The critical factor in determining the risk posed by different types of clinical decision support (CDS) software is whether that support “is mediated by a human being,” stated AMIA in a comment letter sent to the FDA, which is preparing draft guidance on mobile medical applications. The FDA’s most rigorous attention, AMIA advised, should be given to applications that provide CDS in an automatic and autonomous fashion and which intervene directly, based on patient care data.
AMIA cautioned the FDA about the future blurring of lines between CDS information delivery channels and mechanisms, devices, and applications intended primarily for use by clinicians and other providers, contrasted with those intended for patients, consumers and their care-givers. 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.
The FDA held a workshop on the topic that fostered discussion between its officials and interested stakeholders about the agency’s proposed oversight approach to mobile medical applications. The applications under discussion are those that serve as accessories to other medical devices, that are stand-alone software that provide clinical decision support, and that are for use on smartphones and other mobile computing devices. Prior to the workshop, the FDA had identified a subset of mobile medical applications that might have impact on the performance of currently regulated medical devices and, as such, would require FDA oversight.
In its presentation, AMIA focused on the following areas:
- 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, and considers CDS on mobile devices as somehow separate from CDS based on other delivery methods or contexts.
- The importance of addressing rapidly emerging and converging technologies and devices along with new and evolving forms of patient care delivery (such as medical homes and accountable care organizations) and payment methods.