Response to ONC’s 2019 Trusted Exchange Framework Draft 2
In this letter, we provide priority high-level and detailed comments intended to help ONC further refine the second draft of the TEFCA. We share an overall aim to improve the health and health care of patients and our nation through more seamless and secure patient, provider and other appropriate stakeholder access to and use of health information.
In April 2019, ONC published the Trusted Exchange Framework (TEF) Draft 2 for public comment. This updated, second draft TEF package was developed by ONC with input from all of the public comments on the TEF Draft 1 and includes three components: (1) the TEF Draft 2; (2) the Minimum Required Terms and Conditions (MRTCs) Draft 2; and (3) the Qualified Health Information Network (QHIN) Technical Framework (QTF) Draft 1.
The Sequoia Project staff and Board of Directors have carefully reviewed the TEFCA Draft 2 and prepared our response.
Below are the final comments submitted to ONC on June 13, 2019.
Response to ONC 2019 TEF Draft 2:
The Sequoia Project’s response to ONC TEF Draft 2 (PDF) includes:
- Overview of The Sequoia Project Response
- Specific Recommendations and Comments to TEF
- Specific Recommendations and Comments to MRTCs
- Specific Recommendations and Comments to QTF
2019 TEF Draft 2 Response Highlights
- We appreciate the changes ONC made from Draft 1 summarized in the chart on page 20 of the TEFCA Draft 2.
- We urge ONC to be very mindful of the congressional intent that the TEFCA avoid disruption and duplication of “existing exchanges between participants of health information networks”. In our view, as currently drafted, the TEFCA would both disrupt and duplicate existing exchange mechanisms and would require extensive changes to existing activities and revisions to the terms of thousands of legal agreements. We urge ONC to look for every opportunity to minimize or eliminate such duplication and disruption, especially in the need to revise legal agreements that have, in many cases, taken years to be developed and executed in support of large-scale information sharing.
- The TEFCA should address real, material gaps in current exchange networks, frameworks and agreements. One area where we believe that the TEFCA can add real value is harmonization of agreed upon purposes for exchange and use of information.
- We support ONC’s goals for the TEFCA: (1) a single “on-ramp” to nationwide connectivity; (2) enable Electronic Health Information (EHI) to securely follow the patient when and where it is needed; and (3) support nationwide scalability.
- We note that the Carequality trust framework is designed to provide a single on-ramp and to reduce the extent to which “health systems and providers . . . must join multiple networks that do not connect with one another in order to receive the information they need to care for their patients.”
- We support the responsibility for the Recognized Coordinating Entity (RCE) to develop the Additional Required Terms and Conditions (ARTCs), subject to ONC approval. At the same time, because the ARTCs must be consistent with and not revise the Minimum Required Terms and Conditions (MRTCs), we believe that the RCE should also have an important role in finalizing the MRTCs in conjunction with ONC. For both tasks, the RCE should also be able to engage with prospective QHINs, Participants, and Participant Members.
- We strongly support the proposal that, in a shift from TEFCA Draft 1, the Qualified Health Information Network (QHIN) Technical Framework (QTF) would be incorporated by reference in the Common Agreement (CA) and finalized by the RCE.
- We agree with the proposed role of and selection criteria for an experienced private sector RCE to implement and monitor compliance with the Common Agreement as well as the definition of “affiliated entity” in a companion ONC FAQ. We also believe that the final TEFCA and the associated RCE cooperative agreement can be strengthened by enhanced mechanisms to engage with and represent and reflect the perspectives of QHINs, their Participants and Participant Members as the Common Agreement and QTF evolve over time and especially for enhancements that do not conflict with ONC policy imperatives.
- We continue to support the role of the QHIN in the TEFCA process, agree with ONC’s proposed high-level criteria to qualify as a QHIN and appreciate that ONC has made changes (e.g., elimination of the Connectivity Broker concept and limits on participating in other agreements) that should enable a wider variety of organizations to qualify as QHINs. To this end, we ask ONC to clarify that it is the collective capabilities of the QHIN and its constituents that are to provide the level of standards-based connectivity to other QHINs required by the MRTCs, whether that QHIN uses a more federated, centralized, or mixed model.
- We agree with ONC that the TEFCA should not dictate the internal requirements nor structures of QHINs or their components.
- We support the revised exchange modalities and associated definitions proposed by ONC. We emphasize that targeted queries are very common in our experience; we appreciate that Draft 2 seems more supportive of the role of targeted queries by QHINs (as well as by Participants and Participant Members) and encourage continuation of that approach as the Common Agreement is finalized.
- The TEF Draft 2 has a revised and narrowed set of Exchange Purposes. We understand the rationale for narrowing Payment and Operations based on comments received but are also very concerned that these revisions could exclude important use cases that would benefit from TEFCA-enabled exchange. At a minimum, we recommend that ONC provide definitions for the revised Exchange Purposes in the final TEFCA definitions that explicitly state that case management and care coordination are required Exchange Purposes. Fundamentally however, we believe that the full scope of Payment and Health Care Operations, as defined by HIPAA, should be included as Exchange Purposes under the TEFCA, with flexibility provided on what exactly is required for immediate support.
- We agree that QHINs, Participants, and Participant Members should be required to respond to all requests they receive for any of the Exchange Purposes with EHI that they have available (i.e., non-discrimination), to the extent that the organization is authorized by law and its Business Associate Agreements and other partner agreements/contracts (which are in fact legal obligations) to release information for those Exchange Purposes. In addition to HIPAA “minimum necessary” provisions, we suggest that TEFCA participants have some flexibility, guided by the MRTCs and the QTF, to provide the EHI necessary for the applicable use case.
- We ask ONC to be more explicit regarding how fees charged by Participants and Participant Members are handled as part of the Common Agreement, including any limits on such fees or requirements for transparency and disclosure.
- We agree with ONC that, “QHINs, Participants, and Participant Members are in no way limited from voluntarily offering additional exchange modalities and services or from entering into point-to-point or one-off agreements between organizations that are different from the Common Agreement’s MRTCs, provided that such agreements do not conflict with the policies of the Common Agreement”. We urge ONC to provide greater clarity regarding what it means to “not conflict with the . . . Common Agreement”. ONC should be clear that other agreements that do not involve operations under the TEFCA are permitted to reflect different policy conclusions than does the CA, if the organization’s participation under the CA is fully compliant with its terms. More generally, we ask ONC to be clear that participating in alternate (i.e., non-TEFCA) trust agreements is permitted for TEFCA signers.
- We strongly agree with ONC that “[e]stablishing baseline privacy and security requirements shared by all QHINs, Participants, and Participant Members is important for building and maintaining confidence and trust that EHI shared pursuant to the Common Agreement is appropriately protected”. We do, however, urge ONC to be clear on when non-HIPAA covered entities or business associates must meet all HIPAA privacy and security protections versus specific requirements in the MRTCs.
- We suggest that ONC allow less global Meaningful Choice exercises than proposed.
- Based on what we have learned from our partner organizations, we encourage ONC to assess the viability and level of burden of requiring private sector organizations to conduct security assessments related to NIST 800-171 as well as the applicability of the Controlled Unclassified Information (CUI) requirements to the private sector.
- We appreciate ONC’s intent to potentially require a narrower approach to security labeling than might otherwise be the case but believe such a labeling policy is premature and its adoption could greatly slow initial implementation of the TEFCA. We suggest that labeling could be addressed at a later point through ARTC revisions.
- We agree, in general, with each of the proposed high-level principles in the TEF Draft 2 but are uncertain about the extent to which these principles are intended to guide the actions of exchange participants as distinct from the MRTCs, the ARTCs, and the QTF. As part of our detailed comments, we ask ONC to be explicit and clarify its expectation and requirements for application of these principles, clarifying that they have no compliance implications.
- We strongly agree with ONC that the RCE will combine the MRTCs with the RCE-developed ARTCs into a full data sharing agreement, the Common Agreement. We suggest that the Common Agreement provide for phasing in of modalities or specific requirements (e.g., meaningful choice and messaging). Such staging would allow for a faster and less disruptive roll-out of the TEFCA by the RCE. In the attached appendix, we comment selectively on specific MRTCs. In addition, as stated, we believe that the RCE should have an important role in finalizing the MRTCs.
- We generally agree with the perspectives in the Overview section on the QHIN Technical Framework (QTF). We strongly agree with ONC’s proposal that the RCE finalize the QTF based on comments received and urge that consideration of comments and external engagement extend beyond this initial comment period. We generally agree with the standards and profiles proposed for the various use cases and purposes and emphasize that the final QTF will likely require further constraints on some of these profiles. We respond to several of ONC requests for information regarding aspects of the QTF. We also suggest that ONC consider extending the QTF completion date to allow for additional stakeholder feedback.
The Sequoia Project Response to 2018 TEF Draft 1
The Sequoia Project staff and Board of Directors have carefully reviewed the TEFCA and prepared our response.
Below are the final comments submitted to ONC on February 16, 2018.
Response to ONC 2018 Draft TEF Documents:
- The Sequoia Project’s response to ONC Draft TEF, which includes:
- Appendix 1: Suggested criteria for RCE design; and
- Appendix 2: Pertinent background on The Sequoia Project’s relevant initiatives.
- Appendix 3: Detailed technical comments on the draft TEF.
- The Sequoia Project’s response to ONC U.S. Core Data for Interoperability (USCDI).
2018 TEF Draft 1 Response Highlights
2018 Draft 1 Response Overview
- The Sequoia Project appreciates ONC’s efforts to implement provisions in Title IV, Section 4003 of the 21st Century Cures Act (Cures) that call for ONC to convene public-private and public-public partnerships to build consensus and develop or support a trusted exchange framework and common agreement (TEFCA) among health information exchange networks. We support congressional intent and ONC’s goals to leverage a TEFCA to enable interoperability among networks. We applaud ONC’s engagement with stakeholders and intention to leverage the private sector in this process.
- We highlight congressional intent that the TEFCA is to take into account existing trusted exchange frameworks and agreements used by health information networks to avoid disrupting existing exchanges between participants of health information networks. We also agree with and appreciate the voluntary nature of the TEFCA.
- Our comments are based on our significant experience supporting large-scale, nationwide health data sharing initiatives, serving as an experienced, transparent and neutral convener of public and private-sector stakeholders to address and resolve practical challenges to interoperability. This work has required development and implementation of trust frameworks and common agreements.
- Our extensive experience implementing national-level health IT interoperability through common trust frameworks provide a unique perspective on the Draft TEF and criteria for the Recognized Coordinating Entity (RCE).
- The Sequoia Project comments are aimed at helping ONC strengthen the final TEF and successfully carry out its implementation. We stand ready to work with ONC to refine and implement its Draft TEF Our shared overall aim is to improve the health and health care of patients, consumers, and our nation through seamless access to health information.
2018 Draft 1 Focus Areas
- Lessons learned and pertinent best practices from The Sequoia Project and its initiatives, such as Carequality and the eHealth Exchange;
- Detailed suggestions for RCE-selection and operational criteria drawn from our experience as a national convener of diverse stakeholders on health information exchange policy and experience developing innovative models to support exchange – for example, the need for the RCE to operate as a 501(c)(3), focused on lessening government burden, with a high level of transparency and representation of and accountability to stakeholders;
- Ways in which the final TEFCA can enhance innovation, for example, by allowing greater flexibility in exchange architecture and the qualifications of the Qualified Health Information Networks (QHINs), which are intended to facilitate cross-network exchange;
- The need, consistent with congressional intent, to avoid reversing progress and disrupting existing exchange, enabling existing exchange frameworks and networks to continue operations and growth as the TEFCA is phased in – building on and reinforcing such processes, frameworks and agreements already in use by so many partners will be essential to TEFCA success and accelerated progress towards real interoperability at scale;
- The need for ONC to allow and plan for a transition period in which TEFCA implementation can proceed along with the continued normal operations of organizations that become TEFCA participants, whether the RCE, QHINS, participants, or end users;
- The importance of ensuring that the TEFCA does not assume/impose more uniformity in health data exchange than needed to successfully implement its use cases and permitted purposes – careful and deliberate allowance for variation will accommodate current and future organizational and technology models;
- Ways in which the proposal can be more flexible, for example, enabling a wider range of organizations to qualify as QHINs, increasing the ability to support innovation and adapt to a rapidly changing market, consistent with clear ONC, HHS, and the Administration intentions;
- Areas where the proposal may be too prescriptive and also where it is not specific enough to achieve operational success, suggesting that many of the technical details and standards references in the TEF and the Common Agreement be shifted to “use-case”-specific implementation guides maintained by the new RCE;
- Using models like those employed by the Carequality Framework to develop and implement final legal agreements and implementation guides, rather than seeking to formalize all requirements in the TEFCA; and
- Opportunities to reduce: complexity, risk to ONC goals, and regulatory and compliance costs for the federal government, providers, and exchange and technology organizations.
2018 Draft 1 Specific Comments and Recommendations
- We support the overall intent, high-level approach, and policy goals of the Draft TEF.
- We are encouraged by the Draft TEF’s focus on private-sector standards and organizations, including the central role of a Recognized Coordinating Entity (RCE) to achieve effective interoperability.
- As ONC works with the RCE to finalize and implement the TEFC, we urge ONC to adjust its proposed approach to prioritize minimal disruption of existing exchange initiatives and networks that are on a trajectory consistent with both 21st Century Cures provisions and TEFCA goals, while eliminating barriers to their success.
- We are pleased that ONC intends to work with a private-sector RCE to consider comments received and to collaboratively create and implement the final TEFCA.
- We suggest that ONC focus on refining and articulating policy goals and principles, rather than on detailed agreement terms and technical requirements.
- We urge ONC to allow a phased and modular implementation of the TEFCA.
- Based on our years of experience as a coordinator for trusted exchange, we suggest that many of the provisions in the Draft TEF, as well as those envisioned for the Common Agreement, especially in Part B (Minimum Required Terms and Conditions), should be moved from the final TEFCA into use case-specific implementation guides.
- We recommend that ONC, as it works with the RCE to finalize the TEF, revise and expand the definition of a QHIN to enable enough HINs to qualify and participate as QHINs and, in turn, that a wide range of participants and end users are willing and able to connect to a QHIN.
- Flexibility on required standards and how they are defined at an implementation level is essential for the ability of the TEFCA framework to evolve over time.
- We suggest that ONC work with the RCE, drawing on input from the industry, to determine where uniformity of architecture and approach is needed, and where policy goals can be achieved in a more varied environment.
- TEF terms should endure as reflected in the Common Agreement (CA), with implementation-level details evolving over time, in implementation guides incorporated by reference into the Common Agreement, based on real-world implementation experience.
- As a general principle, it will be important to minimize/optimize the extent to which TEFCA parties (i.e., the RCE, QHINs, participants, and/or end users) are held responsible for actions and circumstances beyond their reasonable scope or control. For example, QHINs being responsible for maintaining data quality when they don’t themselves hold or generate the data being exchanged or Participants being responsible for ensuring that medications, allergies, and problems are up to date prior to exchanging these data.
- We appreciate ONC’s recognition of the bandwidth challenges that could accompany both broadcast queries and population-level queries and suggest that the TEFCA address this issue directly and provide a basis for technology and policy approaches that reduce bandwidth pressures, such as being clear on the ability to use asynchronous transfer.
- Some terms in the Draft TEF conflict with fundamental terms supporting large-scale exchange today and may result in unintended consequences.
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