Aug 5 -- The Office of the National Coordinator for Health Information Technology (ONC), Department of Health and Human Services (HHS), invites comments by October 4, 2024 on a proposed rule to advance interoperability, improve transparency, and support the access, exchange, and use of electronic health information through proposals for: standards adoption; adoption of certification criteria to advance public health data exchange; expanded uses of certified application programming interfaces, such as for electronic prior authorization, patient access, care management, and care coordination; and information sharing under the information blocking regulations. It proposes to establish a new baseline version of the United States Core Data for Interoperability. The proposed rule would update the ONC Health IT Certification Program to enhance interoperability and optimize certification processes to reduce burden and costs. The proposed rule would also implement certain provisions related to the Trusted Exchange Framework and Common Agreement (TEFCA), which would support the reliability, privacy, security, and trust within TEFCA.
The Secretary of Health and Human Services has delegated responsibilities to the Office of the National Coordinator for Health Information Technology (ONC) for the implementation of certain provisions in Title IV of the 21st Century Cures Act (Pub. L. 114-255, Dec. 13, 2016) (Cures Act) that are designed to: advance interoperability; support the access, exchange, and use of electronic health information (EHI); and identify reasonable and necessary activities that do not constitute information blocking. ONC is responsible for implementation of certain provisions of the Health Information Technology for Economic and Clinical Health Act (Pub. L. 111-5, Feb. 17. 2009) (HITECH Act) including: requirements that the National Coordinator perform duties consistent with the development of a nationwide health information technology infrastructure that allows for the electronic use and exchange of information and that promotes a more effective marketplace, greater competition, and increased consumer choice, among other goals; and requirements to keep or recognize a program or programs for the voluntary certification of health information technology. This proposed rule seeks to fulfill statutory requirements; provide transparency; advance equity, innovation, and interoperability; and support the access to, and exchange and use of, EHI. Transparency regarding healthcare information and activities—as well as the interoperability and electronic exchange of health information—are all in the best interest of the patient and are central to the efforts of the Department of Health and Human Services to enhance and protect the health and well-being of all Americans.
In addition to addressing the HITECH Act's and Cures Act's requirements described above and advancing interoperability, the proposed rule aligns with and supports Executive Orders (E.O.) 13994, 13985, 14036, and 14058. The President issued E.O. 13994 on January 21, 2021, to ensure a data-driven response to COVID-19 and future high-consequence public health threats. The Cures Act and the information blocking provisions in the 21st Century Cures Act: Interoperability, Information Blocking, and the ONC Health IT Certification Program (85 FR 25642) (ONC Cures Act Final Rule) have enabled critical steps to making data available across the healthcare system. The proposed rule proposes to adopt certification criteria to advance interoperability and support public health reporting and exchange. Because we recognize the need for greater interoperability of public health technology and access to more actionable data by public health authorities (PHA) and their partners, the proposed rule lays out a multi-pronged approach that takes advantage of, and builds upon, the various previous efforts to advance public health reporting, including advancements in HL7® Fast Healthcare Interoperability Resources-based (FHIR®) solutions and evolving standards related to public health interoperability. We have proposed this approach to allow for systems to mature and advance in an aligned fashion, reduce the need for manual workarounds and intervention, and lead to wider adoption of advanced standards-based capabilities.
The proposed adoption of the United States Core Data for Interoperability Standard Version 4 (USCDI v4) would promote the establishment and use of interoperable data sets of EHI for interoperable health data exchange. As discussed in section III.B.1, USCDI v4 would facilitate the collection, access and exchange of data for use in public health and emergency response (e.g., the COVID-19 pandemic) by capturing and promoting the sharing of key data elements related to public health. . . .
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https://www.federalregister.gov/d/2024-14975 [314 pages]
