UK agencies to review and update regulation of digital mental health tools

Men­tal health fund­ing of £1.8m wel­comed by MHRA and NICE to explore reg­u­la­tion of dig­i­tal men­tal health tools (gov.uk):

There has been a large increase in the num­ber of dig­i­tal men­tal health tools on the mar­ket in recent years. How­ev­er, these prod­ucts present reg­u­la­to­ry chal­lenges such as clar­i­ty around whether they are med­ical devices and, if so, which risk clas­si­fi­ca­tion they would fall under.

Well­come has there­fore pro­vid­ed £1.8m of fund­ing to help improve reg­u­la­to­ry cer­tain­ty and safe­ty in this high growth, high impact area, focussing on pro­duc­ing guid­ance for appro­pri­ate, risk-pro­por­tion­ate reg­u­la­tion of dig­i­tal men­tal health products.

The project will review key aspects of med­ical device reg­u­la­tions to pro­duce guid­ance that will sup­port dig­i­tal men­tal health in sev­er­al sig­nif­i­cant areas. These include deter­min­ing what qual­i­fies as a med­ical device, the risk clas­si­fi­ca­tion they would fall under, as well as a review of the cur­rent evi­dence base for these devices…

Mark Salmon, pro­gramme direc­tor for Infor­ma­tion Ser­vices at NICE, said:

“This work is one way both organ­i­sa­tions can sim­pli­fy and stream­line the process of get­ting wide-scale adop­tion of safe, clin­i­cal and cost-effec­tive dig­i­tal men­tal health prod­ucts into the hands of the peo­ple who need them and help ease the pres­sure on the NHS.”

About NICE’s Evidence standards framework for digital health technologies:

As dig­i­tal health tech­nolo­gies (DHTs) devel­op at an increas­ing pace, we’ve worked with stake­hold­ers, sys­tem part­ners and thought lead­ers to devel­op stan­dards that ensure new DHTs are clin­i­cal­ly effec­tive and offer val­ue to the health and care sys­tem: the evi­dence stan­dards frame­work (ESF).

The ESF is a set of evi­dence stan­dards for a wide range of DHTs. Eval­u­a­tors and deci­sion mak­ers in the health and care sys­tem can­con­sis­tent­ly use to help them iden­ti­fy DHTs that are like­ly to offer ben­e­fits to users and to the health and care sys­tem. –> Learn more HERE

News in Context:

• A con­ver­sa­tion at the fron­tier of dig­i­tal health inno­va­tion, FDA reg­u­la­tions, and cog­ni­tive health
• NICE in the UK issues rec­om­men­da­tion for Sleepio app
• The Nation­al Acad­e­my of Med­i­cine (NAM) shares dis­cus­sion paper to help empow­er 8 bil­lion minds
• A call to action: We need the right incen­tives to guide eth­i­cal inno­va­tion in neu­rotech and healthcare
• The FDA cre­ates new Dig­i­tal Health unit to reimag­ine reg­u­la­to­ry paths