digital health innovation

A conversation at the frontier of digital health innovation, FDA regulations, and cognitive health

by

Dig­i­tal Ther­a­peu­tics for MCI and Alzheimer’s dis­ease: A Reg­u­la­to­ry Per­spec­tive (The Jour­nal of Pre­ven­tion of Alzheimer’s Disease):

–This arti­cle is adapt­ed from a com­pre­hen­sive con­ver­sa­tion between Dr. Murali Doraiswamy and Dr. Jef­frey Shuren at the 2021 Clin­i­cal Tri­als on Alzheimer’s Dis­ease (CTAD) con­fer­ence in Boston. Dr. Shuren is a behav­ioral neu­rol­o­gist who has held a vari­ety of lead­er­ship roles at the FDA and CMS, includ­ing as Direc­tor of the Cen­ter for Devices and Radi­o­log­i­cal Health (CDRH).

MD: The CDRH has a flag­ship Dig­i­tal Health Cen­ter of Excel­lence. Can you tell us about it? And can you share your advice for how the Alzheimer’s field can help spur dig­i­tal inno­va­tion? [Read more…] about A con­ver­sa­tion at the fron­tier of dig­i­tal health inno­va­tion, FDA reg­u­la­tions, and cog­ni­tive health

FDA releases first Artificial Intelligence (AI) regulatory plan to promote responsible digital health innovation

by

FDA Releas­es Arti­fi­cial Intelligence/Machine Learn­ing Action Plan (FDA press release):

Today, the U.S. Food and Drug Admin­is­tra­tion released the agency’s first Arti­fi­cial Intelligence/Machine Learn­ing (AI/ML)-Based Soft­ware as a Med­ical Device (SaMD) Action Plan. This action plan describes a mul­ti-pronged approach to advance the Agency’s over­sight of AI/ML-based med­ical soft­ware … The AI/ML-Based Soft­ware as a Med­ical Device Action Plan out­lines five actions that the FDA intends to take, including:

  • Fur­ther devel­op­ing the pro­posed reg­u­la­to­ry frame­work, includ­ing through issuance of draft guid­ance on a pre­de­ter­mined change con­trol plan (for software’s learn­ing over time);

[Read more…] about FDA releas­es first Arti­fi­cial Intel­li­gence (AI) reg­u­la­to­ry plan to pro­mote respon­si­ble dig­i­tal health innovation

Digital health meets consumer electronics and brain training

by

There’s no doubt that the biggest buzz at this year’s Con­sumer Elec­tron­ics Show in Las Vegas didn’t come from the slimmest of tele­vi­sions, the most fash­ion­able head­phones or even a danc­ing robot.

The buzz of CES 2013 was firm­ly cen­tred on all things health and the Dig­i­tal Health Sum­mit is where the action was hap­pen­ing. On the eve of open­ing Ari­an­na Huff­in­g­ton described what was about to hap­pen in Las Vegas as a ‘Per­fect Storm’

“I’m talk­ing about one of those moments in which sev­er­al trends con­verge to cre­ate some­thing larg­er, a moment we will look back on as the time every­thing changed ….. this year’s CES has the poten­tial to be one of the most trans­for­ma­tive ever, and that’s because of a sig­nif­i­cant change in atti­tude about what role tech­nol­o­gy can, and should, be play­ing in our lives. That’s the foun­da­tion of this per­fect storm”. [Read more…] about Dig­i­tal health meets con­sumer elec­tron­ics and brain training