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1) Apr 18 -- The Office of the National Coordinator for Health Information Technology (ONC), Department of Health and Human Services (HHS). invites comment by June 20, 2023 on a proposed rule regarding Health Data, Technology, and Interoperability: Certification Program Updates, Algorithm Transparency, and Information Sharing.

This proposed rule would implement 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 proposed rule would also make several updates to certification criteria and implementation specifications recognized by the Program, including a revised certification criterion for decision support and revised certification criteria for patient demographics and observations and electronic case reporting. This proposed rule would establish a new baseline version of the United States Core Data for Interoperability (USCDI). Additionally, this proposed rule would provide enhancements to support information sharing under the information blocking regulations. The implementation of these provisions would advance interoperability, improve transparency, and support the access, exchange, and use of electronic health information. The proposed rule would also update the Program in additional ways to advance interoperability, enhance health IT certification, and reduce burden and costs.

To be assured consideration, written or electronic comments must be received at one of the addresses provided below, no later than 5 p.m. on June 20, 2023.
 
The Secretary of Health and Human Services has delegated responsibilities to 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) including: the Electronic Health Record (EHR) Reporting Program condition and maintenance of certification requirements under the ONC Health IT Certification Program (Program) and identifying 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) of 2009 including, among other things: 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 would fulfill statutory requirements; provide transparency; advance equity, innovation, and interoperability; and support the access, exchange, and use of electronic health information (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 fulfilling the HITECH Act's and Cures Act's requirements described above and advancing interoperability, the proposed rule would contribute to fulfilling Executive Orders (E.O.) 13994, 13985, 14036, 14058, and 14091. 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 update in this proposed rule to adopt the United States Core Data for Interoperability Standard Version 3 (USCDI v3) would promote the establishment and use of interoperable data sets of EHI for interoperable health data exchange. As discussed in section III.C.1, USCDI v3 would facilitate the gathering, sharing, and publication 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. The proposed updates to Application Programming Interfaces (APIs) Conditions and Maintenance of Certification requirements, as discussed in section III.C.7, would continue ONC's efforts to develop and standardize APIs and would help individuals and other authorized health care providers, including those engaged in public health, to securely access EHI through the broader adoption of standardized APIs.

Additionally, the proposed rule would adopt consensus-based, industry-developed health IT standards for certified Health IT Modules to support electronic case reporting. As discussed in section III.C.4, this would, among other benefits, facilitate faster and more efficient disease tracking and case management. It also would provide more timely and complete data than manual or non-standardized reporting. In addition to proposing new standards to support public health initiatives, we also request comment and seek input from the public in section III.G regarding health IT standards that could be adopted within the Program to strengthen and advance laboratory interoperability.
 
FRN: https://www.federalregister.gov/d/2023-07229 [172 pages]

2) Apr 11 [press release] -- The U.S. Department of Health and Human Services' (HHS) Office of the National Coordinator for Health Information Technology (ONC) today released a Notice of Proposed Rulemaking (NPRM) for public comment on proposals to implement certain provisions of the 21st Century Cures Act (Cures Act) and make several enhancements to the ONC Health IT Certification Program (Certification Program) to advance interoperability, improve transparency, and support the access, exchange, and use of electronic health information.

Proposals include:

-- Implementing the Electronic Health Record Reporting Program as a new Condition of Certification for developers of certified health information technology (health IT) under the Program.
-- Modifying and expanding exceptions in the information blocking regulations to support information sharing.
-- Revising several Certification Program certification criteria, including existing criteria for clinical decision support (CDS), patient demographics and observations, electronic case reporting, and application programming interfaces for patient and population services.
-- Adopting the United States Core Data for Interoperability (USCDI) Version 3 as a standard within the Certification Program and establishing an expiration date for USCDI Version 1 as an adopted standard within the Certification Program.
-- Updating standards and implementation specifications adopted under the Certification Program to advance interoperability, support enhanced health IT functionality, and reduce burden and costs.

Further, in collaboration with federal partners, including the Agency for Healthcare Research and Quality, Food and Drug Administration (FDA), HHS Office for Civil Rights, and U.S. Department of Veterans Affairs (VA), and the Federal Trade Commission (FTC), the ONC rule proposes new policies that, if finalized, would promote greater trust in the predictive decision support interventions (DSIs) used in healthcare. These proposals would help enable users to determine whether the predictive DSI is fair, appropriate, valid, effective, and safe, and enable market competition. Specifically, we sought alignment with the FDA’s recent guidance on CDS. . . .

ONC will be hosting a series of information sessions about the proposed rule in the coming weeks, including an overview session on April 27, 2023. More information can be found at https://www.healthit.gov/topic/laws-regulation-and-policy/health-data-technology-and-interoperability-certification-program and via ONC’s Twitter account, @ONC_HealthIT exit disclaimer icon.

Press release: https://www.hhs.gov/about/news/2023/04/11/hhs-propose-new-rule-to-further-implement-the-21st-century-cures-act.html

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