Governance Workgroup

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HIT Policy Committee

• Governance Workgroup
• Recommendations on Scope of Nationwide Health
  Information Network Governance Functions
• John Lumpkin, MD, MPH, Chair
• Robert Wood Johnson Foundation
• October 20, 2010

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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 OReilly OReilly Media
• Wes Rishel Gartner

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Discussion Topics

• Workgroup charge
• Framing for nationwide health information network
  governance
• Findings from hearing and analysis
• Preliminary recommendations

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Why Address Governance Now?

• HITECH requires it.
• Governance is essential to make decisions needed
  to accomplish national HIT agenda and HITECH
  goals.
• Necessary for the existing limited production
  exchange (Exchange) to expand and grow beyond
  those entities under federal contract, grant or
  cooperative agreement.
• Necessary in order to validate and assure that
  conditions for trust and nationwide
  interoperability exist.
• States are establishing governance roles (e.g.
  for certification of HISPs) in the absence of
  national governance.
• Necessary for transparent oversight, enforcement
  and accountability.

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Governance Workgroup Charge

• CHARGE To draft a set of recommendations on the
  scope and process of governance for nationwide
  health information network, including measures
  to assure accountability and oversight.
• Must engender trust in the nationwide health
  information network (NW-HIN) and
• Promote and facilitate broader participation in
  nationwide health information network exchange
  (exchange).
• Key Questions
• What needs to be governed in a centralized
  fashion?
• When should there be coordination by the federal
  government (e.g. across governance roles, for
  certain functions, services, etc.)?
• The nationwide health information network is in
  the process of being renamed.

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Workgroup Focus
Priority Focus Not a Priority Focus
Determining the processes and structures to ensure trusted health information exchange Determining the specific standards, services or policies
Examining aspects of governance within ONCs authority or control (e.g. establishing a preferred option for HIE) Examining aspects of governance outside of ONCs authority or control, unless a critical dependency
Identifying any mandatory and optional requirements for the preferred approach for health information exchange Mandating requirements for those who do not elect to participate in the preferred approach for HIE
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Governance Workgroup Timeline
Small group evaluates options regarding how and
who should govern
9/28 10/5 10/12 10/18 10/25 11/1 11/8 11/15
10/20Present prelim recs to HITPC (what)
9/28 Governance Hearing
11/12 WG - finalize recs
11/19 - Present final recs (how and who) to
HITPC
11/5 - WG - discuss draft recs
Preliminary Recommendations regarding what
governance should cover Recommendations
regarding how and who should govern
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Nationwide Health Information Network (NW-HIN)
Current Definition

• Standards, services and policies for promoting
  and facilitating secure exchange of health
  information on the internet to improve health and
  health care
• Not a centralized database or single physical
  network.
• Is being put forward potentially as a preferred
  option for trusted and interoperable exchange of
  health information, where various levers could be
  employed to encourage its use.
• Entities that wish to exchange information
  through the NW-HIN would need to demonstrate
  compliance with a set of requirements as a
  pre-condition to using the NW-HIN.
• Includes a set of core functionality for data
  transmission, registries and privacy and
  security.
• Not inclusive of all health information exchange
  (HIE).

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Workgroup Guidance

• Recognize and leverage existing governance
  mechanisms where feasible for the NW-HIN.
• Identify and bridge gaps in existing governance
  mechanisms for the NW-HIN.
• Identify those aspects of NW-HIN governance
  (existing and new) where national-level
  coordination could enhance and/or promote greater
  trust and interoperability, and suggest
  approaches for appropriate coordination.
• Assure maximum flexibility for evolution and
  innovation avoid rigid rulemaking.
• Address barriers and promote exchange of health
  information through the NW-HIN

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FINDINGS
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Governance Hearing Key Themes

• Consumer privacy protections are inherent
  components of governance.
• The federal government plays an important role in
  overall coordination.
• Governance should be parsimonious and adaptable
  to future, unknown needs.
• There is a need for harmonization of policies to
  enable exchange of health information.
• Common standards are needed to ensure
  interoperability and establish trust and security
  of the information.
• Validation mechanisms are needed to ensure
  adherence/compliance with established standards.
• Compliance and enforcement mechanisms are
  essential components of a governance framework.

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NW-HIN Overarching Governance Objectives

• Improve health while establishing trust
• Assure interoperability while protecting
  innovation

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Governance Gap Analysis Findings

• Governance in health information technology is
  widely distributed, including policy development
  and the formulation of trust frameworks.
• Enforcement regimes and accountability mechanisms
  are also distributed but are sometimes lacking.
• In the Federal HIT space, various agencies
  jurisdiction, appear to overlap, potentially
  creating confusion and reducing effectiveness.
• ONC is a critical intermediary given its
  Congressional mandate to coordinate policy making
  and standards setting for health information
  technology.
• Private-sector participation in policy making
  takes place through consultations, Federal
  Advisory Committee, Congressional hearings and
  communications efforts.
• It is unclear whether there are other sufficient
  institutionalized ways for broader scale and
  meaningful public engagement, especially by
  consumers.

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RECOMMENDATIONS
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Nine Sound Principles for NW-HIN Governance

1. Transparency and openness
2. Inclusive participation and adequate
   representation
3. Effectiveness and efficiency
4. Accountability
5. Federated governance and devolution
6. Clarity of mission and consistency of actions
7. Fairness and due process
8. Promote and support innovation
9. Evaluation, learning and continuous improvement

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General Recommendation

• 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.

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Four Core NW-HIN Governance Functions

• The recommended core functions identify the types
  of governance decisions that need to be addressed
  for the NW-HIN
• 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

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1. Establish policies and practices for NW-HIN

• There should be a uniform set of NW-HIN policies
  and practices that are followed as a condition of
  exchanging health information through the NW-HIN
  and that should be reflected in technical design.
• Privacy, security, interoperability, eligibility
  criteria, compliance expectations and
  jurisdiction.
• There should be mechanisms to
• Address gaps in policies and practices
• Coordinate to assure policies and technical
  requirements are consistent.
• Necessary to assure that sufficient privacy
  protections and safeguards are in place to
  facilitate and promote nationwide exchange,
  interoperability and to remove barriers to
  nationwide exchange of health information

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2. Establish technical requirements

• Adopt technical requirements for the NW-HIN
  through a recognized process that coordinates and
  harmonizes standards and that provides for
  stakeholder input, including consumers.
• There should be mechanisms to address
• Transition processes as technical requirements
  change.
• Authorization of technical resources for use in
  NW-HIN (e.g. provider directories, certificate
  authority, registries.)
• Necessary to assure that technical requirements
  are established to accomplish interoperability
  and policy objectives for trust, including a
  defined security level of assurance.

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3. Compliance, accountability and enforcement

• Assure that eligibility criteria are satisfied
  and that compliance with conditions for trust and
  interoperability are met, as well as clear
  accountability and appropriate enforcement.
• Establish and conduct validation to determine
  eligibility and verify compliance with policy and
  technical requirements as a condition of
  exchanging information through the NW-HIN.
• Determine consequences of non-compliance with
  policies, practices and technical requirements.
• Provide a mechanism to address disputes, concerns
  or complaints, taking into account measures
  provided for under existing law.
• Determine how mechanisms for redress, remedies
  and sanctions would be applied.
• Consider need for coordinated investigation,
  enforcement and breach notification.

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4. Oversight of the Governance Mechanisms

• Oversight is necessary to assure governance
  objectives are met and are effective and able to
  adapt over time.
• Track or measure certain issues or activities in
  support of overseeing the effectiveness and
  efficiency of NW-HIN governance.
• Oversee ongoing compliance.
• Conduct ongoing assessments of risks and benefits
  for the NW-HIN governance, including prevention
  of harm.
• Periodically evaluate the performance of the
  overall governance mechanisms and incorporate the
  findings into continuous improvement.
• Resolve disputes regarding decision rights among
  federated governance functions.

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Next Steps

• Consider input from HIT Policy Committee
  regarding preliminary scope recommendations.
• Beginning work to explore who would govern and
  how the governance functions would be addressed.
• Based upon principles of devolution and
  representation, are there currently entities or
  processes governing the identified function?
• Are the goals of NW-HIN governance being met?
• Do the mechanisms operate within the sound
  principles for NW-HIN governance?
• Are the mechanisms scalable for the NW-HIN?
• Is this a role ONC should play or is it best
  delegated? If best delegated, then to whom and
  under what structure?

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Discussion
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