2018 An Inflection Point For mHealth After An Active Year
The past year saw US FDA and industry work hard and fast to prepare for what looks like an inevitable boom in the digital-health sector. According to interviews, the time is ripe for adoption of mobile health apps to help reduce health-care costs, but the brave new world also brings with it big challenges.
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While the mobile health sector and digital health in general is poised for a major boom, a 2014 case, Alice Corp. v. CLS Bank International, continues to be a major hurdle for manufacturers wanting to patent their software. While there are some recent positive trends, attorneys recommend caution and proactive steps to make the best of the current patent environment.
US FDA, industry and other digital health stakeholders huddled at the National Institutes of Health for two days of deep discussions around how the Pre-Certification Pilot was advancing, and how the agency should implement a program that emphasizes certifying "excellence" in company processes. Check out coverage of the meeting and Medtech Insight's exclusive podcast interview with FDA project lead Bakul Patel.