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

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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?

JS: I’m very excit­ed about the Cen­ter of Excel­lence, which we launched last fall. It is an oppor­tu­ni­ty to tru­ly advance the work that we do in dig­i­tal health, by bring­ing togeth­er in a vir­tu­al cen­ter our core experts that sit in our divi­sion of dig­i­tal health with experts around CDRH who are par­tic­i­pat­ing in dig­i­tal health — includ­ing in cyber­se­cu­ri­ty and relat­ed fields — all into one vir­tu­al enti­ty for the pur­pose of bet­ter lever­ag­ing our exper­tise to dri­ve greater inno­va­tion … One such approach, that we call “pre­cer­ti­fi­ca­tion,” is focused on access­ing the capa­bil­i­ties of the devel­op­er and the extent to which we can lever­age that under­stand­ing in our reviews, as opposed to just focus­ing on the tech­nol­o­gy, in order to expe­dite prod­ucts com­ing to the mar­ket­place, and then build in a post-mar­ket feed­back loop that lever­ages real-world data col­lec­tion, maybe even lever­ag­ing data col­lect­ed by the tech­nol­o­gy itself. Today devices are play­ing an increas­ing­ly impor­tant part in data col­lec­tion as a part of clin­i­cal evi­dence gen­er­a­tion. This Cen­ter of Excel­lence is serv­ing a crit­i­cal role in that capac­i­ty. In fact, there are leg­isla­tive pro­pos­als that, if Con­gress ulti­mate­ly sup­ports them, we could have a mod­ern reg­u­la­to­ry frame­work to sup­port dig­i­tal health tech­nolo­gies. And the Cen­ter of Excel­lence will be lead­ing the charge.

MD: How can we spur dig­i­tal health innovation?

JS: In terms of spurring inno­va­tion, one approach is to have a reg­u­la­to­ry par­a­digm that’s bet­ter suit­ed for these devices. Because if you set the bars in the right place, and we’re not talk­ing about chang­ing the US autho­riza­tion stan­dard of safe­ty and effec­tive­ness, but instead pro­vid­ing greater flex­i­bil­i­ty on how that stan­dard is met and bet­ter tai­lored to the tech­nol­o­gy, this cre­ates effi­cien­cies, reduces unnec­es­sary costs, and makes it more attrac­tive to have inno­v­a­tive tech­nol­o­gy come to the U.S. And I’d love to see bet­ter reim­burse­ment avail­able, as well, because we know that will dri­ve great tech­nolo­gies com­ing to the mar­ket­place. And, of course, we’ll see what hap­pens with our user fee nego­ti­a­tions if we get the fund­ing to sup­port this pilot to have greater inter­ac­tion with devel­op­ers of break­through devices, some­thing we call “the total prod­uct life cycle advi­so­ry pro­gram,” or TAP for short. If we get TAP, we think we can advance these tech­nolo­gies and if Con­gress enacts a more mod­ern reg­u­la­to­ry frame­work, then, from an FDA stand­point, I’d say we are in fan­tas­tic shape. And if we can get pay­ment poli­cies to come into align­ment, I think the U.S. would be incred­i­bly attrac­tive for inno­v­a­tive tech­nol­o­gy to be devel­oped and avail­able, and that includes in the Alzheimer’s space.

MD: That’s inspir­ing. You’ve taught us a lot. Thank you for your time.

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