FDA Says There’s An App for That — Medical Apps Guidelines

As California trial and injury lawyers, we have litigated cases involving dangerous supplements and medications that have caused injury and even death. We have represented victims and families whose lives have been changed by dangerous products that have ultimately been recalled by the FDA.

In our view, public access to medical and health information can be a good thing. But is also a mixed blessing when consumers have access without sufficient information or clinical testing.

We cannot foresee the future of the use of mobile media devices and medical information, but the Food and Drug Administration has just published draft guidelines that might give us all an indication as to where things are headed.

It is not surprising that mobile applications are becoming more widespread in the medical and health fields. It is also not surprising that the U.S. Food and Drug Administration is now seeking public comment on its intention to oversee some limited medical and health mobile applications using their regulatory authority. The FDA’s focus is narrow, but the development of guidelines in this area is another sign of the booming apps market and the regulation of medical and health information which has become more and more accessible to the public.

Quoting an outside source, the FDA notes the 500 million smart phone and other mobile device users will use a healthcare app in the next five years. Whether you use an app for fitness, calorie intake, diet guidance or other purposes — these uses are on the rise.

Even physicians are now communicating with patients through email and can review test results, such as MRI’s over mobile communications devices.

The director of the FDA’s Center for Devices and Radiological Health (who is a physician and a lawyer) has noted: ” ‘The use of mobile medical apps on smart phones and tablets is revolutionizing health care delivery … [o]ur draft approach calls for oversight of only those mobile medical apps that present the greatest risk to patients when they don’t work as intended.’ ”

The FDA has issued a draft of the guidelines they propose which is very focused in scope to “a small subset of mobile medical apps that impact or may impact the performance or functionality of currently regulated medical devices.” This subset includes mobile medical apps that: are added to existing medical applications, such as those involved with diagnostic tools and medical professionals’ communications; or those that actually enable the mobile device to become a medical or diagnostic tool, such as the use of a mobile device to detect heart rhythms.

To review the agency’s in-depth draft guidance document, intended for software manufacturers, distributors and others regarding the FDA’s intentions to apply its authority in this area please click here. The current view of the FDA is to apply its authority and regulatory requirements only to a subset of mobile medical applications noted earlier. However, as usage grows and consumers are drawn to these applications, it is possible the regulatory scope will broaden.

The California injury lawyers of Hersh & Hersh represent consumers in a wide-range of health and medical injuries, including medical devices and dangerous drugs. We are currently representing clients injured by transvaginal surgical mesh, DePuy Hip implants and Zimmer NextGen Knee Replacements. Please contact our law office for a free consultation with one of our trial lawyers.