From the Digital Health Coalition on September 26, 2013 – Reactions to the FDA Final Mobile Medical Apps Guidance
“The FDA announced this week their final guidance for developers of medical mobile apps that run on phones, tablets, and the next generation of mobile devices. The agency revealed it will focus regulation and scrutiny on a specific subset of apps that present a “risk” to the patient and end users and exercise discretion within the broader category of apps facilitating education, awareness, disease tracking and medication compliance at a high level. A key point that is good news for the developers concerned about limiting innovation as phones offer a potential tool to impact large populations without the need for additional hardwares … the agency states that if mobile medical apps pose a low risk to consumers they will exercise enforcement discretion over these devices. It’s not a statement to developers to create tools and platforms with no concern for regulation unless it’s a very narrow definition but it does clearly give a green light to developers seeking to build tools that will facilitate health, wellness, and disease management. In the past decade, the FDA has cleared approximately 100 mobile medical apps. To place that in context, there are over 100,000 apps available in the broader category of health and wellness today.
The Digital Health Coalition reached out to several thought leaders in the industry – and members – to get their reaction with regard to what this means for the industry, developers, start-ups and innovation overall….(click here to read)”