Before even more mobile health products flood the market and formats expand into currently unimagined designs, it's imperative for the government to improve how it oversees and regulates healthcare apps and devices, a growing number of industry experts say.
Without a new approach, consumers risk aggravated conditions or even death due to poorly designed, fraudulent, or dangerous technologies, these critics say. Healthcare providers, too, find it increasingly difficult to discern valid from invalid apps, making it tougher to recommend mHealth apps to motivated patients. The market for mHealth apps, expected to reach $26 billion by 2017, needs more oversight -- even as proponents worry about constrictive bureaucracy that strangles innovation and investment.
Some apps disappear naturally, while others were pulled after government intervention. Yet users can still buy apps claiming to "cure" chronic pain, tinnitus, or phobias. Certain apps that claimed to analyze urine or read EKGs are no longer available.
Yet if a developer removes an app from an online store, users can still use the poorly designed or faulty software if they already own it, say Benjamin Jelle Visser and Johnathan Bourman on Medscape. Nor is there always a simple way for consumers to discover any conflict of interest an app developer might have, they said. Privacy concerns abound, and some apps may collect personal health information insecurely. Of the more than 43,000 mHealth apps available on iTunes in mid-2013, most do little more than provide information, with only 16,275 directly related to health and treatment, according to IMS Institute for Healthcare Informatics, in "Patient Apps for Improved Healthcare."
To improve adoption, IMS recommends: "There must be recognition of the role apps can play in healthcare by payers and providers, as well as regulators and policymakers; security and privacy guidelines and assurances established among providers, patients and app developers; a systematic evaluation of apps to inform their appropriate use; and the effective integration of apps with other aspects of patient care."
Today, the Food and Drug Administration (FDA) ensures medical devices are safe and perform as advertised. In April, a federal advisory panel published the "FDASIA Health IT Report," which reported the FDA cleared approximately 100 mHealth apps -- including remote blood pressure, heart rhythm, and patient monitors, plus phone-based ultrasounds, electrocardiographic, and glucose devices. The Office of the National Coordinator for Health Information Technology (ONC), which historically focused on electronic health records, is authorized to certify other forms of healthcare technology. In addition, the Federal Communications Commission, which often works closely with the FDA, has jurisdiction over equipment that uses radio frequencies.
Industry advocates contend too much oversight will stunt the innovation needed for app development. They worry layers of bureaucracy, red tape, or lack of technology understanding will generate unnecessary reviews for even the most mundane upgrade. On average, it takes more than five months for the FDA to clear a 501(k) medical device application, according to Emergo Group's review, based on FDA applications between 2006 and 2013. In both 2012 and 2013, it took an average of 166 days, the survey of more than 24,000 submissions found.
Time is only one consideration -- especially when consumers' health could be at risk, said a recent article in the New England Journal of Medicine (subscription required). More FDA oversight will help protect the public health, increase consumer confidence, and encourage even more innovations, wrote Nathan Cortez, an associate professor of law at Southern Methodist University Dedman School of Law, in NEJM. While the FDASIA report includes a small FDA role, Cortez and his peers recommend a "robust FDA."
Although the department would require more resources, the government could expand the FDA's role to include the existing gray area of mHealth apps: programs that qualify as devices but are believed to pose less risk because they track attacks, check symptoms, or involve behavior modification for patients with psychiatric conditions, the Journal article said.
Some devices, which now fall under the discretionary category of exempt products, according to FDA guidelines, could create consumer confusion or a false sense of comfort (or worry). Some apps the FDA approved are considered "substantially equivalent" to earlier devices; at times, an earlier device may refer to something developed before apps became available, Cortez wrote.
The FDA is acting appropriately to safeguard consumers and provide users with plenty of new options, Jeffrey Shuren, director of the FDA's Center for Devices and Radiological Health told The Hill.
"We have worked hard to strike the right balance, reviewing only the mobile apps that have the potential to harm consumers if they do not function properly," he said. "Our mobile medical app policy provides app developers with the clarity needed to support the continued development of these important products."
Complementary options include sites featuring independent reviews by medical professionals or healthcare organizations' use of enterprise app stores that include only tested and validated apps. It's unlikely many of the following apps will appear in those stores. Click the first slide to find out more.