The U.S Food and Drug Administration (FDA) released draft guidance entitled "Mobile Medical Applications" on 21-JUL, and that opens up a 90-day comment period for their proposed regulations for mobile medical apps. It's a 2-pager and it's interesting to review because it breaks mHealth applications into two distinct groups: apps which are "used an accessory to a regulated medical device" and apps that "transform a mobile platform into a regulated medical device."
The guidance shows that federal regulation in the US will be a major factor in how connected products and applications are categorized and brought to market, and though it's a tiny solicitation for feedback, the ramifications may be huge for the M2M, mHealth, and Connected Health industries. Axeda's customers are at the forefront of this emerging market and I'm glad to see that the FDA is separating these two types of mHealth applications in their review process. I'm all for device "accessories" which may assist in my general health monitoring, but I also want to be sure that some regulatory review is being done for mobile devices used by the healthcare industry to assure they are accurately and securely moving my digital data to my doctor for review.
The PDF of the summary report has some great use cases to get you thinking. It's available now and has links to more formal guidance documents and methods for you to send feedback. Please share the visibility of this document with your technology and product teams and help shape this market and a new generation of mHealth solutions. The clock is ticking for your feedback.
