September 13, 2011
Statement Type Regulatory Comment
In response to the U.S. Food and Drug Administration (FDA) invitation AMIA participated in a public workshop on the FDA’s Draft Guidance on mobile medical applications. AMIA, the association for informatics professionals, made a presentation and participated in panel discussions that advised the FDA on how it should approach its oversight of clinical decision support systems.
The critical factor, stated AMIA, in determining the risk classification of different types of software that provide clinical decision support (CDS) is whether the CDS is mediated by a human being or not. The FDA’s most rigorous attention should be given to applications that provide CDS in an automatic and autonomous fashion, and which intervene directly based on patient care data. AMIA’s comments were delivered by Meryl Bloomrosen, AMIA Vice President for Public Policy and Government Relations.
Update: Click here to view a recording of the workshop.
- Anticipating and addressing the unintended consequences of health IT and policy (JAMIA 2011)
- AMIA's "Roadmap for National Action on Clinical Decision Support" (2006)
- Clinical Decision Support Town Hall Meeting (2008)
- Recommendations for Responsible Monitoring and Regulation of Clinical Software Systems (JAMIA 1997)
Click below to read the full transcript of AMIA’s comments.