MHealth Regulation

Background

The Food and Drug Administration (FDA) FDA first issued draft guidance "Policy for the Regulation of Computer Products" in 1989. The guidance was never finalized and instead retracted in 2005. It wasn't till February 15, 2011 that the FDA issued a regulation regarding computer and software that could transfer, store, display, or convert medical device data. The FDA later issued specific guidance for MHealth applications (apps) on September 25, 2013 which has been replaced by updated guidance on February 9, 2015. From the guidance we understand that the FDA doesn't want to regulate all MHealth applications since the "FDA intends to apply its regulatory oversight to only those mobile apps that are medical devices and whose functionality could pose a risk to a patient’s safety if the mobile app were to not function as intended."

MHealth Apps defined

The FDA guidance describes regulated apps as "meets the definition of device in section 201(h) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and either is intended: to be used as an accessory to a regulated medical device; or to transform a mobile platform into a regulated medical device.". The intent of an app considered when determining the applicability of regulation as a MHealth app. The MHealth app is designed or marketed to with the ability to perform medical device functions.

Regulated MHealth Apps

The 2015 FDA guidance provides three distinct classes of MHealth Apps which require regulation. They are:

1. Mobile apps that are an extension of one or more medical devices by connecting to such device(s) for purposes of controlling the device(s) or for use in active patient monitoring or analyzing medical device data.
2. Mobile apps that transform the mobile platform into a regulated medical device by using attachments, display screens, or sensors or by including functionalities similar to those of currently regulated medical devices. Mobile apps that use attachments, display screens, sensors or other such similar components to transform a mobile platform into a regulated medical device are required to comply with the device classification associated with the transformed platform.
3. Mobile apps that become a regulated medical device (software) by performing patient-specific analysis and providing patient-specific diagnosis, or treatment recommendations. These types of mobile medical apps are similar to or perform the same function as those types of software devices that have been previously cleared or approved.

Potentially Exempt from MHealth Apps

In addition to the areas listed above for regulated apps there are seven types of MHealth Apps which the FDA will apply discretion in regulating

1. Mobile apps that provide or facilitate supplemental clinical care, by coaching or prompting, to help patients manage their health in their daily environment.
2. Mobile apps that provide patients with simple tools to organize and track their health information.
3. Mobile apps that provide easy access to information related to patients’ health conditions or treatments (beyond providing an electronic “copy” of a medical reference).
4. Mobile apps that are specifically marketed to help patients document, show, or communicate to providers potential medical conditions.
5. Mobile apps that perform simple calculations routinely used in clinical practice.
6. Mobile apps that enable individuals to interact with PHR systems or EHR systems.
7. Mobile apps that meet the definition of Medical Device Data Systems.

References

Submitted by (Eric J. Vinson)