Research On The Admission System Of Medical Artificial Intelligence

With the increasing maturity of artificial intelligence technology,medical artificial intelligence is gradually being recognized and used by people,which has strongly promoted the development of the new medical device market.On the one hand,medical artificial intelligence has brought precise and efficient medical services;on the other hand,it has also brought an impact on the market supervision of traditional medical devices.Traditional medical devices are subject to prior supervision,and access management is carried out according to their degree of risk.As a new type of medical equipment,medical artificial intelligence undoubtedly has its own special risks.The risks are derived from the operating basis of medical artificial intelligence,namely data collection and use,algorithm design and programming.It is precisely because of the existence of such unique risks that it is difficult for the traditional medical device access system to fully cover the access management needs of new medical devices such as medical artificial intelligence.The classification of medical artificial intelligence is different,and the substantive and procedural requirements for registration and approval should also be different: data collection and analysis under the premise of protecting personal privacy,reasonable explanations for algorithm design,and integration of the autonomy and autonomy of medical artificial intelligence It is reclassified according to the degree of special risk;at present,the legal documents on which medical artificial intelligence is registered and approved in China have a low level of effectiveness,which hinders the supervision of medical artificial intelligence and requires legislative means to enhance its binding and compulsory power;medical devices in China The negative list in the market access system is still the rule that medical artificial intelligence should follow when entering the market,but the risk of medical artificial intelligence is completely different from traditional medical machinery,which will inevitably lead to confusion in medical artificial intelligence market access.This article attempts to make recommendations from the perspective of the legalization of medical artificial intelligence access.On the issue of medical artificial intelligence access,legal thinking needs to be used to promote its rule of law.Under the premise of determining the basic principles of human-oriented access,the classification of medical artificial intelligence is refined and passed legislation to raise it to higher-level laws and regulations;starting with the basic characteristics and unique risks of medical artificial intelligence,Try to build a negative list of medical artificial intelligence access system.