FDA Decides To Not Regulate Health Apps and Devices That Pose Low Health Threat
Finally health tech developers, those who develop health-related apps and other relevant software in US, will be feeling healthier as the Food and Drug Administration has decided to show them a softer disposition.
The FDA has assured that it’ll no longer focus its regulatory approach on health apps and medical devices that don’t pose real health threat, and will take a hands-off approach to most medical device data systems (MDDS).
A statement from the agency reads: “The MDDS guidance confirms our intention to not enforce compliance with applicable regulations for technologies that receive, transmit, store, or display data from medical devices. We hope that finalization of this policy will create an impetus for the development of new technologies to better use and display this data.”
Confirming its new decision, the FDA said it will not regulate all those medical apps which work on the mobiles and not pose any threat to its users.
The guidance bill, which the agency has passed, suggests that all the apps which have a proper functioning like that of a diagnostic or treatment platform, will fit the bill and will be immune to FDA’s investigations. In FDA’s version, devices which “transform a mobile platform into a regulated medical device by using attachments, display screens, sensors, or other such methods.”
So those insufficient apps need to worry now. Apple developers must be careful now because FDA will not accept apps which just help user recognize particular symptoms of a disease, and then left him on his own, providing no proper advice for the treatment of the illness.
Obviously, the FDA is trying to reduce, or rather eliminate, the risk factor in health-related technology as their misuse can have severe implications on the users – sometime the harms can be greater than the benefits such health apps promise. And the agency is aware of the significance of its initiative.
“The implications are profound, both for MDDS-type software, but also for what it suggests about the future for health information technology generally,” said FDA regulation specialist, attorney Brad Thompson, who works with medical devices makers. “FDA is quite earnestly working to ensure that it uses the lightest regulatory touch appropriate for software.”