Response to ONC’s 2019 Draft Trusted Exchange Framework
The Sequoia Project is preparing a response to the 21st Century Cures Act: Interoperability, Information Blocking, and the ONC Health IT Certification Program released in February 2019. Our response will be posted here soon.
In January 2018, ONC published a Draft Trusted Exchange Framework (TEF) for public comment. The Draft TEF is meant to build on and recognize the significant work done by the industry over the last few years to broaden the exchange of data to meet the needs of patients and the providers who serve them. It aims to ease the flow of information between healthcare stakeholders and expand patient access to their health data, while allowing for a competitive marketplace that fosters innovation and development of new technologies to improve care coordination, population health management, and patient outcomes.
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).
Draft 2018 TEF Response Highlights
- 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.
- 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.
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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