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Into 2019: Digital Leads US Policy Innovations, But Public Medtech Scrutiny Grows

 
• By David Filmore

Scott Gottlieb's FDA continues to push out policy reforms and experiments at a rapid pace, with special focus on digital and AI technologies. In parallel, US Medicare officials are more publicly signaling plans to roll out policies for a quicker path to reimbursement for new devices. However, public scrutiny of whether device regulations properly protect patient safety is growing, and it could have an impact. 

Artificial intelligence (AI) technology moved squarely into the clinic in 2018 with multiple US Food and Drug Administration approvals and clearances throughout the year. In addition, the agency approved its first high-profile consumer mobile apps in 2018, with the Apple Watch ECG apps and another company's contraceptive app.

On top of these product-by-product advances, the FDA moved toward a launch of an experimental "pre-certification" approach to digital health...

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