mHealth apps which the FDA will not regulate

18th June 2014 by Neeta Camadoo

The FDA issued its mobile medical application guideline back in 2013. This guideline applies only to medical apps that transform a mobile device into a medical device or an accessory to a regulated medical device, such as an app that regulates an installed pacemaker. Since this guidance was issued the FDA has provided a list of examples of mobile apps that they will not regulate because they pose a lower risk to the public. Good news for digital health? The list includes but not limited to:
  • 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];
  • providers that help track or manage patient immunizations by assessing the need for immunization, consent form, and immunization lot number [Added March 12, 2014];
  • 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];
  • 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 FDA will not view educational and informational apps as medical devices. However, apps that measure something are considered diagnostic; for example, a glucometer as it measures blood sugar. The glucometer itself would not be regulated as the screen provides information but the software that does the measuring will be regulated. The FDA will also look at how a device is used. If the glucometer is used to view blood sugar for better nutrition it will not be regulated. If it is marketed for diabetes it is likely be regulated as a medical device.