In September 2024, the Assistant Secretary for Technology Policy/Office of the National Coordinator for Health Information Technology (ASTP/ONC) released the 2024 status report to Congress on the Cures Act. The Act requires ASTP/ONC to conduct activities in support of the Health IT Certification Program, Health Information Exchange including TEFCA, and Industry Coordination, including the activities of the Health IT Advisory Committee (HITAC), and this report reviews the progress that ASTP/ONC feels it has made on these activities during 2024. While progress has been substantial, the impact on public health is more limited, and the prospects for public health with respect to some of these initiatives are still uncertain.
The report reviews changes to various provisions that were released in the HTI-1 Final Rule in January 2024, as well as provisions in the HIT-2 Proposed Rule, some of which have now been finalized. Various requirements related to registries in the Cures Act are also mentioned, most notably adoption of USCDI standards for interoperability, use of FHIR and Bulk FHIR which are being tested and implemented within public health, and clinical quality measures.
TEFCA is featured prominently in the report, as QHINs (the health information organizations that operate the TEFCA network) are now selected and active. Despite an active Community of Practice related to TEFCA and public health currently managed by ASTHO, TEFCA continues to be a bit of a challenge in the broader public health community where point-to-point interfaces continue to be the dominant style of interoperability, and where use cases for FHIR (one option for TEFCA) have yet to be fully fully realized. TEFCA is not well suited for existing point-to-point interoperability making adoption potentially slower. Early adopters within public health continue to demonstrate how TEFCA can bring value despite some of these limitations, and TEFCA and public health will continue to evolve together to meet public health’s needs.
Information Blocking (interfering with the appropriate flow of health information) continues to be a major topic of discussion and regulation both within TEFCA and in general, including active discussion of exceptions to information blocking and its oversight. Interestingly, the most recent Final Rule related to HTI-2 has made some clarifications with respect to public health and information blocking,
We emphasized in the HTI– 2 Proposed Rule (at 89 FR 63632) that actors would continue to be subject to other Federal laws, and to State and Tribal laws. With regard to public health reporting, we stated in an information blocking FAQ (IB.FAQ43.1.2022FEB) 47 that where a law requires actors to submit EHI to public health authorities, an actor’s failure to submit EHI to public health authorities could be considered an interference under the information blocking regulations. For example, many states legally require reporting of certain diseases and conditions to detect outbreaks and reduce the spread of disease. Should an actor that is required to comply with such a law fail to report, the failure could be an interference with access, exchange, or use of EHI under the information blocking regulations. (p. 102543)
Though the final rule also shows on the same page that when asked if information blocking applies to “non-clinical public health (e.g., disease surveillance programs)” that, “Opining or advising on whether a particular type of organization or function would or would not meet the § 171.102 ‘actor’ definition is beyond the scope of this final rule.” This last statement does not help advocate for public health reporting.
The report discusses activities and progress on other Cures Act requirements: patient access to health data; HITAC and other public committee activities; and patient safety trends and initiatives. But the final section reviews remaining interoperability gaps, some of which are quite relevant to public health including interoperability between EHRs and public health registries,(discussed extensively in our comments on the HTI-2 Notice of Proposed Rule); TEFCA (also discussed above and extensively in past posts); and use of standards-based APIs, largely a code word for “FHIR” in which public health is engaged, though with few production implementations.
As the new administration takes over in Washington, we’ll see just how engaged it becomes in health IT issues, and whether Congress takes any steps to modify Cures Act requirements or direction.