The Mobile Medical Applications and FDA Oversight

December 2012Articles Garden State Focus

Development of Mobile Medical Applications (MMAs) is nothing new in the health care industry. These are software programs that run on mobile platforms such as iPhones and facilitate user’s access to certain medical information. They cover a wide range of capabilities, from allowing individual users to monitor their heart rate, blood pressure, calorie intake for healthy weight maintenance, to allowing doctors to view a patient’s X-rays on a mobile communications device. More advanced programs may even allow communications among patients who have downloaded the same MMAs, or their health care providers.

Aside from patient’s privacy-related issues surrounding the dissemination of one’s medical information, the information provided by the MMAs may cause the ultimate users or their health care providers to make treatment decisions. This idea prompted the U.S. Food and Drug Administration (FDA) to put the industry on notice as to the level of scrutiny that may be imposed on MMA develops.

Health care facilities relying on MMAs should exercise diligence in their procurement practices to minimize the impact on patient’s safety, particularly if a developer had a product recalled.

Facilities officers should be diligent in their procurement practices to ensure that MMA systems that facilitate exchange of information among staff or health care providers sufficiently satisfy their regulatory requirements. Should such products undergo a post facto FDA review and face a recall, the institution may be harmed in its daily operations. Therefore to avoid future loss of investment or delays in operational services, procurement officers should take the necessary steps to ensure adequate compliance of MMAs with the FDA regulations.