NIEM_HealthDomain_Recommendation_v0.9 by panniuniu

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									Office of the National Coordinator (ONC)
              For Health IT

           Establishment of
 National Information Exchange Model
               (NIEM)
        Health Domain at HHS
              Whitepaper

             12 August 2011

               Release 0.9




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Contents
1    Summary                                         .......................................................................................................... 3
2    Background and Introduction                     .......................................................................................................... 4
  2.1     Document Scope and Intended Audience .................................................................................... 4
  2.2     References .......................................................................................................................................... 4
  2.3     NIEM Adoption Approach ............................................................................................................. 5
3    Establishment of a NIEM Health Domain .......................................................................................... 6
  3.1     Challenges in establishing a Health Domain ................................................................................. 6
  3.2     Phase 1 - Identification of Candidate Healthcare Exchanges..................................................... 7
  3.3     Phase 2 - Engage Health Stakeholders .........................................................................................10
     3.3.1    Identify Stakeholders ..............................................................................................................10
     3.3.2    Establish a Governance Process ...........................................................................................10
  3.4     Phase 3 - Publish NIEM Health Domain to Community.........................................................10
  3.5     Health Domain Maintenance ........................................................................................................11
4    Conclusions                                     ........................................................................................................11
Appendix - Acronyms                                  ........................................................................................................12




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1 Summary
The Office of the National Coordinator (ONC) and specifically the Office of Standards and
Interoperability (OSI) has been charged with establishing a Health Domain within NIEM. Given the
abundance of standards and standards development organizations within the healthcare domain (for
e.g HL7, IHE, CDISC, etc.) this task is further complicated by the availability of multiple
vocabularies and value sets to describe clinical data exchanges. Since January 2011, OSI has been
exploring various options to start establishing and operating the NIEM Health Domain. This paper
is a culmination of those efforts and recommends a path forward. If accepted, the team will move
forward with operationalization of these recommendations. At the highest level, our
recommendation consists of:

       Establish a Health Domain in the context of the existing NIEM framework (as opposed to
        establishing a separate NIEM Health core – a strategy which had been considered earlier)
       Identify high value individual data exchanges and build the domain iteratively
       Leverage data elements and their definitions from existing models such as the FHIM, HL7
        RIM, etc as appropriate for the identified high value exchanges
       Use NIEM domain governance model to govern the NIEM Health Domain
       Extend NIEM tooling to enable use of standard vocabularies and value sets when
        describing healthcare exchange data elements
       Establish the NIEM Health Domain by focusing on high value data exchanges that can be
        modeled within NIEM as opposed to creating a NIEM Health Domain for the entire
        healthcare using existing models which may never be used

We recommend starting the NIEM domain creation activities by selecting one of the recommended
exchanges in this document and start building the community of interest along with the NIEM
Health Domain.

We realize that this approach may be considered at odds with the traditional domain modeling
exercises undertaken by SDO and other organizations (e.g. FHIM by the FHA, BRIDG by NCI,
RIM by HL7 etc.). However, we intend to reuse the existing standards, vocabularies and value sets
from these models wherever possible, thus ensuring that interoperability is maintained. We believe
this pragmatic approach will keep the NIEM Health Domain populated with high value exchange
centric data elements and not every possible healthcare concept that can be modeled irrespective of
its practical utility. It will also keep the community focused to those affected by the exchange and
not just those interested in modeling activities; thus leading to a more sustainable NIEM Health
Domain.




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2 Background and Introduction
   The purpose of this white paper is to recommend a plan of action for establishing a NIEM
   Health Domain at HHS. HHS has identified NIEM as an effective, potential framework for
   enhancing the interoperability and standardization of health information exchange. NIEM offers
   a proven approach for developing standardized, reusable information exchanges and has already
   been widely adopted across the Federal, State, and local sectors.

   As mentioned earlier, HHS has previously explored the use of NIEM for standardized health
   information exchange; though none of these earlier efforts were successful in establishing a
   NIEM Health Domain. Among these efforts was a joint initiative between ONC and the HHS
   EA PMO to develop a NIEM-conformant exchange for a patient summary care record. Another
   related ONC-driven effort was to create a completely separate NIEM Health domain separate
   from the existing NIEM core and domains using NIEM processes and tools.

   Building on lessons learned from these earlier efforts, this whitepaper describes a pragmatic
   approach for HHS to establish a NIEM Health Domain. The approach leverages the proven
   domain creation process from NIEM PMO which advocates the development of individual
   information exchanges and forming a community of interest around those exchanges. This
   document also identifies specific information exchanges that are suggested as candidates for
   NIEM Health Domain establishment along with the criteria to be used for selecting the
   candidate exchanges.

2.1 Document Scope and Intended Audience
The scope of this document is to outline the approach to establish a NIEM Health Domain. The
document does not specify the exact technical and operational details for establishment of the
NIEM Health Domain. These details will be elaborated once the ONC and HHS leadership
approves the approach and recommendations proposed in this document.

This document is intended for the leadership of ONC Office of Standards and Interoperability,
HHS Office of the CIO, and NIEM Program Management Office.

2.2 References
The following links provide additional information about ONC’s previous efforts to establish a
NIEM Health Domain as well as background information about NIEM and relevant NIEM success
stories. These materials have been leveraged in the creation of this paper.

      S&I Framework and NIEM:
       http://jira.siframework.org/wiki/pages/viewpage.action?pageId=20709494
      NIEM Background Information: http://niem.gov/
      Existing and Successful NIEM Domains: http://www.niem.gov/domains.php.
      NIEM Case Study: NYC HHS integration of federal benefit application processes:
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             http://www.niem.gov/pdf/NYC_HHS-connect.pdf
            NIEM Case Study: Collaboration between HHS and the National Center for State Courts to
             help children at risk: http://www.niem.gov/pdf/NIEM_helping_children.pdf

     2.3 NIEM Adoption Approach
     Through its experience working with organizations to establish new domains, as well as supporting
     the growth of existing domains, the NIEM PMO has identified a successful approach to domain
     creation. The process has been proven by establishing successful domains such as the Maritime and
     Family Services domain. It is a three phase approach that results in the formal recognition of a new
     domain by the NIEM Executive Steering Council (ESC). The following diagram outlines the key
     activities of this process:
                                    Figure 1: NIEM Domain Establishment Process



                     I: Identify Business                  II: Stakeholder                 III: Formal Domain
                          Exchange                          Engagement                           Creation

  Key       1. Identify candidate information     1. Identify           stakeholders   1. Complete       an     initial
Activities:    sharing scenarios that will           affiliated with the initial          Domain Scope Definition
                drive the initial scope of the       exchange being developed             document,         including
                domain.                              and      invite      them    to      scope,           objectives,
             2. Document use cases for the           participate       in    domain       resources,        exchange
                initial information exchange.        activities.                          scenarios, and sample data
             3. Determine the overlap of          2. Define       initial    domain       model.
                exchange data with existing          governance structure and          2. Review Scope Definition
                NIEM content and identify            operations plans.                    with the NIEM PMO.
                any content that is not already   3. Establish a flexible O&M          3. Present domain value
                in NIEM; this could form the         plan that will allow the             proposition to NIEM
                initial scope of Health              domain to respond flexibly           Business Architecture and
                Domain.                              to changing stakeholder              Technical      Architecture
             4. Develop a model that                 needs.                               Committees.
                represents the initial domain                                          4. Gain ESC approval to
                content and scope. At this                                                establish Health Domain
                stage, define integration with                                            and       sign      domain
                existing standards.                                                       stewardship agreements.

  Results:                                           Establishment of Health
                      Initial domain scope                                                Formal ESC recognition
                            identified              COI and participation in the
                                                        NIEM community                      of domain and COI




     The key to establishing a successful domain is to focus not just on the data model, but also on the
     represented exchanges and communities of interest (COI) as demonstrated by the Maritime and
                                                      5
Family Services domain. The following considerations should be accounted for when identifying
initial exchanges to form the scope of a new domain:
      Alignment of the exchange with strategic mission priorities
      Potential for substantial reuse of the exchange
      Relevance of the exchange to stakeholder business needs
Identifying an agreed-to business exchange or mission need will drive the future phases of domain
establishment, providing initial model scope, as well as determining the community of interest that
should be engaged. By bringing together a COI that is affiliated with the initial exchange,
stakeholders are immediately engaged in domain activities and momentum is set for continued use
of the content.

Once a domain is established, it continues to mature and grow iteratively, with the scope expanding
in response to needs identified through the stakeholder community. A COI is a critical component
of a successful domain, as it is responsible for identifying user requirements, new business
exchanges, and changes that will influence the content of the domain model itself.

This NIEM Adoption approach has been used successfully in practice and many NIEM domains
have been created; the references for these domains can be found at
http://www.niem.gov/domains.php.

3 Establishment of a NIEM Health Domain
HHS will apply the NIEM PMO’s recommended domain creation strategy to establish the NIEM
Health Domain. Throughout the domain establishment process, HHS will actively engage
stakeholders to ensure that the NIEM Health Domain reflects the business needs of the health
community.

HHS will initiate the domain establishment process by identifying and prioritizing specific high-value
information exchanges that align with the healthcare community’s business needs. After these
exchanges have been identified, the Community of Interest will develop the exchanges with the
support of ONC and HHS. These initial exchanges will form the foundation of the NIEM Health
Domain. Once the NIEM Health Domain has been established, HHS and other domain
stakeholders can continue to expand the domain by creating and implementing additional exchanges
that address their particular business needs. The following sections describe some of the challenges
that will need to be considered during the establishment of the NIEM Health Domain and outline
the specific steps that HHS will take to establish the domain.

3.1 Challenges in Establishing a Health Domain
Throughout the process of establishing a NIEM Health Domain, challenges specific to the
healthcare industry must be taken into consideration. Some of the significant challenges and
recommended actions that should be followed during the establishment of a NIEM Health Domain
are summarized in the table below:
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                   Challenge                          Recommended Action to address challenge

Leveraging work done by existing SDO’s Engage SDO’s relevant to the high value
although their development approaches are not exchanges early using open processes that
NIEM conformant                               encourage transparent communication between
                                              the NIEM Health Domain stewards and SDO’s

Healthcare organizations have adopted many            Harmonize existing Healthcare standards with
Healthcare standards such as HL7, NCPDP,              NIEM where possible as part of the high value
IHE, DICOM along with terminologies and               exchanges and reuse existing terminologies and
vocabularies which may not map well to NIEM           value sets to minimize impact to organizations
concepts

Most healthcare organizations are working             Identify the high value exchanges that align with
towards national priorities such as Meaningful        the national priorities to spur adoption and
use, ACA and are highly resource constrained to       establish a strong community of interest around
adopt NIEM                                            the exchange

Making changes to existing healthcare systems in Identify the high value exchanges which are
not trivial and require substantial ROI already present part of organizations roadmaps
justification for NIEM adoption                  and enable efficient implementation of these
                                                 exchanges to justify investments.



3.2 Phase 1 - Identification of Candidate Healthcare Exchanges
High Value exchanges need to be identified to serve as the initial content of the NIEM Health
Domain. This is in alignment with Phase 1 of the domain establishment process and also leads to
the identification of stakeholders who will be engaged in Phase 2. The criteria used for the selection
of these exchanges are of paramount importance more than the exchanges themselves due to the
fact that a successful NIEM Health Domain will require not just the exchange, but a community of
interest that maintains the domain and builds other exchanges on the established NIEM Health
Domain.

The criterion that was used in identifying the candidate exchanges were derived from the NIEM
domain establishment process and are outlined below:

      High value exchanges that get selected should lend themselves towards identification of
       stakeholders who will be interested in the creation and maintenance of the exchange. In turn,
       the exchange should offer a level of value to the stakeholders such that they will remain
       engaged in the exchange and the NIEM Health Domain.
      Align high value exchanges with strategic national priorities

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          o Align the exchanges with Affordable Care Act (ACA) and Meaningful Use which are
              the current healthcare national priorities
      High value exchanges that get selected should show potential for reuse between multiple
       exchange partners.

The candidate exchanges that ONC should evaluate are summarized in the table below:

Data Exchange Data Exchange Summary                           Alignment with exchange selection
Name                                                          criteria

ACA Section 1561 The Affordable Care Act (ACA)                This exchange is directly tied to the
– Eligibility and Section 1561 includes a set of              national priority of ACA and could lay
Enrollment data guidelines        and     requirements        a solid foundation for communities to
exchanges         intended to facilitate consumer             interact which involves CMS, State
                  determination of eligibility and            Medicaid systems, private agencies
                  enrollment in Federal and State             providing Medicaid services and other
                  Health and Human Services                   federal agencies that need to provide
                  programs. This process includes             information      for   eligibility and
                  verification of core data elements to       enrollment. The reuse exists across all
                  determine eligibility, and many of          of the above stakeholders and
                  these core elements reside in               potentially new use cases down the
                  disparate systems across many               line.
                  federal agencies.

Exchanges dealing     CMS uses quality measures in its        This initiative is aligned with ACO’s
with   calculating    various quality initiatives. Several    and Meaningful use and provides a
and transmitting      initiatives exist and additional ones   solid foundation for a community with
CMS        quality    are being considered. Many              CMS and many organizations that are
measures              initiatives require collection of       currently engaged in quality reporting
                      information from single points,         initiatives with CMS. This can expand
                      such as a selected healthcare           in the future to potentially all
                      delivery organization and provide       organizations interacting with CMS or
                      quality metrics that help improve       are interested in sharing quality
                      healthcare quality and reduce costs.    measures with each other.

Public       Health   In order for public health to           This exchange is part of many national
Reporting      and    function, departments must collect      priorities like meaningful use and ACA
Syndromic             a variety of epidemiologic data from    and potentially allows a variety of
Surveillance          highly disparate systems ranging        stakeholders to form a community of
                      from individual health inspectors to    interest which include state health
                      massive hospital systems. The costs     departments, CDC, public research
                      for this data collection are some of    organizations etc. The reuse potential
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Data Exchange Data Exchange Summary                          Alignment with exchange selection
Name                                                         criteria

                    the highest costs borne by these across these agencies will be significant
                    departments and involve many once the data exchange is standardized
                    different standards.             for the various use cases.

Emergency           This data exchange involves              This data exchange is aligned with the
Response            coordination        across      many     priorities of sharing information across
Information         departments and systems including        disparate industries which include
Exchange            public safety, first responders, and     public safety, healthcare, homeland
                    healthcare institutions and there is a   security etc. This data exchange brings
                    need for seamless data interchange.      together these various industries
                                                             together to harmonize on a set of
                                                             standards       for     seamless    data
                                                             interchange. Since there has been
                                                             considerable work already performed
                                                             on this exchange in NIEM Emergency
                                                             domain, it may serve as a natural
                                                             starting point for NIEM Health
                                                             Domain creation.

Prison      Health Health information of prisoners is        This data exchange is aligned with the
Information        required across many agencies             priorities of sharing information across
Sharing            including healthcare, homeland            disparate industries and federal
                   security, and justice among others.       agencies which include public safety,
                   This requires a set of standards that     healthcare institutions, homeland
                   facilitate seamless exchange of           security, department of justice etc. This
                   health information.                       data exchange brings together these
                                                             various agencies and industries
                                                             together to harmonize on a set of
                                                             standards       for     seamless     data
                                                             interchange.




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3.3 Phase 2 - Engage Health Stakeholders
To ensure that the NIEM Health Domain is aligned with stakeholder business needs, HHS will
build a community of interest that is based around each of the prioritized high value information
exchanges. These community members will play a critical role in developing and maintaining the
Health Domain.

3.3.1 Identify Stakeholders
HHS will identify and bring together appropriate stakeholders for each information exchange as it is
developed and engage these stakeholders in domain activities. The COI should include exchange
partners as well as any other stakeholders affiliated with the NIEM Health Domain, such as HIT
standards development organizations and vendors.

3.3.2 Establish a Governance Process
Governance for the NIEM Health Domain will be grounded in the leadership of a domain steward
and the active participation of the domain’s community of interest. The domain steward is the
official sponsor of the NIEM Health Domain. However, the domain steward may not be
responsible for managing domain operations and/or participating in NIEM governance committees.
Instead, the NIEM Health Domain steward may choose to designate a domain point of contact that
is responsible for these day-to-day activities. Additionally, there may be working groups or
committees within the domain that focus on specific areas of domain governances, such as a Data
Governance Working Group. The NIEM Health Domain’s governance structure will be
documented in a domain charter.

A key governance activity for the domain steward (or domain operational point of contact) will
involve coordinating the domain’s community of interest. The COI should be actively engaged in
contributing to the data model, developing information exchange artifacts, and identifying/resolving
issues to help the domain stay relevant to current stakeholder business needs. The NIEM Health
Domain should establish a formal plan for maintaining and managing the domain, including
activities such as monthly COI calls.

3.4 Phase 3 - Publish NIEM Health Domain to Community
This phase officially establishes the NIEM Health Domain and makes the tools, processes and
models available for consumption by the industry. This involves the ONC creating the necessary
charter with goals and objectives for the domain along with the data exchanges and data models that
will be part of the domain upon initial establishment. This phase implements the governance
structures and the processes for the NIEM Health Domain under the guidance of NIEM Business,
Technical and Executive Steering Council. All of the above activities make the NIEM Health
Domain a recognized domain NIEM domain. The NIEM PMO will assist the ONC in executing
this phase once phase 1 and phase 2 are mature and will provide recommendations and best
practices for successfully launching a NIEM Health Domain.

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3.5 Health Domain Maintenance
After the NIEM Health Domain has been initially established, the domain’s data model will grow as
new exchanges are developed and added to the domain. When creating a new exchange, developers
may be able to reuse existing NIEM exchanges or exchange components. However, new exchanges
may also require content that has not yet been captured in an existing exchange. These new
requirements should be incorporated into the NIEM Health Domain’s data model, as appropriate
following the NIEM Health Domain governance processes that would be established.

The NIEM Health Domain steward along with the community of interest will be responsible for
managing and updating the data model based on new requirements and issues identified by
stakeholders. This self-management approach will enable the domain to adapt and respond to the
needs of its stakeholders. As part of managing the domain data model, the domain steward, or a
designated data governance body, should track issues/new requirements and publish updated
domain schemas. The NIEM PMO will provide guidance and a structured approach for data model
management based on accumulated best practices across the various domains.

4 Conclusions
As outlined in this document, we recommend establishing the NIEM Health Domain by identifying
high value exchange(s), establishing a community of interest around the high value exchange to build
the data model which will be the foundation of the NIEM Health Domain. If accepted, the next
steps will include:

           Identify the exchange participants used to establish the first NIEM exchange for
            healthcare
           Identify governance body representatives as outlined in the NIEM governance process
           Explore technology options for including vocabularies and value sets for NIEM Health
            Domain model.
           Extend NIEM tooling to use vocabulary resources (from NLM or ONC) to populate the
            domain model.

Please direct any questions or clarifications to:

Anand Basu,

Director, Standards Division

Office of Standards and Interoperability, ONC, HHS

Anand.Basu@hhs.gov




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Appendix – Acronyms
ACA – Affordable Care Act
BRIDG – Business Research and Information Development Group
CCD – Continuity of Care Document
CCR – Continuity of Care Record
CDC – Centers for Disease Control
CDISC – Clinical Data Interchange Standards Consortium
CIO – Chief Information Officer
CMS – Centers for Medicare & Medicaid Services
COI – Community of Interest
DICOM – Digital Imaging and Communications in Medicine
EA     – Enterprise Architecture
ESC – Executive Steering Committee
FHA – Federal Health Architecture
FHIM – Federal Health Information Model
HHS – Health and Human Services
HIT – Healthcare Information Technology
HL7 – Health Level Seven
IHE – Integrating the Healthcare Enterprise
NIEM – National Information Exchange Model
NCPDP – National Council for Prescription Drug Programs
NLM – National Library of Medicine
O&M – Operations and Management
OASIS – Organization for the Advancement of Structured Information Standards
ONC – Office of the National Coordinator
OSI – Open Society Institute
PMO – Program Management Office
RIM – Reference Information Model
ROI – Return on Investment
S&I Framework – Standards and Interoperability Framework
SDO – Standard Developing Organization




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