Governance Workgroup Recommendations on Scope of Nationwide Health Information Network Governance Functions John Lumpkin, MD, MPH, Chair Robert Wood Johnson Foundation October 20, 2010 HIT Policy Committee 1

Workgroup Members Members: Laura AdamsRhode Island Quality Institute Christine BechtelNational Partnership for Women & Families Neil CalmanInstitute for Family Health Carol DiamondMarkle Foundation Linda FischettiDepartment of Veterans Affairs John GlaserSiemens Leslie HarrisCenter for Democracy & Technology John HoustonUniversity of Pittsburgh; NCVHS Michael MatthewsMedVA John MattisonKaiser Permanente Girish Kumar NavanieClinicalWorks Tim O’ReillyO’Reilly Media Wes RishelGartner Chair: John Lumpkin, Robert Wood Johnson Foundation 2

Discussion Topics Workgroup charge Framing for nationwide health information network governance Findings from hearing and analysis Preliminary recommendations 3

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. 4

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. 5

Workgroup Focus Priority FocusNot 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 ONC’s authority or control (e.g. establishing a preferred option for HIE) Examining aspects of governance outside of ONC’s 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 6

11/12 – WG - finalize recs Governance Workgroup Timeline 9/2810/510/12 10/18 10/2511/111/811/15 11/5 - WG - discuss draft recs 10/20–Present prelim recs to HITPC (“what”) Preliminary Recommendations regarding “what” governance should cover Recommendations regarding “how” and “who” should govern 11/19 - Present final recs (“how” and “who”) to HITPC Small group evaluates options regarding “how” and “who” should govern 9/28 – Governance Hearing 7

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). 8

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 9

FINDINGS 10

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. 11

NW-HIN Overarching Governance Objectives Improve health while establishing trust Assure interoperability while protecting innovation 12

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. 13

RECOMMENDATIONS 14

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 15

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. 16

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: 1.Establish policies for privacy, security, interoperability and to promote adoption of the NW-HIN. 2.Establish technical requirements to assure policy and technical interoperability. 3.Establish appropriate mechanisms to assure compliance, accountability and enforcement 4.Provide oversight of the governance mechanisms 17

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 18

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. 19

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. 20

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. 21

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? 22

Discussion 23