Ja­pan to pro­mote AI based medicines

BioSpectrum (Asia) - - Regulatory News -

Ja­pan plans to cre­ate com­pre­hen­sive rules gov­ern­ing the use of artificial in­tel­li­gence (AI) in med­i­cal equip­ment, aim­ing to speed the de­ploy­ment of tools that can im­prove ac­cu­racy and ef­fi­ciency in a health care sys­tem bur­dened by an ag­ing pop­u­la­tion. The min­istry of health will draw up guide­lines this fis­cal year for evaluating the safety and ef­fi­cacy of AI-based med­i­cal equip­ment. No such cri­te­ria now ex­ist, so man­u­fac­tur­ers face un­cer­tainty on whether their de­vice will be ap­proved to go to mar­ket. Set­ting clear stan­dards could en­cour­age more com­pa­nies to en­ter the field, has­ten­ing ad­vance­ments in med­i­cal tech­nol­ogy. The new rules will also make clear that the ul­ti­mate re­spon­si­bil­ity for di­ag­nos­ing and treat­ing dis­ease rests with doc­tors. This point has been seen as par­tic­u­larly im­por­tant for AI, which blurs the line be­tween ma­chine and hu­man judge­ment. While adopt­ing th­ese tools will raise health care in­vest­ment in the short term, ex­perts pre­dict they could re­duce costs in the long run by im­prov­ing ef­fi­ciency.

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