Issue link: http://viewer.e-digitaledition.com/i/373900
O NE BY-PRODUCT OF health care reform, or perhaps even in its absence (given today's emphasis on patient- centered medical homes, as well as preventive and wellness initiatives), is that many patients — not just Millennials — are taking greater control of their personal health. Couple that with the ubiquitous use of smartphone technology, and is it any wonder that the number of mobile medical apps is proliferating like dandelions that pop up on my lawn each spring. In fact, the research company GlobalData predicts that the mobile health technology market is expected to exceed $8 billion by 2018. We're way past Medical Diagnosis for Dummies and other such "self-help" books. We're even beyond WebMD, the website that allows patients, after just a few minutes, to become more "expert" about their medical issue than what the treating physician knows after years of education, training, and experience. We're talking about literally hundreds of medically themed applications that are now available, with simply a click to download, at Apple's App Store, Google Play, and myriad of other sourcing venues. Among the apps is a cuff-less instant blood pressure monitor that, according to the manufacturer's description, "lets you measure your blood pressure using only your iPhone." Apparently, all you have to do is press your smartphone against your chest, put your index finger against the camera, and voila--in less than 50 seconds, you get a systolic, diastolic, and heart rate measurement. Does it really work? Is the reading accurate? Maybe, maybe not. The "Instant Blood Pressure" app does contain the obligatory disclaimers: "for entertainment purposes only" and "not an FDA cleared medical device." The FDA recognizes and regulates mobile medical apps as devices, according to its "Mobile Medical Applications Guidance for Industry Food and Drug Administration Staff," issued last year. According to its website, the FDA focuses "only on apps that present a greater risk to patients if they don't work as intended and on apps that cause smartphones or other mobile platforms to impact the functionality or performance of traditional medical devices." Specifically, the FDA takes a tailored, risk-based approach, focusing on a small subset of mobile apps that meet the regulatory definition of "device," which "… are intended to be used as an accessory to a regulated medical device, or transform a mobile platform into a regulated medical device." The FDA's mobile medical apps policy does not extend to the sale or consumer use of apps that are available at general app stores. Consumers are left to rely on manufacturer claims, which may be exaggerated, and on readings that may not be accurate and ironically, may even prove dangerous. Non-FDA regulated medical theme apps, in some limited cases, may be adjunctive to the broad armamen- tarium of resources available to physician and patient alike. But, they do not take the place of traditional medical devices. Physicians cannot rely on what patients report as "results" from these apps and expect to meet the standard of care. In addition to asking patients questions about their use of OTC drugs and herbal supplements, physicians may consider inquiring about their use of mobile medical apps, and counsel them on reasonable, prudent expectations, as well as awareness of limitations. Joe Feltes is an attorney with Buckingham, Doolittle & Burroughs in Canton and a member of its Health & Medicine Practice Group. He is also the managing partner of Buckingham Canton. For more information about the law firm, go to www.bdblaw.com or e-mail Feltes at JFeltes@BDBLAW.com. ■ By Joseph J. Feltes, JD Patient, Heal Thyself? 1 8 | Cleveland/Akron/Canton MD NEWS ■ M D N E W S . CO M ■ S E P T E M B E R /O C T O B E R 2 0 1 4