These days there is an app for everything.
There’s an app for how to cook a nice meal. An app to remind you to meditate. Countless apps for finding your soul mate. An app for losing weight, walking your dog, taking out the trash. There’s even an app for reminding you which apps you are missing out on!
For all these new apps, the FDA is starting to take notice of one particular niche in the app department: medical apps. In case you are not aware, even healthcare providers have stepped up their app game as of late.
There are thousands of apps that help healthcare providers diagnose and treat patients. Many of these apps also help patients manage their health conditions.
For the most part, the FDA has kept its nose out of the medical app sector. As one can imagine, while some of these apps are high quality, others are can lead to incorrect diagnoses and treatments that can be risky for patients and healthcare providers alike. The FDA has therefore been working on ways to provide oversight and management of these forms of information.
The FDA has announced a large scale digital innovation plan that will change how they view and approach digital health. It will allow the FDA to have more regulation while also giving more guidance to app companies.
The plan essentially outlines that the FDA will have more clear and direct policies for app software developers. This will allow developers to use the new guidelines on their own, without having to seek out the FDA’s approval or position on every change in technology and software development.
There are many modifications in store that will change the look of digital health, but overall, it looks like the FDA will have more of an active role and involvement in the medical app market.
The FDA will do less individualized examining of every app and will offer more specific guidance and guidelines for overall quality insurance. Also, in an effort to ensure more quality apps, there will be a third-party certification program for medical apps and devices.
