North Carolina Health Information Exchange Governance Workgroup Date: March 31, 2011 Time: 2:00 pm – 4:00 pm Location: NC Respiratory Care 1100 Navaho Drive, Suite 242, Raleigh, NC Dial in: ; Participant Code: #

2 Agenda TopicLeadsTime Welcome Roll call Review progress to date and today’s objectives Co-Chairs2:00 – 2:10 Development of Recommendations Related to Qualified Organizations (QOs) Selection Criteria Co-Chairs & Manatt 2:10 – 3:45 Next StepsCo-Chairs & Manatt 3:45 – 3:50 Public CommentN/A3:50 – 4:00

3 Statewide HIE Governance...Primary Tasks 1. Who Will Participate in Statewide HIEStatus 1. Participation Model Board determined participation to be voluntary Board determined that participation would be through “Qualified Organizations” 2. Definition of Qualified Organization Board approved definition of a Qualified Organization Board approved principles for Qualified Organizations 3. Candidates for Qualified Organizations Workgroup and Board identified candidate types of organizations 4. Criteria for Qualified Organizations  To be developed 2. Rules and Policies for ParticipationStatus 1. Participation Mechanism Board determined that Qualified Organizations must sign a participation agreement with NC HIE 2. Terms and Conditions  To be developed and informed by Governance, Legal/Policy and Clinical/Technical Operations Workgroups 3. Enforcement and OversightStatus 1. Enforcement Approach Board determined that there will be a process and policies established for ongoing oversight 2. Enforcement and Oversight Roles and Responsibilities  To be developed 3. Enforcement and Oversight Mechanisms  To be developed

4 Statewide HIE Governance...Today’s Objectives Continue Process of Developing Recommendations for QO Approach  Selection Criteria (today’s primary focus)  Review draft criteria recommendations made by Workgroup at last meeting  Continue development of recommendations for remaining selection criteria  Process for Selecting  Oversight and Enforcement of Obligations

5 Criteria for Qualified Organizations

6 Proposed Selection Criteria for Qualified Organizations (STRAWMAN – FOR DISCUSSION ONLY) 1.Organized as a non-profit or for-profit corporation with a certificate of good standing. 2.Agree to comply with Statewide Policy Guidance (including technical specifications and privacy and security requirements) and ensure QO participants comply with them. 3.Agree to comply with “fair information” policy principles and require that QO participants comply with them. 4.Provide list of current participants and plan for adding more participants. 5.Submit a Program Plan that describes specific activities in which the QO will engage (e.g., provider outreach, managing agreements with participants). 6.Obtain the required insurance in amounts specified by the NC HIE Board. 7.Submit financial statement showing minimum net worth of amount determined by NC HIE. Important Topics to Consider in Selection of Criteria  Extent to which criteria limit entities that could serve as QOs  Establishing and maintaining overall system efficiency  Understanding the administrative implications of compliance Important Topics to Consider in Selection of Criteria  Extent to which criteria limit entities that could serve as QOs  Establishing and maintaining overall system efficiency  Understanding the administrative implications of compliance

7 Draft QO Criteria Recommendations from Workgroup’s March 3 Meeting

8 1. QO is organized as a non-profit or for-profit corporation with a certificate of good standing Implementation Considerations QO applicants would submit articles of incorporation and certificates. Workgroup Recommendation: QO participation should be open to both non-profit and for-profit entities and selection criteria should not limit the types of organizations that can be a QO. –The definition of QOs and related criteria – at least at this phase – should reflect that the main focus of QOs is to be an organizer/ aggregator of providers for the purposes of connecting them to the statewide network. Work Group Preliminary Recommendation AcceptRejectFurther Development Required X

9 2. Compliance with Statewide Policy Guidance (including tech specifications and privacy & security requirements) and ensure QO participants’ compliance Implementation Considerations Criterion is consistent with NC HIE principle that “Qualified Organizations will have a participation agreement/contract with the Statewide HIE, binding participants to compliance with the Statewide HIE’s policy guidance and rules...” QO applicant will need to conduct a test that demonstrates the entities capabilities to access and consume statewide HIE services in accordance with agreed upon technical specifications. Workgroup Recommendation QOs should be required to comply with Statewide Policy Guidance (including technical specifications and privacy & security requirements) as well as ensure the compliance of QO participants with whom they have contracts. Work Group Preliminary Recommendation AcceptRejectFurther Development Required X

10 3. Agree to comply with “fair information” policy principles and require that QO participants comply with them Implementation Considerations NC HIE will need to define “fair information” policy principles. Workgroup Recommendation: QOs should be required to comply with fair information policy principles as well as ensure the compliance of QO participants with whom they have contracts; however, principles must be refined and carefully crafted so that they explicitly state related obligations. Work Group Preliminary Recommendation AcceptRejectFurther Development Required XX

11 Additional Proposed Criteria for Discussion

12 4. Provide list of current participants and plan for adding more participants Implementation Considerations NC HIE will need to define the information that QOs will be required to collect from their participants. NC HIE will need to define the periodicity of the updating the list of participants (i.e., will participation lists be updated periodically or immediately upon the addition or removal of participants?) Additional Issues/Questions What constitutes participation? Is it access to the QOs services or actual use? What level of rigor will be applied to measuring the credibility of plans for adding more participants? Should there be a minimum threshold for number of QO participants? Should there be prescribed limits on the rates charged to QO participants? Work Group Preliminary Recommendation AcceptRejectFurther Development Required

13 5. Submit a Program Plan that describes specific activities in which the QO will engage Implementation Considerations Potential activities that QOs could be required to address include: 1.Marketing the HIE and recruiting participants 2.Enrolling and billing participants for QO and HIE services 3.Collecting and maintaining agreements with their participants 4.Maintaining a help desk to field participant questions 5.Creating and maintaining fair grievance process 6.Allocate resources for participation in state-wide HIE collaborative process Additional Issues/Questions Should the Program Plan contain a mission statement which defines its goals/objectives with regard to information sharing in the state of North Carolina? How frequently will a QO’s Program Plan be assessed? Work Group Preliminary Recommendation AcceptRejectFurther Development Required

14 6. Obtain insurance in amounts specified by the NC HIE Board Implementation Considerations Insurance products could include: –Directors and officers insurance –Cyber-liability insurance Additional Issues/Questions TBD Work Group Preliminary Recommendation AcceptRejectFurther Development Required

15 7. Submit financial statement showing minimum net worth Implementation Considerations Establishing a reasonable threshold will be essential to ensure that this criterion isn’t overly restrictive. Additional Issues/Questions Are there QO candidates that wouldn’t disclose their financial statements? Work Group Preliminary Recommendation AcceptRejectFurther Development Required

16 Next Steps

17 Governance Workgroup – Next Steps Finalize Qualified Organization selection criteria recommendations for Board Develop recommendations related to selection process. High level overview of steps might include: –NC HIE establishes application process for interested entities. –NC HIE establishes application review process. –Those entities that meet the selection criteria are provisionally qualified for specified period of time. –Board may change/strengthen criteria based on initial implementation experience. –NC HIE establishes ongoing re-qualification process. Develop recommendations related to enforcement and oversight: –Define Metrics –Create evaluation process (ongoing compliance) –Establish processes for Dispute resolution Organizations seeking to voluntarily rescind QO status Expulsion of non-compliant QOs

18 NC HIE Workgroups...Working Timelines JanFebMarAprMayJunJul Develop Qualified Org Criteria Qualified Organizations Participation Agreements Develop Participation Agreement Tasks Legal/Policy Workstream Finalize draft legislation 2011 Enforcement and Oversight Define Oversight Roles and Enforcement Mechanisms Develop RFPReview, Negotiate, Award Core Services Deploy Services Develop Privacy and Security Policy and Procedures

19 Public Comment

20 Attachments

21 Principles to Guide Development of Qualified Organizations 1.Workgroup recommends a Qualified Organization approach to participation in the NC statewide HIE. 2.The NCHIE should establish an application process for organizations that wish to participate as a Qualified Organizations. The Statewide HIE will need to verify Qualified Organizations (through a structured review or accreditation process). 3.Qualified Organizations will have a participation agreement/contract with the Statewide HIE, binding participants to compliance with the Statewide HIE’s policy guidance and rules and there will also be policies and processes in place to identify “bad actors” and terminate their participation. Accountability and enforcement of policies must be central in implementing this model. 4.Accepted Qualified Organizations would be able to connect to the Statewide HIE to access core and value-added services. The following principles were developed by the Work Group and endorsed by the NC HIE Board at its July 2010 meeting to guide the development of Qualified Organizations:

22 5.Participation in the Statewide HIE will be voluntary. If an organization elects to withdraw its participation, they will be subject to reasonable withdrawal rules and processes. 6.Statewide policy would include application process, privacy and security rules, technical rules, financial rules, vendor contract requirements, ongoing governance structure and participation and enforcement mechanisms. 7.The Statewide HIE should have a commitment to a principle of “ No Provider Left Behind ” and provide reasonable alternate pathways for eligible providers that are not part of a Qualified Organization to be able to participate. 8.The Workgroup recommends that the Clinical/Technical Operations and Finance Workgroups explore including an internet-based connection portal that clinicians could access in cases where participating through another Qualified Organization is not a possibility and suggested that the NCHIE should consider partnering with the Regional Extension Center for identification and outreach of those providers. Principles to Guide Development of Qualified Organizations

23 Qualified Organizations Business, Technical & Legal Relationships

24 Statewide HIE Components North Carolina Health Information Exchange (NC HIE) –NC HIE is North Carolina’s public-private partnership that supports an open and transparent, statewide, collaborative process which creates statewide policy guidance (i.e., “rules of the road”) for the statewide HIE network –NC HIE provides core technology services and selected “value-added” services accessible via the statewide HIE network. State of North Carolina –The State of North Carolina, working through the NC State HIT Coordinator and its various Departments, (1) identifies and protects the public interest through its regulatory roles, (2) collects, stores, and provides access to health information in support of its various missions, such as Medicaid and public health, and (3) supports efforts to obtain public funds for HIE. NC HIE Policy Guidance –Statewide Policy Guidance, developed by the NC HIE through the Workgroup process and with Board approval, provides a common and consistent technical, privacy, security, and legal framework for participants in HIE and ensures the secure, interoperable exchange of data through the statewide network. –Statewide Policy Guidance typically includes: (1) detailed rules for privacy and security, technical interoperability, and financial obligations; (2) vendor contract requirements; (3) ongoing governance structure and participation; and (4) enforcement mechanisms.

25 Qualified Organization (QO)* –QOs are entities that have permission to access, consume and make available HIE services on the statewide HIE network. –QOs meet a set of established criteria, have gone through an approval process, and have signed agreements to abide by Statewide Policy Guidance. –QOs ensure that participants and vendors with which they have contracts meet the requirements to carry out statewide policies. Qualified Organization Participant –A provider or entity that participates in the statewide network through a QO. Statewide HIE Components (continued) *Note: As the Work Group develops criteria and requirements for QOs, it will be important to consider access to the statewide HIE network through means other than Qualified Organizations.

26 Core HIE Services –Foundational services hosted by NC HIE that facilitate exchange health information across organizational boundaries, such that multiple entities can: Identify and locate each other in a manner they both trust; Reconcile the identity of the individual patient to whom the information pertains; Exchange information in a secure manner Statewide HIE Components (continued) Provider Directory Message / Record Routing / Return Receipt Identity Management and Authentication NHIN Gateway Security Services Transaction LoggingConsent Management Terminology ServiceTransformation Service Patient Matching / RLS Immuniz Access Lab Normalization Med Hx Lab Results Delivery Rad Results Delivery CCD Exchange Lab routing for reporting Quality Reporting Procedure Results Delivery Rad Image Delivery CCD Translation Access to Aggregated Data Clinical Decision Support Disease Surveillance Value-Added HIE Services –Services that support the clinical priorities and use cases to help providers, patients, and care givers improve the safety, quality, and cost effectiveness of heath care. –Value-added services will be accessible via core services –Value-added Services can be offered at the state, regional, or enterprise level. –Value-Added services will be incrementally deployed based on feasibility, cost, and magnitude of benefits Phase 1 Value Added Services proposed in Operational Plan Phase 2 Value-Added Services proposed in Operational Plan Final decision regarding phased implementation will be informed by forthcoming statewide HIE RFP

27 Technical Relationships: Core HIE Services, QOs, & QO Participants Provider Directory Message / Record Routing / Return Receipt Identity Management and Authentication NHIN Gateway Security ServicesTransaction Logging Consent ManagementTerminology ServiceTransformation ServicePatient Matching / RLS Large Hospital System Physician Practice Physicians (IPA, PHO, PO) Regional HIO Hospital Physician Practice Example QOs... Example QO Participants... Key Points: *Core services provide a foundation for identifying QOs, ensuring security, and providing a gateway to other QOs and additional HIE services *QOs link to core services by conformance to interoperability specifications *QOs provide a gateway to core services for their participants Key Points: *Core services provide a foundation for identifying QOs, ensuring security, and providing a gateway to other QOs and additional HIE services *QOs link to core services by conformance to interoperability specifications *QOs provide a gateway to core services for their participants NC HIE

28 Provider Directory Message / Record Routing / Return Receipt Identity Management and Authentication NHIN Gateway Security ServicesTransaction Logging Consent ManagementTerminology ServiceTransformation ServicePatient Matching / RLS Large Hospital System Physician Practice Physicians (IPA, PHO, PO) Hospital Physician Practice Technical Relationships: Value-added Services, QOs, & QO Participants Large Hospital System Physician Practice NC Immunization Registry 3. CCD Translation Key Points: *Value-added Services are available to network participants and can be hosted by different entities. For example: 1.NC HIE could host a CCD Exchange service 2.The Dept of Health could host an Immunization Access service 3.A QO could host a CCD Translation service *Based on considerations of efficiency and practicality, the NC HIE Tech/Clinical Ops Work Group continues to evaluate the ideal location for Value-added Services Key Points: *Value-added Services are available to network participants and can be hosted by different entities. For example: 1.NC HIE could host a CCD Exchange service 2.The Dept of Health could host an Immunization Access service 3.A QO could host a CCD Translation service *Based on considerations of efficiency and practicality, the NC HIE Tech/Clinical Ops Work Group continues to evaluate the ideal location for Value-added Services NC HIE 1. CCD Exchange 2. Immuniz Access Regional HIO

29 Policy/Contractual Relationships: Interconnecting Participants State of North Carolina Provides Input Manages Work Groups Statewide Policy Guidance* * Statewide Policy Guidance will be approved by NC HIE Board Governance Clinical/Tech Ops Finance Legal/Policy NC HIE Qualified Organization QO Participant HIE Vendor EHR Vendor Provides access to data Contract for access to HIE services Contracts for Technical services Abide Statewide Policy Guidance Contract for technical services Output Abide Statewide Policy Guidance HIE Vendor Contract for technical services Abide Statewide Policy Guidance Contracts for access to HIE services, with reciprocating agreement to abide by Statewide Policy Guidance

30 Approaches to Qualified Organization Criteria Mandatory –One set of mandatory criteria for all QOs –State example: Maryland Establishment of “Optional” Criteria –One set of mandatory criteria that all QOs (or categories of QOs) must meet; additional “optional” criteria –State example: Tennessee Creation of an Exceptions Process –One set of mandatory criteria for all QOs, ability to appeal for exceptions on a case- by-case basis or by stakeholder category –State example: Tennessee Tiering of Qualified Organizations –Data sharing partners are grouped by size, service level, and organization type, among other factors. Different criteria are applied to each group (or tier). For instance, small provider groups may be required to meet different criteria than large IDNs. –State example: Oregon