FDA Regulation and Digital Health Research: What You Need to Know

By: Emily G. Lattie, MS, SBM Digital Health Council member | Published: March 27, 2015

On February 9, 2015, the FDA released updated guidance regarding the regulation of mobile medical applications. With rapid advances in mobile technology, many believe that the continued revision of these guidelines will be needed to ensure patient and user safety. With a growing constituent of our members involved in digital health research, the Digital Health Council offers this examination of the potential impact of FDA regulation for behavioral medicine research.

As the guidelines currently stand, the mobile applications most frequently developed and evaluated by SBM members will likely not be subject to FDA regulation. For example, mobile applications intended to serve as educational tools for medical training or as straightforward educational resources for patients are not classified as medical devices. However, the tools that many of our members are developing and evaluating are likely to fall into a category in which the FDA intends to exercise enforcement discretion. This means that formal approval by the FDA will not be needed prior to commercialization but the agency retains the option to take enforcement actions if safety concerns are identified. Included in this category are those applications designed to teach and prompt behavioral coping skills, to track health information and prompt suggestions based on tracked information, and to access personal health information and communicate with health care professionals. The applications included in the recently launched Apple ResearchKit appear to all fall into this category, as they are primarily tracking symptoms and lifestyle activities with regards to asthma, Parkinson’s disease, diabetes, breast cancer treatment, and cardiovascular disease.

The types of mobile applications under the focus of FDA regulatory oversight at present are those that transform the mobile medical platform into an already regulated medical device. Examples of these include an application that can control or change settings on a device such as a blood pressure cuff, an application that uses an attachment to the mobile platform to measure blood glucose, or an application that uses a tool within the mobile platform such as the speaker to produce tones used for conducting a diagnostic hearing evaluation that could assist in the diagnosis of disorder. The current guidelines further state that, as long as they do not introduce the devices in to commercial distribution, both licensed practitioners who manufacture mobile medical applications for their own professional practice and individuals who manufacture these applications solely for research, teaching, and/or analysis are exempt from registering their devices. As the mHealth ecosystem grows, within initiatives such as Apple’s ResearchKit and others that are sure to emerge, it will be interesting to see the distribution of tools that fall within and outside of FDA regulatory oversight, and whether the anticipation of FDA approval requirements pushes innovators toward less device-integrated solutions.

In short, commercial applications that function as diagnostic tools or control the function of existing medical devices are up for regulation, while most applications based in behavioral medicine will continue to be generally exempt from FDA regulation.

How appropriate do you think these regulations are in the current health care climate? Please answer a one-question poll and view the results.

These regulations raise a number of questions for us. What does the possibility of FDA regulation mean for the future of digital health in behavioral medicine? How can we ensure that the products we’re developing are safe and efficient for health care consumers? How might mobile medical device regulation impact our abilities to disseminate and implement the products we’re developing? Join our discussion on LinkedIn.