“There’s an app for that,” the catchy buzz-phrase trademarked by Apple in 2009, speaks to the abundance of mobile apps available in leading app stores. (Interestingly, while Apple owns the phrase, Google Play has a larger share of the market: as of March 2017, they offer 2.8 million apps vs. Apple’s 2.2 million.)
As of 2016, there were about 260,000 healthcare-related mobile (mHealth) apps available worldwide; analysts segment them in slightly different ways, but the apps fall into the following general categories:
- Overall health apps, designed to track and promote nutrition, fitness, and weight control.
- Women’s health apps, which focus on issues such as fertility, pregnancy, childbirth, and breastfeeding.
- Diagnostic apps, designed to generate awareness of and increase knowledge about various medical conditions for the general population; these apps can also act as a reference for health care professionals.
- Apps to help manage chronic conditions, such as asthma, high blood pressure, diabetes, cancer, and mental health diagnoses.
- Medication management apps, designed to improve adherence by creating schedules and alerts for the taking of prescription medicine.
- Health record apps, which allow people to store their personal health information (e.g. conditions, medications, allergies, test results); some allow sharing of this information with the person’s health care team.
There is a distinct difference between mHealth apps and mobile medical apps. While both are apps that run on smartphones and other mobile communication devices, mobile medical apps (as indicated on the FDA’s website) “meet the definition of a medical device and are an accessory to a regulated medical device or transform a mobile platform into a regulated medical device.”
So what exactly is a medical device? A simple definition, pulled from a medical dictionary, is “any health care product that is intended for the diagnosis, prevention, or treatment of disease and does not primarily work by effecting a chemical change in the body.” (The FDA’s official definition, as you might expect, is longer and more complicated.)
The bottom line for mobile medical app developers is that the FDA will “apply the same risk-based approach the agency uses to assure safety and effectiveness for other medical device” and provides a guidance document outlining how they might regulate certain moderate-risk and high-risk mobile medical apps.
The FDA also encourages developers to contact the FDA as early in their development process as possible if they have any questions about the level of risk of their app, and whether a “premarket” application is required; the email address is firstname.lastname@example.org.