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This final rule implements the Electronic Health Record (EHR) Reporting Program provision of the 21st Century Cures Act by establishing new Conditions and Maintenance of Certification requirements for health information technology (health IT) developers under the ONC Health IT Certification Program (Program). This final rule also makes several updates to certification criteria and standards recognized by the Program. The Program updates include revised certification criteria for “decision support interventions,” “patient demographics and observations,” and “electronic case reporting,” as well as a new baseline version of the United States Core Data for Interoperability (USCDI) standard to Version 3. Additionally, this final rule provides enhancements to support information sharing under the information blocking regulations. The implementation of these provisions advances interoperability, improves algorithm transparency, and supports the access, exchange, and use of electronic health information (EHI). This final rule also updates numerous technical standards in the Program in additional ways to advance interoperability, enhance health IT certification, and reduce burden and costs for health IT developers and users of health IT. This final rule is effective on February 8, 2024.

The Office of the National Coordinator for Health Information Technology (ONC) is the principal federal entity charged with coordinating nationwide efforts to implement and use advanced health IT and to facilitate the electronic exchange of health information. ONC is at the forefront of the administration's health IT efforts and is a resource to the entire health system to support the adoption of health IT and the promotion of nationwide, standards-based health information exchange to improve healthcare. ONC is focused on two strategic objectives: (1) advancing the development and use of health IT capabilities; and (2) establishing expectations for data sharing. ONC's overall mission, consistent with the policies adopted in this final rule, is to create systemic improvements in health and care through the access, exchange, and use of data.

This final rule fulfills statutory requirements and aligns with administrative priorities; advances equity, innovation, and interoperability; and supports the access, exchange, and use of EHI. It also promotes the responsible development and use of artificial intelligence through transparency and improves patient care through policies that advance standards-based interoperability and EHI exchange, which are central to the Department of Health and Human Services' efforts to enhance and protect the health and well-being of all Americans.

The Secretary of Health and Human Services has delegated to ONC the responsibility to implement certain provisions in Title IV of the 21st Century Cures Act (Pub. L. 114–255, Dec. 13, 2016) (Cures Act) including: the Electronic Health Record (EHR) Reporting Program condition and maintenance of certification requirements under the ONC Health IT Certification Program (Program) and the identification of reasonable and necessary activities that do not constitute information blocking. ONC is also responsible for implementing certain provisions of the Health Information Technology for Economic and Clinical Health Act (Pub. L. 111–5, Feb. 17. 2009) (HITECH Act) of 2009, including, but not limited to, 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, as well as requirements to keep, or recognize, a program or programs for the voluntary certification of health information technology.

This final rule adopts new and revised standards and requirements for the certification of health IT under the Program. For example, key provisions of this final rule implement the EHR Reporting Program through new Conditions and Maintenance of Certification requirements (referred herein as the Insights Condition) for developers of certified health IT, which will provide transparency into the use and benefits of certified health IT, with an initial focus on interoperability. This final rule revises several Program certification criteria, including criteria related to decision support, electronic case reporting, and standards-based application programming interfaces (APIs), as well as raises the baseline version of the USCDI from Version 1 to Version 3. The adoption of new and revised standards and criteria in this final rule will facilitate interoperability through standardized health information and functionality, which will lead to better care and health outcomes for patients, while reducing burden and costs. Finally, this rule continues to implement the provisions of the Cures Act to improve information sharing—and address information blocking—by providing refined definitions of statutory terms and further identifying practices that are reasonable and necessary and, therefore, do not constitute information blocking.

In addition to fulfilling the HITECH Act's and Cures Act's requirements described above, this final rule supports implementation of Executive Orders (E.O.) 13994, 13985, 14036, 14058, 14091, and 14110. 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. . . .

We are also committed to advancing health equity, and this final rule is consistent with E.O. 13985 of January 20, 2021, Advancing Racial Equity and Support for Underserved Communities Through the Federal Government, and E.O. 14091 of February 16, 2023, Further Advancing Racial Equity and Support for Underserved Communities Through the Federal Government. . . .

Additionally, the DSI certification criterion and surrounding transparency requirements are especially aligned with E.O. 14110, Safe, Secure, and Trustworthy Development and Use of Artificial Intelligence, issued October 30, 2023. The finalized DSI requirements will improve transparency, promote trustworthiness, and incentivize the development and wider use of fair, appropriate, valid, effective, and safe Predictive DSIs to aid decision-making in healthcare. . . .

The finalized DSI certification criterion also aligns with the public availability and transparency policy goals of the Office of Science and Technology Policy (OSTP) memorandum “Ensuring Free, Immediate, and Equitable Access to Federally Funded Research.” The memorandum provides policy guidance to federal agencies and departments to promote improved public access to and transparency of federally funded research. The finalized DSI certification criterion aligns with the goals of the memorandum by establishing requirements to make information available through § 170.315(b)(11)(iv), including information created through federally funded research and evaluations, that will enable users to determine if a Predictive DSI supplied by a health IT developer as part of its Health IT Module is acceptably fair, appropriate, valid, effective, and safe.

President Biden's E.O. 14036, Promoting Competition in the American Economy, issued on July 9, 2021, established a whole-of-government effort to promote competition in the American economy and reaffirmed the policy stated in E.O. 13725 of April 15, 2016 (Steps to Increase Competition and Better Inform Consumers and Workers to Support Continued Growth of the American Economy). This final rule fosters competition by advancing foundational standards for certified API technology, which enable—through applications (apps) and without special effort—improved legally permissible sharing of EHI among clinicians, patients, researchers, and others. As described in section III.C.7, competition is advanced through these improved API standards that can help individuals connect to their information and can help authorized health care providers, involved in the patient's care, securely access information. For example, these standards are designed to foster an ecosystem of new applications that can connect through the API technology to provide patients with improved electronic access to EHI.

Further, as described in section IV, this final rule provides enhancements to support information sharing under the information blocking regulations and promote innovation and competition, as well as address market consolidation. As we have noted, addressing information blocking is critical for promoting innovation and competition in health IT and for the delivery of healthcare services to individuals. In both the ONC Cures Act Proposed Rule (84 FR 7508) and Final Rule (85 FR 25790 through 25791), we discussed how the information blocking provisions provide a comprehensive response to the issues identified by empirical and economic research. This research suggested that information blocking may weaken competition, encourage consolidation, and create barriers to entry for developers of new and innovative applications and technologies that enable more effective uses of EHI to improve population health and the patient experience. We explained that the information blocking provisions of the Public Health Service Act (PHSA) itself expressly addresses practices that impede innovation and advancements in EHI access, exchange, and use, including care delivery enabled by health IT (section 3022(a)(2)(C)(ii) of the PHSA). Actors subject to the information blocking provisions may, among other practices, attempt to exploit their control over interoperability elements to create barriers to entry for competing technologies and services that offer greater value for health IT customers and users, provide new or improved capabilities, and enable more robust access, exchange, and use of EHI (85 FR 25820). Information blocking may not only harm competition in health IT markets, but also in markets for healthcare services (85 FR 25820). In the ONC Cures Act Final Rule, we described practices that dominant market health care providers may leverage and use to control access and use of their technology, resulting in technical dependence and possibly leading to barriers to entry by would-be competitors, as well as making some market health care providers vulnerable to acquisition or inducement into arrangements that enhance the market power of incumbent health care providers to the detriment of consumers and purchasers of healthcare services (85 FR 25820). The implementation of the new information blocking provisions detailed in section IV of this final rule promote innovation, encourage market competition, and address consolidation in the interest of the patient to advance interoperability, improve transparency, and support the access, exchange, and use of EHI.

Lastly, in support of E.O. 14058, Transforming Federal Customer Experience and Service Delivery to Rebuild Trust in Government, issued on December 16, 2021, we are committed to advancing the equitable, inclusive, and effective delivery of services with a focus on the experience of individuals, health IT developers, and health care providers. . . .

FRN: https://www.federalregister.gov/d/2023-28857 [247 pages]

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