FDA announces plans to regulate mobile medical apps
The U.S. Food and Drug Administration announced Monday that it will regulate mobile medical applications that could put someone’s life at risk if they malfunction.
The FDA defines a mobile medical app as one used as an accessory to a medical device or that transforms a phone, tablet or other device into a medical device. For example, the FDA will regulate mobile apps that allow you to use your phone as an electrocardiogram to measure the electrical activity of your heart. If the app malfunctions, timely treatment could be delayed.
The FDA will not regulate mobile apps that help people manage but not treat their diseases, access personal or electronic health records, or give medical instructions or guidelines.
For example, the FDA won’t regulate the American Heart Association’s Pocket First Aid & CPR Smartphone app, which provides step-by-step instructions for basic first aid and CPR during a medical emergency.
Although online tools like the American Heart Association’s Heart360 act like other mobile apps, they won’t be regulated because they aren’t distributed through common app sites like Apple iTunes or Google Play. Heart360 will launch a responsive mobile website later this year.
The guidance is needed, given that by 2015, 500 million smartphone users worldwide will be using a healthcare application. By 2018, 1.7 billion smartphone and tablet users are expected to have downloaded mobile health applications, according to the FDA.
Click here for more information about the AHA/ASA blood pressure monitoring program.
Stories available for linking, quoting, excerpting, reprinting
Stories appearing on blog.heart.org under the "By American Heart Association News" byline are available for linking, quoting, excerpting and reprinting. Copyright is owned or held by the American Heart Association, Inc., and all rights are reserved. Permission is granted, at no cost and without need for further request, to link to, quote, excerpt or reprint from these stories in any medium as long as no text is altered and proper attribution is made to the American Heart Association. Additional conditions may apply to the use of these stories in printed materials.
American Heart Association additional conditions for linking, quoting, excerpting, reprinting stories in print media
- A credit line of American Heart Association News must be prominently placed on the page in which the American Heart Association materials appear.
- The American Heart Association logo and service marks may only be used if they appear on the materials requested.
- Stories reprinted may be edited for length, but no other deletions, alterations or other changes may be made without the prior written consent of the American Heart Association.
- Artwork labeled "American Heart Association" may be reprinted, but other artwork may not. For artwork permission questions, contact firstname.lastname@example.org
- Stories reprinted may not be placed adjacent to any advertisement, photo, graphic or other content that could be considered inappropriate by the American Heart Association. For questions about whether content is inappropriate, contact email@example.com.
- Stories may not be displayed in any way that gives the appearance that the American Heart Association endorses (implied or otherwise) or is affiliated with any product, service or company.