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    HIT Policy CommitteeHIT Policy Committee

    PCAST WorkgroupSummary of Public CommentSummary of Public CommentResponses to ONC Request for Comment on PCAST ReportResponses to ONC Request for Comment on PCAST Report

    Office of the National Coordinator

    Jodi Daniel and Doug Fridsma

    January 27, 2011

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    Disclaimer

    The following presentation will show the initial analysis

    and summary of public comments made in response to

    ONCs Request for Comment on the PCAST report"Realizing the Full Potential of Health Information

    Technology to Improve Healthcare for Americans: The

    Path Forward. This summary does not reflect the

    position of the Office of the National Coordinator.

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    ONC Request for Comment Overview

    On Dec 8, 2010, the Presidents Council of Advisors on Science

    and Technology released their Report entitled "Realizing the Full

    Potential of Health Information Technology to Improve Healthcare

    for Americans: The Path Forward."

    On the same day, ONC published a Request for Comment asking

    the public 9 questions regarding:

    The impact of PCAST on ONC activities

    Initial thoughts on PCAST recommendations

    How they want ONC to act on the PCAST recommendations

    Public comment was due on Jan 19th, by which we received 107

    comments

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    Commenter Profile

    We received comments from:

    Associations, EHR and PHR vendors, HIT Software

    Companies - around 35%

    Infrastructure experts, HIEs and StandardDevelopment Organizations under 15%

    Providers, Pharmacy or Pharmacy Organizations,

    Hospitals and Health Plans 20%

    Others including Patient Advocates, IndividualCitizens and State Health Employees remaining

    30%

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    Common Themes of Comments

    Timeline IssuesTimeline Issues

    Effects on ONC ProgramsEffects on ONC Programs

    Process of Implementing PCASTProcess of Implementing PCASTRecommendationsRecommendations

    Privacy and Security IssuesPrivacy and Security Issues

    StandardsStandards

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    Question #1a, 1b

    What standards, implementation specifications,

    certification criteria, and certification processes for

    electronic health record (EHR) technology and other

    HIT would be required to implement the followingspecific recommendations from the PCAST report:

    a. That ONC establish minimal standards for the

    metadata associated with tagged data elements;

    b. That ONC facilitate the rapid mapping of existing

    semantic taxonomies into tagged data elements;

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    Question #1a, 1b: Summary of Responses

    Process of Implementing PCAST RecommendationsProcess of Implementing PCAST Recommendations

    Use an open, consensus-driven process

    Do not reinvent the wheel: leverage existing meta-data standards

    and registries and leverage existing taxonomies and vocabularies

    Keep meta-data requirements to a minimum

    StandardsStandards

    Harmonize existing taxonomies: the industry needs widely

    available harmonized taxonomies; e.g., SNOMED CT to ICD-

    9/ICD-10

    Beware of losing clinical context: the true meaning of data can be

    lost when tagging at the atomic level Choose the right granularity of data-tagging: dataset-level might

    be the happy medium between document-level and atomic-level

    Use a model-driven approach: tags, terminology and value sets

    need to be defined in an information model

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    Question #1c

    What standards, implementation specifications,

    certification criteria, and certification processes for

    electronic health record (EHR) technology and other

    HIT would be required to implement the following

    specific recommendations from the PCAST report:

    c. That certification of EHR technology and other HIT

    should focus on interoperability with reference

    implementations developed by ONC.

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    Question #1c: Summary of Responses

    Timeline IssuesTimeline Issues

    Incremental process using pilot demonstration will reduce the

    risk

    Effects on ONC ProgramsEffects on ONC Programs

    Certification based as much as possible on ONC-developed

    reference implementations is essential to realization of

    opportunities identified by PCAST

    Process of Implementing PCAST RecommendationsProcess of Implementing PCAST Recommendations

    Build reference implementations: these create real-world

    validation of the PCAST concepts and give a solid basis for

    certification

    Validate data at rest (i.e., within EHRs) and during interchange

    9

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    Question #2

    What processes and approaches would facilitate the

    rapid development and use of these standards,

    implementation specifications, certification criteria and

    certification processes?

    10

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    Question #2: Summary of Responses

    Effects on ONC ProgramsEffects on ONC Programs

    Incentivize development and adoption through federally-

    sponsored programs, e.g., CMS, DoD, ONC

    Process of Implementing PCAST RecommendationsProcess of Implementing PCAST Recommendations Achieve broad industry participation built on openness andtransparency

    Build on processes that work, e.g., IHE, MITA, Direct Project,

    etc.

    StandardsStandards Incentivize development and adoption through federally-

    sponsored programs, e.g., CMS, DoD, ONC, etc.

    Provide common tools that enable development, collaboration,

    pilots, and testing for efforts such as mapping terminologies

    and taxonomies 11

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    Question #3a, 3b

    Given currently implemented information technology

    (IT) architectures and enterprises, what challenges will

    the industry face with respect to transitioning to the

    approach discussed in the PCAST report?

    a. Given currently implemented provider workflows,

    what are some challenges to populating the

    metadata that may be necessary to implement the

    approach discussed in the PCAST report?

    b.Alternatively, what are proposed solutions, or best

    practices from other industries, that could be

    leveraged to expedite these transitions?

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    Question #3a, 3b: Summary of Responses

    Process of Implementing PCAST RecommendationsProcess of Implementing PCAST Recommendations

    Providers must have general availability of sufficient

    broadband and computing resources before implementing

    PCAST recommendations

    Privacy and Security IssuesPrivacy and Security Issues atomic-level data tagging may further effect patient identity and

    matching issues as well as issues of data ownership

    StandardsStandards

    Must have consensus on the correct level of data granularity

    New PCAST standards should harmonize with existingsystems, standards to maintain workflow dynamics and avoid

    potential patient safety issues

    Build on existing document-level tagging approach instead of

    atomic-level tagging, or at least enable interoperability among

    the two 13

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    Question #4

    What technological developments and policy actions

    would be required to assure the privacy and security of

    health data in a national infrastructure for HIT that

    embodies the PCAST vision and recommendations?

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    Question #4: Summary of Responses

    Process of Implementing PCAST RecommendationsProcess of Implementing PCAST Recommendations

    Implementation of granular consent and data segmentation must allow for

    dynamic privacy metadata that allows patients to update their privacy

    preferences.

    Design of granular patient privacy control features should be patient-centric not

    data-centric Privacy and Security IssuesPrivacy and Security Issues

    DEAS-based infrastructure must ensure public trust by:

    Performing risk analysis

    Upgrading outdate privacy policy that do not take into account the health

    network

    Having infrastructures that are certified Having reliable patient identification

    Having built-in technology solutions for patient identification without

    acceptable false positives rates

    Data sharing infrastructure must have an acceptable accountability/oversight

    framework and should avoid an over-reliance on consent

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    Question #5

    How might a system of Data Element Access Services

    (DEAS), as described in the report, be established, and

    what role should the Federal government assume in

    the oversight and/or governance of such a system?

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    Question #5: Summary of Responses

    Outside of privacy and security concerns,Outside of privacy and security concerns, commenterscommenters had the followinghad the following

    input in regards to the DEAS framework proposed by PCAST:input in regards to the DEAS framework proposed by PCAST:

    Process of Implementing PCAST RecommendationsProcess of Implementing PCAST Recommendations

    Commenters that suggested financial incentives may be necessary to

    spur development of DEAS. Commenters acknowledged that multiple models exist on which

    DEAS could be structured and governed. Suggestions included using

    an SOA or having DEAS reside in an HIE. However, there was no

    predominant opinion among comments received for this RFC.

    StandardsStandards

    Commentors suggested that ONC could make software or animplementation specification available for DEAS framework.

    Some suggested that ONC examine XDS, and the experience of

    intermediaries (e.g. Surescripts) and patient record locator services

    when developing this DEAS implementation specification

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    Question #6

    How might ONC best integrate the changes envisioned

    by the PCAST report into its work in preparation for

    Stage 2 of Meaningful Use?

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    Question #6: Summary of Responses

    Timeline IssuesTimeline Issues

    There was broad consensus among the variety of commenter groups

    that full implementation of atomic data tagging and DEAS deployment

    cannot be realized in the timeframe of MU stage 2 and 3. Many felt

    that existing systems could not be upgraded in time and the cost of

    new systems would be unrealistic.

    In addition, commenters stated that delays in the PCAST timeframe

    may occur while new metadata standards are developed

    However, many felt that it would be timely to have DEAS and other

    PCAST technology pilots during Stage 2

    Effects on ONC ProgramsEffects on ONC Programs

    Many comments asked ONC to focus MU Stage 2 on: Improved interoperability and connectivity to state systems

    Value-based MU criteria rather than technology adoption goals

    Outcome research, assessments, new quality measures

    Decision Support

    Biosurveillance and Biometrics 19

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    Question #7

    What are the implications of the PCAST report on HIT

    programs and activities, specifically, health information

    exchange and Federal agency activities, and how could

    ONC address those implications?

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    Question #7: Summary of Responses

    Process of Implementing PCAST RecommendationsProcess of Implementing PCAST Recommendations

    Many commenters wanted to see the government:

    Hosting, as part of the S&I Interoperability Framework, an HIE

    Interface Initiative for an implementation specification of the EHR

    to HIE interface consistent with the NW-HIN Exchange (HIE-to-HIE interface).

    Engaging the various state HIEs (to which edge EHR are to be

    connected), HIE vendors, EHR vendors and other stakeholders in

    this definition so that consistency be ensured across all

    state/regional/community HIEs.

    Including this implementation specification for Stage 2 or 3, EHRcertification.

    Establishing a voluntary HIE testing program, based on this

    implementation specification.

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    Question #8

    Are there lessons learned regarding metadata tagging

    in other industries that ONC should be aware of?

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    Question #8: Summary of Responses

    Timeline IssuesTimeline Issues

    Once again, many pointed out that no precedents exist in otherOnce again, many pointed out that no precedents exist in other

    industries that portray the massive scale of metaindustries that portray the massive scale of meta--data tagging,data tagging,

    fragmentation and voracious capacity requirements forfragmentation and voracious capacity requirements for

    complexity of health information.complexity of health information.

    Process of Implementing PCAST RecommendationsProcess of Implementing PCAST Recommendations

    Implementation using complex metadata may be

    difficult to implement

    StandardsStandardsAvoid reinventing standards and learn from

    successes and problems experienced with epSOS,

    HL7 V3 RIM, ASCX12, GIS and others

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    Question #9

    Are there lessons learned from initiatives to establish

    information sharing languages (universal languages)

    in other sectors?

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    Question #9: Summary of Responses

    StandardsStandardsExamples from other industries include:

    Banking and the Internet

    Data Fusion Centers -Department of Homeland Security (DHS) and

    Department of Justice (DOJ)

    Examples of previous standards work to review include:

    DICOM, ICAM, LCs MARC (MODS, MADS), ADLs SCORM,

    W3Cs RDF, OWL, Dublin Cores DCMI Abstract Model, Global

    JXDM, and OAI-PMH.

    Examples of countries looking at health data exchange:

    England: Abandoned data level architecture for CDA model Finland: Using CDA model of exchange

    European NW-HIN called epSOS: Using CDA model of exchange

    .

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    Timeline Comment Summary

    Timeline:Timeline:

    ManyMany commenterscommenters were glad to see PCAST recommendationswere glad to see PCAST recommendations

    push toward an increased focus on information exchangepush toward an increased focus on information exchange

    before the release of Stage 2 MU criteria and certificationbefore the release of Stage 2 MU criteria and certification

    criteria.criteria. However, majority ofHowever, majority of commenterscommenters were concerned about thewere concerned about the

    timeline effects of implementing full PCAST recommendationstimeline effects of implementing full PCAST recommendations

    in the midst of rolling out MU stage 2 and 3 along with otherin the midst of rolling out MU stage 2 and 3 along with other

    changing standards such as IC9 to IC10. They werechanging standards such as IC9 to IC10. They were

    concerned that there would be negative effects on patientconcerned that there would be negative effects on patientsafety.safety.

    Many reviewers specifically recommended that PCASTMany reviewers specifically recommended that PCAST

    recommendations be a long term strategy rather than anrecommendations be a long term strategy rather than an

    immediate deviation from the current groundwork that hasimmediate deviation from the current groundwork that has

    already been laid.already been laid.26

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    Effects on ONC ProgramsEffects on ONC Programs Comment Summary

    Effects on ONC ProgramsEffects on ONC Programs

    Most commenters urged ONC to leverage success of

    current ONC and private HIT programs without

    reinventing the wheel in the midst in the HITECH

    incentive period.

    Many stated that full implementation of PCAST

    recommendation would require redesign of much of the

    ongoing federal HIT grants and contract; which would

    incur substantial cost and may discourage participation

    of current players

    Many commentors did suggest the ONC begin smaller

    pilots to develop and test PCAST technology solutions. If

    successful, these solutions can later be more widely

    implemented. 27

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    Privacy and Security Comment Summary

    Privacy and Security

    Many commenters were very supportive of the concept of

    giving patients granular consent as envisioned in the

    PCAST report.

    However, many were worried that tagging patient privacypreferences to the data would lead to a static, rather than a

    dynamic, data control environment that prevented patients

    from updating their privacy preference once the data was

    released.

    Commenters from the research community were supportiveof PCAST concept of creating a subset of de-identified data

    for the purpose research

    However, others were not supportive of this PCAST

    recommendation because they were skeptical that data can

    truly be de-identified 29

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    Standards Comment Summary

    A few commenters wanted ONC to avoided competition

    between existing standards and instead move to a

    completely new approach as outlined in PCAST

    because:

    They felt that current standards are strict and do not allow forinnovation and flexibility or allow scalability.

    They also felt that the CDA is not a suitable framework for the

    exchange of metadata tagged elements, as it is document-centric and

    exists primarily as a wrapper for many different kinds of documents

    However, most commenters stated that PCAST goalsof interoperability and data liquidity can be met with

    existing and emerging standards, particularly those

    developed by ANSI accredited SDOs such as ICD-10,

    SNOMED, and LOINC.30

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    Next Steps

    Next Steps:

    ONC is currently working to:

    Further analyze the comments received Create a summary report of the comments that will

    be available to the WG

    We request workgroup members to inform us ofspecific types of analysis they would like us to perform

    of the comments during this time.

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