**October 20, 2006**

**Version 1.0**

HITSP Interoperability Specifications:\
Electronic Health Records Laboratory Results Reporting HITSP/IS-01

Biosurveillance HITSP/IS-02

Consumer Empowerment HITSP/IS-03

Executive Overview

![](media/image1.jpeg){width="2.65625in" height="2.5833333333333335in"}

*Submitted to:*

**American Healthcare Information Community**

*Submitted by:*

**Healthcare Information Technology Standards Panel**

DOCUMENT CHANGE HISTORY

  ---------------------------------------------------------------------------
  Version   Description of       Name of Author                 Date
  Number    Change                                              Published
  --------- -------------------- ------------------------------ -------------
  1.0       Final Draft          HITSP Project Team             October 20,
                                                                2006

                                                                

                                                                
  ---------------------------------------------------------------------------

**Table of Contents**

[FOREWORD 4](#foreword)

[Executive Overview 7](#executive-overview)

[Electronic Health Record (EHR) Laboratory Results Reporting
7](#electronic-health-record-ehr-laboratory-results-reporting)

[Biosurveillance 9](#biosurveillance)

[Consumer Empowerment 11](#consumer-empowerment)

# FOREWORD

This document introduces the first set of Interoperability
Specifications developed as an artifact of the Healthcare Information
Technology Standards Panel (HITSP) standards harmonization process. An
Interoperability Specification is a suite of documents that provides
implementation level guidance that will:

-   Identify standards and specific implementation context for those
    standards

-   Describe specific value sets for unambiguous data exchange and
    system to system interaction

-   Provide the necessary instruction to implement the specific
    standards in commercial and self-developed systems.

The American Healthcare Information Community charged the HITSP with
harmonizing health interoperability standards for three specific
situations:

-   ***Electronic Health Records***: Allow ordering clinicians to
    electronically access laboratory results, and allow non-ordering
    authorized clinicians to electronically access historical and other
    laboratory results for clinical care.

-   ***Biosurveillance:*** Transmit essential ambulatory care and
    emergency department visit, utilization, and lab result data from
    electronically enabled health care delivery and public health
    systems in standardized and anonymized format to authorized Public
    Health Agencies with less than one day lag time.

-   ***Consumer Empowerment:*** 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 following paragraphs provide background information about the HITSP
and its role in the overall U.S. efforts to realize large scale
interoperability of health information. It also describes the HITSP
process for health standards harmonization. If you are familiar with
HITSP, please proceed to the next major section titled -- Executive
Overview.

***U.S. Nationwide Health Information Interoperability***

Studies published by the Institute of Medicine and others have raised
awareness of the extent to which the fragmented nature of clinical
information adversely impacts the quality of care across the U.S. health
IT can be used to enable better integration of clinical information.
However, as of 2006, only a small number of U.S. healthcare providers
have fully adopted health IT due, in part, to technical barriers
associated with a lack of unambiguous and nationally recognized
interoperability standards.

![](media/image2.wmf){width="3.25in" height="2.229861111111111in"}The
American Health Information Community[^1] (AHIC), a 2005
federally-chartered commission made up of leaders from public and
private health sectors, was formed to provide recommendations on how to
make health records digital and interoperable, and assure that the
privacy and security of those records are protected, in a smooth,
market-led way. At the same time, the Department of Health and Human
Services, through the Office of the National Coordinator for Health IT
(ONC) awarded contracts to 1) identify interoperability standards to
facilitate the exchange of patient data (HITSP), 2) define a process for
certifying that health IT products comply with appropriate standards The
Certification Commission for Healthcare Information Technology (CCHIT),
and 3) develop a series of prototypes to establish the requirements of a
Nationwide Health Information Network (NHIN). These activities share the
goal of widespread adoption of interoperable electronic health records
within 10 years through public-private collaboration.

***HITSP's Role within Nationwide Interoperability Efforts***

The HITSP[^2] is a multi-stakeholder coordinating body designed to
provide the process within which affected parties can identify, select,
and harmonize standards for communicating healthcare information
throughout the healthcare spectrum. As used by HITSP, the term
"standard" refers, but is not limited to:

-   Specifications

-   Implementation Guides

-   Codes Sets

-   Terminologies

-   Integration Profiles

HITSP functions as a partnership of the public and private sectors and
operates with a neutral and inclusive governance model administered by
the American National Standards Institute. The goal of the Panel is to:

-   Facilitate the development of harmonized Interoperability
    Specifications (IS) and information policies, including Standards
    Development Organization (SDO) work products (e.g. standards,
    technical reports). These policies, profiles and work products are
    essential for establishing privacy, security and interoperability
    among healthcare software applications

-   Coordinate, as appropriate, with other national, regional and
    international groups addressing healthcare informatics to ensure
    that the resulting standards are globally relevant

-   Be Use Case driven, using information from stakeholders and basing
    decisions on industry needs

The work of HITSP is conducted through formally chartered Technical
Committees of volunteer members. The artifact of the Technical Committee
activities is an Interoperability Specification (IS) and related
documents referred to as IS Transaction Packages, IS Transactions, or IS
Components.

***How Use Cases and HITSP Interoperability Specifications are
Developed***

The American Health Information Community (AHIC), as the representative
of public and private health sector stakeholders, identified the three
Use Cases (available at [www.hitsp.org](http://www.hitsp.org/) ) that
drove the initial efforts of the HITSP. Nationwide public and private
health sector priorities continue to focus the efforts of the HITSP. The
Use Case driven HITSP harmonization process is implemented by formally
chartered Technical Committees. The volunteers that comprise a Technical
Committee follow an 8 step process, depicted in the figure below.

HITSP Harmonization Process Steps

![](media/image3.wmf){width="5.997916666666667in"
height="0.9791666666666666in"}

The current version of each Interoperability Specification has been
approved by the HITSP as *Ready for Implementation Testing*, which is
the first action in Step VIII, Interoperability Specification Release
and Dissemination. Upon successful completion on the Implementation
Testing, the Interoperability Specifications will be considered *Ready
for Implementation.*

# Executive Overview

Each Interoperability Specification (IS) is actually a suite of
documents that, taken as a whole, provide a detailed map to existing
standards and specifications that will satisfy the requirements imposed
by a given Use Case. It identifies and constrains standards where
necessary, and creates groupings of specific actions and actors to
further describe the relevant contexts. Where gaps and overlaps are
identified, the Interoperability Specification provides recommendations
and a roadmap for corrections to be made. Each Interoperability
Specification includes IS Transaction Packages, IS Transactions, and IS
Components relevant to a specific Use Case. In all there are 23
documents that make up the three Interoperability Specifications. Of the
23 documents, eight are referenced by multiple Interoperability
Specifications. This modular approach will support future re-use of
HITSP artifacts.

The Interoperability Specifications summarized in this document can be
retrieved from the HITSP website using the following links:

> [Electronic Health Record Laboratory Results Reporting
> HITSP/IS-01](http://publicaa.ansi.org/sites/apdl/Documents/Forms/AllItems.aspx?RootFolder=%2Fsites%2Fapdl%2FDocuments%2FStandards Activities%2FHealthcare Informatics Technology Standards Panel%2FInteroperability Specification%2FReady for Implementation Testing%2FElectronic Health Records&View={21C60355-AB17-4CD7-A090-BABEEC5D7C60})
>
> [Biosurveillance
> HITSP/IS-02](http://publicaa.ansi.org/sites/apdl/Documents/Forms/AllItems.aspx?RootFolder=%2Fsites%2Fapdl%2FDocuments%2FStandards Activities%2FHealthcare Informatics Technology Standards Panel%2FInteroperability Specification%2FReady for Implementation Testing%2FBiosurveillance&View={21C60355-AB17-4CD7-A090-BABEEC5D7C60})
>
> [Consumer Empowerment
> HITSP/IS-03](http://publicaa.ansi.org/sites/apdl/Documents/Forms/AllItems.aspx?RootFolder=%2Fsites%2Fapdl%2FDocuments%2FStandards Activities%2FHealthcare Informatics Technology Standards Panel%2FInteroperability Specification%2FReady for Implementation Testing%2FConsumer Empowerment&View={21C60355-AB17-4CD7-A090-BABEEC5D7C60})

For each Interoperability Specification, this executive overview
provides the business problem to be addressed, highlights the prominent
challenges encountered and describes how they were resolved, and lists
the HITSP recommended standards selected to meet the requirements of
each Use Case.

## Electronic health record (EHR) Laboratory Results Reporting

This Interoperability Specification is designed to meet the specific
requirements of sending laboratory results to clinicians for patient
care. Lack of harmonization among data interoperability standards
including vocabulary and laboratory and other messaging standards,
contributes to duplicate and unnecessary laboratory testing. Both of
which impact the quality and cost of healthcare.

The HITSP EHR Interoperability Specification is relevant to clinical
care providers who wish to have laboratory test results and laboratory
interpretations electronically available for patients for whom they are
providing care. Laboratory test results and interpretations are
available for integration into an electronic health record (EHR), local
or remote, or another clinical system. The Use Case includes two
scenarios that cover typical interfaces involving an EHR system (or
equivalent) and laboratory results.

The HITSP EHR Interoperability Specification describes both a laboratory
message transaction and a document sharing paradigm. Ordering providers
of care always receive results as a laboratory message, non-ordering
providers of care access historical laboratory results as documents, and
\"copy-to\" providers of care may receive either messages or document
availability notifications. The dual path of message and document
provides a greater degree of implementation flexibility.

Challenges

The EHR Technical Committee has identified gaps in terminology standards
for reporting laboratory results. These gaps are minimized by the
selection of standards that give the widest coverage, but vocabulary
domains with clinical content are very large and encompass many
specialties. The innovation in healthcare informatics is fast-paced,
resulting in gaps as the standards attempt to catch up. In addition to
gaps, there is a significant overlap. This overlap is well understood
and monitored by the sponsoring SDO. A mapping from the Health Level
Seven (HL7) Version 2.5 ORU\^R01 message to the Integrating the
Healthcare Enterprise (IHE) Laboratory Technical Framework XD\*-LAB
constrained HL7Clinical Document Architecture (CDA) document is a
necessary accessory to this specification. This mapping will be the
basis for interoperability between messages and documents.

***Transactions***

The core transactions that comprise this Interoperability Specification
include the following:

-   ***Send Laboratory Result:*** This includes all the data definitions
    and interactions for the HL7 V2.5 Laboratory Result Message. It
    relies on two components:

    -   The Laboratory Result Message Component (HITSP/ISC-36) specifies
        constraints on the HL7 V2.5 message and

    -   The Laboratory Result Terminology Component (HITSP/ISC-35)
        describes the vocabulary constraints

-   ***Manage Sharing of Documents:*** This is a generic
    document-sharing paradigm that can be used for any electronic
    document. For this specification, the specific document of interest
    is the HL7 CDA specification based on the Integrating the IHE
    Laboratory Technical Framework XD\*-LAB. The HITSP Laboratory Report
    Document Structure Component Specification (HITSP/ISC-37) describes
    the Laboratory CDA document and the Laboratory Result Terminology
    Component (HITSP/ISC-35) describes the vocabulary constraints

Ancillary transactions address Web Services, Notification of Document
Availability, Patient Demographics Query (PDQ) and Patent ID
Cross-Referencing (PIX).

Recommended Standards

The Interoperability Specification is the result of an assessment of the
current practices in electronic laboratory results reporting and the
requirements of the EHR Use Case. The EHR Technical Committee (EHR TC)
chose this combination of standards because they meet the requirements
of the Use Case and reflect both current practice and future directions
for healthcare information sharing.

The following table lists the standards selected to implement the entire
ONC harmonized Use Case for EHR LAB. It is important to note that the
industry use of HL7 v3.0 and HL7 2.5 standards is evolving, and the
expectation is that these standards will become more broadly used.  The
HL7 Clinical Document Architecture (CDA) is a document markup standard
that specifies the structure and semantics of \"clinical documents\" for
the purpose of exchange. The CDA Release 2.0 distribution includes a
prose document in HTML, XML schemas, data dictionary, and sample CDA
documents.  The HL7 CDA Release 2.0 is a limited subset of HL7 V3.  It
builds upon other HL7 standards, including the HL7 Reference Information
Model (RIM), Data Structures, Vocabulary, and the XML Implementation
Technology Specifications for Data Types and V3 Structures.  This
Implementation Specification does not imply a full adoption of HL7V3,
but just refers to HL7 CDA R2 and the limited subset of HL7V3 artifacts
used by HL7 CDA R2.

  -----------------------------------------------------------------------
  *Recommended Standards*
  -----------------------------------------------------------------------
  Clinical Laboratory Improvement Amendments (CLIA) of 1988

  Health Insurance Portability and Accountability Act (HIPAA) \--
  Administrative Simplification

  Health Level Seven (HL7) Version 2.5

  Health Level Seven (HL7) Version 3.0 Clinical Document Architecture
  (CDA/CDA R2)

  Integrating the Healthcare Enterprise (IHE) Laboratory Technical
  Framework Supplement 2006-2007 Revision 1.0

  Integrating the Healthcare Enterprise (IHE) IT Infrastructure Technical
  Framework (ITI-TF) Revision 2.0

  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®)

  Systematized Nomenclature of Medicine -- Clinical Terms (SNOMED CT®)

  Unified Code for Units of Measure (UCUM)
  -----------------------------------------------------------------------

## Biosurveillance

This Interoperability Specification is designed to meet the specific
requirements of the Biosurveillance Use Case, defined as implementation
of near real-time, nationwide public health event monitoring to support
early detection, situational awareness, and rapid response management
across care delivery, public health, and other authorized Government
agencies.

The scope addressed in the Interoperability Specification is the
transmission of essential data from ambulatory care and emergency
department visits, utilization, and lab result data from electronically
enabled healthcare delivery and public health systems in a standardized
and anonymized format, to authorized Public Health Agencies with less
than one day lag time. While the system and processes ultimately must
also support the ability for authorized public health personnel to go
back to the data source to seek to re-link the anonymized
biosurveillance data to the data source as part of an appropriate public
health investigation, such re-linking has been deferred for future
effort.

The management of data to ensure proper routing, security, privacy, and
timely reporting is critical to enabling biosurveillance activities.
Potential architectural solutions to data flow issues include using
individual facility data sources (e.g., single hospitals or ambulatory
care sites) or networked system such as a multi-facility system or
supporting organization that uses data in the course of providing other
services and sends data to all appropriate public health agencies. Other
permutations of these two models can also be considered. The role of the
data or network system can be accomplished by several different
stakeholders, including hospital systems, health plans, independent
laboratories, and other possibilities. However, this IS was defined to
be independent of architecture choice and is intended to support any
variant of the architectural choices identified above.

Challenges

The Biosurveillance Technical Committee has focused its work around an
analysis of the Biosurveillance Use Case provided by the American Health
Information Community (AHIC). This work has also been informed by the
proceedings of the AHIC Biosurveillance Data Steering Group (BDSG). Even
so, an implementer of this Interoperability Specification must provide
the technical infrastructure and security framework necessary to support
operations in accordance with law, regulation, best practices and
business agreements.

The Technical Committee worked with the United States Health Information
Knowledgebase to evaluate the metadata and repository for use in
standards selection using demographic and encounter data as a test case.
The results and the resource will be used to extend this
Interoperability Specification to additional domains and clinical data
information exchange standards.

The BIO Technical Committee has selected standards with more options
than might otherwise be defined between communication partners. As
Biosurveillance is based upon secondary use of clinical data, the
processes and data capture options are somewhat opportunistic, and
associated data mining processes have more latitude in translation and
data preparation processes. Since it is important to maximize the data
sources to contribute data to the biosurveillance information system,
information exchange selections include options for data capture from
both legacy environments and emerging environments. Vocabulary, message,
and content standards have been selected in consideration of providing
the most comprehensive, machine process able fulfillment of the data
requirements provided by the AHIC BDSG.

Transactions

The core transactions that comprise this Interoperability Specification
include the following:

-   ***Pseudonymize Data:*** Apply a common standard to Codify Document
    Content, Anonymize or Pseudonymize patient data to protect patient
    identity from undesired disclosure when communicating care data
    to/from external parties.

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-   ***Anonymize Data:*** Apply a common standard to Codify Document
    Content, Anonymize or Pseudonymize patient data to protect patient
    identity from undesired disclosure when communicating care data
    to/from external parties.

Ancillary transactions address Manage Sharing of Documents, Retrieve
Form from Data Capture, Notification of Document Availability,
Acknowledgements, and Patent ID Cross-Referencing (PIX).

  -----------------------------------------------------------------------
  Recommended Standards
  -----------------------------------------------------------------------
  American Medical Association (AMA) Current Procedural Terminology
  (CPT®) Fourth Edition (CPT-4)

  Clinical and Laboratory Standards Institute (CLSI) \[formerly the
  National Committee for Clinical Laboratory Standards (NCCLS)\]

  Clinical Care Classification (CCC) Version 2.0 \[formerly known as the
  Home Healthcare Classification (HHCC) System\]

  Clinical Laboratory Improvement Amendments (CLIA) of 1988

  College of American Pathologists Systematized Nomenclature of Medicine
  Clinical Terms (SNOMED CT®)

  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

  HCPCS Level II Code Set

  Health Insurance Portability and Accountability Act (HIPAA) \--
  Administrative Simplification

  Health Level Seven (HL7) Version 2.5

  Health Level Seven (HL7) Version 3.0 Clinical Document Architecture
  (CDA/CDA R2)

  Integrating the Healthcare Enterprise (IHE) Laboratory Technical
  Framework Supplement 2006-2007 Revision 1.0

  Integrating the Healthcare Enterprise (IHE) IT Infrastructure Technical
  Framework (ITI-TF) Revision 2.0

  Integrating the Healthcare Enterprise (IHE) Patient Care Coordination
  (PCC) Technical Framework Revision 1.0

  Integrating the Healthcare Enterprise (IHE) Radiology Technical
  Framework Revision 7.0

  International Classification of Diseases, Ninth Edition, Clinical
  Modifications (ICD-9-CM)

  International Classification of Diseases, 10^th^ revision, Related
  Health Problems (ICD-10 CM)

  International Organization for Standardization (ISO) Health Informatics
  \-- Pseudonymization, Unpublished Technical Specification \# 25237

  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 Specifications Manual

  Organization for the Advancement of Structured Information Standards
  (OASIS) Emergency Data Exchange Language (EDXL) Hospital AVailability
  Exchange (HAVE)

  Organization for the Advancement of Structured Information Standards
  (OASIS) Emergency Data Exchange Language (EDXL) Distribution Element
  (DE)

  Unified Code for Units of Measure (UCUM)
  -----------------------------------------------------------------------

## Consumer Empowerment

Consumer Empowerment is the active involvement of consumers (i.e.,
individuals) in managing their healthcare and gaining the benefits of
having their health information in a format easily accessible to them.
This includes having a personal health record (PHR) to track patient
information, insurance, family history, medications, and other special
conditions.

As part of a personal health record, this Interoperability Specification
addresses two key areas: the patient's registration data and medication
history.

A vital part of a personal health record is registration information.
Going to the doctor or hospital frequently requires filling out multiple
forms. These forms collect information such as name, address, insurance,
medications, allergies, etc. Then, when an individual requires
laboratory work or other testing, the same information has to be
collected again. A single electronic registration will make it easier
for individuals to give their information and for clinicians to use it.
Additionally, the consumer could update the information once and share
it with all healthcare providers.

An electronic medication history provides the consumer with an updated
list of all pertinent medications and allergies in an easily accessible
format. Most individuals do not know the specific medications and exact
dosages that have been prescribed to them, and often do not know their
allergies. In addition, clinicians do not always have consistent
prescription information about the same individual nor do they have easy
access to medication information directly from the patient. Too often,
this results in errors or unnecessary treatments. An electronic
medication history would have all the current data available to the
individual and to each authorized healthcare provider. The need for an
electronic medication history was highlighted by the high interest in
the KatrinaHealth.org web tool. Having a complete electronic medication
list would also prevent drug-to-drug or allergic reactions when
subsequent prescriptions are written.

Based on the charge from the American Health Information Community, the
Consumer Empowerment Use Case presumes some level of linkage between
consumer's registration summary and their medication history. This
linkage is an important consideration for identifying and locating
individual consumers and their available medication information across
network systems. For the purposes of this Use Case, the linking of a
consumer's registration summary to the medication history includes: (1)
identity matching, (2) linkages between the data, (3) and the ability to
incorporate both types of data simultaneously into a system (although
they may come from different systems themselves).

The Consumer Empowerment Interoperability Specification addresses three
scenarios to satisfy the harmonized Use Cases defined by ONC. They are:

-   Consumer creates account to host registration summary & medication
    history

-   Consumer visits Healthcare Provider and provides registration
    summary information

-   Authorized Healthcare Provider reviews medication history

This Interoperability Specification defines an interoperable
registration and medication history document; one means of which to
share this type of document is by registering them in a record locator
and retrieving them from the referenced document repository.  Some of
the other HITSP Use Cases define other types of documents (e.g. a
laboratory report in the EHR Use Case) which may also be used as part of
information exchange to and from a consumer PHR).  Other types of
interoperable documents may be defined by HITSP in the future for
radiology reports, images, electrocardiogram (ECG) reports, etc.  These
other types of documents are out of scope of the current Use Case.

Challenges

The CE Technical Committee has been charged with introducing the
consumer, and the PHR, as an integral partner of the healthcare
information flow representing a new paradigm in healthcare
interoperability. This paradigm establishes the consumer as the active
participant in health information exchange that touches all segments of
the industry; providers/care facilities, health plans,
pharmacies/prescription benefit managers, and others. This challenge is
exacerbated by the current information technology situation wherein
providers, health plans, pharmacies, and pharmacy benefit manager
industry segments each have created different standards based on
differing business needs and timing, with shared and overlapping data
elements via three different standards developers: HL7, ASC X12, and
NCPDP SCRIPT.

In addition to these aforementioned standards, a fourth standard
initiative from ASTM targeting the provider-provider and
provider-consumer interoperability space, entitled the Continuity of
Care (CCR), passed favorable ballot in October 2005. In the latter phase
of the successful CCR balloting process, ASTM and HL7 initiated a formal
harmonization effort regarding their respective efforts addressing the
same interoperability space. This harmonization initiative resulted in
the joint development of the Continuity of Care Document (CCD) which was
issued as an HL7 ballot in August 2006.

The CE Technical Committee has determined that it is in the best
interest of HITSP harmonization efforts to wholeheartedly support this
HL7-ASTM harmonization initiative and leverage its deliverables to the
highest degree possible. To this end, in the absence of having a
balloted CCD standard to reference, the approach taken by the CE TC is
to align its Interoperability Specification to the expected technical
design characteristics of the CCD. This CE Interoperability
Specification artifact is therefore intended to facilitate the
transition from the current disparate standards environment to a
harmonized state through use of a preliminary specification that is on
the convergence path of the promised HL7-ASTM harmonization. HITSP is
committed to migrate this preliminary specification to the final
balloted result of this HL7-ASTM harmonization work as soon as it's
officially available. The HITSP has set a target date of six months
(i.e. March-April 2007) for the release of the final approved HL7 CCD.
At this time the situation will be revisited and a determination will be
made as to whether the publication of an interim HITSP Interoperability
Specification is appropriate.

Transactions

The Consumer Empowerment Use Case includes:

-   Enabling consumers to establish permissions and access rights for
    viewing their data

-   Authenticating consumers, designated caregivers, and health
    professionals

-   Querying other organizations for data and matching to the consumer

-   Accepting "batch" data from other organizations and matching to the
    appropriate consumers

-   Accessing, viewing, and sharing registration summaries and
    medication histories

-   Recording of interactions to enable access and viewing tracking and
    generation of system logs.

  -----------------------------------------------------------------------
  Recommended Standards
  -----------------------------------------------------------------------
  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 Continuity of Care Record (CCR): \# E2369-05

  Council for Affordable Quality Health Care (CAQH) Committee on
  Operating Rules for Information Exchange (CORE) Phase I Operating Rules

  Federal Medication Terminologies

  Health Level Seven (HL7) Version 3.0 Continuity of Care Document (CCD)

  Health Level Seven (HL7) Version 3.0 Clinical Document Architecture
  (CDA/CDA R2)

  Health Level Seven (HL7) Version 2.5

  Health Level Seven (HL7) EHR System Functional Model Draft Standard for
  Trial Use (DSTU)

  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 1.0

  Logical Observation Identifiers Names and Codes (LOINC®)

  National Council for Prescription Drug Programs (NCPDP) SCRIPT Standard
  Version 8.1
  -----------------------------------------------------------------------

\* \* \*

HITSP refers you to hitsp.org for additional information about the
HITSP, its charter, membership, and work products. You can contact the
Panel Secretariat, Ms. Michelle Maas Deane, by phone at (212) 642-4884,
or by email using <mmaasdeane@ansi.org>.

# Appendix -- Complete lists of standards

## 

## EHR Laboratory Results Reporting List of Standards

  -----------------------------------------------------------------------------------------------------------
  Standard                 Description
  ------------------------ ----------------------------------------------------------------------------------
  Clinical Laboratory      Establishes quality standards for all laboratory testing to ensure the accuracy,
  Improvement Amendments   reliability, and timeliness of patient test results regardless of where the test
  (CLIA) of 1988           is performed. The Centers for Medicare and Medicaid Services (CMS) regulates all
                           laboratory testing (except research) performed on humans in the U.S. based on
                           CLIA. Visit [www.fda.gov/cdrh/clia](http://www.fda.gov/cdrh/clia) and
                           [www.cms.hhs.gov/clia](http://www.cms.hhs.gov/clia) for more information.

  Health Insurance         A listing of national standards plus rules adopted by federal regulation for
  Portability and          electronically communicating specified administrative and financial healthcare
  Accountability Act       transactions, and protecting the security and privacy of healthcare information,
  (HIPAA) \--              as applied to the three types of defined covered entities: health plans,
  Administrative           healthcare clearinghouses, and healthcare providers who conduct any of the
  Simplification[^3]       specified healthcare transactions. See the Code of Federal Regulations, Title 45,
                           Parts 160, et. seq. for more information.

  Health Level Seven (HL7) The HL7 Version 2.5 Messaging Standard is an application protocol for electronic
  Version 2.5              data exchange in healthcare. It and prior versions have widespread use in the US
                           and internationally. Both message formats and value sets / code tables (e.g.,
                           diagnosis type, gender, patient class) are contained in the standard. Of
                           particular focus for HITSP Interoperability Specifications are message formats
                           described in Chapters 2, 3, 5, and 7 including patient demographic (ADT) and lab
                           result reporting. These are also used within composite standards from IHE for
                           Patient Identity Cross-Referencing and Feed (PIX), Patient Demographics Query
                           (PDQ), and Acknowledgements. Visit [http://www.hl7.org](http://www.hl7.org/) for
                           more information.

  Health Level Seven (HL7) The HL7 Clinical Document Architecture is an XML-based document markup standard
  Version 3.0 Clinical     that specifies the structure and semantics of clinical documents for the purpose
  Document Architecture    of exchange. CDA is one instantiation of HL7\'s Version 3.0 Reference Information
  (CDA/CDA R2)             Model (RIM) into a specific message format. Of particular focus for HITSP
                           Interoperability Specifications are message formats for Laboratory Results and
                           Continuity of Care (CCD) documents. Release 2 of the HL7 Clinical Document
                           Architecture (CDA) is an extension to the original CDA document markup standard
                           that specifies the structure and semantics of clinical documents for the purpose
                           of exchange. CDA R2 includes a prose document in HTML, XML schemas, data
                           dictionary, and sample CDA documents. CDA R2 further builds upon other HL7
                           standards beyond just the Version 3.0 Reference Information Model (RIM) and
                           incorporates Version 3.0 Data Structures, Vocabulary, and the XML Implementation
                           Technology Specifications for Data Types and Structures. Visit
                           [http://www.hl7.org](http://www.hl7.org/) for more information. Visit www.hl7.org
                           for more information.

  Integrating the          The IHE Laboratory Technical Framework introduces a content Integration Profile
  Healthcare Enterprise    Sharing Laboratory Reports (XD\*-LAB) that describes a clinical laboratory report
  (IHE) Laboratory         as a human-readable electronic document. This document, which may also contain
  Technical Framework      data in a machine-readable format and contains the complete set of final results
  Supplement 2006-2007     produced by a clinical laboratory in fulfillment of one or more test orders for a
  Revision 1.0             patient. This document is focused on the sharing of sets of laboratory results in
                           the form of a laboratory report structured document, and is not intended to
                           address ordering or return of laboratory results to the ordering provider.

  Integrating the          The IHE IT Infrastructure Technical Framework defines specific implementations of
  Healthcare Enterprise    established standards to achieve integration goals that promote appropriate
  (IHE) IT Infrastructure  sharing of health information to support optimal patient care. IHE Integration
  Technical Framework      Profiles, offer a common language that healthcare professionals and vendors may
  (ITI-TF) Revision 2.0    use in communicating requirements for the integration of products. The current
                           version of the ITI-TF, rev. 2.0 for Final Text, specifies the IHE transactions
                           defined and implemented as of August 2005. Of particular focus for HITSP
                           Interoperability Specifications are Patient Identifier Cross-Referencing and Feed
                           (PIX), Patient Demographics Query (PDQ), Cross Enterprise Document Sharing (XDS),
                           and Notification of Document Availability (NAV) Integration Profiles. The latest
                           version of the IHE Technical Framework is available at
                           <http://www.ihe.net/Technical_Framework>.

  International            Describes eXtensible Markup Language (XML) and its usage characteristics. Consists
  Organization for         of 4 parts: ebCPP, ebMS, ebRIM, and ebRS. Part 4 ebRS defines the interface
  Standardization (ISO)    between the registry and the registry clients, as well as the interaction
  Electronic business      protocols, message definitions and XML schema. Visit
  eXtensible Markup        [http://www.iso.org](http://www.iso.org/) for more information.
  Language (ebXML),        
  Technical Specification  
  \# 15000 \-- Part 4:     
  Registry services        
  specification (ebRS),    
  May, 2004                

  Logical Observation      A database of Universal identifiers for laboratory and other clinical observations
  Identifiers Names and    maintained by Regenstrief Institute. The laboratory portion of the LOINC database
  Codes (LOINC®)           contains the usual categories of chemistry, hematology, serology, microbiology
                           (including parasitology and virology), toxicology; etc. Contact the Regenstrief
                           Institute at e-mail: <loinc@regenstrief.org> or visit
                           [www.regenstrief.org/loinc](http://www.regenstrief.org/loinc) for more
                           information.

  Systematized             A validated clinical healthcare terminology and infrastructure that makes
  Nomenclature of Medicine healthcare knowledge more usable and accessible. The SNOMED CT Core terminology
  -- Clinical Terms        provides a common language that enables a consistent way of capturing, sharing and
  (SNOMED CT®)             aggregating health data across specialties and sites of care. Among the
                           applications for SNOMED CT are electronic medical records, ICU monitoring,
                           clinical decision support, medical research studies, clinical trials, computerized
                           physician order entry, disease surveillance, image indexing and consumer health
                           information services. Maintained by the College of American Pathologists (CAP),
                           information is available at
                           [www.snomed.org/snomedct/index.html](http://www.snomed.org/snomedct/index.html).

  Unified Code for Units   The Unified Code for Units of Measure is a code system intended to include all
  of Measure (UCUM)        units of measure used in science, engineering, and business with the goal of
                           facilitating unambiguous electronic communication of quantities together with
                           their units.
  -----------------------------------------------------------------------------------------------------------

## Biosurveillance List of Standards

+--------------------------+-------------------------------------------+
| **Standard**             | **Description**                           |
+==========================+===========================================+
| American Medical         | A uniform coding system used primarily to |
| Association (AMA)        | identify medical services and procedures  |
| Current Procedural       | furnished by physicians and other         |
| Terminology (CPT®)       | healthcare professionals. Visit           |
| Fourth Edition (CPT-4)   | ww                                        |
|                          | w.ama-assn.org/ama/pub/category/3113.html |
|                          | for more information.                     |
+--------------------------+-------------------------------------------+
| Clinical and Laboratory  | A global, nonprofit, standards-developing |
| Standards Institute      | organization that promotes the            |
| (CLSI) \[formerly the    | development and use of voluntary          |
| National Committee for   | consensus standards and guidelines within |
| Clinical Laboratory      | the healthcare community. Visit           |
| Standards (NCCLS)\]      | www.nccls.org for more information.       |
+--------------------------+-------------------------------------------+
| Clinical Care            | Provides a standardized framework and a   |
| Classification (CCC)     | unique coding structure for assessing,    |
| Version 2.0 \[formerly   | documenting, and classifying home health  |
| known as the Home        | and ambulatory care. This system consists |
| Healthcare               | of two interrelated taxonomies: CCC of    |
| Classification (HHCC)    | Nursing Diagnoses and CCC of Nursing      |
| System\]                 | Interventions classified by 21 Care       |
|                          | Components that represent the Functional, |
|                          | Health Behavioral, Physiological, and     |
|                          | Psychological Patterns of patient care.   |
|                          | The 21 Care Components serve as a         |
|                          | standardized framework for mapping and    |
|                          | linking the two interrelated CCC          |
|                          | taxonomies to each other and to other     |
|                          | health-related classifications. Visit     |
|                          | [ww                                       |
|                          | w.sabacare.com](http://www.sabacare.com/) |
|                          | for more information.                     |
+--------------------------+-------------------------------------------+
| Clinical Laboratory      | Establishes quality standards for all     |
| Improvement Amendments   | laboratory testing to ensure the          |
| (CLIA) of 1988           | accuracy, reliability, and timeliness of  |
|                          | patient test results regardless of where  |
|                          | the test is performed. The Centers for    |
|                          | Medicare and Medicaid Services (CMS)      |
|                          | regulates all laboratory testing (except  |
|                          | research) performed on humans in the U.S. |
|                          | based on CLIA. Visit                      |
|                          | www.fda.gov/cdrh/clia and                 |
|                          | www.cms.hhs.gov/clia for more             |
|                          | information.                              |
+--------------------------+-------------------------------------------+
| College of American      | SNOMED CT consists of a technical design, |
| Pathologists             | core content architecture, and Core       |
| Systematized             | content. SNOMED CT Core content includes  |
| Nomenclature of Medicine | the technical specification of SNOMED CT  |
| Clinical Terms (SNOMED   | and fully integrated multi-specialty      |
| CT®)                     | clinical content. The Core content also   |
|                          | includes a concepts table, description    |
|                          | table, relationships table, history       |
|                          | table, ICD-9-CM mapping, and Technical    |
|                          | Reference Guide. Additionally, SNOMED CT  |
|                          | provides a framework to manage language   |
|                          | dialects, clinically relevant subsets,    |
|                          | qualifiers and extensions, as well as     |
|                          | concepts and terms unique to particular   |
|                          | organizations or localities. Visit        |
|                          | www.snomed.org/snomedct/index.html for    |
|                          | more information.                         |
+--------------------------+-------------------------------------------+
| Digital Imaging and      | Adds a mechanism for selective protection |
| Communications in        | of individual attributes within arbitrary |
| Medicine (DICOM)         | DICOM service-object pair (SOP)           |
| Attribute Level          | instances. It may be used to achieve      |
| Confidentiality          | protection of identifying information,    |
| Supplement: \# 55        | e.g. a reversible anonymization or        |
|                          | pseudonymization of DICOM SOP instances   |
|                          | while continuing to use unmodified lower  |
|                          | level message and protocol services for   |
|                          | network transfer, storage, and media      |
|                          | exchange of composite image information   |
|                          | objects. Visit                            |
|                          | [http://medi                              |
|                          | cal.nema.org/](http://medical.nema.org/ ) |
|                          | for more information.                     |
+--------------------------+-------------------------------------------+
| Federal Information      | A set of two-digit numeric codes and a    |
| Processing Standards     | set of two-letter alphabetic codes for    |
| (FIPS) Codes for the     | representing the 50 states, the District  |
| Identification of the    | of Columbia and the outlying areas of the |
| States, the District of  | United States, and associated areas. The  |
| Columbia and the         | standard covers all land areas under the  |
| Outlying Areas of the    | sovereignty of the United States, the     |
| United States, and       | freely associated states of Federated     |
| Associated Areas         | States of Micronesia and Marshall         |
| Publication \# 5-2, May, | Islands, and the trust territory of       |
| 1987                     | Palau. Visit                              |
|                          | <http://www.itl.nist.gov/fipspubs/> for   |
|                          | more information. NOTE: ASC X12           |
|                          | transactions and ASC X12N Implementation  |
|                          | Guides do not allow use of this standard; |
|                          | instead they require use of the U.S.      |
|                          | Postal Service\'s National Zip Code and   |
|                          | Post Office Directory \-- which provides  |
|                          | similar alphabetic code values.           |
+--------------------------+-------------------------------------------+
| HCPCS Level II Code Set  | Level II of the HCPCS is a standardized   |
|                          | coding system that is used primarily to   |
|                          | identify products, supplies, and services |
|                          | not included in the CPT codes (Level I of |
|                          | HCPCS) for billing purposes. In some      |
|                          | cases a HCPCS code may be used to         |
|                          | identify a unusual ordered service mapped |
|                          | to the AHIC data set. CMS maintains HCPCS |
|                          | codes. www.cms.hhs.gov/MedHCPCSGenInfo/.  |
+--------------------------+-------------------------------------------+
| Health Insurance         | A listing of national standards plus      |
| Portability and          | rules adopted by federal regulation for   |
| Accountability Act       | electronically communicating specified    |
| (HIPAA) \--              | administrative and financial healthcare   |
| Administrative           | transactions, and protecting the security |
| Simplification           | and privacy of healthcare information, as |
|                          | applied to the three types of defined     |
|                          | covered entities: health plans,           |
|                          | healthcare clearinghouses, and healthcare |
|                          | providers who conduct any of the          |
|                          | specified healthcare transactions. See    |
|                          | the Code of Federal Regulations, Title    |
|                          | 45, Parts 160, et. seq. for more          |
|                          | information.                              |
+--------------------------+-------------------------------------------+
| Health Level Seven (HL7) | The HL7 Version 2.5 Messaging Standard is |
| Version 2.5              | an application protocol for electronic    |
|                          | data exchange in healthcare. It has       |
|                          | widespread use in the US and              |
|                          | internationally. Both message formats and |
|                          | value sets / code tables (e.g., diagnosis |
|                          | type, gender, patient class, result       |
|                          | status, specimen collection method,       |
|                          | abnormal flags, observation result status |
|                          | codes interpretation, timestamp format )  |
|                          | are contained in the standard. Of         |
|                          | particular focus for HITSP                |
|                          | Interoperability Specifications are       |
|                          | message formats described in Chapters 2,  |
|                          | 3, 5, and 7 for Patient Identifier        |
|                          | Cross-Referencing and Feed (PIX), Patient |
|                          | Demographics Query (PDQ), Laboratory      |
|                          | Results Reporting, and Acknowledgements.  |
|                          | Visit [www.hl7.org](http://www.hl7.org/)  |
|                          | for more information.                     |
+--------------------------+-------------------------------------------+
| Health Level Seven (HL7) | The HL7 Clinical Document Architecture is |
| Version 3.0 Clinical     | an XML-based document markup standard     |
| Document Architecture    | that specifies the structure and          |
| (CDA/CDA R2)             | semantics of clinical documents for the   |
|                          | purpose of exchange. CDA is one           |
|                          | instantiation of HL7's Version 3.0        |
|                          | Reference Information Model (RIM) into a  |
|                          | specific message format. Of particular    |
|                          | focus for HITSP Interoperability          |
|                          | Specificaitons are message formats for    |
|                          | Laboratory Results and Continuity of Care |
|                          | (CCD) documents. Release 2 of the HL7     |
|                          | Clinical Document Architecture (CDA) is   |
|                          | an extension to the original CDA document |
|                          | markup standard that specifies the        |
|                          | structure and semantics of clinical       |
|                          | documents for the purpose of exchange.    |
|                          | CDA R2 includes a prose document in HTML, |
|                          | XML schemas, data dictionary, and sample  |
|                          | CDA documents. CDA R2 further builds upon |
|                          | other HL7 standards beyond just the       |
|                          | Version 3.0 Reference Informaiton Model   |
|                          | (RIM) and incorporates Version 3.0 Data   |
|                          | Structures, Vocabulary, and the XML       |
|                          | Implementation Technology Specifications  |
|                          | for Data Types and Structures. Visit      |
|                          | [www.hl7.org](http://www.hl7.org/) for    |
|                          | more information.                         |
+--------------------------+-------------------------------------------+
| Integrating the          | The IHE Laboratory Technical Framework    |
| Healthcare Enterprise    | introduces a content Integration Profile  |
| (IHE) Laboratory         | Sharing Laboratory Reports (XD\*-LAB)     |
| Technical Framework      | that describes a clinical laboratory      |
| Supplement 2006-2007     | report as a human-readable electronic     |
| Revision 1.0             | document. This document, which may also   |
|                          | contain data in a machine-readable format |
|                          | and contains the complete set of final    |
|                          | results produced by a clinical laboratory |
|                          | in fulfillment of one or more test orders |
|                          | for a patient. This document is focused   |
|                          | on the sharing of sets of laboratory      |
|                          | results in the form of a laboratory       |
|                          | report structured document, and is not    |
|                          | intended to address ordering or return of |
|                          | laboratory results to the ordering        |
|                          | provider.                                 |
+--------------------------+-------------------------------------------+
| Integrating the          | The IHE IT Infrastructure Technical       |
| Healthcare Enterprise    | Framework defines specific                |
| (IHE) IT Infrastructure  | implementations of established standards  |
| Technical Framework      | to achieve integration goals that promote |
| (ITI-TF) Revision 2.0    | appropriate sharing of health information |
|                          | to support optimal patient care. IHE      |
|                          | Integration Profiles, offer a common      |
|                          | language that healthcare professionals    |
|                          | and vendors may use in communicating      |
|                          | requirements for the integration of       |
|                          | products. The current version of the      |
|                          | ITI-TF, rev. 2.0 for Final Text,          |
|                          | specifies the IHE transactions defined    |
|                          | and implemented as of August 2005. Of     |
|                          | particular focus for this HITSP           |
|                          | Interoperability Specification is Patient |
|                          | Identifier Cross-Referencing and Feed     |
|                          | (PIX), Patient Demographics Query (PDQ),  |
|                          | Cross Enterprise Document Sharing (XDS),  |
|                          | and Notification of Document Availability |
|                          | (NAV) Integration Profiles. The latest    |
|                          | version of the IHE Technical Framework is |
|                          | available at                              |
|                          | <http://www.ihe.net/Technical_Framework>. |
+--------------------------+-------------------------------------------+
| Integrating the          | The IHE Patient Care Coordination         |
| Healthcare Enterprise    | Technical Framework (PCC TF) defines      |
| (IHE) Patient Care       | specific implementations (called          |
| Coordination (PCC)       | Integration Profiles) of established      |
| Technical Framework      | standards to deal with integration issues |
| Revision 1.0             | that cross providers, patient problems or |
|                          | time. The Exchange of Personal Health     |
|                          | Record Content (XPHR) Integration Profile |
|                          | describes the content and format of       |
|                          | summary information extracted from a PHR  |
|                          | system for import into an EHR system, and |
|                          | vice versa. The purpose of this           |
|                          | Integration Profile is to support         |
|                          | interoperability between PHR systems used |
|                          | by patients and EHR systems used by       |
|                          | healthcare providers. The Cross           |
|                          | Enterprise Document Sharing of Medical    |
|                          | Summaries (XDS-MS) Integration Profile    |
|                          | enables sharing of health information     |
|                          | between enterprises of a regional health  |
|                          | network. In the registry, healthcare      |
|                          | providers publish pointers to documents   |
|                          | stored in distributed repositories. Other |
|                          | healthcare providers may search and       |
|                          | retrieve these and other documents.       |
+--------------------------+-------------------------------------------+
| Integrating the          | The IHE Radiology Technical Framework     |
| Healthcare Enterprise    | specifies the Cross Enterprise Document   |
| (IHE) Radiology          | Sharing for Imaging (XDS-I) Integration   |
| Technical Framework      | Profile which enables sharing of imaging  |
| Revision 7.0             | documents such as radiology images and    |
|                          | reports across healthcare enterprises.    |
|                          | XDS-I extends XDS by sharing, locating    |
|                          | and accessing DICOM instances from its    |
|                          | original local sources, e.g. for          |
|                          | radiologists or oncologists.              |
+--------------------------+-------------------------------------------+
| International            | A two part, three volume, coding system   |
| Classification of        | used to identify diseases and treatments. |
| Diseases, Ninth Edition, | ICD-9-CM Volumes 1 and 2 describe codes   |
| Clinical Modifications   | for diseases, injuries, impairments, and  |
| (ICD-9-CM)               | other health problems; along with their   |
|                          | causes. ICD-9-CM Volume 3 describes codes |
|                          | for procedures and actions taken for      |
|                          | prevention, diagnosis, treatment, and     |
|                          | management. Visit                         |
|                          | http://www.cdc.gov/nchs/ for more         |
|                          | information.                              |
+--------------------------+-------------------------------------------+
| International            | The International Statistical             |
| Classification of        | Classification of Diseases and Related    |
| Diseases, 10^th^         | Health Problems, 10th revision (ICD-10)   |
| revision, Related Health | is used for mortality statistics          |
| Problems (ICD-10 CM)     | reporting. It is owned and published by   |
|                          | the World Health Organization (WHO). The  |
|                          | National Center for Health Statistics     |
|                          | (NCHS) is responsible for use of the      |
|                          | (ICD-10) in the United States and has     |
|                          | developed a clinical modification of the  |
|                          | classification for morbidity purposes.    |
|                          | ICD-10-CM, has more codes and             |
|                          | classifications and expanded ambulatory   |
|                          | coverage compared to ICD-9-CM. ICD-10-CM  |
|                          | is not yet approved for implementation in |
|                          | the US.                                   |
+--------------------------+-------------------------------------------+
| International            | Health Informatics -- Pseudonymisation.   |
| Organization for         | Still under development as of October,    |
| Standardization (ISO)    | 2006. Scheduled for ballot December 2006. |
| Health Informatics \--   | The HITSP Biosurveillance TC recognizes   |
| Pseudonymization,        | that ISO/DTS 25237 is a draft standard.   |
| Unpublished Technical    | An informal Liaison relationship is       |
| Specification \# 25237   | established to harmonize the ongoing work |
|                          | of this TC and assure consistency with    |
|                          | this draft standard that we expect will   |
|                          | continue to inform the work of this TC.   |
|                          | Visit www.iso.org for more information.   |
+--------------------------+-------------------------------------------+
| Logical Observation      | A database of universal identifiers for   |
| Identifiers Names and    | laboratory and other clinical             |
| Codes (LOINC®)           | observations. The laboratory portion of   |
|                          | the LOINC database contains the usual     |
|                          | categories of chemistry, hematology,      |
|                          | serology, microbiology (including         |
|                          | parasitology and virology), and           |
|                          | toxicology; as well as categories for     |
|                          | drugs and the cell counts typically       |
|                          | reported on a complete blood count or a   |
|                          | cerebrospinal fluid cell count.           |
|                          | Antibiotic susceptibilities are a         |
|                          | separate category. The clinical portion   |
|                          | of the LOINC database includes entries    |
|                          | for vital signs, hemodynamics,            |
|                          | intake/output, EKG, obstetric ultrasound, |
|                          | cardiac echo, urologic imaging,           |
|                          | gastroendoscopic procedures, pulmonary    |
|                          | ventilator management, selected survey    |
|                          | instruments, and other clinical           |
|                          | observations. Visit                       |
|                          | [www.loinc.org](http://www.loinc.org/)    |
|                          | for more information.                     |
+--------------------------+-------------------------------------------+
| National Library of      | Provides standard names for (1) clinical  |
| Medicine (NLM) Unified   | drugs and (2) drug dose forms as          |
| Medical Language System  | administered to a patient. Also provides  |
| (UMLS) RxNorm            | links from clinical drugs, both branded   |
|                          | and generic, to their active ingredients, |
|                          | drug components (active ingredient +      |
|                          | strength), and related brand names. Food  |
|                          | and Drug Administration (FDA) National    |
|                          | Drug Codes (NDCs) for specific drug       |
|                          | products and many of the drug             |
|                          | vocabularies commonly used in pharmacy    |
|                          | management and drug interaction software  |
|                          | are additionally linked to RxNorm. Visit  |
|                          | http://www.nl                             |
|                          | m.nih.gov/research/umls/rxnorm/index.html |
|                          | for more information.                     |
+--------------------------+-------------------------------------------+
| National Uniform Billing | A code set identifying status of patient  |
| Committee (NUBC) Uniform | discharge on an institutional claim       |
| Bill Version 1992        | (e.g., inpatient, outpatient, hospice,    |
| (UB-92)/Current UB Data  | home care). Visit www.nubc.org for more   |
| Specifications Manual    | information.                              |
+--------------------------+-------------------------------------------+
| Organization for the     | Specifies an XML-formatted document that  |
| Advancement of           | allows healthcare provider organizations  |
| Structured Information   | to communicate specific utilization       |
| Standards (OASIS)        | information and status of a facility      |
| Emergency Data Exchange  | (e.g., hospital, trauma center, nursing   |
| Language (EDXL) Hospital | home) and its resources; including bed    |
| AVailability Exchange    | capacity and availability, emergency      |
| (HAVE)                   | department status, the available service  |
|                          | coverage, and the status of a hospital's  |
|                          | facility and operations. HAVE is          |
|                          | initially intended for use in disaster or |
|                          | emergency situations. Visit www.          |
|                          | Oasis-open.org for more information.      |
|                          |                                           |
|                          | Reasoning:  The BIO TC has identified the |
|                          | Hospital Availability Exchange (HAVE)     |
|                          | dataset as being closely aligned with the |
|                          | data elements identified by the           |
|                          | Biosurveillance Data Steering             |
|                          | Committee.   The HAVE specification is    |
|                          | being proposed as an Organization for the |
|                          | Advancement of Structure Information      |
|                          | Standards (OASIS) standard, but has not   |
|                          | yet been fully reviewed and adopted.      |
|                          | HAVE was derived from the results of the  |
|                          | HAVBed project sponsored by the Agency    |
|                          | for Health Resources and Quality.  While  |
|                          | it is anticipated that the HAVE           |
|                          | specification will soon be approved by    |
|                          | Oasis, and is likely to meet the          |
|                          | requirements for reporting the data       |
|                          | elements for hospitals and health         |
|                          | resource availability identified by the   |
|                          | BDSG, pending this formal approval the    |
|                          | choice of a specific standard to          |
|                          | represent these data elements remains a   |
|                          | gap as defined in the HITSP policies.     |
|                          | HAVE specification contains terminology   |
|                          | specific to utilization information and   |
|                          | allows communication of the status of a   |
|                          | hospital and its resources to other       |
|                          | emergency agencies, including bed         |
|                          | capacity and availability, emergency      |
|                          | department status, the available service  |
|                          | coverage, and the status of a hospital\'s |
|                          | facility and operations.                  |
|                          |                                           |
|                          | Qualifier: The needs of biosurveillance   |
|                          | would be better suited if this            |
|                          | terminology were instantiated as a coded  |
|                          | vocabulary                                |
+--------------------------+-------------------------------------------+
| Organization for the     | Describes a standard message distribution |
| Advancement of           | framework for data sharing among          |
| Structured Information   | emergency information systems using the   |
| Standards (OASIS)        | XML-based EDXL. This format may be used   |
| Emergency Data Exchange  | over any data transmission system. DE is  |
| Language (EDXL)          | initially intended for use in disaster or |
| Distribution Element     | emergency situations. Visit               |
| (DE)                     | www.oasis-open.org for more information.  |
|                          |                                           |
|                          | Reasoning:                                |
|                          |                                           |
|                          | The Emergency Data Exchange Language      |
|                          | (EDXL) is a suite of specific XML based   |
|                          | standards intended as a suite of          |
|                          | emergency data message types including    |
|                          | resource queries and requests, situation  |
|                          | status, message routing instructions and  |
|                          | the like, needed in the context of        |
|                          | cross-disciplinary, cross-jurisdictional  |
|                          | communications related to emergency       |
|                          | response. It is the result of a project   |
|                          | of the Disaster Management eGov           |
|                          | Initiative of the Department of Homeland  |
|                          | Security (DHS) as a means to enhance XML  |
|                          | based inter-agency emergency data         |
|                          | communications.  DHS partnered with       |
|                          | industry members of the Emergency         |
|                          | Interoperability Consortium (EIC) to      |
|                          | bring the work to OASIS for advancement   |
|                          | and standardization.                      |
+--------------------------+-------------------------------------------+
| Unified Code for Units   | A code system intended to include all     |
| of Measure (UCUM)        | units of measures being contemporarily    |
|                          | used in international science,            |
|                          | engineering, and business. The purpose is |
|                          | to facilitate unambiguous electronic      |
|                          | communication of quantities together with |
|                          | their units. The focus is on electronic   |
|                          | communication, as opposed to              |
|                          | communication between humans. Visit       |
|                          | http://aurora.regenstrief.org/UCUM/ for   |
|                          | more information.                         |
+--------------------------+-------------------------------------------+

## Consumer Empowerment List of Standards

+-----------------------+----------------------------------------------+
| **Standard**          | **Description**                              |
+=======================+==============================================+
| Accredited Standards  | Detailed Implementation Guides keyed to      |
| Committee (ASC) X12   | release 004010 of the X12 standards. These   |
| Insurance             | Implementation Guides provide details on the |
| Subcommittee (X12N)   | use of X12 standards to accomplish specific  |
| Implementation Guides | transaction functions. Some of the version   |
| Version 004010 plus   | 004010 Implementation Guides, but not all,   |
| Addenda 004010A1      | have been adopted as Implementation          |
|                       | Specifications under HIPAA. Many of the      |
|                       | version 004010 Implementation Guides,        |
|                       | including all of those adopted under HIPAA,  |
|                       | have Addenda that contain updates \-- only   |
|                       | \-- to the original Implementation Guides.   |
|                       | These Addenda are identified as version      |
|                       | 004010A1. Implementation Guides 004010X092   |
|                       | and 004010X092A1 describe transactions for   |
|                       | Eligibility Inquiry and Response.            |
|                       | Implementation Guides are published by       |
|                       | Washington Publishing Company. Visit         |
|                       | [www.x12.org](http://www.x12.org/) for more  |
|                       | information.                                 |
+-----------------------+----------------------------------------------+
| Accredited Standards  | Release (version) 004010 of the Accredited   |
| Committee (ASC) X12   | Standards Committee (ASC) X12 standards      |
| Standards Release     | including the X12.5 Interchange Control,     |
| 004010                | X12.6 Application Control Structure, 270     |
|                       | Eligibility, Coverage or Benefit Inquiry,    |
|                       | 271 Eligibility, Coverage or Benefit         |
|                       | Information and other control standards for  |
|                       | the uniform electronic interchange of        |
|                       | business transactions. Published by the Data |
|                       | Interchange Standards Association (DISA).    |
|                       | Visit [www.x12.org](http://www.x12.org/) for |
|                       | more information.                            |
+-----------------------+----------------------------------------------+
| American Society for  | A core data set of the most relevant and     |
| Testing and Materials | timely facts about a patient's healthcare.   |
| (ASTM) Standard       | It is to be prepared by a practitioner at    |
| Specification for     | the conclusion of a healthcare encounter in  |
| Continuity of Care    | order to enable the next practitioner to     |
| Record (CCR): \#      | readily access such information. It includes |
| E2369-05              | a summary of the patient's health status     |
|                       | (e.g., problems, medications, allergies) and |
|                       | basic information about insurance, advance   |
|                       | directives, care documentation, and care     |
|                       | plan recommendations. An XML version of the  |
|                       | CCR, known as the Continuity of Care         |
|                       | Document (CCD), prepared by Health Level     |
|                       | Seven (HL7) in collaboration with ASTM, also |
|                       | exists and described under Health Level      |
|                       | Seven standards. Visit                       |
|                       | [www.astm.org](http://www.astm.org/) for     |
|                       | more information.                            |
+-----------------------+----------------------------------------------+
| Council for           | Provide agreed-upon business rules and       |
| Affordable Quality    | guidelines for using and processing          |
| Health Care (CAQH)    | eligibility inquiry and response             |
| Committee on          | transactions between providers and health    |
| Operating Rules for   | plans; in particular those that have been    |
| Information Exchange  | adopted under HIPAA. Visit                   |
| (CORE) Phase I        | [www.caqh.org](http://www.caqh.org/) for     |
| Operating Rules       | more information.                            |
+-----------------------+----------------------------------------------+
| Federal Medication    | A set of federal terminologies related to    |
| Terminologies         | medications, including the Food and Drug     |
|                       | Administration's names and codes for         |
|                       | ingredients, manufactured dosage forms, drug |
|                       | products and medication packages, the        |
|                       | National Library of Medicine's RxNORM for    |
|                       | describing clinical drugs, and the Veterans  |
|                       | Administration's National Drug File          |
|                       | Reference Terminology (NDF-RT) for specific  |
|                       | drug classifications.                        |
|                       |                                              |
|                       | This leverages the controlled terminology    |
|                       | from three medication models that are        |
|                       | maintained by the federal government:        |
|                       |                                              |
|                       | National Drug File Reference Terminology     |
|                       | (NDF-RT)                                     |
|                       |                                              |
|                       | \- Veterans Health Administration            |
|                       |                                              |
|                       | Structured Product Labeling (SPL)            |
|                       |                                              |
|                       | \- Food and Drug Administration              |
|                       |                                              |
|                       | RxNorm                                       |
|                       |                                              |
|                       | \- National Library of Medicine              |
+-----------------------+----------------------------------------------+
| Health Level Seven    | The Continuity of Care Document (CCD)        |
| (HL7) Version 3.0     | constrains the HL7 Clinical Document         |
| Continuity of Care    | Architecture Release 2 (CDA R2) in           |
| Document (CCD)        | accordance with requirements specified in    |
|                       | American Society for Testing and Materials   |
|                       | (ASTM) standard E 2369-05, \"Standard        |
|                       | Specification for Continuity of Care Record  |
|                       | (CCR).\" The resulting CCD specification is  |
|                       | developed as a collaborative effort between  |
|                       | ASTM and HL7, and is intended as an          |
|                       | alternate implementation to the one          |
|                       | specified in ASTM E2369-05 for those         |
|                       | organizations preferring to use HL7 Clinical |
|                       | Document Architecture (CDA) to communicate   |
|                       | this information. Visit                      |
|                       | [www.hl7.org](http://www.hl7.org/) for more  |
|                       | information.                                 |
+-----------------------+----------------------------------------------+
| Health Level Seven    | The HL7 Clinical Document Architecture is an |
| (HL7) Version 3.0     | XML-based document markup standard that      |
| Clinical Document     | specifies the structure and semantics of     |
| Architecture (CDA/CDA | clinical documents for the purpose of        |
| R2)                   | exchange. CDA is one instantiation of HL7\'s |
|                       | Version 3.0 Reference Information Model      |
|                       | (RIM) into a specific message format. Of     |
|                       | particular focus for HITSP Interoperability  |
|                       | Specifications are message formats for       |
|                       | Laboratory Results and Continuity of Care    |
|                       | (CCD) documents. Release 2 of the HL7        |
|                       | Clinical Document Architecture (CDA) is an   |
|                       | extension to the original CDA document       |
|                       | markup standard that specifies the structure |
|                       | and semantics of clinical documents for the  |
|                       | purpose of exchange. CDA R2 includes a prose |
|                       | document in HTML, XML schemas, data          |
|                       | dictionary, and sample CDA documents. CDA R2 |
|                       | further builds upon other HL7 standards      |
|                       | beyond just the Version 3.0 Reference        |
|                       | Information Model (RIM) and incorporates     |
|                       | Version 3.0 Data Structures, Vocabulary, and |
|                       | the XML Implementation Technology            |
|                       | Specifications for Data Types and            |
|                       | Structures. Visit                            |
|                       | [www.hl7.org](http://www.hl7.org/) for more  |
|                       | information.                                 |
+-----------------------+----------------------------------------------+
| Health Level Seven    | The HL7 Version 2.5 Messaging Standard is an |
| (HL7) Version 2.5     | application protocol for electronic data     |
|                       | exchange in healthcare. It and prior         |
|                       | versions have widespread use in the U.S. and |
|                       | internationally. Both message formats and    |
|                       | value sets / code tables (e.g., diagnosis    |
|                       | type, gender, patient class) are contained   |
|                       | in the standard. Of particular focus for     |
|                       | HITSP Interoperability Specifications are    |
|                       | message formats described in Chapters 2, 3,  |
|                       | 5, and 7 including patient demographic (ADT) |
|                       | and lab result reporting. These are also     |
|                       | used within composite standards from IHE for |
|                       | Patient Identifier Cross-Referencing and     |
|                       | Feed (PIX), Patient Demographics Query       |
|                       | (PDQ), and Acknowledgements. Visit           |
|                       | [www.hl7.org](http://www.hl7.org/) for more  |
|                       | information.                                 |
+-----------------------+----------------------------------------------+
| Health Level Seven    | The HL7 EHR System Functional Model and      |
| (HL7) EHR System      | Standard documents key functions of          |
| Functional Model      | Electronic Health Record Systems (EHR-S) to  |
| Draft Standard for    | enable consistent expression of system       |
| Trial Use (DSTU)      | functionality. The functions are organized   |
|                       | in two ways: as a hierarchy within the broad |
|                       | headings of care delivery and infrastructure |
|                       | functions; and as a list of functions that   |
|                       | are deemed essential or desirable within     |
|                       | four common care settings. Visit             |
|                       | [www.hl7.org](http://www.hl7.org/) for more  |
|                       | information.                                 |
+-----------------------+----------------------------------------------+
| Integrating the       | The IHE Laboratory Technical Framework       |
| Healthcare Enterprise | introduces a content Integration Profile     |
| (IHE) Laboratory      | Sharing Laboratory Reports (XD\*-LAB) that   |
| Technical Framework   | describes a clinical laboratory report as a  |
| Supplement 2006-2007  | human-readable electronic document. This     |
| Revision 1.0          | document, which may also contain data in a   |
|                       | machine-readable format and contains the     |
|                       | complete set of final results produced by a  |
|                       | clinical laboratory in fulfillment of one or |
|                       | more test orders for a patient. This         |
|                       | document is focused on the sharing of sets   |
|                       | of laboratory results in the form of a       |
|                       | laboratory report structured document, and   |
|                       | is not intended to address ordering or       |
|                       | return of laboratory results to the ordering |
|                       | provider. Visit                              |
|                       | [www.ihe.net](http://www.ihe.net/) for more  |
|                       | information.                                 |
+-----------------------+----------------------------------------------+
| Integrating the       | The IHE Patient Care Coordination Technical  |
| Healthcare Enterprise | Framework (PCC TF) defines specific          |
| (IHE) Patient Care    | implementations (called Integration          |
| Coordination (PCC)    | Profiles) of established standards to deal   |
| Technical Framework   | with integration issues that cross           |
| Revision 1.0          | providers, patient problems or time. The     |
|                       | Exchange of Personal Health Record Content   |
|                       | (XPHR) Integration Profile describes the     |
|                       | content and format of summary information    |
|                       | extracted from a PHR system for import into  |
|                       | an EHR system, and vice versa. The purpose   |
|                       | of this Integration Profile is to support    |
|                       | interoperability between PHR systems used by |
|                       | patients and EHR systems used by healthcare  |
|                       | providers. The Cross Enterprise Document     |
|                       | Sharing of Medical Summaries (XDS-MS)        |
|                       | Integration Profile enables sharing of       |
|                       | health information between enterprises of a  |
|                       | regional health network. In the registry,    |
|                       | healthcare providers publish pointers to     |
|                       | documents stored in distributed              |
|                       | repositories. Other healthcare providers may |
|                       | search and retrieve these and other          |
|                       | documents. Visit                             |
|                       | [www.ihe.net](http://www.ihe.net/) for more  |
|                       | information.                                 |
+-----------------------+----------------------------------------------+
| Logical Observation   | A database of universal identifiers for      |
| Identifiers Names and | laboratory and other clinical observations.  |
| Codes (LOINC®)        | The laboratory portion of the LOINC database |
|                       | contains the usual categories of chemistry,  |
|                       | hematology, serology, microbiology           |
|                       | (including parasitology and virology), and   |
|                       | toxicology; as well as categories for drugs  |
|                       | and the cell counts typically reported on a  |
|                       | complete blood count or a cerebrospinal      |
|                       | fluid cell count. Antibiotic                 |
|                       | susceptibilities are a separate category.    |
|                       | The clinical portion of the LOINC database   |
|                       | includes entries for vital signs,            |
|                       | hemodynamics, intake/output, EKG, obstetric  |
|                       | ultrasound, cardiac echo, urologic imaging,  |
|                       | gastroendoscopic procedures, pulmonary       |
|                       | ventilator management, selected survey       |
|                       | instruments, and other clinical              |
|                       | observations. Visit                          |
|                       | [www.loinc.org](http://www.loinc.org/) for   |
|                       | more information.                            |
+-----------------------+----------------------------------------------+
| National Council for  | Provides for the real-time electronic        |
| Prescription Drug     | transfer of prescription data between        |
| Programs (NCPDP)      | pharmacies and providers. Functions          |
| SCRIPT Standard       | supported include communication of new       |
| Version 8.1           | prescriptions, prescription changes, refill  |
|                       | requests, prescription fill status           |
|                       | notifications, and prescription              |
|                       | cancellations. Visit                         |
|                       | [www.ncpdp.org](http://www.ncpdp.org/) for   |
|                       | more information.                            |
+-----------------------+----------------------------------------------+

[^1]: <http://www.hhs.gov/healthit/ahic.html>

[^2]: [www.hitsp.org](http://www.hitsp.org/)

[^3]: Using the full Interoperability Specification, please refer to
    section 2.1 Overview for discussion of Standard Transactions and
    Codesets and to section 2.2.5 for information relating to HIPAA
    Security and Privacy