Mobile medical apps: To regulate, or not to regulate?

Innovative uses of existing technology can advance disease management but may also bring potential for harm when used incorrectly

Hundreds, if not thousands, of mobile medical apps (MMAs) are available with an easy touch of a screen, promising anything from all-encompassing diagnoses and foolproof diet, medication, and exercise plans to turning your phone into a personal blood pressure monitor or disease tracker.

While this technology makes health care information more accessible to the public and can help patients become more autonomous and perhaps even more engaged, it also leaves room for confusion and misinterpretation of information that may do more harm than good.

FDA has defined MMAs as mobile apps that meet the definition of a “device” under existing FDA regulations (on FDA’s website, see [FD&C Act]) and is intended “to be used as an accessory to a regulated medical device; or to transform a mobile platform into a regulated medical device.”In essence, an app intended for use in diagnosing, mitigating, treating, preventing, or curing a disease is considered an MMA that is subject to FDA’s scrutiny. 

Rules and regulations

Observing the rapid expanse of app innovation, FDA recently released a guidance document to inform manufacturers, distributors, and consumers of their intent to evaluate and judge the potential risk of some of these mobile apps.1

For most mobile apps that pose a lower risk to patients, FDA abides by its “enforcement discretion,” which essentially means they will evaluate risk if the app is used incorrectly but will not enforce regulation as presented in the FD&C Act. Such apps include those that help patients manage their own diseases without actually providing specific treatment suggestions, provide patients simple tools to organize or track their health information (e.g., medication adherence alarms, blood pressure logs and trackers), and engage patients to interact with their electronic health records. 

FDA will regulate apps with more complex functions, including those that

  • Act as an accessory to a connected device and use the mobile platform to control inflation or deflation of a blood pressure cuff or delivery of insulin on a pump.
  • Serve as a medical device, such as a glucometer or stethoscope.
  • Use patient-specific information to calculate dosage plans or suggest treatment for disease. 

For apps that meet the criteria for a medical device, FDA will hold the app manufacturer accountable to the requirements associated with the corresponding class of the actual medical device.   

Impact on pharmacy

Many pharmacists readily use apps that identify drug interactions and provide a quick overview of dosing and adverse effects. These types of mobile apps, including medical dictionaries and training tools, will not be affected by the recent guidance. Newer technology that extends beyond the usual information lookup, promising to turn your phone into a blood pressure monitor, will be subject to stricter rules and regulations to ensure patient safety, privacy, and evidence-based information for the public. 

As pharmacists continue to help patients manage their diseases, simple tools for medication reminders, patient portal access, or even apps using GPS locators to help patients identify the time and place of their asthma triggers, for example, can still be used without worry. 

Innovative uses of existing technology can advance disease management but may also bring potential for harm when used incorrectly. Holding patient safety as the utmost priority, we must continue to learn about the various advances in technology and remember to check in with our patients from time to time to learn about their experiences as well.

Reference

Mobile medical applications: guidance for industry and Food and Drug Administration staff. . Accessed October 25, 2013.