“Federal officials are quietly withdrawing a Trump administration plan to end regulatory review of 83 types of mHealth devices, saying the original plan was flawed and could have put the lives of Americans using that technology in danger.”
“In a notice posted last week in the Federal Register, the Health and Human Services Department and the Food and Drug Administration announced that they won’t enforce an HHS notice posted on January 15 that, among other things, would have exempted 83 class II devices and one unclassified device from premarket notification. Another 50 devices would have been exempted from review because there had been no reports of deaths associated with their use.”
“The decision affects dozens of connected health tools, including mHealth apps, smart devices and digital therapeutic services.”
“Officials said the devices were selected based on a lack of adverse events reported in the FDA’s Manufacturer and User Facility Device Experience (MAUDE) database. But just because adverse events aren’t reported, officials said, doesn’t mean they aren’t happening or could happen…”
“The issue highlights a long-standing effort to determine how best to regulate mHealth and telemedicine technology, especially as these tools and platforms develop capabilities that not only identify health concerns but support providers in clinical decisions. Left unregulated, apps, wearables and other kinds of technology could harm or even kill the people using them.”
“Examples of products that fit this category include mHealth apps that assess skin lesions for signs of cancer, wearables that track heart rhythms for evidence of atrial fibrillation, digital health platforms for behavioral health and substance abuse (such as smoking) and smart ventilators designed for home health programs.” Read the full article here.
Source: HHS, FDA Backtrack from Plan to Deregulate mHealth Devices, Apps — By Eric Wicklund, April 22, 2021. mHealth Intelligence.