Washington, DC—In response to the U.S. Food and Drug Administration’s (FDA) invitation to participate in a public workshop related to FDA’s Draft Guidance on mobile medical applications, AMIA—the association for informatics professionals—advised the FDA on how it should approach oversight of clinical decision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, AMIA pointed out, 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, 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 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.
"AMIA’s comments are premised upon practical evidence that the health sector is exploding with an array of clinical information systems for potential use in a broad range of settings," said AMIA President and CEO Edward H. Shortliffe, MD, PhD, FACMI. "A growing volume of research demonstrates that health information technology in many forms and on many kinds of devices can improve the quality and safety of patient care, and promote efficiencies in overall care delivery. In this modern era of ubiquitous electronic data and access, it is important to have regulations that keep pace with clinicians—many of whom are becoming quite expert at using technology to access pertinent information, and thereby streamlining healthcare delivery and improving overall health."
The Sept. 12-13 workshop fostered discussion between FDA officials and interested stakeholders about the FDA’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 several key 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.
To view the full transcript of AMIA’s comments, click here www.amia.org/public-policy/positions-and-statements
AMIA is the center of action for 4,000 informatics professionals from more than 65 countries. As the voice of the nation’s top biomedical and health informatics professionals, AMIA and its members play a leading role in moving basic research findings from bench to bedside, evaluating interventions across communities, assessing the affect of health innovations on health policy, and advancing the field of informatics. AMIA actively supports five domains in informatics: translational bioinformatics, clinical research informatics, clinical informatics, consumer health informatics, and public health informatics.
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