digital health

The Federal Trade Commission (FTC) hardens data security rules for health apps and devices

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FTC says it will fine dig­i­tal health com­pa­nies that don’t dis­close data breach­es (mobi­health­news):

With data breach­es on the rise, the FTC is look­ing to make health apps more account­able for telling patients when their data has been exposed.

The FTC released a new state­ment spec­i­fy­ing that all health apps that cap­ture sen­si­tive patient infor­ma­tion noti­fy users, the com­mis­sion itself and in some cas­es the media when a secu­ri­ty breach has com­pro­mised iden­ti­fi­able health data. If the com­pa­ny fails to do so it could face a fine of $43,792 per day of vio­la­tion. [Read more…] about The Fed­er­al Trade Com­mis­sion (FTC) hard­ens data secu­ri­ty rules for health apps and devices

Study: Self-guided sleep app Sleepio, combined with standard care for depression and anxiety, delivers better outcomes than standard care alone

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Study backs ben­e­fit of insom­nia DTx Sleepio on men­tal health (pharmapho­rum):

The study – pub­lished in the jour­nal Behav­iour Research and Ther­a­py – test­ed the Sleepio app devel­oped by dig­i­tal health spe­cial­ist Big Health as an add-on to stan­dard NHS care for anx­i­ety and depres­sion under the improv­ing access to psy­cho­log­i­cal ther­a­pies (IAPT) policy.

Patients who signed up to use Sleepio – a six-week dig­i­tal cog­ni­tive behav­iour­al ther­a­py (CBT) course – achieved sig­nif­i­cant­ly bet­ter improve­ment in symp­toms com­pared to con­trols, with an IAPT recov­ery rate of near­ly 65% ver­sus 58% in the con­trol group. [Read more…] about Study: Self-guid­ed sleep app Sleepio, com­bined with stan­dard care for depres­sion and anx­i­ety, deliv­ers bet­ter out­comes than stan­dard care alone

On centenarians, memory, Mars, tDCS, ADHD, digital health, beautiful brains, and more

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Hen­drik­je van Andel Schip­per (1890–2005)

Wel­come to a new edi­tion of Sharp­Brains’ e‑newsletter, fea­tur­ing ten time­ly resources and research find­ings for life­long brain and men­tal fitness.

#1. Let’s start with a fas­ci­nat­ing sto­ry and study 🙂

Study with 330 cen­te­nar­i­ans finds that cog­ni­tive decline is not inevitable … (Henne Hol­stege, PhD, assis­tant pro­fes­sor at Ams­ter­dam Uni­ver­si­ty Med­ical Cen­ter) said her inter­est in research­ing aging and cog­ni­tive health was inspired by the “fas­ci­nat­ing” sto­ry of Hen­drik­je van Andel Schip­per, who died at age 115 in 2005 “com­plete­ly cog­ni­tive­ly healthy.”

#2. Neu­ro­sci­en­tist Lisa Gen­o­va, author of the beau­ti­ful nov­el Still Alice, releas­es non-fic­tion book on Mem­o­ry: “It is sober­ing to real­ize that three out of four pris­on­ers who are lat­er exon­er­at­ed through DNA evi­dence were ini­tial­ly con­vict­ed on the basis of eye­wit­ness tes­ti­mo­ny. “You can be 100 per­cent con­fi­dent in your vivid mem­o­ry,” Gen­o­va writes, “and still be 100 per­cent wrong” … Gen­o­va assures her read­ers that only two per cent of Alzheimer’s cas­es are of the strict­ly inher­it­ed, ear­ly-onset kind. For most of us, our chances of devel­op­ing the dis­ease are high­ly amenable to interventions…”

#3. Time­ly tips for the week­end: Shape your envi­ron­ment, shape your mind

  • Sur­round your­self with nature
  • Cre­ate oppor­tu­ni­ties for awe
  • Clear the clutter

#4. “For a mis­sion to suc­ceed, high men­tal and cog­ni­tive func­tion would be absolute­ly crit­i­cal; astro­nauts would be called on to per­form demand­ing tasks in a demand­ing envi­ron­ment. Los­ing 20 IQ points halfway to Mars is not an option … Stress—an emo­tion­al or men­tal state result­ing from tense or over­whelm­ing circumstances—and the body’s response to it, which involves mul­ti­ple sys­tems, from metab­o­lism to mus­cles to memory—may be the chief chal­lenge that astro­nauts face.” Next in NASA’s path to Mars: Over­com­ing astro­nauts’ cog­ni­tive and men­tal health challenges

#5. Study: Depres­sion affects visu­al per­cep­tion … mak­ing it more accu­rate (based on a cool opti­cal illusion)

#6. It’s good to have more tools in the neu­ro toolkit…assuming we use them wise­ly: Emerg­ing appli­ca­tions of tran­scra­nial Direct Cur­rent Stim­u­la­tion (tDCS): e‑sports skills train­ing, cog­ni­tive enhance­ment in old­er adults

#7. Does ADHD treat­ment enable long-term aca­d­e­m­ic suc­cess? (Yes, espe­cial­ly when phar­ma­co­log­i­cal and non-phar­ma treat­ments are combined)

#8. Men­tal Health in the Dig­i­tal Age: From dig­i­tal ther­a­peu­tics to per­son­al­ized men­tal health solu­tions: Pear Ther­a­peu­tics expands plat­form via part­ner­ships with Empat­i­ca, etec­tRx, Key­Wise, and Winterlight

#9. The award was won last year by Indi­an vil­lage teacher Ran­jitsinh Disale; who will be next? Final day to nom­i­nate teach­ers for the $1M Glob­al Teacher Prize 2021

#10. And last, but cer­tain­ly not least, let’s wel­come Men­tal Health Month (May) by appre­ci­at­ing our beau­ti­ful brains

Wish­ing you a men­tal­ly healthy and cog­ni­tive­ly stim­u­lat­ing month of May,

The Sharp­Brains Team

On Awe, Wonder, Biofeedback, CBSM, Virtual Reality, Privacy, Being Wrong, and more

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Wel­come to a new edi­tion of Sharp­Brains’ e‑newsletter, this time fea­tur­ing eleven time­ly resources and research find­ings for life­long brain health and men­tal well-being.

#1. “Awe is the feel­ing we expe­ri­ence when encoun­ter­ing vast things that we don’t under­stand. Around the world and in cul­tur­al­ly vary­ing ways, stud­ies show, we expe­ri­ence awe in response to oth­ers’ kind­ness and courage, nature, music, reli­gious or spir­i­tu­al prac­tice, the visu­al and dra­mat­ic arts, and epiphany … It leads us to share, col­lab­o­rate, and won­der. In expe­ri­ences of awe, peo­ple often speak as if they have found their soul.”

Some­times it IS awesome to learn how the sausage was made: How Pixar’s “Soul” met the Sci­ence of Awe

#2. Here are six sug­ges­tions to incor­po­rate awe into dai­ly rou­tines and improve men­tal well-being, based on the new book Awestruck: Linger, Slow down, Appre­ci­ate your sens­es, Unplug, Awe walks, Awe journaling.

#3. Speak­ing of Awe and Won­der, why not take a few min­utes to appre­ci­ate our most pre­cious nat­ur­al resource via these
five brain teasers?

A few won­derful news for many with unmet mental/ brain health needs:

#4. Pre­dic­tion: In just a few years we’ll look back at today and won­der, why did­n’t we all, of all ages, access biofeed­back tools and games designed to mea­sure and retrain heart rate vari­abil­i­ty? Grow­ing research sup­ports Heart Rate Vari­abil­i­ty (HRV) biofeed­back train­ing to low­er stress and anx­i­ety, increase sports performance

#5. Blue Note Ther­a­peu­tics rais­es $26M to help treat can­cer-relat­ed dis­tress via cog­ni­tive behav­ioral stress man­age­ment (CBSM): “Near­ly half of all can­cer patients expe­ri­ence psy­choso­cial dis­tress, anx­i­ety, or depres­sion. If left untreat­ed, these feel­ings can low­er a can­cer sur­vivors’ qual­i­ty of life and may neg­a­tive­ly affect survival.”

#6. Applied­VR rais­es $29M to help make vir­tu­al real­i­ty the stan­dard of care for treat­ing chron­ic pain: “Chron­ic pain is one of the most com­mon med­ical con­di­tions in the world, yet it still is incred­i­bly debil­i­tat­ing to patients, cost­ly to the sys­tem and com­plex to treat. While our mis­sion has always been to demon­strate that VR can be a pow­er­ful anal­gesic in any set­ting, the COVID-19 pan­dem­ic has cre­at­ed a surge in demand for dig­i­tal med­i­cines like VR that can be deliv­ered safe­ly to patients in their own homes” — Matthew Stoudt, co-founder and CEO of AppliedVR

#7. Hap­pi­fy Health rais­es $73M to deep­en part­ner­ships with phar­ma­ceu­ti­cal com­pa­nies and insur­ance pay­ers: “We are also work­ing with five lead­ing phar­ma­ceu­ti­cal part­ners on dig­i­tal ther­a­peu­tic solu­tions and four out of the five nation­al pay­ers to help sup­port their mem­bers’ men­tal health and chron­ic ill­ness needs. We look for­ward to reach­ing an even big­ger audi­ence with the sup­port of our new part­ners.” — Tomer Ben-Kiki, cofounder and CEO of Happify

This grow­ing num­ber and range of inno­v­a­tive dig­i­tal health tools demands more and bet­ter research, smarter reg­u­la­tions, and more trans­par­ent pri­va­cy policies:

#8. Con­sumer Reports finds unclear, ques­tion­able pri­va­cy prac­tices and poli­cies among pop­u­lar men­tal health apps. “In gen­er­al, these men­tal health ser­vices act­ed like many oth­er apps you might down­load. For instance, we spot­ted apps shar­ing unique IDs asso­ci­at­ed with indi­vid­ual smart­phones that tech com­pa­nies often use to track what peo­ple do across lots of apps. The infor­ma­tion can be com­bined with oth­er data for tar­get­ed adver­tis­ing. Many apps do that, but should men­tal health apps act the same way? At a min­i­mum, Con­sumer Reports’ pri­va­cy experts think, users should be giv­en a clear­er expla­na­tion of what’s going on.”

#9. Tip for dig­i­tal health start-ups: To nav­i­gate reg­u­la­to­ry gray areas, “engage ear­ly and engage often” with the FDA. Impor­tant advice as “…a grow­ing num­ber of com­pa­nies are find­ing them­selves in a gray area of enforce­ment dis­cre­tion, a term the FDA uses for low­er-risk prod­ucts that meet the def­i­n­i­tion of a med­ical device, but do not require reg­u­la­to­ry sub­mis­sion, review and autho­riza­tion before head­ing to market”

#10. Inno­va­tion in COVID times: Otsu­ka and Click Ther­a­peu­tics announce ful­ly vir­tu­al clin­i­cal tri­al, lever­ag­ing Verily’s Project Base­line: “We do believe that the treat­ment land­scape in men­tal dis­ease is going to evolve in a way where obvi­ous­ly phar­ma­cother­a­py will always play a role, but we do think dig­i­tal ther­a­peu­tics can play an addi­tion­al role, and to some extent, sub­sti­tute as well as aug­ment phar­ma­co­log­i­cal inter­ven­tion.” — Otsu­ka Chief Med­ical Offi­cer Christoph Koenen

#11. Final­ly, much of the oppor­tu­ni­ty around applied neu­ro­science and neu­ro­plas­tic­i­ty relies not on tools but on mind­sets, as dis­cussed in this fan­tas­tic inter­view (To pre­vent “cog­ni­tive entrench­ment,” think like a sci­en­tist and be wrong often):

“JS: You write that being wrong is tied to a more joy­ful life. Why is that?

AG: I had noticed Dan­ny Kah­ne­man [the Nobel prize–winning behav­ioral econ­o­mist] just lights up with joy when he finds out that one of his hypothe­ses is false … In some ways, the joy of being wrong is the free­dom to keep learn­ing. If you can embrace the joy of being wrong, then you get to anchor your iden­ti­ty more in being some­one who’s eager to dis­cov­er new things, than some­one who already knows every­thing or is expect­ed to know everything.”

Wish­ing you a healthy and stim­u­lat­ing month of April,

The Sharp­Brains Team

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

Innovation in COVID times: Otsuka and Click Therapeutics announce fully virtual clinical trial, leveraging Verily’s Project Baseline

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Otsu­ka launch­es piv­otal tri­al of dig­i­tal ther­a­peu­tics for depres­sion (Med­C­i­ty News):

Otsu­ka Phar­ma­ceu­ti­cal is launch­ing a vir­tu­al study to see if dig­i­tal ther­a­peu­tics can reduce depres­sion symptoms.

It’s the next step in a part­ner­ship between the Tokyo-based drug­mak­er and Click Ther­a­peu­tics, a dig­i­tal health start­up that is devel­op­ing pro­grams for smok­ing ces­sa­tion, depres­sion and insom­nia. [Read more…] about Inno­va­tion in COVID times: Otsu­ka and Click Ther­a­peu­tics announce ful­ly vir­tu­al clin­i­cal tri­al, lever­ag­ing Verily’s Project Baseline