Since issuing its mobile medical applications guidance, the FDA has offered a number of clarifying statements, intended to give the regulated community a clearer idea of whether and when to expect any particular mHealth application to be considered a device.

Last week, the FDA added a category of applications with respect to which it intends to "exercise enforcement discretion" (i.e., not regulate):

  • Mobile apps that allows a user to collect, log, track and trend data such as blood glucose, blood pressure, heart rate, weight or other data from a device to eventually share with a heath care provider, or upload it to an online (cloud) database, personal or electronic health record. [Added June 11, 2014].

Other recent additions to the list include:

  • Mobile apps for providers that help track or manage patient immunizations by assessing the need for immunization, consent form, and immunization lot number [Added March 12, 2014];
  • Mobile apps that provide drug-drug interactions and relevant safety information (side effects, drug interactions, active ingredient) as a report based on demographic data (age, gender), clinical information (current diagnosis), and current medications [Added March 12, 2014];
  • Mobile apps that enable, during an encounter, a health care provider to access their patient’s personal health record (health information) that is either hosted on a web-based or other platform [Added March 12, 2014];

The more specific the FDA is willing to be, the better. Clarity is key for both the regulators and the regulated community. The FDA is apparently looking to greater self-regulation on the EHR front, and that sensibility seems to be rubbing off a bit here, too.

David Harlow
The Harlow Group LLC
Health Care Law and Consulting