Devices & Diagnostics

Does your mobile health app need FDA clearance? Checklist gives guidance for digital health entrepreneurs

A week after the Congressional hearings discussed how the US Food and Drug Administration’s impending regulatory guidelines (expected by October) will impact mobile health apps, aspiring and current digital health entrepreneurs may be rethinking their path. In a report dubbed “FDA 101,” health startup accelerator Rock Health has compiled a handy report to help digital […]

A week after the Congressional hearings discussed how the US Food and Drug Administration’s impending regulatory guidelines (expected by October) will impact mobile health apps, aspiring and current digital health entrepreneurs may be rethinking their path. In a report dubbed “FDA 101,” health startup accelerator Rock Health has compiled a handy report to help digital health entrepreneurs assess whether their mobile health apps would be classified as medical devices by the FDA and require 510(k) clearance.

Some of the pressure to clear the waters has come from technology developments that have simply outpaced the regulatory environment. Another is that provisions of health care reform call for making greater use of remote monitoring, to reduce healthcare costs. Providers are pretty keen to reduce costs where they can as well. Remote monitoring would be particularly helpful when it comes to patients with chronic conditions, such as congestive heart failure or diabetes or both, so they can have shorter hospital stays and care managers can be alerted for any changes in their vital signs.

According to Rock Health’s report, more than 41 percent of consumers have a strong interest in using remote monitors to track their condition, according to the report. About 19 percent of smartphone users are downloading apps to help them quantify their own health such as, say, to keep track of any side effects they might be feeling from medication or as they train for a race.

The draft guidance explained that it would treat mobile health apps as medical devices if they serve as implants, implements, instruments or in vitro reagents used in the diagnosis of a disease, or in the cure, mitigation, treatment or prevention of a disease or serve as an accessory in one of those functions. By RockHealth’s reckoning, about 100 apps have been reviewed as medical devices by the FDA since 1997 and 67 have received 510(k) clearance through 2012. Though a fair few are remote monitors, the first iPhone medical apps to be approved was Mobile Mim by Mim Software. The app can shrink the size of radiology images and transfer them securely but allowed physicians to measure distance of the image and image intensity values. It can be used to make a diagnosis when a physician does not have access to a workstation.

Among the recommendations outlined in the report, entrepreneurs should ask themselves whether their app qualifies as a Class I, Class II or Class III medical device. They should also consider employing an adviser fulltime because they would be is more likely to think long term and develop methods that are workable and appropriate for the company. They will also have to live with the procedures they design.

It also taps the brains of digital health entrepreneurs with experience of getting FDA clearance for mobile health apps and devices. WellDoc Chief Strategy and Commercial Officer Chris Bergstrom recommends entrepreneurs ask themselves: “What’s your product and what’s your value proposition? Then marry those with the appropriate regulatory path and business model. For example, if your model is based on reimbursement, then you’ll likely need published clinical outcomes and FDA clearance.”