Which of the following actions did NOT occur as a reaction by the ONC regarding EHRs?

• A. Collaboration with NIST to develop EHR usability measures
• B. Overseeing the establishment of Authorized Testing and Certification Bodies
• C. Initiating a panel discussion by the Institute of Medicine on HIT and safety
• D. Recommending stricter regulations by the FDA on EHR design and implementation

Answer: (D)

Focusing on how ONC has shaped EHRs, the emphasis is on policy actions that promote interoperability, safety, and certification rather than regulating FDA rules. ONC has driven the certification framework for EHR technology, working with bodies authorized to test and certify these systems. It has also partnered with NIST to develop usability measures for EHRs, aiming to improve safety and usefulness in practice. Additionally, ONC has supported or initiated expert discussions, such as an Institute of Medicine panel, to explore HIT safety and patient safety implications. In contrast, tightening FDA regulations on EHR design and implementation falls outside the ONC’s typical remit; FDA regulation of software as a medical device is a separate pathway. So the action that did not occur as an ONC reaction is recommending stricter FDA regulations on EHR design and implementation.