To keep up with the ever-evolving software applications intended for use on mobile or on general-purpose computing platforms and their potential benefits and risks to public health, on September 27, 2019, FDA issued a final guidance entitled “Policy for Device Software Functions and Mobile Medical Applications

FDA’s stance on regulating digital health products

FDA uses the term “digital health” as a synonym for “connected health”, focused on personalized medicine, which gives greater importance to patients and their needs, and on increasing the efficiency and quality of health care (digital healthcare).

The definition of “digital health” includes categories such as: mHealth (mobile health), health information technology, wearables, telehealth and telemedicine, as well as personalized medicine.

Focusing on certain aspects of software functionality present in mobile medical applications (or “apps”), the FDA expresses the intention to impose its regulatory control on “only those software functions that are Medical Devices and whose functionality could pose a risk to a patient’s safety if the device were to not function as intended.

Meanwhile, for low-risk functions, the FDA intends to exercise “enforcement discretion” (also known as selective application of the legislation) – a power that Government institutions and/or Competent Authorities (such as the FDA) have at their disposal.

Published on October 30, 2019