“WHEN BAKUL PATEL started as a policy advisor in the US Food and Drug Administration in 2008, he could pretty much pinpoint when a product was going to land in front of the reviewers in his division. Back when medical devices were heavy on the hardware—your pacemakers and your IUDs—it would take manufacturers years to get them ready for regulatory approval. FDA reviewers could keep up pretty well…Today, machine learning powers more and more medical device software. And because it is always learning and improving, it is constantly changing products on the fly. For most regulators, an ever-changing algorithm is their worst nightmare. But Patel is one of those rare Washington bureaucrats who’s also a fervently optimistic futurist.
…the FDA is creating a new unit dedicated strictly to digital health. Patel will be hiring 13 engineers—software developers, AI experts, cloud computing whizzes—to prepare his agency to regulate a future in which health care is increasingly mediated by machines…He’s also got plans to reimagine the path these machines will take to regulatory approval… he envisions a model something more like the TSA security line at the airport: New developers or manufacturers with spotty track records would still have to take off their shoes and go through the body scanner. But trusted companies with demonstrated histories of excellence could keep their footwear and stroll through the metal detector. Patel’s not yet sure exactly how it would work, but it’s one of the ideas he’s toying with and running by industry stakeholders.”
To Learn More: FDA’s Digital Health section
The broad scope of digital health includes categories such as mobile health (mHealth), health information technology (IT), wearable devices, telehealth and telemedicine, and personalized medicine.…The use of technologies such as smart phones, social networks and internet applications is not only changing the way we communicate, but is also providing innovative ways for us to monitor our health and well-being and giving us greater access to information. Together these advancements are leading to a convergence of people, information, technology and connectivity to improve health care and health outcomes.
CDRH has established the Digital Health Program which seeks to better protect and promote public health and provide continued regulatory clarity by Fostering collaborations and enhancing outreach to digital health customers, and Developing and implementing regulatory strategies and policies for digital health technologies.
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