The United States will supervise and only regulate apps implying health risks for patients

On the past 25 September, the FDA published the report Mobile Medical Applications. Guidance for Industry and Food and Drug Administration Staff. In this guide, the North American medical agency set out the control it will exercise over the “mobile medical applications” which fit in the established definition of “medical device”, and particularly those of greater risk to patients if they failed to work as expected.

Therefore, the group of applications that the FDA will regulate includes the apps which turn smartphones or tablets into medical devices, such as that which can turn a mobile telephone into a portable electrocardiogram machine (ECG), an application which has already been approved by the agency. The team responsible will also supervise the applications used as accessories by medical devices already regulated by the FDA, such as those that serve to electronically record blood pressure data obtained with a tensiometer, to mention but one.

The United States agency will apply the same risk-based criterion they had already used to guarantee the efficiency and safety of the healthcare devices it regulates, by distinguishing moderate risk from high risk apps. For example, in the case of an app to interpret x-ray images on a mobile apparatus, the FDA will have to consider aspects that might cause distortion in the diagnosis: the limited size of the display, poorer image contrast or the effects of environmental light.

As for the mobile medical applications that fall within the definition of a mobile device but whose risk is small for users, the FDA will act on its own discretion, that is, it may act or refrain from doing so. It will not be necessary for manufacturers of apps to register them or present an application for revision by the agency before they are marketed. This case includes the apps which:

• Help patients as users to deal with their own illness or health problems without offering specific treatment conditions.
• Provide patients with simple tools to organise and follow up on their health data.
• Provide patients access to information related to their health condition or treatment.
• Help patients to document, show or report health problems to the doctors.
• Allow patients or healthcare professionals to interact with personal health records or other electronic health recording systems.

However, the document does not contemplate the regulation of the sale or general use of smartphones or tablets by citizens of the United States. The FDA will not act on organisations exclusively distributing mobile medical apps either, such as the iTunes or Google Play stores. Furthermore, the agency will have no power over the manufacturers of mobile platforms even though the mHealth apps work or are run on such apparatuses. 

25 years regulating healthcare ICTs in the United States

This regulation dates back to 1989, when the FDA drew up a software policy project to determine whether computers or specific software might be considered medical devices and if so, how this should be regulated. With the exponential growth in the use of ICTs in healthcare and the diversification of the products, the policy project was withdrawn in 2005.
Later, in 2011, the FDA published a regulation to classify the devices used in electronic transfers, storage, viewing or conversion of data formats obtained with other medical devices.

With the report in September 2013, the FDA hopes to give a drive to apps that truly improve healthcare and provide reliable health information for both citizens and healthcare professionals. When it is necessary to add new policies to the project, the North American agency has planned to follow a public process in which the opinion of patients, healthcare professionals and apps creators and distributors will be considered.

Further information

• Mobile Medical Applications. Guidance for Industry and Food and Drug Administration Staff. U.S. Department of Health and Human Services – Food and Drug Administration, Center for Devices and Radiological Health, Center for Biologics Evaluation and Research, 25 September 2013 [access: 3 October 2013]. Available at: http://www.fda.gov/downloads/…
• Mobile Medical Applications. FDA. U.S. Food and Drug Administration, 25 September 2013 [access: 3 October 2013]. Available at: http://www.fda.gov/MedicalDevices/…
• F.D.A. to Regulate Some Health Apps. New York Times, 23 September 2013 [access: 3 October 2013]. Available at: http://www.nytimes.com/…