Tip for digital health start-ups: To navigate regulatory gray areas, “engage early and engage often” with the FDA

FDA’s enforce­ment dis­cre­tion for dig­i­tal health is more ambigu­ous than ever in 2021 (Mobi­Health­News): The dig­i­tal health ecosys­tem has swelled to encom­pass a broad range of prod­ucts over the years. On one end of the spec­trum is soft­­ware-as-med­i­cal-devices (SaMD) and pre­scrip­tion dig­i­tal ther­a­peu­tics, prod­uct cat­e­gories for which a com­pre­hen­sive reg­u­la­to­ry strat­e­gy and engage­ment with the FDA…

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Happify Health raises $73M to deepen partnerships with pharmaceutical companies and insurance payers

Hap­pi­fy Health rais­es $73M to expand its dig­i­tal ther­a­peu­tic care deliv­ery capa­bil­i­ties (Mobi­Health News): Found­ed in 2012, Hap­pi­fy is best known for dig­i­tal pro­grams that pro­vid­ed auto­mat­ed self-guid­ed sup­port across var­i­ous areas of men­tal health and well­ness, such as stress man­age­ment for employ­ees or health plan mem­bers. Should the user need addi­tion­al sup­port, the platform…

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The latest on brain health, neurotechnology, artificial intelligence and “never stop wondering”

Wel­come to a new edi­tion of Sharp­Brains’ e‑newsletter, fea­tur­ing a life well lived, the lat­est news on brain health and inno­va­tion, and some brain teasers in hon­or of Inter­na­tion­al Brain Teas­er Month. #1. Thank you, Sharon. We won’t. “Nev­er stop won­der­ing” — Sharon Beg­ley, sci­ence jour­nal­ist, RIP #2. Write injuries in sand, kind­ness­es in ____________. Milk the…

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

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…

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