The recent surge of new health and fitness apps holds many implications for the Food and Drug Administration (FDA). As overseers of public health and safety, the FDA will have its hands full with the new wave of health apps expected to be released in the near future. Current apps are non-clinical and are used as step counters or heart beat monitors. However, new health apps are expected to include more advanced biometrics and measure real-time blood pressure, glucose and oxygen levels. Many are wondering if the FDA is prepared to regulate these complex devices to ensure maximum safety and productivity.
The FDA has a responsibility to monitor the safety and efficacy of consumer health products. Recently, these products include more clinical apps as well as devices purchased at the drugstore. Dr. David Bates of Brigham and Women's Hospital and Physicians Organization chaired a group of FDA advisors on how to review health apps and to advise the product developers.
“It was intended to help them think through the risk factors involved with these products and then give guidance on how to stay within the guidelines,” Bates said. “The device makers were asking from some guidance from The FDA on what types of things would be accepted and what wouldn’t,” When asked about how the FDA's guidelines would affect new medical devices, Bates replied, “The FDA definitely wants innovation to continue in clinical devices. In general the FDA knows that the vast majority of apps are just informational.”
FDA Spokeswoman Jennifer wrote in an email to VentureBeat that her agency is concerned with two types of app/device combinations. The first are apps that are used as accessories to medical devices that are already regulated by the FDA. An example of this would be an app that allows a doctor or physician to access an image from a hospital database and make a subsequent diagnosis based on it. The second type of apps the FDA is focused on are those that turn a smartphone or tablet into a medical device by using that device's sensors, software or accessories. An example of this would be an app that turns your smartphone into a machine that allows to you monitor heart rhythms.
The difficulty with regulating the new health apps is that the line between “consumer-focused” and “clinical-focused” is becoming blurrier, according to Orthospinenews.com. Some of the consumer health apps and devices that will soon be connecting with the new health platforms offered by large tech companies like Apple (Health Kit) and Google (Google Fit) may present new mixtures of clinical and non-clinical features and functions. The FDA will need to continue refining its review and approval process for such products.
To solve this issue, the FDA needs a special group to monitor consumer health apps and devices, according to Epstein Becker & Green attorney Brad Thompson. “Within the compliance division at the Center for Devices and Radiological Health (the unit within FDA that has responsibility for medical devices), they should develop a small unit, perhaps even just one person, to spend their time looking at the various mobile app marketplaces, searching for certain keywords that are indicative of FDA regulated functionality,” Thompson said. “It would really not take much in the way of resources to do exactly that. I think they're doing a little bit of that now, but not very much.”
As the larger software companies begin to bring health apps into the mainstream, safety regulations from government agencies will increase. The FDA must be prepared to handle this situation effectively and monitor these devices to ensure consumer safety. It should work together with big software companies like Apple and Google to develop and regulate health devices that benefit the consumers, eventually leading to a more fit and happy nation.
Edited by
Maurice Nagle
