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

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.

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As seen in The New York Times, The Wall Street Journal, BBC News, CNN, Reuters,  SharpBrains is an independent market research firm tracking how brain science can improve our health and our lives.

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