RWJF-Health Affairs Policy Brief: mHealth and FDA Guidance

This policy brief from the Robert Wood Johnson Foundation and Health Affairs examines the recent FDA guidance for regulation of medical applications (“apps”) on mobile devices. Consumers may use mobile health (“mHealth” apps to monitor their own health. Doctors or other health care providers similarly can use the apps to engage patients in the tracking of their health. New mHealth apps enter the marketplace daily, and they will continue to do so, particularly as mobile devices become more common and as the technology behind mobile hardware and software advances. Such technology allows for increasingly sophisticated mHealth applications and may even transform a smartphone or a tablet into a medical device. Unlike a tracking mechanism that merely captures data, medical devices are instruments that help diagnose, prevent, or treat an illness or condition.

Part of the Food and Drug Administration’s mission is to protect the public by making sure drugs, medical devices, and other health-related products are both safe and effective. To continue this mission in the mHealth sphere, the agency must ensure that certain mobile health apps, specifically those considered to be medical devices, are demonstratively safe and that the apps function as the companies who make them claim.

It is also the FDA’s mission to advance public health by moving lifesaving technologies through regulation, both to ensure products’ safety and to help them come to market. With this in mind, it is also important that the FDA provide guidance to the companies that make and sell mHealth apps, so that the companies know when regulations apply and how to comply while making new products available to consumers.

The stakes are extremely high as this emerging market for mHealth apps grows rapidly. Industry experts suggest that 500 million consumers and health care providers will use a mobile health app within the next two years. In five years, half of the 3.4 billion mobile device users worldwide will download a health app. The FDA already receives thousands of medical devices to review each year. Between fiscal years 2008 and 2010, for example, the agency received more than 13,600 devices for review. Regulating new mobile medical devices will add to that burden. The FDA has cleared more than 100 mobile health apps during the past 10 years, 40 of which came through during the past two.

In September 2013, the FDA issued guidance on the regulation of medical mobile apps: “The FDA intends to apply its regulatory oversight to only those mobile apps that are medical devices and whose functionality could pose a risk to a patient’s safety if the mobile app were to not function as intended.” By using its enforcement discretion to provide oversight to a small subset of health apps, the FDA hopes to strike a balance, ensuring patient safety without stifling innovation.

The FDA will not regulate consumer-operated apps that track general health or health care-operated apps that monitor health records or medical appointments. Nor will it regulate any that make available reference materials such as prescription drug directories or medical texts or are otherwise used for educational purposes. These types of mHealth apps are not typically considered to be medical devices and pose a minimum risk to consumers and patients.

The FDA will, however, regulate apps that are classified as medical devices, either working together with existing medical equipment or turning a mobile device into a medical device. In either case, this means that the device is intended to diagnose, treat, or cure specific health problems. If such apps were to malfunction, they pose a risk to consumers and patients. The FDA’s decision to regulate such apps is in line with the agency’s role in the oversight of medical devices in general. Mobile health apps that require FDA oversight will go through the same stringent reviews already required for medical equipment.

The FDA’s September 2013 does not have the enforcement authority of legislation or regulations. The agency is proceeding cautiously while the medical mobile app market continues to evolve. Meanwhile, the Safety and Innovation Act does require the FDA, working with the Office of the National Coordinator for Health Information Technology, and the Federal Communications Commission to help develop a broad risk-based regulatory framework for health information technology (IT) that includes regulation of mobile medical applications. The FDA’s report must be submitted to Congress by January 2014. Among many topics, it is expected outline how mobile health regulation will work in practice.

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