wellness apps

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

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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 are manda­to­ry. On the oth­er are well­ness apps and oth­er low-risk dig­i­tal tools that like­ly spend more time wor­ry­ing about over­sight from the Fed­er­al Trade Com­mis­sion than the health reg­u­la­tor. [Read more…] about Tip for dig­i­tal health start-ups: To nav­i­gate reg­u­la­to­ry gray areas, “engage ear­ly and engage often” with the FDA

Four guidelines for smart use of smartphones

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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 see­ing mul­ti­ple points of view on impor­tant issues. As a soci­ety, we are increas­ing­ly con­cerned that tech­nolo­gies like smart­phones and social media result in more social com­par­i­son, bul­ly­ing, and loneliness—all stum­bling blocks to hap­pi­ness. Tech­nol­o­gy seems to be bad for our hap­pi­ness when it inter­feres with the men­tal, social, emo­tion­al, and behav­ioral process­es that con­tribute to well-being.

But we often fail to real­ize (and dis­cuss) the ways that tech­nol­o­gy can also sup­port hap­pi­ness and well-being—for exam­ple [Read more…] about Four guide­lines for smart use of smartphones