clinical decision support

Subscribe to clinical decision support

The Department of Health and Human Services Office of the National Coordinator for Health Information Technology (ONC) has published its first final rule on Health Data, Technology and Interoperability. The rule, known as the HTI-1 rule, takes effect on February 8, and governs updates to the ONC’s Health IT Certification Program, as well as regulations on information blocking.

Among the program criteria that the rule addresses include those related to decision support, electronic case reporting and standards-based application programming interfaces (APIs). To address the question of information blocking, the rule provides refined definitions of statutory terms and identifies practices that cannot constitute information blocking as they are considered by ONC to be “reasonable and necessary.”Continue Reading ONC Finalizes Information Sharing and Algorithm Transparency Rule

On September 27, 2022, FDA announced the publication of a  final guidance  document entitled Clinical Decision Support Software, Guidance for Industry and Food and Drug Administration Staff (Final CDS Guidance), which focuses on clarifying the types of clinical decision support (CDS) software functions that are excluded from the definition of device by the criteria in section 520(o)(1)(E) of the Federal Food Drug and Cosmetic Act.

This final guidance document addresses industry comments made in response to FDA’s September 2019 draft guidance (Draft CDS Guidance). The Final CDS Guidance streamlines the Draft CDS Guidance by focusing the scope on CDS intended to be used by state licensed, registered, or certified health care professionals , rather than those also used by patients and caregivers, which were included in the scope of the Draft CDS Guidance.Continue Reading FDA Announces Final Guidance on Clinical Decision Support Software

The Food and Drug Administration (FDA) recently released new draft guidance documents to clarify its approach to regulating software as a medical device. The first draft guidance, Clinical and Patient Decision Support Software, addresses provision of the 21st Century Cures Act that exempts certain clinical decision support software from the definition of a medical device. …