Regulatory Standpoint: Wearables and Healthcare

by: Dinesh Puppala

Wearables have raised up as the next big thing in medical field. A number of tech giants are pouring into this segment, wearables have already shown an impact on various fields such as communication and navigating; but perhaps the greatest potential lies in healthcare.

Widespread adoption of Wearables to monitor the wearer’s vital signs and other indicators seems to be the future of healthcare, making it easier for data collections which in turn could reduce health care costs. Many early adopters, patients and clinicians are already using mHealth apps on their smartphones and other devices, According to Robert Wood Johnson Foundation reports number of wearables and apps will grow by 25 percent a year. Their study also projects that by 2018, 1.7 billion people worldwide will download a health app and use some wearable device. Some experts say we are already in the Wearables era and Apple Inc., has taken it to the next step by releasing the HealthKit few months back. Stanford university hospital and Duke University have already launched trials with diabetics and chronic disease patients using this unique platform to integrate data from applications already used by medical devices such as glucose monitors and blood pressure tracking devices.

Wearables along with being used as a personal fitness, sleep tracker can be a potential solution to in-house monitoring and many other challenges faced during clinical trials. One important such problem faced in various studies involves a connecting number of surface electrodes to the participant/patient to collect data, which may be intimidating and may affect their natural responses. But the use of wearables which makes little or no difference will help record data measures as naturally as possible. As the potential applications are almost limitless, investors and industries are currently very active making the market buoyant at the moment. As wearable technologies evolve to be clinically-focused, U.S. Food and Drug Administration is rightly concerned about the potential problems caused to consumers, more importantly focused on the security of these medical devices. FDA released its latest guidelines “Steps to strengthen cybersecurity of medical devices” on October 1st, 2014 and also had a workshop scheduled for the industry on October 21st. Key recommendations in the guidelines were focused on data security to be considered from the initial stages of product design, and not added on as a patch. Specific concerns include malware, data corruption and unauthorized dissemination of patient information and password leaks. The U.S FDA regulates medical devices which are classified based on their intended use, most fitness apps and current wearables don’t fall under its jurisdiction, but clinically focused mHealth apps and devices will. The U.S FDA intends to exercise enforcement discretion for the majority of mobile apps that meet the definition of device. U.S FDA has cracked down on a small number of mobile medical apps and medical device companies which make medical claims, but did not seek regulatory approval in recent years. To avoid liability, developers typically include disclaimers in their terms of use. But these are often buried, stating “Warning: The instrument, although accurate, is not an actual medical equipment. Consult your physician” but most users tend to ignore such information from the app’s description.

A 2012 study by the New England Center for Investigative Reporting revealed that of 1,500 health apps it evaluated, 20 percent claimed to treat or cure medical problems, but only a small percentage of them had been clinically tested or approved. Although Regulatory authorities across the globe are trying to enforce strict regulations to avoid such applications and devices to be marketed. To truly make this technology the future of healthcare, wearable technology in healthcare has to cross the boundary from consumer electronics devices to regulated medical devices, Companies need be more proactive in self reporting and help the user make an informed decision.

Be on the lookout for oppurtunities to work in these device companies which are actively recruiting biomedical engineers, regulatory and quality associates among many other positions. Some popular wearable tech companies would be Google, Apple, Fitbit, Pebble, Philips, and Atlas wearables (Johns Hopkins Alumni Startup).

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