The Department of Health and Human Services has issued two long-awaited final rules — one from the Centers for Medicare & Medicaid Services (CMS) and the other from the Office of the National Coordinator for Health Information Technology (ONC) — intended to improve the interoperability of health information. The final rules include provisions for hospitals and other providers, health plans, and health information technology vendors.
Notably, CMS finalized an addition to the Medicare Conditions of Participation (CoP) that will require hospitals, including psychiatric and critical access hospitals, to transmit electronic patient event notifications for admission, discharge, and transfer (ADT) notifications. CMS modified its proposal to include patients in the emergency department and under observation, while refining recipients of the ADT notifications to providers and suppliers with an established relationship to the patient. The new CoP will be effective six months after publication of the final rule in the Federal Register.
The ONC rule finalizes several provisions related to information blocking, including a more limited definition of electronic health information (EHI) than proposed. Specifically, ONC has revised the scope of EHI to mean electronic protected health information as the term is defined for HIPAA. ONC also clarifies that, for the first 24 months following publication of the final rule, EHI will be limited to the data elements included in the United States Core Data for Interoperability standard.
ONC notes the information-blocking provisions are effective six months following publication of the final rule, and enforcement of civil monetary penalties for information blocking will be established in future notice and comment rulemaking.
The final rules include several additional provisions, including requirements for health plans related to patient access of information via application programming interface (APIs), certification of electronic health records, and API standards.
CMS and ONC have made the following fact sheets available:
- CMS Final Rule Fact Sheet
- ONC Final Rule Overview
- ONC Overview of Changes and Clarifications from the Proposed to Final Rule
- ONC Information Blocking Actors Fact Sheet
- ONC Information Blocking Exceptions Fact Sheet
- ONC 2015 Edition Health IT Certification Criteria Updates
- ONC Standards-based Application Programming Interface (API) Certification Criterion
- ONC APIs Conditions and Maintenance of Certification