The FDA will scrutinize medical apps that act as an accessory to a medical device and those that transform the mobile device into a medical device. A draft guidance issued by the FDA includes an extensive list of applications that will have to undergo review. Examples of apps that fall under the regulatory oversight are:
* Applications that allow the user to view medical images, such as digital mammography or digital images of potentially cancerous lesions on a mobile platform, and those that perform a health analysis or provide a diagnosis by trained health care professionals.
* Applications that allow the user to view patient-specific lab results.
* Applications that connect to a home use diagnostic medical device to collect historical data, or to receive, transmit, store, analyze, and display measurements from connected devices.Great, right? The apps that do heavy lifting of patient information and connect to real medical devices get regulated, but the fun and educational apps I am working on remain free and open. Still, Harvey Castro, my favorite EM-doc-and-app-developer, was worried:
“Overall, I believe safety is the most important item when it comes to providing patient care,” said Harvey Castro, MD, an app developer (www.deeppocketseries.com) and emergency physician. “Unfortunately, I believe this will hurt small businesses and entrepreneurs by making it cost-prohibitive to enter the market.”
“Applications will be dominated by a few companies capable of paying the high fees to get FDA approval. I will be saddened to see these changes in the future.”