2.0 [formerly
known as the Home Healthcare Classification (HHCC) System]
[cir] Removed from Interoperability Specification
Clinical Laboratory Improvement Amendments (CLIA) of 1988
[cir] Designated as Federally Adopted Standards
Digital Imaging and Communications in Medicine (DICOM)
Attribute Level Confidentiality Supplement: 55
[cir] Removed from Interoperability Specification
Health Insurance Portability and Accountability Act
(HIPAA)--Administrative Simplification
[cir] Designated as Federally Adopted Standards
Health Level Seven (HL7) Version 2.5/2.5.1
[cir] Has been expanded upon to add more detail/clarity
Health Level Seven (HL7) Version 3.0
[cir] Has been expanded upon to add more detail/clarity
Healthcare Common Procedure Coding System (HCPCS) Level II
Code Set
[cir] Removed from Interoperability Specification
Integrating the Healthcare Enterprise (IHE) IT
Infrastructure Technical Framework (TF) Supplement
[cir] Has been expanded upon to add more detail/clarity
Integrating the Healthcare Enterprise (IHE) Laboratory
Technical Framework Supplement 2006-2007 Revision 1.0
[cir] Removed from Interoperability Specification
Integrating the Healthcare Enterprise (IHE) Patient Care
Coordination (PCC) Technical Framework Revision 3.0
[cir] Has been expanded upon to add more detail/clarity
Integrating the Healthcare Enterprise (IHE) Radiology
Technical Framework Revision 7.0
[cir] Has been expanded upon to add more detail/clarity
International Organization for Standardization (ISO)
Electronic business eXtensible Markup Language (ebXML), Technical
Specification 15000--Part 4: Registry services specification
(ebRS), May 2004
[cir] Removed from Interoperability Specification
National Library of Medicine (NLM) Unified Medical
Language System (UMLS) RxNorm
[cir] Removed from Interoperability Specification
Organization for the Advancement of Structured Information
Standards (OASIS) Emergency Data Exchange Language (EDXL) Distribution
Element (DE)
[cir] Removed from Interoperability Specification
IS03--Consumer Empowerment and Access to Clinical Information via
Networks V3
Below is a list of the HITSP constructs that have been added as
referenced by this HITSP Interoperability Specification since
previously recognized.
HITSP/C19 Entity Identity Assertion Component (V1)
HITSP/C26 Nonrepudiation of Origin Component (V1)
HITSP/C35 Lab Result Terminology Component (V2)
HITSP/C37 Lab Report Document Component (V2)
HITSP/T15 Collect and Communicate Security Audit Trail
Transaction (V1)
HITSP/T16 Consistent Time Transaction (V1)
HITSP/T17 Secured Communication Channel Transaction (V1)
HITSP/TP20 Access Control Transaction Package (V1)
HITSP/TP30 Manage Consent Directives Transaction Package
(V1)
Below is a list of Selected Standards that have been added for this
HITSP Interoperability Specification since previously recognized.
American Society for Testing and Materials (ASTM) Standard
Guide for Electronic Authentication of Health Care Information:
E1762-95 (2003)
European Telecommunications Standards Institute (ETSI)
Technical Specification TS 101 903: XML Advanced Electronic Signatures
(XadES)
Health Level Seven (HL7) V3 RBAC, R1-2008, HL7 Version 3
Standard: Role Based Access Control (RBAC) Healthcare Permissions
Catalog, Release 1, February 2008
Health Level Seven (HL7) Version 2.3.1
Health Level Seven (HL7) Version 2.5.1
Health Level Seven (HL7) Version 3.0 Privacy Consent
related specifications RCMR--RM010001--Data Consent
Integrating the Healthcare Enterprise (IHE) IT
Infrastructure Technical Framework (ITI-TF) Revision 4.0, Section 10
Cross-Enterprise Document Sharing (XDS.a)
Integrating the Healthcare Enterprise (IHE) IT
Infrastructure Technical Framework (ITI-TF) Volume 2 Supplement 2007-
2008 Cross-Enterprise Document Sharing-B (XDS.b)
Integrating the Healthcare Enterprise (IHE) IT
Infrastructure Technical Framework (ITI-TF) Revision 4.0, Patient
Identifier Cross-Referencing Integration Profile (PIX)
Integrating the Healthcare Enterprise (IHE) IT
Infrastructure Technical Framework (ITI-TF) Revision 4.0, Audit Trail
and Node Authentication (ATNA) Integration Profile
Integrating the Healthcare Enterprise (IHE) IT
Infrastructure Technical Framework (ITI-TF) Revision 4.0, Consistent
Time (CT) Integration Profile
Integrating the Healthcare Enterprise (IHE) IT
Infrastructure Technical Framework (ITI-TF) Supplement 2007-2008 Basic
Patient Privacy Consents (BPPC)--Trial Implementation
Integrating the Healthcare Enterprise (IHE) IT
Infrastructure
[[Page 3604]]
Technical Framework (ITI-TF) Volume 2 Supplement 2007-2008 Cross-
Enterprise User Assertion (XUA)
Integrating the Healthcare Enterprise (IHE) IT
Infrastructure Technical Framework (TF) Supplement Volume 3--Document
Digital Signature (DSG) Content Profile
Integrating the Healthcare Enterprise (IHE) IT
Infrastructure Technical Framework Supplement 2008-2009, Pediatric
Demographics, Draft for Trial Implementation (August 22, 2008)
Integrating the Healthcare Enterprise (IHE) IT
Infrastructure Technical Framework (ITI-TF) Revision 4.0, Patient
Demographics Query (PDQ) Integration Profile
Integrating the Healthcare Enterprise (IHE) Laboratory
Technical Framework Volume 3 (LAB TF-3) Document-based Transactions,
Revision 2.0--For Trial Implementation, August 16, 2007
International Health Terminology Standards Development
Organisation (IHTSDO) Systematized Nomenclature of Medicine Clinical
Terms (SNOMED CT[supreg])
Internet Engineering Task Force (IETF) Network Time
Protocol (Version 3) Specification, Implementation and Analysis,
``Request for Comment'' (RFC) 1305, March, 1992
Internet Engineering Task Force (IETF) Simple Network Time
Protocol (SNTP) Version 4, ``Request for Comment'' (RFC)
2030, October, 1996
Organization for the Advancement of Structured Information
Standards (OASIS) Security Assertion Markup Language (SAML) v2.0 OASIS
Standard; ITU-T X.1141
Organization for the Advancement of Structured Information
Standards (OASIS) WS-Federation Web Services Federation Language (WS-
Federation), Version 1.1, December 2006
Organization for the Advancement of Structured Information
Standards (OASIS) WS-Trust Version 1.3, March 2007
Organization for the Advancement of Structured Information
Standards (OASIS) eXtensible Access Control Markup Language (XACML),
ITU-T Recommendation X.1142, February 2005
Unified Code for Units of Measure (UCUM)
Below is a list of standards that have been removed, re-
categorized, or expanded on for this HITSP Interoperability
Specification since previously recognized.
Accredited Standards Committee (ASC) X12 Insurance
Subcommittee (X12N) Implementation Guides Version 004010 plus Addenda
004010A1
[cir] Removed from Interoperability Specification
Accredited Standards Committee (ASC) X12 Standards Release
004010
[cir] Removed from Interoperability Specification
American Society for Testing and Materials (ASTM) Standard
Specification for Coded Values Used in the Electronic Health Record:
E1633-02
[cir] Removed from Interoperability Specification
American Society for Testing and Materials (ASTM) Standard
Specification for Continuity of Care Record (CCR): E2369-05
[cir] Removed from Interoperability Specification
CDC Race and Ethnicity Code Sets
[cir] Removed from Interoperability Specification
Council for Affordable Quality Healthcare (CAQH) Committee
on Operating Rules for Information Exchange (CORE) Phase I Operating
Rules
[cir] Designated as Informative Reference
Federal Medication Terminologies
[cir] Removed from Interoperability Specification and replaced by
specific named terminologies
Health Level Seven (HL7) HER System Functional Model Draft
Standard for Trial use (DSTU)
[cir] Removed from Interoperability Specification
Health Level Seven (HL7) Version 2.5/2.5.1
[cir] Has been expanded upon to add more detail/clarity
Health Level Seven (HL7) Version 3.0
[cir] Has been expanded upon to add more detail/clarity and listed
as Informative Reference
U.S. National Uniform Claims Committee Health Care
Provider Taxonomy Code Set
[cir] Removed from Interoperability Specification
International Organization for Standardization (ISO)
Electronic business eXtensible Markup Language (ebXML), Technical
Specification 15000--Part 4: Registry services specification
(ebRS), May, 2004
[cir] Removed from Interoperability Specification
Integrating the Healthcare Enterprise (IHE) IT
Infrastructure Technical Framework (ITI-TF) Revision 3.0
[cir] Removed from Interoperability Specification
Integrating the Healthcare Enterprise (IHE) IT
Infrastructure Technical Framework (ITI-TF) Revision 4.0
[cir] Has been expanded upon to add more detail/clarity and listed
as Informative Reference
Integrating the Healthcare Enterprise (IHE) Patient Care
Coordination (PCC) Technical Framework Revision 3.0
[cir] Removed from Interoperability Specification
National Council for Prescription Drug Programs (NCPDP)
SCRIPT Standard Version 8.1
[cir] Removed from Interoperability Specification
Revisions to the Standards for the Classification of
Federal Data on Race and Ethnicity
[cir] Designated as Informative Reference
IS04--Emergency Responder Electronic Health Record V1
Below is a list of the HITSP constructs used by this HITSP
Interoperability Specification.
HITSP/C19 Entity Identity Assertion Component (V1)
HITSP/C28 Emergency Care Summary Document Using IHE
Emergency Department Encounter Summary (EDES) Component (V1)
HITSP/C32 Summary Documents Using HL7 Continuity of Care
Document (CCD) Component (V2)
HITSP/C39 Encounter Message Component (V2)
HITSP/C48 Encounter Document Using IHE Medical Summary
(XDS-MS) Component (V2)
HITSP/T15 Collect and Communicate Security Audit Trail
Transaction (V1)
HITSP/T16 Consistent Time Transaction (V1)
HITSP/T17 Secured Communication Channel Transaction (V1)
HITSP/T23 Patient Demographics Query Transaction (V2)
HITSP/TP13 Manage Sharing of Documents Transaction Package
(V2)
HITSP/TP20 Access Control Transaction Package (V1)
HITSP/TP22 Patient ID Cross-Referencing Transaction
Package (V2)
HITSP/TP30 Manage Consent Directives Transaction Package
(V1)
Below is a list of Selected Standards for this HITSP
Interoperability Specification.
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
Health Level Seven (HL7) Implementation Guide: CDA Release
2--
[[Page 3605]]
Continuity of Care Document (CCD), April 01, 2007
Health Level Seven (HL7) V3 RBAC, R1-2008, HL7 Version 3
Standard: Role Based Access Control (RBAC) Healthcare Permissions
Catalog, Release 1, February 2008
Health Level Seven (HL7) Version 2.3.1
Health Level Seven (HL7) Version 2.5
Health Level Seven (HL7) Version 3.0 Clinical Document
Architecture (CDA/CDA R2)
Health Level Seven (HL7) Version 3.0 Privacy Consent
related specifications RCMR--RM010001--Data Consent
Integrating the Healthcare Enterprise (IHE) IT
Infrastructure Technical Framework (ITI-TF) Revision 4.0, Audit Trail
and Node Authentication (ATNA) Integration Profile
Integrating the Healthcare Enterprise (IHE) IT
Infrastructure Technical Framework (ITI-TF) Revision 4.0, Consistent
Time (CT) Integration Profile
Integrating the Healthcare Enterprise (IHE) IT
Infrastructure Technical Framework (ITI-TF) Volume 2 Supplement 2007-
2008 Cross-Enterprise User Assertion (XUA)
Integrating the Healthcare Enterprise (IHE) IT
Infrastructure Technical Framework (ITI-TF) Revision 4.0, Patient
Demographics Query (PDQ) Integration Profile
Integrating the Healthcare Enterprise (IHE) IT
Infrastructure Technical Framework (ITI-TF) Revision 4.0, Section 10
Cross-Enterprise Document Sharing (XDS.a)
Integrating the Healthcare Enterprise (IHE) IT
Infrastructure Technical Framework (ITI-TF) Volume 2 Supplement 2007-
2008 Cross-Enterprise Document Sharing-B (XDS.b)
Integrating the Healthcare Enterprise (IHE) IT
Infrastructure Technical Framework (ITI-TF) Revision 4.0--Registry
Stored Query Transaction for XDS Profile Supplement [ITI-18]
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 (ITI-TF) Supplement 2007-2008 Basic
Patient Privacy Consents (BPPC)--Trial Implementation
Integrating the Healthcare Enterprise (IHE) IT
Infrastructure Technical Framework Supplement 2008-2009, Pediatric
Demographics, Draft for Trial Implementation (August 22, 2008)
Integrating the Healthcare Enterprise (IHE) IT
Infrastructure Technical Framework (ITI-TF) Revision 4.0, Patient
Identifier Cross-Referencing Integration Profile (PIX)
Integrating the Healthcare Enterprise (IHE) Patient Care
Coordination (PCC)--Emergency Department Encounter Summary (EDES),
Technical Framework Supplement, Volume I, Revision 3.0, 2007-2008.
Integrating the Healthcare Enterprise (IHE) Patient Care
Coordination (PCC), Revision 3.0, 2007-2008, Cross-Enterprise Sharing
of Medical Summaries (XDS-MS) Integration Profile
International Classification of Diseases, 10th Revision,
Procedure Coding System (ICD-10-PCS)
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])
Internet Engineering Task Force (IETF) Network Time
Protocol (Version 3) Specification, Implementation and Analysis,
``Request for Comment'' (RFC) 1305, March, 1992
Internet Engineering Task Force (IETF) Simple Network Time
Protocol (SNTP) Version 4, ``Request for Comment'' (RFC)
2030, October, 1996
Logical Observation Identifiers Names and Codes
(LOINC[supreg])
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 (OASIS) Security Assertion Markup Language (SAML) v2.0 OASIS
Standard; ITU-T X.1141
Organization for the Advancement of Structured Information
Standards (OASIS) WS-Federation Web Services Federation Language (WS-
Federation), Version 1.1, December 2006
Organization for the Advancement of Structured Information
Standards (OASIS) WS-Trust Version 1.3, March 2007
Organization for the Advancement of Structured Information
Standards (OASIS) eXtensible Access Control Markup Language (XACML),
ITU-T Recommendation X.1142, February 2005
Unified Code for Units of Measure (UCUM)
IS05--Consumer Empowerment and Access to Clinical Information via Media
V1
Below is a list of the HITSP constructs used by this HITSP
Interoperability Specification.
HITSP/C19 Entity Identity Assertion Component (V1)
HITSP/C32 Summary Documents Using HL7 Continuity of Care
Document (CCD) Component (V2)
HITSP/C35 Lab Result Terminology Component (V2)
HITSP/C37 Lab Report Document Component (V2)
HITSP/T15 Collect and Communicate Security Audit Trail
Transaction (V1)
HITSP/T16 Consistent Time Transaction (V1)
HITSP/T23 Patient Demographics Query Transaction (V2)
HITSP/T33 Transfer of Documents on Media Transaction (V1)
HITSP/TP20 Access Control Transaction Package (V1)
HITSP/TP22 Patient ID Cross-Referencing Transaction
Package (V2)
HITSP/TP30 Manage Consent Directives Transaction Package
(V1)
Below is a list of Selected Standards for this HITSP
Interoperability Specification.
Digital Imaging and Communications in Medicine (DICOM)
Part 3.12: Media Formats and Physical Media for Media Interchange
Health Level Seven (HL7) Clinical Document Architecture
Release 2 (CDA R2)
Health Level Seven (HL7) Implementation Guide: CDA Release
2--Continuity of Care Document (CCD), April 01, 2007
Health Level Seven (HL7) Implementation Guide: CDA Release
2--Continuity of Care Document (CCD), April 01, 2007
Health Level Seven (HL7) Implementation Guide: CDA Release
2--Continuity of Care Document (CCD), April 01, 2007
Health Level Seven (HL7) V3 RBAC, R1-2008, HL7 Version 3
Standard: Role Based Access Control (RBAC) Healthcare Permissions
Catalog, Release 1, February 2008
Health Level Seven (HL7) V3 RBAC, R1-2008, HL7 Version 3
Standard: Role Based Access Control (RBAC) Healthcare Permissions
Catalog, Release 1, February 2008
Health Level Seven (HL7) Version 2.3.1
[[Page 3606]]
Health Level Seven (HL7) Version 2.5
Health Level Seven (HL7) Version 2.5.1
Health Level Seven (HL7) Version 3.0 Privacy Consent
related specifications RCMR--RM010001--Data Consent
Integrating the Healthcare Enterprise (IHE) IT
Infrastructure Technical Framework (ITI-TF) Volume 2 Supplement 2007-
2008 Cross-Enterprise User Assertion (XUA)
Integrating the Healthcare Enterprise (IHE) IT
Infrastructure Technical Framework (ITI-TF) Volume 2 Supplement 2007-
2008 Cross-Enterprise User Assertion (XUA)
Integrating the Healthcare Enterprise (IHE) IT
Infrastructure Technical Framework (ITI-TF) Revision 4.0, Audit Trail
and Node Authentication (ATNA) Integration Profile
Integrating the Healthcare Enterprise (IHE) IT
Infrastructure Technical Framework (ITI-TF) Revision 4.0, Consistent
Time (CT) Integration Profile
Integrating the Healthcare Enterprise (IHE) IT
Infrastructure Technical Framework (ITI-TF) Revision 4.0, Patient
Demographics Query (PDQ) Integration Profile
Integrating the Healthcare Enterprise (IHE) IT
Infrastructure Technical Framework (ITI-TF) Revision 4.0, Patient
Identifier Cross-Referencing Integration Profile (PIX)
Integrating the Healthcare Enterprise (IHE) IT
Infrastructure Technical Framework (ITI-TF) Revision 4.0, Section 10
Cross-Enterprise Document Sharing (XDS.a)
Integrating the Healthcare Enterprise (IHE) IT
Infrastructure Technical Framework (ITI-TF) Volume 2 Supplement 2007-
2008 Cross-Enterprise Document Sharing-B (XDS.b)
Integrating the Healthcare Enterprise (IHE) IT
Infrastructure Technical Framework (ITI-TF) Revision 4.0--Registry
Stored Query Transaction for XDS Profile Supplement [ITI-18]
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 (ITI-TF) Supplement 2007-2008 Basic
Patient Privacy Consents (BPPC)--Trial Implementation
Integrating the Healthcare Enterprise (IHE) IT
Infrastructure Technical Framework Supplement 2008-2009, Pediatric
Demographics, Draft for Trial Implementation (August 22, 2008)
Integrating the Healthcare Enterprise (IHE) Laboratory
Technical Framework Volume 3 (LAB TF-3) Document-based Transactions,
Revision 2.0--For Trial Implementation, August 16, 2007
International Health Terminology Standards Development
Organisation (IHTSDO) Systematized Nomenclature of Medicine Clinical
Terms (SNOMED CT [supreg])
International Organization for Standardization (ISO)
Health informatics--9660 Level 1
Internet Engineering Task Force (IETF) Network Time
Protocol (Version 3) Specification, Implementation and Analysis,
``Request for Comment'' (RFC) 1305, March, 1992
Internet Engineering Task Force (IETF) Simple Network Time
Protocol (SNTP) Version 4, ``Request for Comment'' (RFC)
2030, October, 1996
Logical Observation Identifiers Names and Codes (LOINC
[supreg])
Organization for the Advancement of Structured Information
Standards (OASIS) Security Assertion Markup Language (SAML) v2.0 OASIS
Standard; ITU-T X.1141
Organization for the Advancement of Structured Information
Standards (OASIS) WS-Trust Version 1.3, March 2007
Organization for the Advancement of Structured Information
Standards (OASIS) WS-Federation Web Services Federation Language (WS-
Federation), Version 1.1, December 2006
Organization for the Advancement of Structured Information
Standards (OASIS) eXtensible Access Control Markup Language (XACML),
ITU-T Recommendation X.1142, February 2005
Unified Code for Units of Measure (UCUM)
USB Removable Device Type 2.0 (USB Implementers Forum)
XDM Supplement to the Integrating the Healthcare
Enterprise (IHE) IT Infrastructure Technical Framework (ITI-TF)
IS06--Quality V1
Below is a list of the HITSP constructs used by this HITSP
Interoperability Specification.
HITSP/C19 Entity Identity Assertion Component (V1)
HITSP/C25 Anonymize Component (V2)
HITSP/C26 Nonrepudiation of Origin Component (V1)
HITSP/C34 Patient Level Quality Data Message Component
(V1)
HITSP/C38 Patient Level Quality Data Document Using IHE
Medical Summary (XDS-MS) Component (V1)
HITSP/T15 Collect and Communicate Security Audit Trail
Transaction (V1)
HITSP/T16 Consistent Time Transaction (V1)
HITSP/T17 Secured Communication Channel Transaction (V1)
HITSP/T23 Patient Demographics Query Transaction (V2)
HITSP/T24 Pseudonymize Transaction (V2)
HITSP/T29 Notification of Document Availability
Transaction (V2)
HITSP/T31 Document Reliable Interchange Transaction (V1)
HITSP/TP13 Manage Sharing of Documents Transaction Package
(V2)
HITSP/TP20 Access Control Transaction Package (V1)
HITSP/TP21 Query for Existing Data Transaction Package
(V1)
HITSP/TP22 Patient ID Cross-Referencing Transaction
Package (V2)
HITSP/TP30 Manage Consent Directives Transaction Package
(V1)
HITSP/TP50 Retrieve Form for Data Capture Transaction
Package (V2)
Below is a list of Selected Standards for this HITSP
Interoperability Specification.
American Medical Association (AMA) Current Procedural
Terminology (CPT [supreg]) Fourth Edition (CPT-4); CPT Evaluation and
Management Codes
American Society for Testing and Materials (ASTM) Standard
Guide for Electronic Authentication of Health Care Information:
E1762-95(2003)
Centers for Medicare and Medicaid Services (CMS) National
Provider Identifier (NPI)
Digital Imaging and Communications in Medicine (DICOM)--
Part 16: Content Mapping Resource
European Telecommunications Standards Institute (ETSI)
Technical Specification TS 101 903: XML Advanced Electronic Signatures
(XadES)
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
Health Level Seven (HL7) Version 2.3.1
Health Level Seven (HL7) Version 2.5
Health Level Seven (HL7) Version 3.0
Health Level Seven (HL7) Version 3.0 Privacy Consent
related
[[Page 3607]]
specifications RCMR--RM010001--Data Consent
Health Level Seven (HL7) V3 RBAC, R1-2008, HL7 Version 3
Standard: Role Based Access Control (RBAC) Healthcare Permissions
Catalog, Release 1, February 2008
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, Section 10
Cross-Enterprise Document Sharing (XDS.a)
Integrating the Healthcare Enterprise (IHE) IT
Infrastructure Technical Framework (ITI-TF) Volume 2 Supplement 2007-
2008 Cross-Enterprise Document Sharing-B (XDS.b)
Integrating the Healthcare Enterprise (IHE) IT
Infrastructure Technical Framework (ITI-TF) Revision 4.0--Registry
Stored Query Transaction for XDS Profile Supplement [ITI-18]
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 (ITI-TF) Revision 4.0, Patient
Demographics Query (PDQ) Integration Profile
Integrating the Healthcare Enterprise (IHE) IT
Infrastructure Technical Framework (TF) Supplement--ITI-25 Notification
of Document Availability (NAV) Jun 28, 2005
Integrating the Healthcare Enterprise (IHE) IT
Infrastructure Technical Framework Supplement 2008-2009, Pediatric
Demographics, Draft for Trial Implementation (August 22, 2008)
Integrating the Healthcare Enterprise (IHE) IT
Infrastructure Technical Framework (ITI-TF) 2006-2007 Trial
Implementation Supplement Cross-Enterprise Document Reliable
Interchange (XDR)
Integrating the Healthcare Enterprise (IHE) IT
Infrastructure Technical Framework (ITI-TF) Revision 4.0, Patient
Identifier Cross-Referencing Integration Profile (PIX)
Integrating the Healthcare Enterprise (IHE) IT
Infrastructure Technical Framework (ITI-TF) Revision 4.0, Audit Trail
and Node Authentication (ATNA) Integration Profile
Integrating the Healthcare Enterprise (IHE) IT
Infrastructure Technical Framework (ITI-TF) Revision 4.0, Consistent
Time (CT) Integration Profile
Integrating the Healthcare Enterprise (IHE) IT
Infrastructure Technical Framework (ITI-TF) Volume 2 Supplement 2007-
2008 Cross-Enterprise User Assertion (XUA)
Integrating the Healthcare Enterprise (IHE) IT
Infrastructure Technical Framework (TF) Supplement Volume 3--Document
Digital Signature (DSG) Content Profile
Integrating the Healthcare Enterprise (IHE) IT
Infrastructure Technical Framework (TF) 2007-2008 Supplement, Retrieve
Form for Data Capture (RFD)
Integrating the Healthcare Enterprise (IHE) Patient Care
Coordination (PCC) Technical Framework Volume 1, Revision 3.0 2007-2008
Integrating the Healthcare Enterprise (IHE) Patient Care
Coordination (PCC), Revision 3.0, 2007-2008, Cross-Enterprise Sharing
of Medical Summaries (XDS-MS) Integration Profile
International Classification of Diseases, 10th Revision,
Procedure Coding System (ICD-10-PCS)
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--Pseudonymisation, Unpublished Technical
Specification 25237
International Organization for Standardization (ISO)
Health Informatics--Pseudonymization, Unpublished Technical
Specification 25237
Internet Engineering Task Force (IETF) Network Time
Protocol (Version 3) Specification, Implementation and Analysis,
``Request for Comment'' (RFC) 1305, March 1992
Internet Engineering Task Force (IETF) Simple Network Time
Protocol (SNTP) Version 4, ``Request for Comment'' (RFC) 2030,
October 1996
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 2007 (UB-04) Current UB Data Specification Manual Field 22,
Patient Discharge Status, Codes
Organization for the Advancement of Structured Information
Standards (OASIS) Simple Object Access Protocol (SOAP) Version 1.1, 1.2
Organization for the Advancement of Structured Information
Standards (OASIS) Security Assertion Markup Language (SAML) v2.0 OASIS
Standard; ITU-T X.1141
Organization for the Advancement of Structured Information
Standards (OASIS) WS-Federation Web Services Federation Language (WS-
Federation), Version 1.1, December 2006
Organization for the Advancement of Structured Information
Standards (OASIS) WS-Trust Version 1.3, March 2007
Organization for the Advancement of Structured Information
Standards (OASIS) eXtensible Access Control Markup Language (XACML),
ITU-T Recommendation X.1142, February 2005
Unified Code for Units of Measure (UCUM)
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 agency that administers or
sponsors a Federal health care program (as defined in that Executive
Order), 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 and as permitted by applicable law, health information
technology systems and products that meet interoperability standards
recognized by the Secretary. Therefore, those Federal agencies would be
required to appropriately consider health information technology
systems and products that comply with these Interoperability Standards,
once recognized, when implementing, acquiring, or upgrading such items
or systems.
Similarly, the EO 13410 also directs those 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 Interoperability Standards
recognized by the Secretary.
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)
[[Page 3608]]
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, among other characteristics:
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 it can incorporate all applicable
standards and certification criteria recognized by the Secretary into
its certification processes; and
Have the ability to adapt its 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
Standards, once recognized, for the certified products to be deemed
interoperable under the physician self-referral exception and anti-
kickback safe harbor, respectively, and, thus, eligible for donation to
certain health care providers under the physician self-referral law and
the anti-kick back statute.
The Department 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, the Department would review whether the
software was interoperable at the time of donation, as defined in the
regulations. The Department 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 Department 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.'' (See 71 FR
45156 and 71 FR 45127.)
The Department believes that the one-year period between acceptance
in January 2008 and recognition in January 2009 provided both the
public and private sectors with adequate time to review, test, and
provide input on the identified HITSP Interoperability Specifications
prior to their recognition. Based on the above, the Secretary has now
recognized these HITSP Interoperability Specifications.
FOR FURTHER INFORMATION CONTACT: Judith Sparrow at (202) 690-7151.
Dated: January 14, 2009.
Marc R. Weisman,
Executive Director, Office of the National Coordinator for Health
Information Technology.
[FR Doc. E9-1068 Filed 1-16-09; 8:45 am]
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