The Wild West of mobile health apps may be getting a little smaller but it remains a part of the landscape. Despite an FDA that doesn’t shy away from issuing warning letters when it believes app developers make false medical claims, it’s also giving app makers the chance to come into compliance voluntarily. A Wired article took a closer look at a few blood pressure apps that are at best misleading and at worst, pose a danger to the public.
In an interview, Dr. Iltifat Husain, a faculty member in the Emergency Medicine department at the Wake Forest University School of Medicine, was critical of apps like Instant Blood Pressure for the lack of transparency and scientific evidence explaining how they function. Although Aura Labs claims to use a patent-pending process developed by a team from Johns Hopkins University, a call to the university made it clear that the developers had no affiliation with Johns Hopkins and that Aura Labs should expect to receive a cease and desist order.
The Instant Blood Pressure app is popular — the article notes it has been among the top 30 most-downloaded apps in the App Store’s Health and Fitness section. It claims it can take blood pressure readings without a blood pressure cuff by having users press their phone against their chest, and put their index finger against the camera. Despite the fact that each of the devices included in the article specifically say they are not cleared as medical devices and are for “recreational use” only, that kind of information tends to get buried in a sea of fine print. Few consumers will trouble themselves to read it.
Husain says he likes some mhealth apps, particularly drawMD and MicroMedx, so a bias against mobile health apps doesn’t come into it.
There have been efforts to whittle down the number of snake oil medical apps. The Better Business Bureau has cracked down on some and IMS Health called attention to a bunch. Ben Chodor’s efforts to set up a certification program at Happtique looked like they were going well until his departure from the organization last year. The program was suspended amidst criticism of security shortcomings. But it was never envisioned as a substitute for the FDA’s efforts. Hopefully, as the medical app market matures, app stores will also work with developers to do a better job of clearly labeling and categorizing these apps and do a better job of explaining any scientific merits.
