Walk into a hospital or clinic these days and it’s increasingly likely you will find the doctor carrying a mobile tablet or smartphone. Use of these handheld digital devices has proliferated as medical professionals and the world at large find much to like in their mobility, ease of use, and growing app offerings.
So popular are these devices, the U.S. Food and Drug Administration (FDA) estimates that by 2015 the number of smartphone users across the world will reach some 500 million. Not surprisingly perhaps, the FDA is now looking to regulate any apps intended for health- or medical-related purposes.
According to a recent post on the Foreign Exchange Translations blog, the FDA recently took the first step by releasing draft guidelines for regulation. It has separated mobile apps into four categories, each with a distinct regulatory strategy. These include:
• Apps that display, store, or transmit patient-specific medical device data in an original format
• Apps that control the intended use, function, modes, or energy source of a connected medical device
• Apps that turn the mobile platform into a regulated medical device (e.g., electronic stethoscope apps that use the phone’s microphone)
• Apps that create alarms, recommendations, or new information by analyzing or interpreting medical device data
The FDA is inviting the public to comment on its app regulation proposals. And that public, especially the app developer community, may indeed have a good deal to say.
Till next time,