The FDA creates new Digital Health unit to reimagine regulatory paths in the age of scalable, AI-enhanced innovation

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Med­i­cine Is Going Dig­i­tal. The FDA Is Rac­ing to Catch Up (Wired):

“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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  1. Jeremy says

    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.