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FDA Announces Regulations of Mobile Medical Applications

Mobile medical applications (MMAs) are on the rise, providing immediate resources for people to manage their own healthcare from virtually anywhere. MMAs cover a wide range of functions, from apps that monitor caloric intake and suggest exercise routines apps that purport to differentiate between different types of skin cancer. Other apps give health care providers guidance in making diagnoses and treatments. But with the rising number of accessible virtual health care, and a predicted 500 million people using MMAs worldwide by 2015, the FDA has decided to step in and implement some standard regulations.

New FDA regulations are based on the same “risk-based approach the agency uses to assure safety and effectiveness for other medical devices.” There are guidelines for moderate-risk and high-risk mobile medical apps, apps that are not mobile devices, apps that the FDA will exercise enforcement discretion, and apps that the FDA will regulate.

The FDA will regulate MMAs that meet the definition of “device,” that are intended to be used as an accessory to a medical device, or transform a mobile platform into a regulated medical device. Enforcement discretion will be exercised on MMAs that fall under the definition of “device” but pose minimal risks to patients, such as apps that help patients self-manage their disease and enable patients to interact with Personal Health Records. Furthermore, the FDA will not regulate the sales or use of smart phones, entities that exclusively distribute mobile apps are not considered medical device manufacturers, and the policy does not apply to mobile apps that function as an electronic health record.

Examples of MMAs the FDA is regulating include ones that use a sensor or attachment to measure the electrical signal produced by the heart, the degree of tremor caused by certain diseases, and blood glucose levels. One even uses an attachment to treat acne, reduces wrinkles, and remove hair. MMAs that the FDA has cleared or approved, as of June 6, 2013, include a blood pressure monitor, diabetes management tracker, and ultrasound imaging system.

The rise of MMAs presents exciting new ways for physicians assistants to provide healthcare. Yet they also present a new challenge to stay on top of a growing field and to be knowledgeable about various apps that patients may be using. 

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Image: Wikimedia Commons