Draft QHIN Onboarding & Designation SOP Version 2.0
and Draft QHIN Application Version 2.0 Feedback

Communication of Onboarding & Designation Status by Applicant

The SOP describes that “[b]y submitting an intent to apply for QHIN Designation, the applicant agrees that it will only communicate its status at any point during this Onboarding & Designation process in accordance with the RCE’s Communications Protocols, available at https://rce.sequoiaproject.org/tefca-andrce-resources/.”

We support the information being made available via the website. However, we also support transparent communication materials being made available for interested TEFCA Participants and others (e.g., individual consumers, those who are not or who may become QHIN Applicants). To enhance awareness of the processes, we believe more can be done for consumer-facing Frequently Asked Questions (FAQs) and similar materials being made available via a website.

Procedure

“In Section 1, “Eligibility Requirements,” it states that a signatory must demonstrate that it meets the definition of a U.S. Entity and is not owned or controlled by any non-U.S. person(s) or entity(-ies).” Our reading of this section and previously-released materials is that the QHIN SOPs require domicile of the QHIN entity in the U.S., but there is not much specificity available for the actual exchange operations that may be carried on outside of the U.S. or managed by an offshore vendor (e.g., page 12 speaks to vendors but is quiet to offshore access or operations). We request clarification on this point.

The SOP goes on to explain that the Signatory must demonstrate that it has the ability to perform all of the required functions of a QHIN as required by the Common Agreement, the SOPs, the QTF, and all other applicable guidance from the RCE, with an ability to perform a least 1 million transactions per day. We understand the rationale for this policy, but we remain concerned that it may limit new entries and innovative approaches. An alternative solution could be developed to enable innovative QHINs. We encourage the RCE to do more outreach and to solicit ideas on this option.

In the “Testing” section, it explains comprehensive technical information, which can be difficult for non-technical professionals to understand. Due to the short turn-around time for comments during the holiday period, we request an additional 30 days to submit supplemental comments on this section before the SOP is made final.

Additionally, our reading of this section is that all QHINs must complete testing with a Production Validation Partner and a QHIN must coordinate data with its Production Validation Partner so that connectivity can be confirmed for all required transactions. However, the time period for these activities is unclear (i.e., completed within 30 calendar days) and we request more fulsome explanations for the process in this section. Will re-testing be required, and if so, in what context and timeframes? If an entity is unable to complete testing in a specific timeframe, please provide guidance for the options for QHINs and other interested Participants and Subparticipants. We also recommend that testing section discuss the use of FHIR standards.”

Additional Comments and Considerations

“Nothing in the SOPs or the Application appears to address the validation requirements for the endpoints of Participants or Subparticipants. We recognize that the networks are not currently FHIR-enabled. It is key for payers and other entities to understand these mechanics (i.e., how identities are validated, audited, maintained, etc.). We request clarification of when FHIR will be built into the SOP.

We also offer these additional questions for clarification:

• If a plan is currently participating in multiple HIEs, how does this transition if those HIEs apply to become QHIN’s?
• If HIE’s do not have any current or future planned capabilities to move to FHIR, how does this meet the FHIR roadmap for TEFCA? Payers may have FHIR capabilities and could not need an HIE to connect to providers, as long as provider directories are complete.
• Will each local QHIN set the exchange rates for exchanging QHIN to QHIN? How does each Participant understand this cost information?”

Procedure

“Eligibility Requirements (Procedure, Section 1)
The eHealth Exchange is surprised by this proposed change since it introduces a new legal entity into the mix. We can appreciate the need for flexibility, but we are concerned that this proposed change could create uncertainty into the trust framework. We are assuming that the “parent” Health Information Network (“Parent HIN”) will not have signed the Common Agreement based on the proposed revisions to the SOP. This means that the Parent HIN will not be legally bound to comply with the terms of the Common Agreement, the SOPs, the QTF and other TEFCA requirements. If a QHIN relies upon its parent organization to provide the HIN for the QHIN, the eHealth Exchange recommends that the QHIN be required to demonstrate that it has documentation that requires the Parent HIN to comply with Common Agreement, the QTF and the SOPs just like the QHIN.

Experience supporting query transactions (Procedure, Section 1, Eligibility Requirements, sub-section 3(b) – No comment

Governing Body
The eHealth Exchange has already submitted its QHIN Application and has provided documentation about how Designated Network Governing Body will operate. We assume that we do not have to supplement our application unless we receive specific questions from the RCE asking for specific information .

Quorum requirements (Procedure, Section 1, Eligibility Requirements, sub-section 4(f))
WE ARE ALREADY RESPONDING TO A QUESTION FROM THE RCE ABOUT THE DNGB COMPOSITION AND QUROUM, SO NO COMMENT IS NEEDED.

Final decision-making authority (Procedure, Section 1, Eligibility Requirements, sub-section 4(g)) and QHIN financial/personnel resources (Procedure, Section 1, Eligibility Requirements, sub-section 4(i)) – No comment

Participation in other networks (Procedure, Section 1, Eligibility Requirements, sub-section 4(k)) – no comment, however we have some questions.

• Will the RCE share this information with all other QHINs?
• Will the RCE use this information to consider suspending or terminating the QHIN that has been suspended or terminated from another network?
• Will the governing body be involved in evaluating this information?”

Part IV – Organizational Infrastructure and Legal Authority

“Revised Question 26 requests a description of the process used for resolving disputes: 1) among Participants and Subparticipants in the Designated Network; (2) between a Participant or Subparticipant and Signatory; and (3) between Signatory and another QHIN, and to explain the role of the Designated Network’s Governance Body in each. Correspondingly, revised section I.4(g)(ii) of the Onboarding and Designation SOP requires the same.

We recommend revising Question 26 to read:
Please provide a description of (i) the process for resolving the following types of disputes: (1) among Participants and Subparticipants in the Designated Network (the “Dispute Resolution Process”); and (ii) how the role of the Designated Network Governance Body meets the participation requirements in Part 4, Section I.4(g)(ii) of the Onboarding and Designation SOP. Please provide documentation of the Dispute Resolution Process. If you do not have such documentation, then in your project plan (Part VI of this application), you must explain the steps you are taking to create such documentation for implementation and operationalization and the timelines for doing so within twelve (12) calendar months of application acceptance.

We agree that it is reasonable to expect prospective QHINs to describe the process used for resolving disputes amongst Participants and Subparticipants of the Designated Network and the role of the Designated Network’s Governance Body in resolving such disputes. A core tenet of establishing a trust framework for interoperability is having an impartial method of resolving disputes between co-equal exchange partners in the framework.

We recommend removing the requirement to provide a description of the process for resolving disputes between a Participant and Signatory and the corresponding explanation of how the Designated Network’s Governance Body would be involved in resolving such a dispute. Prospective Participants of TEFCA are free to choose to connect via any QHIN they believe would meet their connectivity needs. Upon selecting a QHIN, the prospective Participant would be required to enter a contractual relationship between it and the selected QHIN. The contract would need to include the Required Flow Downs of the Common Agreement. In practice, such contracts would also include standard terms related to administration of the contract, including termination of the relationship, and addressing failures of a party to meet its obligations.

If a Participant believed that its QHIN was failing to meet its contractual obligations to provide connectivity services, it should be empowered to resolve that matter independently through procedures defined by its contract with the QHIN or through the legal system (e.g., to seek injunctive relief). Participants and QHINs should not be required to involve the Designated Network’s Governance Body to resolve private contractual matters—especially since the specific terms of the individual contract between a QHIN and the Participant may be confidential. Ultimately, if a Participant is dissatisfied with the services of its selected QHIN, it should be free terminate the relationship and select a new QHIN’s connectivity services without following a dispute resolution process involving its original QHIN’s Governance Body.

We also recommend removing the requirement to provide a description of the process for resolving disputes between Signatory and another QHIN. Such disputes would be adjudicated/resolved according to the TEFCA-level Dispute Resolution SOP. Any process maintained by a QHIN to resolve a dispute with another QHIN would necessarily be overridden by the requirements and process of that SOP, since it would need to be resolved through the independent process maintained by the RCE.”

Procedure

“Health Gorilla has feedback on a few elements within the Procedure section, in particular within Part 4, Section I.4.

Governance Functions:

We support the proposed approach to the Governance Functions and the separation of the operational processes for the Governance Functions, from the role of the Designated Network Governance Body. Changes to I.4a, I.4c, I.4e(v), and throughout I.4g all contribute to this beneficial shift. That said, we note that I.4d does not have corresponding updates, and still refers to the Designated Network Governance Body performing the Governance Functions. We encourage the RCE to make corresponding updates to I.4d.

Further, given the proposed shift in emphasis for the Designated Network Governance Body, we encourage the RCE to consider more significant modifications to I.4d, or even removing it entirely. If the RCE believes that I.4d in some form is still necessary, we suggest the following wording:
“”If the Signatory’s corporate organizational documents reserve for its corporate Board of Directors any authority that would conflict with or potentially override any proposed role of the Designated Network Governance Body in any of Signatory’s Governance Function processes, Signatory must submit, at the time of application, evidence that its Board of Directors has delegated the necessary authority to the Designated Network Governance Body.””

Third-Party Vendors:

We also support the proposed change in I.4h related to third party vendors, which provides welcome clarification as to specifically which third party vendors are relevant.

Dispute Resolution:

With respect to I.4g(ii)(a), we note that disputes between Signatory and another QHIN fall within the jurisdiction of the RCE’s own dispute resolution process, and do not need to be addressed by each Signatory’s dispute resolution process.

Audited Financials:

We support the RCE’s proposed updates with respect to the audited financials that applicants must submit. These updates provide welcome clarity and achieve a reasonable balance between the RCE’s duty to determine Common Agreement compliance, and the need to avoid imposing unnecessary burden on applicants.”

Part II – Organizational Requirements

“Health Gorilla has no concerns about the proposed changes to Part II.”

Part III – Exchange of Required Information and Ability to Perform Functions of a QHIN

“Health Gorilla has no concerns about the proposed changes to Part III.”

Part IV – Organizational Infrastructure and Legal Authority

“Health Gorilla has feedback on several questions within Part IV. We do not have any concerns or other feedback about proposed changes to any questions not specifically listed.

Question 19 – Please refer to our feedback on Part 4 Section I.4 of the QHIN Onboarding & Designation SOP, specifically with respect to Governance Functions and delegation of authority to the Designated Network Governance Body. We believe that if the current part I.4d in the SOP is removed, Question 19 could be simplified to read:
“”Please provide the Designated Network Governance Body charter or equivalent policy.””

If the RCE wishes to account for cases in which an applicant’s corporate organizational documents do, in fact, reserve relevant powers for its Board of Directors, Question 19 could be updated to include two parts.

• The first would be an assertion from the applicant as to whether there is any conflict between any authority reserved for the applicant’s Board, and the role proposed for the Designated Network Governance Body with respect to the Governance Functions.
• The second part would provide for the submission, if applicable based on the first part, of a relevant Board consent or equivalent document that delegated the necessary authority.

Question 22 – We support this proposed change, as it removes uncertainty for applicants as to what constitutes “”all supporting documentation””.

Question 26 – We appreciate the greater specificity in the proposed update to this question, but note that disputes “”between Signatory and another QHIN”” are within the purview of the RCE’s own Dispute Resolution Process and do not need to be addressed separately in each QHIN’s own dispute processes.

Question 31 – We believe that “”in connection with”” is an improvement over “”for””, but feel that the intent of this question could still be further clarified to assist applicants in answering it. We suggest that the RCE duplicate the proposed additional wording in the QHIN Onboarding & Designation SOP Procedure section, Part 4 Section I.4h, which clarifies that third party vendors with access to TI are relevant. While this may seem unnecessary given the proposed update to the SOP, we feel that the language is brief and straightforward, such that it can be added to the application as well.

Question 31 – We strongly support the RCE’s proposed updates with respect to clarifying the audited financials that must be submitted.”

Part V – QHIN Privacy and Security Requirements

“Health Gorilla has feedback on several questions within Part V. We do not have any concerns or other feedback about proposed changes to any questions not specifically listed.

Question 36 – We support this update and thank the RCE for its consideration of applicant feedback.

Questions 39, 40, & 42 – We support the additional specificity provided by the proposed updates.”

Part VII – Background References

Despite the fact that the introductory text for Part VII refers to three references, Health Gorilla believes it is still helpful for clarity to include the expected number of references within the text of Question 45, itself, to avoid confusion.

Communication of Onboarding & Designation Status by Applicant

No comments – Kaiser Permanente is in agreement.

Procedure

“Kaiser Permanente is in agreement with the Signatory having the capability to include the Parent Network information in several of the eligibility criteria, particularly so long as the Signatory remains in provisional status if it relied on the Parent Network to satisfy the Historic Experience requirement.

We mostly agree with the Dispute Resolution procedures defined in 4(g)(ii)(a-b), but emphasize that dispute resolution between QHINs should not be defined specifically by the QHINs themselves, but by the RCE in the Common Agreement.”

Part I – Basic Applicant Information

No comments – Kaiser Permanente is in agreement.

Part II – Organizational Requirements

No comments – Kaiser Permanente is in agreement.

Part III – Exchange of Required Information and Ability to Perform Functions of a QHIN

Question 9 should include an asterisk so that the requirement can be demonstrated by the Parent Network as well.

Part IV – Organizational Infrastructure and Legal Authority

No comments – Kaiser Permanente is in agreement.

Part V – QHIN Privacy and Security Requirements

No comments – Kaiser Permanente is in agreement.

Part VI – Project Plan

No comments – Kaiser Permanente is in agreement.

Part VII – Background References

No comments – Kaiser Permanente is in agreement.

Part VIII – Attestation

No comments – Kaiser Permanente is in agreement.