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

By SharpBrains | March 22, 2021

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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Four guidelines for smart use of smartphones

By Greater Good Science Center | November 14, 2019

These days, you can’t go any­where with­out hear­ing about how tech­nol­o­gy is ruin­ing every­thing, includ­ing our hap­pi­ness. There is some truth to this, but it’s not the whole sto­ry. Tech­nol­o­gy can be bad for us—for exam­ple, when social media gives us FOMO (fear of miss­ing out) or traps us in fil­ter bub­bles that pre­vent us from…

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