Medical Apps: The Wild West of Medical Technology
The introduction of medical apps have provided consumers the ability to track their medical, physical, or fitness progress. They can obtain medication information and track how many calories they burn. Recent data has estimated there are more than 100,000 mobile health apps available for Android and iOS systems.1 In addition, a recent study suggested there will be 142 million downloads of mobile health care apps by 2016.2
The major concern of the medical community and regulatory bodies is that these medical apps represent a “wild west” phenomenon. Very limited regulation, including guidelines and the ability of the FDA to enforce this technology, is available. Only 103 mobile apps are FDA regulated.3 Without proper oversight, medical apps can have a detrimental effect on patients, causing more harm than good. Pharmacists are concerned that patients receiving drug information from a medical app that is inaccurate can lead to a medication error. In addition, a recent editorial in the New England Journal of Medicine that addressed this issue suggested that mistakes with health apps might affect thousands of patients at a time, often without ready mechanisms for detection and correction.4
The FDA has begun the process of regulating apps associated with medical devices, but it is unable to keep up with what is entering the market. Case in point, an app called Instant Blood Pressure claims it can take your blood pressure reading in under one minute with no blood pressure cuff. It claims to use a patent-pending process developed by researchers at Johns Hopkins, a world leader in innovation. However, the device has never proven its efficacy, nor has it been tested in a scientific study. Aura Labs, the maker of the app, has received a cease and desist letter from Johns Hopkins as they are not affiliated with the technology.5
That any company can make a claim and then cleverly market information or a device is detrimental to patients. I can see how a patient would feel comfortable using technology that supposedly has been endorsed by researchers from a world-renowned institution. Although there is a “for entertainment purposes only” disclaimer, it is not readily visible on the Apple store or Google Play.5 Patients may experience a false sense of security using something that has not been proven or approved by the FDA. Currently, the FDA in investigating this app and others like it to ensure that consumers do not mistake them for medical devices. If warnings are not sufficient, the FDA plans to ask software companies to stop promoting the app, as well as asking companies such as Apple and Google to pull the app.
What are your thoughts on medical apps? Do you see them more of a benefit or hindrance? As a pharmacist, have you had patients using medical apps to receive medical information? Do you feel that patients are beginning to trust medical technology more than health professionals?
Michael J. Cawley, PharmD, RRT, CPFT, FCCM, is a Professor of Clinical Pharmacy at the Philadelphia College of Pharmacy, University of the Sciences. He has more than 25 years of experience practicing in the areas of medical, surgical, trauma, and burn intensive care as both a critical care clinical pharmacist and registered respiratory therapist.
References:
1. Boxall A. 2014 is the year of health and fitness apps, says Google. Digital Trends. www.digitaltrends.com. 2014 Dec 11.
2. Pelletier SG. Explosive growth in health care apps raises oversight questions. Reporter. www.aamc.org. 2012 Oct.
3. 103 FDA regulated mobile medical apps. Mobile Health News Research. www.mobilehealthnews.com. Accessed July 16, 2015.
4. Cortez NG, Cohen IG, Kesselheim AS. FDA regulation of mobile health technology. N Engl J Med. 2014;371(4): 372-379.
5. McMillan R. These medical apps have doctors and the FDA worried. www.wired.com. 2014 Jul 29.
