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 ofremote 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.