Raise your hand if you have ever downloaded a fitness or nutrition tracker app. What about an app to track your fertility or blood sugar levels? While one source states nearly 2 out of 3 medical/health apps focus on general health topics like diet, stress, or fitness, other apps focus on specific health conditions like pregnancy, diabetes, mental health, or medication information and reminders.
The number of health and medical apps available for smartphones is growing exponentially (as of 2015, upwards of 165,000). A cross-sectional survey of mobile phone users indicates that those who have downloaded apps trust the accuracy of apps and that their data is safe (Krebs, 2015). But is anyone or anything monitoring or regulating these apps for their legitimacy?
The Food and Drug Administration (FDA) and Federal Trade Commission (FTC) are the two agencies tasked with overseeing the development and marketing of medical apps. However, they oversee a fairly small proportion of the available apps. This is because the FDA limits their oversight to those apps that are considered a medical device, meaning anything intended to diagnose, cure, or prevent disease or to affect the structure or function of the body. The FTC only looks in to apps that make unsubstantiated health claims.
At this time, there isn’t enough evidence to identify which apps work better than others. So, if you find yourself in the market for an app for health or wellness reasons, keep the following in mind:
- What is the risk of using the product? If the app is intended to diagnose or help treat a medical condition, it will likely need to have FDA approval and you want to be careful with your selection.
- What is the evidence behind the app? Does the app’s website provide any links to legitimate evidence that the app supports or leads to the intended effect?
Technology has provided a wonderful opportunity for monitoring our health, promoting and supporting behavior change, and sharing information with our health providers. But with all the available options and potentially for positive, or negative effects, we need to be informed consumers.
Federal Trade Commission. Developing a mobile health app? Find out which federal laws you need to follow. https://www.ftc.gov/tips-advice/business-center/guidance/mobile-health-apps-interactive-tool
Krebs P & Duncan DT. Health app use among US mobile phone owners: A national survey. JMIR Mhealth Uhealth. 2015 Oct-Dec; 3(4): e101.
Mirsa, S. New report finds more than 165,000 mobile health apps now available, takes close look at characteristics and use. iMedical Apps + MedPage Today. September 17, 2015. https://www.imedicalapps.com/2015/09/ims-health-apps-report/
Molenti, M. Wellness apps evade the FDA, only to land in court. Wired. April 3, 2017. https://www.wired.com/2017/04/wellness-apps-evade-fda-land-court/
Radcliffe S. Who regulates all these health-related apps? Healthline. September 14, 2017. https://www.healthline.com/health-news/who-regulates-all-these-health-related-apps#4
US Food & Drug Administration. Is the product a medical device? https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/ClassifyYourDevice/ucm051512.htm