On March 2019, the Office of the National Coordinator for Health Information Technology (ONC) issued a Proposed Rule, 21st Century Cures Act: Interoperability, Information Blocking and the ONC Health Information Certification Program. The Final Rule was then published on May 1, 2020 in the Federal Register. The enacted regulation established various compliance dates for enforcement of the regulation on its applicable actors. The Cures Act expands the definition of responsible individuals by using the term Actors rather than Covered Entities. The implication of this change is that additional participants that hold electronic PHI but do not meet the definition of a Covered Entity are subject to elements of the Cures Act.
October 6, 2022, is a second compliance date within the Cures Act, where the definition of Electronic Health Information (EHI) is expanding beyond the initial data elements represented in the United States Core Data for Interoperability (USCDI). The EHI definition will now include all the electronically maintained Protected Health Information (PHI) that is part of an entity’s Designated Record Set as defined in the Health Insurance Portability and Accountability Act (HIPAA).
Actors regulated under the 21st Century Cures Act and the Final Rule enacted should take affirmative steps to review their internal process, policies and procedures, and what changes should be implemented in order to achieve compliance with the upcoming new compliance requirements starting on October 6, 2022. Ankura’s team of Healthcare compliance and security experts can assist your organization in reviewing the internal policies and procedures and design controls that comport with the 8 identified exceptions to behaviors that the 21st Century Cures Act defines as Information Blocking.
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