On April 11, 2023, the Office of the National Coordinator for Health Information Technology (ONC) released a proposed rule that would further the aims of the 21st Century Cures Act.
The 21st Century Cures Act is a landmark healthcare bill released in 2016, which gives federal agencies such as the ONC and the Center for Medicare and Medicaid (CMS) the ability to create regulations and guidelines on certain federal interoperability initiatives.
This proposed rule would build on a program titled the ONC Health IT Certification Program, which is a program that requires EHRs and certain developers of certified technology to meet specific interoperability standards that are set by the ONC, and largely considered best practices in the interoperability space. Under the proposed rule, the ONC would implement the Electronic Health Record Reporting Program as a new requirement and build on other criteria such as clinical decision support, patient demographics and observations, electronic case reporting, and application program interfaces (APIs) for patient services. In addition, the program would require compliance with USCDI v3, which is two versions ahead of what other interoperability rules, such as the CMS Patient Access rule require.
Another notable proposal is to “modify and expand” information blocking rule exceptions. Because it has been two years since compliance for the rule has begun, there has been increased dialogue on some of the exceptions, how they will work in practice, and if further updates are needed. This proposed rule will address the Content and Manner exception of the information blocking rule specifically with updated guidance.
Lastly, 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), worked with the ONC to proposes new initiatives that would promote greater trust in the predictive decision support interventions (DSIs) used in healthcare.
While we release more information on this rule in the upcoming weeks, please feel free to reach out to Shreya.Patel@mihin.org for any questions or concerns. If you are a stakeholder that would like to submit comments to the ONC in collaboration with MiHIN, we would also love to hear from you!