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The Food and Digital Administration

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The FDA is creating a new unit dedicated to digital health. Staffed with experts in agile systems, machine learning, cloud computing, and other specialties, their goal is to draft new guidance that advances healthcare in 2017 and beyond. Let’s take a look…

Last year was the busiest yet for the FDA in terms of digital health guidance and medical device approvals. Check out our summary post, which outlines an astonishing breadth of action throughout 2016, including patient access to data, use of real world evidence, software as a device, cybersecurity, and the 21st Century Cures Act, among others.

All that activity was welcome after years of playing catch up, the FDA acknowledging that the pace of change and its impact involve numerous and diverse stakeholders, all of whom need clarity using practical approaches that balance benefits and risks. Amid this flurry of guidance, approvals, and rejections—and advanced tech—now comes a dedicated unit.


Dedicated to Digital

Bakul Patel, ‎associate center director for digital health at the FDA, described the new department to eager attendees at MedCon in Cincinnati last week. Paid for by the Medical Device User Fee Amendment, the dedicated unit will first work to ensure proper coordination and consistency of digital health efforts across the FDA.

Another goal will be establishing premarket approval and/or clearance pathways specifically tailored for digital health, taking into account real world evidence. Expertise areas and training include artificial intelligence, advanced analytics, the cloud, wireless medical devices, telemedicine, interoperability, health IT, and cybersecurity.

To make it happen, Patel is initially hiring 13 engineers, including software developers, AI and machine learning experts, pros in cloud computing and mobile tech. The idea for creating a dedicated digital health unit came out of the struggle to review over 1,400 comments submitted for the software as a medical device guidance document.


Regulatory Pre-Clearance?

Realizing he had to “start with a clean sheet of paper,” Patel now envisions a kind of “pre-clearance” set up, similar to TSA security at an airport: Trusted companies and institutions with proven track records in digital health would receive expedited approvals, while unknowns and prior offenders would get more scrutiny.

“The idea is to get safe products to market faster, by having people compete on excellence rather than compliance,” Patel said. Noting how the digital health world is evolving into one powered by AI, machine learning, and natural language processing, he wants to answer the question: “How do we align our regulations to radically different development timelines?”

As we’ve seen, speed in healthcare has become key, “survival of the fastest.” For the first time, the FDA not only understands this paradigm shift, but has structured a dedicated unit to address the need. Actively recruiting in Silicon Valley, Seattle, and Boston, Patel is reaching out to the digital health community not only for comments, but FDA employees. Exciting times indeed!


A New Era at the FDA?

The inherently interactive nature of digital greatly complicates pharma marketing and communications. From space limitations to user generated content to data sharing, ensuring fair balance within the channel is an ongoing battle. Draft guidance has been helpful, but many brand stewards remain apprehensive.

The creation of a dedicated digital health unit at the FDA is welcome, and suggests that new guidance and innovative process improvements will provide additional clarity, and help expedite approvals. We’ll keep you posted on the latest developments, and provide thought leadership and POVs as the dedicated unit grows. Stay tuned…

More About the Author

Michael Spitz

A digital health expert since before digital health was cool, Spitz has since developed omnichannel campaigns for top pharma and device brands, and helps drive agency innovation, digital transformation, and emerging channels. See him present at conferences, read his blogs, and follow him for the latest trends and opinions on Twitter @SpitzStrategy.

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