Does the FDA Regulate Mobile Apps Designed for Health and Wellness?

Health and wellness mobile apps and online programs raise a variety of legal and regulatory issues that require legal expertise in structuring a health education or healthcare products or services business.

Telemedicine issues are at fore, with questions such as licensing, privacy and confidentiality (and HIPAA), and contractual issues.

FDA issues also can arise. Healthcare apps can have a variety of purposes. Some can help patients keep track of health goals, or, can help coach patients toward those goals. Others provide information storage for physicians and other members of the caregiving team, such as chiropractors, acupuncturists, wellness coaches, homeopathic physicians, naturopathic doctors, and others. Still other mobile apps have functions such as connecting doctors and patients.

In general, whenever a product makes a claim related to diagnosis or treatment, it can be regulated by the FDA as a medical device. If the product’s claims are limited to general health, wellness, and lifestyle, and do not claim a medical purpose, the product is not a medical device and thus is outside FDA purview. A product is a medical device if it is as “an instrument, apparatus, implement, machine, contrivance . . . which is . . . intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man,” among other things. FDC Act § 201(h).

The FDA has a Draft Guidance for Industry and Food and Drug Administration Staff – Mobile Medical Applications (issued 7/11/11). In this guidance, the FDA states that mobile apps such as the following are outside the medical device definition:

  • Mobile apps that are solely used to log, record, track, evaluate, or make decisions or suggestions related to developing or maintaining general health and wellness, if not intended to cure, treat, diagnose, or mitigate a specific disease, disorder, patient state, or any specific, identifiable health condition.
  • Mobile apps that are used as dietary tracking logs and appointment reminders, or provide dietary suggestions based on a calorie counter, posture suggestions, exercise suggestions, or similar decision tools that generally relate to a healthy lifestyle and wellness and are not intended to cure, mitigate, diagnose, or treat a disease or condition.

On the other hand, the apps below likely would be considered subject to medical device regulation:

  • Apps that allow users to input their health information and through the application of formulas, data comparisons, or processing algorithms, issue a diagnosis or treatment recommendation that is specific to that person, such as his or her risk for colon cancer or heart disease, or recommend that the patient take a certain medication or seek a particular treatment.
  • Software that is intended to be used to physically or wirelessly connect to and download information from a diagnostic device like a glucose meter to allow the user to display, store, analyze, and/or keep track of his or her medical data values.

One of the key issues in analyzing whether a mobile application is subject to FDA regulation is to look at the claims or indications and whether these bring the product within the definition of a medical device, as elaborated within the FDA guidance.

Contact the Cohen Healthcare Law Group’s FDA legal team for legal advice concerning your mobile app. Be sure your marketing materials, including website, get legal compliance review to determine whether FDA medical device regulations are triggered.

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