Washington, DCIn 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to the U.S. Food and Drug Administration's (FDA) invitation to participate in a public workshop related to FDA's Draft Guidance on mobile medical applications, AMIAthe association for informatics professionalsadvised the FDA on how it should approach oversight of clinical decision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 cliniciansmany of whom are becoming quite
|Contact: Nancy Light|
American Medical Informatics Association