This past August, Apple released stricter guidelines for the health applications it will feature in its app store. In its developer guidelines, Apple states the apps may not disclose patient data to third party users, must require patient consent in order to disclose said information, may not peddle false information, and that these apps must be approved by an independent ethics review board. With roughly 20,000 medical apps available as of 2015, keeping track of which apps may potential harm users is no easy task.
Apps fall under a spectrum of general wellness products, according to the FDA’s 13 page General Wellness Guidelines for Low Risk Devices. The FDA defines a general wellness product as having “an intended use that relates to maintaining or encouraging a general state of health or a healthy activity.” According to guidelines, the FDA is the responsible party for monitoring and approving medical applications.
Currently, FDA guidelines surrounding health apps are extremely vague. In a statement, the FDA explained that they take “a hands-off approach to the regulation of low risk general wellness products that only promote a healthy lifestyle or that promote a well-known association between a healthy lifestyle and a certain disease or condition.” With that said, the FDA also claims to “monitor any safety signals that arise from the use of these products and take appropriate action necessary to protect the public health.”
It remains to be seen how Apple and the FDA plan to keep potentially unsafe apps off of the market.
“There’s plenty of opportunity to push crap,” between these guidelines, said Adrian Gropper, MD of HealthURL Consulting. His advice for helping to ensure apps available to consumers? Open source software.
“Medicine was never secret or proprietary until it started to be digital,” said Gropper. “If people had any notion of what it takes to have safe and effective advice they would not install anything that’s not open source software.”
Other groups are also considering ways to tackle this significant challenge. One of these is Ranked Health, run by MIT’s Hacking Medicine Institute and headed by Dr. Maulik Majmudar of Massachusetts General Hospital and Dr. Adam Landman of Brigham & Women’s Hospital. Ranked Health relies on the evaluations of researchers, clinicians and patients to determine which health apps are potentially unsafe. Their system for evaluating the apps is modeled on the peer review system: two reviewers independently review an application from the top 100 free and paid health apps in the Apple and Android store. Then, they grade it using three main criteria: effectiveness, functionality, and usability. These reviewers then coordinate for discrepancies and publish their grade to the Ranked website, where patients and consumers can view it.
Currently, the project is small in scope, focusing primarily on apps that cover chronic conditions, such as mental health, and conditions that affect large segments of the population, such as weight loss. The apps that Ranked Health review fall under both categorizations of a wellness product listed in the guidelines, so these efforts aid the FDA in monitoring potentially dangerous apps; however, if the project gains traction, they do state that they want to expand their review to rarer diseases and broader health categories.
This ranking system is one of the only ones of its kind currently on the market, as the site was launched in May 2016. Other app curators such as Jiff and Healthtap have seen success, but doctors are their main audience, not patients. And since the FDA is not involved in the creation or maintenance of these third-party review databases, doctor and patient communication is vital
Julia is a 2015 graduate of Mount Holyoke College, where she studied Psychology and Linguistics. Outside her work at MedTech Boston, she can be found playing ice hockey, cooking, and exploring the DC Metro area. Find her on Twitter @jkitsjulia
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