May 26, 2019: Final Rule to Implement Provisions of the 21st Century Cures Act

On May 1, 2020, the Office of the National Coordinator for Health Information Technology (ONC) and the Centers for Medicare and Medicaid Services (CMS) announced a final rule to implement provisions of the 21st Century Cures Act. The final rule is intended to advance interoperability and support the access, exchange, and use of electronic health information by patients and their caregivers.

“Patients should be able to access their electronic medical record at no extra cost. Providers should be able to choose their IT tools that allow them to provide the best care for patients, without excessive costs or technical barriers.” —ONC Cures Act Final Rule Fact Sheet

To enable the use of smartphone applications (apps) for secure access to healthcare data, the rule requires standardized, open application programming interfaces (APIs) to be built using HL7’s FHIR (Fast Health Interoperability Standard). Part of the intention of the rule is to promote competition and support provider and patient independence in choosing which certified apps to acquire and use for healthcare purposes.

The rule establishes the United States Core Data for Interoperability (USCDI) standard, which sets forth data classes and elements that support nationwide interoperability; it also includes a broad range of data elements, such as clinical notes, test results, and medications. The final rule includes a prohibition on “information blocking” to restrict practices that are likely to interfere with access to or exchange of health information.

The rule is effective on June 30, 2020, and compliance is required by November 2, 2020.