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HIT Policy Committee Meeting

HIT Policy Committee Meeting. Nationwide Health Information Network Governance Workgroup Recommendations on Nationwide Health Information Network Governance Roles and Responsibilities 11/19/10 John Lumpkin, MD, MPH, Chair Robert Wood Johnson Foundation. Pre-Decisional Draft.

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HIT Policy Committee Meeting

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  1. HIT Policy Committee Meeting Nationwide Health Information Network Governance Workgroup Recommendations on Nationwide Health Information Network Governance Roles and Responsibilities 11/19/10 John Lumpkin, MD, MPH, Chair Robert Wood Johnson Foundation Pre-Decisional Draft

  2. Workgroup Members Chair:John Lumpkin, Robert Wood Johnson Foundation Members: • Laura Adams Rhode Island Quality Institute • Christine Bechtel National Partnership for Women & Families • Neil Calman Institute for Family Health • Carol Diamond Markle Foundation • Linda Fischetti Department of Veterans Affairs • John Glaser Siemens • Leslie Harris Center for Democracy & Technology • John Houston University of Pittsburgh; NCVHS • Michael Matthews MedVA • John Mattison Kaiser Permanente • Girish Kumar Navani eClinicalWorks • Tim O’Reilly O’Reilly Media • Wes Rishel Gartner Pre-decisional DRAFT.  For HITPC Consideration – 11/19/10

  3. Discussion Topics * The nationwide health information network is in the process of being renamed. The acronym “NW-HIN” is used solely for convenience. • Workgroup approach • Initial recommendations October regarding governance functions. • Additional recommendations regarding governance roles and interactions. • Nationwide health information network (NW-HIN)* context • Findings from assessment of existing mechanisms, including public input. • Ecosystem of NW-HIN governance activities • Recommendations regarding roles: • General recommendations • Roles and responsibilities • Conditions for Interoperability and Trust • Federal role • Non-Governmental Organization role • Validation role • Relationships among roles • Open questions and considerations Pre-decisional DRAFT.  For HITPC Consideration – 11/19/10

  4. Workgroup Approach • Phase 1 recommendations in October • Conducted environmental scan and hearing to understand existing governance landscape. • Defined sound NW-HIN governance principles. • Developed NW-HIN governance framework for governance objectives and functions. • Phase 2 recommendations regarding governance roles • Frame NW-HIN governance ecosystem. • Consider testimony from September hearing regarding roles. • Enlist public input to assess where to leverage existing mechanisms. • Identify essential governance roles; recommend new entity(ies). • Consider interactions of NW-HIN governance entities. • Recommend how governance functions should be implemented and by whom. Pre-decisional DRAFT.  For HITPC Consideration – 11/19/10

  5. NW-HIN CONTEXT Pre-decisional DRAFT.  For HITPC Consideration – 11/19/10

  6. Nationwide Health Information Network ONC Definition: A set of policies, standardsand services that enable the Internet to be used for secure and meaningful exchange of health information to improve health and health care. Private and secure health information exchange enables information to follow the patient when and where it is needed for better care. The Federal government is working to enable a wide range of innovative and complementary approaches that will allow secure and meaningful exchange within and across states, but all of our efforts must be grounded in a common foundation of standards, technical specifications, and policies. Our efforts must also encourage trust among participants and provide assurance to consumers about the security and privacy of their information. This foundation is the essence of the nationwide health information network. David Blumenthal, May 14, 2010 Pre-decisional DRAFT.  For HITPC Consideration – 11/19/10 6

  7. Workgroup Consideration of NW-HIN for Governance (1) • What is NW-HIN? • An environment of trust and interoperability created by NW-HIN standards, services and policies, and • A preferred approach for exchange of health information nationwide supported by the federal government, with strong incentives to vigorously promote adoption. • When is exchange considered NW-HIN and subject to NW-HIN governance? • When that exchange complies with applicable NW-HIN standards, services and policies (i.e. NW-HIN conditions of trust and interoperability (COTIs); and • When those exchanging health information assert they are doing so under the auspices of NW-HIN. • When is exchange not considered NW-HIN and, therefore, not subject to NW-HIN governance? • When not asserted to be NW-HIN compliant. • If there is only compliance with a portion of the applicable NW-HIN requirements (e.g. exchange complies with NW-HIN technical requirements, but not NW-HIN policies, or vice versa) Pre-decisional DRAFT.  For HITPC Consideration – 11/19/10 7

  8. Workgroup Consideration of NW-HIN for Governance (2) • Who is part of NW-HIN? • Any entity, large or small, or aggregation of entities, large or small, that engages in the exchange of health information, asserts itself as being NW-HIN compliant and is recognized to have met NW-HIN conditions of trust and interoperability (COTIs). • Why would entities want to be part of NW-HIN? • Entities will be more willing and able to exchange with unfamiliar partners who are recognized as meeting NW-HIN COTIs. • Provides a benchmark for entities who wish to qualify for Federal contracts, exchange with federal entities, and be eligible for other federally-supported incentives. • Entities may believe that they would be advantaged competitively in the marketplace if they meet widely recognized conditions of trust and interoperability. Pre-decisional DRAFT.  For HITPC Consideration – 11/19/10 8

  9. Key Findings Regarding Governance Roles: Public Hearing • Leverage and coordinate across existing federal authorities. • Provide strong federal leadership, engagement and participation. • Federal role needed to: • Set national-level policy and adopt interoperability standards only where critical to enable trust and interoperability for nationwide exchange. • Oversee and coordinate across a set of governance processes that, together, comprise NW-HIN governance. • Assure NW-HIN governance includes ability to evaluate, learn and adapt on an ongoing basis. Pre-decisional DRAFT.  For HITPC Consideration – 11/19/10

  10. Key Findings Regarding Governance Roles: Public Hearing (cont’d) • Recognize that there will likely be a variety of approaches and multiple levels of coordination, validation, and enforcement: • Different views expressed regarding need for national-level validation mechanisms, such as certification and accreditation. Some recommended it; others cautioned that it was premature to do this. • Need for national-level coordination across wide range of stakeholders to build consensus and inform development of NW-HIN requirements. • Recognition that enforcement occurs at various levels, through other federal authorities (e.g. FTC, OCR) states, local, and exchange partners, often through contractual mechanisms. Pre-decisional DRAFT.  For HITPC Consideration – 11/19/10

  11. PHASE 1 RECOMMENDATIONS Pre-decisional DRAFT.  For HITPC Consideration – 11/19/10

  12. Nine Sound Principles for NW-HIN Governance • Transparency and openness • Inclusive participation and adequate representation • Effectiveness and efficiency • Accountability • Federated governance and devolution • Clarity of mission and consistency of actions • Fairness and due process • Promote and support innovation • Evaluation, learning and continuous improvement Pre-decisional DRAFT.  For HITPC Consideration – 11/19/10

  13. General Recommendations (phase 1) ONC should establish a national framework for governance of the NW-HIN that reflects “governance of governances” based upon the nine sound governance principles. Governance of the NW-HIN should include a core set of functions, with national-level coordination and oversight across those functions. Governance of the NW-HIN should include opportunities for broad stakeholder input, including consumers, on the strategic direction for the NW-HIN. Pre-decisional DRAFT.  For HITPC Consideration – 11/19/10

  14. NW-HIN Governance Objectives and Functions • NW-HIN Governance Objectives: • Improve health while establishing trust. • Assure interoperability while protecting innovation. • NW-HIN Governance Functions: • Establish policies for privacy, security, interoperability and to promote adoption of the NW-HIN. • Establish technical requirements to assure policy and technical interoperability. • Establish appropriate mechanisms to assure compliance, accountability and enforcement. • Provide oversight of the governance mechanisms. Pre-decisional DRAFT.  For HITPC Consideration – 11/19/10

  15. PHASE 2 FINDINGS Pre-decisional DRAFT.  For HITPC Consideration – 11/19/10

  16. Assessment: Where to Leverage Existing Governance Mechanisms for the NW-HIN • Are there existing entities or processes performing a particular governance function? If so: • Does it accomplish the NW HIN governance objectives and principles? • Can it scale to meet NW-HIN needs? • Which essential functions or activities are not currently addressed, but are needed now to overcome barriers and to promote exchange through the NW-HIN? • Should the federal government perform that function directly or delegate it? • If delegated, to whom? • If a new entity is needed, what type of structure / attributes should it have? Pre-decisional DRAFT.  For HITPC Consideration – 11/19/10

  17. Key Findings Regarding Governance Roles: Public Comment • 234 Commenters: • Blog – 33 • E-mail – 201 • Need for public education and use of plain language • Commenters generally seemed unclear over the function and role of the NW-HIN. • More emphasis should be placed on safety. • Greatest concern was privacy and security of protected health information (PHI), and need for strong privacy and security protections, e.g. mechanisms for consent, control, authorization, and explicit policies for data reuse. • Public comments varied but mainly sought to leverage existing mechanisms where appropriate. Pre-decisional DRAFT.  For HITPC Consideration – 11/19/10

  18. Key Findings Regarding Governance Roles: Public Comment • Specific suggestions for: • State / federal partnership. • Public-private collaborative structure to act as a convener and support adoption of NW-HIN. • Need for national-level policies and standards, with input from HITPC. • National accreditation program for qualified entities. • Suggestions for leveraging existing governance structures: • For policies and practices: FCC, state regulatory frameworks, Exchange Coordinating Committee, Data Use and Reciprocal Support Agreement (DURSA). • For interoperability requirements: Standards Development Organizations (SDOs). • For validation: CCHIT, EHNAC, ONC-ATCB model. Pre-decisional DRAFT.  For HITPC Consideration – 11/19/10

  19. Ecosystem of NW-HIN Governance Functions Ecosystem of NW-HIN Governance Functions Establish technical requirements Develop NW-HIN policies and eligibility criteria • Governance Objectives: • Engender trust • Encourage interoperability • Foster innovation Oversee NW-HIN Governance Assure compliance, accountability, enforcement Pre-decisional DRAFT.  For HITPC Consideration – 11/19/10

  20. Ecosystem of NW-HIN Governance Functions Ecosystem of NW-HIN Governance Functions • Establish technical requirements • - Establish NW-HIN technical requirements that reflect policy and harmonized standards • Authorize shared technical resources • Manage transition for changes Develop NW-HIN policies and eligibility criteria - Identify and prioritize needs; address gaps; federal-level coordination - Establish NW-HIN policies, eligibility criteria • Provide support for implementation • - Identify and address issues related to implementation and validation • Facilitate and provide input across broad range of stakeholder communities • Governance Objectives: • Engender trust • Encourage interoperability • Foster innovation Oversee NW-HIN Governance - Address issues, disputes, redress, remedies, sanction and enforcement - Evaluate performance and risk and continuously improve - Monitor and communicate resolution of matters Assure compliance, accountability, enforcement - Verify compliance, identify and address non-compliance - Coordinate to align with NW-HIN requirements - Render compliance decision (e.g. authorize, deny or revoke) Pre-decisional DRAFT.  For HITPC Consideration – 11/19/10

  21. Existing Mechanisms for NW-HIN Governance and Identified Gaps Pre-decisional DRAFT.  For HITPC Consideration – 11/19/10 21

  22. PHASE 2 RECOMMENDATIONS Pre-decisional DRAFT.  For HITPC Consideration – 11/19/10

  23. Recommendations Topics General recommendations Roles and responsibilities Conditions of trust and interoperability (COTIs) Federal role (ONC and other federal agencies) Non-governmental role Validation role Relationships among roles Pre-decisional DRAFT.  For HITPC Consideration – 11/19/10

  24. General Recommendations (phase 2) In order for the NW-HIN to be successful, there must be strong federal leadership, support and engagement in the NW-HIN. Requirements for trust and interoperability are essential to the success of the NW-HIN. While the Federal government should establish the fundamental conditions to ensure the public good, other governance entities should have specific appropriate roles in providing input to their development, validating that entities have met them, and supporting their consistent implementation.   Certain aspects of governance, such as accountability, dispute resolution, enforcement, and oversight, should apply across the recommended NW-HIN governance roles in a manner appropriate to that role. Pre-decisional DRAFT.  For HITPC Consideration – 11/19/10

  25. Recommendations for NW-HIN Governance Roles and Responsibilities * The government should determine whether any factor should preclude an entity from eligibility, temporarily or permanently. Pre-decisional DRAFT.  For HITPC Consideration – 11/19/10

  26. Federal Role: Attributes Accountable for assuring public trust. Continuing focus on nationwide exchange. Ability to coordinate across the federal government. Authority and ability to assure that there is appropriate coordination across the various NW-HIN governance roles. Authority to oversee various governance entities that, together, govern NW-HIN efforts. Active leadership, engagement and participation in the NW-HIN. Pre-decisional DRAFT.  For HITPC Consideration – 11/19/10

  27. Non-Governmental Organization (NGO) Role: Attributes Sufficient authority for delegated responsibilities. Subject matter expertise to facilitate and address implementation-level issues related to NW-HIN. Meets requirements of OMB circular A-119 for Federal participation. Openness and transparency. Broad stakeholder community representation, including consumers. Effective facilitation, communication and decision-making processes. Balanced interests. Support quality improvement processes. Provisions for accountability. Results oriented. Pre-decisional DRAFT.  For HITPC Consideration – 11/19/10 27

  28. Validation Role: Attributes Sufficient authority for results to be binding (e.g. authorize, deny, revoke), subject to appeal mechanisms. Expertise in the domains that will be validated. Leverage, where appropriate, existing mechanisms. Allow for differing routes to validation based upon appropriate considerations (e.g. types of COTIs of nature of exchange or entity exchanging). Strong coordination with the federal and NGO roles. Objective, repeatable processes that are efficient, effective and able to scale on a national level. Appropriate management and operation of validation activities. Pre-decisional DRAFT.  For HITPC Consideration – 11/19/10

  29. Recommendations on NW-HIN Conditions of Trust and Interoperability (COTIs) • ONC, with advice from the FACAs and input from designated NGO entity(ies), should identify, prioritize and establish a set of policies, eligibility criteria and technical requirements for the NW-HIN (“NW-HIN conditions of trust and interoperability” (COTIs)). • There should be a set of universally required COTIs that apply across all NW-HIN scenarios, with focus on those elements critical to engender trust, promote interoperability, address barriers to nationwide exchange while remaining technology agnostic. • There may be COTIs that apply in particular circumstances (e.g. based upon particular functions). • There should be a mechanism to waive certain required COTIs if necessary to facilitate experimentation and innovation. • NW-HIN governance should recognize that additional requirements may be specified by particular NW-HIN entities or groups that may or may not be part of NW-HIN COTIs. Pre-decisional DRAFT.  For HITPC Consideration – 11/19/10

  30. Potential COTIs: Example Topics • Privacy • Fair information practices • Consent • Purposes for exchanging through NW-HIN, including secondary use, re-identification • Security • Encryption • Identity proofing • Authentication • Auditing • Participant access policies • Eligibility criteria • Qualifications to exchange through the NW-NHIN • Interoperability • Level of conformance • Policies to promote information sharing • Technical requirements • Secure transport • Data lookup and retrieval, • Notification of availability of new / updated data • Subject-data matching capabilities • Data content Pre-decisional DRAFT.  For HITPC Consideration – 11/19/10

  31. Federal Role: Recommendations • ONC specifically should: • Ensure coordination across federal activities and authorities and identify needs to strengthen them for effective NW-HIN governance. • Coordinate to establish incentives to vigorously promote use of the NW-HIN. • Establish NW-HIN COTIs. • Develop validation criteria to reflect the COTIs. • Provide sufficient authority to NW-HIN NGO entity(ies) to assure effective actions and oversee NGO entity. • Recognize overarching NW-HIN validation entity and oversee validation role. • Monitor and highlight innovation and address governance barriers to it. • Oversee the NW-HIN governance ecosystem. • Federal entities should be expected to meet NW-HIN COTIs as any other entity exchanging through the NW-HIN. • Enforcement mechanisms available under existing law and federal authorities should be leveraged as applicable to the NW-HIN. • Existing state authorities across all relevant domains should be recognized and needs for coordination and harmonization identified. Pre-decisional DRAFT.  For HITPC Consideration – 11/19/10

  32. Non-Governmental Organization Role: Recommendations • Non-governmental entity(ies) should be established or recognized, if existing, and provided the authority necessary to support the implementation of COTIs: • Identify implementation issues and make recommendations to the appropriate federal authority, e.g.: • Is implementation consistent with NW-HIN goals, governance principles, objectives, and NW-HIN COTIs with a deference to devolution? • Does implementation of COTIs negatively impact other NW-HIN entities/groups, impede competition or create barriers to exchange? • Coordinate broad stakeholder community engagement with outputs that carry a significant amount of weight with ONC and other authorities to inform identification, prioritization, development and maintenance of NW-HIN COTIs and NW-HIN policies. • Provide input to ONC and validation entity(ies) on performance of criteria and validation processes. Pre-decisional DRAFT.  For HITPC Consideration – 11/19/10 32

  33. Validation Role: General Recommendation • There should be recognized NW-HIN validation entity(ies) to verify that applicable NW-HIN conditions established by ONC are met. • Validation mechanisms should be sustainable and should aim to minimize burden on those validated. • Validation Responsibilities: • Apply established and applicable eligibility criteria to determine eligibility. • Verify that systems used to exchange through the NW-HIN meet NW-HIN COTIs, including technical requirements, with the type and level of testing to be determined by the governing authority. • Allow other equivalent certification and validation processes to satisfy NW-HIN validation (e.g. validation by NW-HIN group, EHR certification, state-HIE certification / accreditation programs, etc.) • Verify that practices are consistent with applicable NW-HIN policies. • Issue validation decision to approve, deny, revoke NW-HIN recognition, as authorized. • Investigate possible non-conformance with COTIs and take appropriate remedial action including revoking NW-HIN recognition when warranted, with provision for appeals. Pre-decisional DRAFT.  For HITPC Consideration – 11/19/10

  34. Validation Role: Specific Recommendation • There should be an overarching NW-HIN validation authority established or, if existing, granted the authority to facilitate NW-HIN validation: • Oversee validation process. • Determine whether there should be one or multiple validation bodies based upon identified needs, capacity and capability. • Accredit NW-HIN validation bodies like the approach used for meaningful use EHR certification and oversee their activities. • Establish equivalency criteria to recognize multiple pathways for validation of NW-HIN COTIs, as necessary and appropriate. For example: • Determine whether validation of a group satisfies validation for its affiliated members. • Determine whether a group has equivalent validation mechanisms that could be leveraged for NW-HIN validation. • Establish or recognize other non-accreditation approaches and monitor them to assure coordination and consistency with NW-HIN COTIs. Pre-decisional DRAFT.  For HITPC Consideration – 11/19/10 34

  35. NW-HIN Governance Role Interactions Pre-decisional DRAFT.  For HITPC Consideration – 11/19/10 35

  36. NW-HIN Governance NW-HIN Governance Pre-decisional DRAFT.  For HITPC Consideration – 11/19/10 36

  37. OPEN QUESTIONS AND CONSIDERATIONS Pre-decisional DRAFT.  For HITPC Consideration – 11/19/10

  38. NW-HIN Conditions of Trust and Interoperability: Open Questions • Given that ONC should determine the applicability of “universal” COTIs to specific exchange scenarios, to what extent should entities/groups be able to further specify NW-HIN COTIs, recognizing: • NW-HIN COTIs (or subsets) may apply differently depending upon function, e.g. access to sensitive data. • There will be a need to apply, adapt and implement NW-HIN COTIs for specific implementations. • Governance should provide the potential for innovation. • Should these added conditions be adopted as “NW-HIN”? • If so, a process should be established that entities/groups have to follow to identify more specific, legitimate requirements. • Regardless of whether officially considered NW-HIN or outside of NW-HIN, should these added conditions be subject to review or monitoring for potential impact to competition and impediments to exchange? • How does this work with the varying entities / groups (e.g. large or small) exchanging data? • Are there other unintended consequences if different conditions are permitted for different entities / groups? Pre-decisional DRAFT.  For HITPC Consideration – 11/19/10

  39. NGO Role: Open Questions • Should there be one or more NW-HIN NGOs? • Based upon whether there would be clear boundaries and sufficient segregation of duties between multiple entities. • Based upon areas of expertise. • Further clarification of the functions that need to be performed. Pre-decisional DRAFT.  For HITPC Consideration – 11/19/10 39

  40. Considerations about Validation Desired level of assurance, based on risks and barriers to exchange Certification / Accreditation Contracts Self Attestation Voluntary, with audit or complaint-based Entirely voluntary, no audit or compliance Strength of validation There are a range of validation methods with varying degrees of certainty that COTIs are met. There may be cost considerations as degree of validation increases. Pre-decisional DRAFT.  For HITPC Consideration – 11/19/10

  41. Validation Role: Open Questions • Who is being validated? • Entities large and small: is any further description / categorization needed? • How to implement validation to promote trust and interoperability while avoiding burdens that might discourage some entities or prove too costly in resource constrained environment? • Who should pay for cost of developing and maintaining validation mechanisms (e.g. federal government, exchange entities, etc.)? Pre-decisional DRAFT.  For HITPC Consideration – 11/19/10 41

  42. Discussion 42 Pre-decisional DRAFT.  For HITPC Consideration – 11/19/10

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