The U.S. Food and Drug Administration maintains a list of types of mobile apps the FDA could possibly regulate under the department's regulation framework, but for which it has chosen to exercise discretion.
On June 11, the FDA added a category to this list that mentions many of the features of Apple's new HealthKit mobile platform: "Mobile apps that allows a user to collect, log, track and trend data such as blood glucose, blood pressure, heart rate, weight or other data from a device to eventually share with a heathcare provider, or upload it to an online (cloud) database, personal or electronic health record."
Introduced June 2, Apple's HealthKit combines data from other health-tracking apps and displays composite information in a dashboard format through a new app called Health. The platform is designed to help users monitor their own health and fitness, and also to provide a new way to communicate with providers. Developed in partnership with Rochester, Minn.-based Mayo Clinic and Epic, the app is expected to be able to interface with providers' IT systems to allow patients to share information with providers or add directly to their EHR.
"With your permission, each app can use specific information from other apps to provide a more comprehensive way to manage your health and fitness," according to an Apple news release. "For example, your blood pressure app could share its data with a physician app, such as the Mayo Clinic app, so your doctor can provide high-quality guidance and care."
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