Cortez, N.G., Cohen, I., & Kesselheim, A.S. (2014). FDA regulation of mobile health technology. New England Journal of Medicine, 371, 372-379. doi: 10.1056/NEJMhle1403384. PMID: 25054722.
Since March 2013, more than 97,000 Mobile Health (mHealth) applications have become available to consumers. These mHealth applications allow consumers to use portable devices (smartphone, tablets) for medical purposes. mHealth applications have several potential benefits and could be used to improve the quality of medical care, decrease the number of office visits required for chronic conditions, and improve access to care for patients who are unable or unwilling to attend office visits. Despite these potential benefits of mHealth, the authors explain that most mHealth applications lack scientific support. While the Food and Drug Administration (FDA) typically review all medical devices, many mHealth applications are low risk so can be approved with minimal regulations, or are cleared without review because of substantial similarities to other approved medical devices. Although approved medical devices are subjected to FDA postmarketing surveillance, the traditional surveillance system is not easily adaptable to software because of the constant updates required to maintain software programs. The authors describe new FDA recommendations published in April 2014. These guidelines separate mHealth applications into three categories based on purpose: administrative applications, health and medication management applications, and applications performing medical device functions. The new recommendations propose having the FDA only oversee and regulate mHealth applications acting as medical devices. Other recently proposed bills also seek to limit FDA oversight of mHealth applications. The authors suggest that the challenge for the FDA is creating a regulatory program for mHealth interventions that encourages innovation, but prevents ineffective and unsafe applications from being sold to consumers. The authors propose updating FDA guidelines to include the regulation of software, and creating a different regulation pathway for mHealth interventions.