This week, the American Medical Informatics Association delivered a presentation during an FDA workshop advising the agency on how to approach oversight of mobile clinical decision support systems, Health Data Management reports (Goedert, Health Data Management, 9/14).
FDA's workshop aimed to spark conversation about the agency's recent draft guidance on the regulation of mobile medical applications (Rodak, Becker's Hospital Review, 9/14).
During its presentation, AMIA recommended that FDA not focus solely on clinical decision support systems or consider mobile health apps independently of other delivery systems.
The presentation stated that clinical decision support programs "are likely elements in all clinical systems, whether implemented on mobile platforms or on tethered workstations." It added, "Their safe and effective use will be dependent on the quality of the associated [health IT] environment, regardless of whether it is running on a mobile device or in a main frame setting."
AMIA also called for the development of best practices in health IT design and deployment, which could "have a major effect on the quality of [clinical decision support] implementations" (Health Data Management, 9/14).
Experts Discuss Definitions of Mobile Health Accessories
Also during the workshop, FDA sought feedback on how it should approach regulation of mobile medical device accessories (Becker's Hospital Review, 9/14).
Bryan Benesch -- a consumer safety officer in FDA's Center for Devices and Radiological Health -- said, "Traditionally an accessory just physically connects to a medical device," adding, "There may be situations where you have many products tied in a string until it ultimately gets to the device. And that’s not a situation that we generally see or regulate."
Benesch solicited comments from workshop participants, who offered recommendations on how FDA could define medical device accessories.
FDA officials said the agency will post workshop materials to its website as documents become available (Pearson, CMIO, 9/13).