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FDA guidelines for mobile health apps relevant to cognitive/ mental health

fda-logo21 types of health apps the FDA could reg­u­late but won’t (Mobi­Health­News):

The FDA final guid­ance final­ly pub­lished last week and it includ­ed very few sur­pris­es. One new sec­tion in the final guide­lines — that was not includ­ed in the draft guid­ance — is a list of the types of apps that the FDA says will fall under its enforce­ment dis­cre­tion. That means that these apps may meet the def­i­n­i­tion of a med­ical device, but the “FDA intends to exer­cise enforce­ment dis­cre­tion for these mobile apps because they pose low­er risk to the public…In the pages to fol­low is a roundup of the FDA’s list of apps that it does not intend to reg­u­late even though they meed the def­i­n­i­tion of a med­ical device.”

product-moodhacker#1 Some Psy­chi­atric Apps

Accord­ing to the FDA’s guid­ance, some psy­chi­atric apps might meet the def­i­n­i­tion of a mobile device, but it will choose not to reg­u­late some of these apps: “Mobile apps that help patients with diag­nosed psy­chi­atric con­di­tions (e.g., post-trau­mat­ic stress dis­or­der (PTSD), depres­sion, anx­i­ety, obses­sive com­pul­sive dis­or­der) main­tain their behav­ioral cop­ing skills by pro­vid­ing a ‘Skill of the Day’ behav­ioral tech­nique or audio mes­sages that the user can access when expe­ri­enc­ing increased anx­i­ety”

#8 Pre­ven­ta­tive screen­ing apps from estab­lished med­ical sources

Mobile apps that use patient char­ac­ter­is­tics such as age, sex, and behav­ioral risk fac­tors to pro­vide patient-spe­cif­ic screen­ing, coun­sel­ing and pre­ven­tive rec­om­men­da­tions from well-known and estab­lished author­i­ties;”

#15 Teth­ered PHR apps

Mobile apps that pro­vide patients a por­tal into their own health infor­ma­tion, such as access to infor­ma­tion cap­tured dur­ing a pre­vi­ous clin­i­cal vis­it or his­tor­i­cal trend­ing and com­par­i­son of vital signs (e.g., body tem­per­a­ture, heart rate, blood pres­sure, or res­pi­ra­to­ry rate);”

#21 Many fit­ness and well­ness apps

Mobile apps that are intend­ed for indi­vid­u­als to log, record, track, eval­u­ate, or make deci­sions or behav­ioral sug­ges­tions relat­ed to devel­op­ing or main­tain­ing gen­er­al fit­ness, health or well­ness,…”

–> Full arti­cle: 21 types of health apps the FDA could reg­u­late but won’t (Mobi­Health­News)

–> Read the FDA’s final guid­ance for mobile med­ical apps (PDF)

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