In response to the FDA's invitation to participate in a public workshop related to FDA’s Draft Guidance on mobile medical apps, AMIA—the association for informatics professionals—advised the agency on how it should approach oversight of clinical decision support (CDS) systems.
AMIA stated that in determining the risk classification of different types of software that provide clinical decision support (CDS), the FDA should look at whether the CDS is mediated by a human being or not.
AMIA continued that the FDA’s most rigorous attention should be given to applications that provide CDS in an automatic and autonomous way, and which intervene directly, based on patient care data. AMIA’s comments were delivered by Meryl Bloomrosen, vice president for public policy and government relations.
AMIA cautioned the FDA about the future blurring of lines between CDS information delivery channels and mechanisms, devices, and applications intended for the use by clinicians and other providers, contrasted with those intended for patients, consumers and caregivers. AMIA also questioned the singling out of "stand-alone" CDS delivered via "mobile medical devices" as being suitable for FDA oversight, more than other kinds of clinical software environments, such as desktop computers.
In its presentation, during an FDA workshop on Sept. 12 and 13, AMIA focused on several areas for the FDA to focus on, including:
- The need for the FDA to articulate how it characterizes and defines "CDS."
- The need to coordinate efforts among federal agencies and public- and private-sector research and practice communities.
- The potential limitations if FDA focuses too narrowly on CDS; considerations of CDS on mobile devices as being separate from other CDS delivery methods or contexts.
- The importance of addressing emerging and converging technologies and devices, as well as new and evolving forms of patient care delivery (e.g., medical homes and accountable care organizations) and payment methods.