Call for better regulation of AI-based medical products
Products based on artificial intelligence should be regulated like drugs, and those that are deemed unsafe should be removed from the market, according to a new report.
The report commissioned by NHS Digital noted that AI-based products are likely to fall under the remit of the UK’s regulator, the Medicines and Healthcare products Regulatory Agency (MHRA).
But they will also have implications for other organisations, according to the report from the Academy of Medical Royal Colleges, Artificial Intelligence in Healthcare, who investigated the clinical, ethical and practical issues of using the technology in the NHS.
Other organisations affected will be the medical regulator, the General Medical Council, which will need to give clear guidelines on appropriate use of AI.
Medical defence organisations may need to be prepared given the increasing number of patients given AI-generated decisions and recommendations.
The Care Quality Commission regulator for hospitals and clinics will have to consider how AI systems will impact on the quality of care, with NHS Digital taking a role in risk management.
But the report commissioned by the NHS has found AI is unlikely to replace clinicians “for the foreseeable future” and that doctors should instead be trained in data science as well as medicine.
The report made seven recommendations – with the first being that “politicians and policymakers should avoid thinking that AI is going to solve all the problems” facing the UK health system.
Patient safety must be regulated, and the doctors of the future will need to be well versed in using AI technology.
Data should be shared more widely among those who meet information and governance standards, and it should be for the government to decide how widely it is shared.
There is also a need for “joined up regulation” and providers of AI services should be regulated like every other healthcare product.
“As with the pharmaceutical industry, licensing and post-market surveillance are critical and methods should be developed to remove unsafe systems,” report authors said.
AI should be used to reduce, not increase health inequality, the report added.
"Tunaomba sheria bora kwa bidhaa za matibabu zinazotegemea akili bandia, ""Kulingana na ripoti mpya, bidhaa zinazotegemea akili bandia zinapaswa kudhibitiwa kama dawa, na zile ambazo zinachukuliwa kuwa zisizo salama zinapaswa kuondolewa soko." Kwa mujibu wa ripoti hiyo, bidhaa zinazotumiwa na AI zitakuwa chini ya mamlaka ya shirika la Uingereza linaloongoza katika masuala ya dawa na huduma za afya (MHRA). "Hii ni kwa sababu ya utafiti wa ""Artificial Intelligence in Healthcare"" uliofanywa na Chuo cha Chuo cha Royal cha Tiba, ambao ulijaribu kugundua masuala ya kliniki, maadili na vitendo ya kutumia teknolojia hiyo katika NHS." "Mashirika mengine yatakayoathiriwa ni ""msimamizi wa matibabu, Baraza Kuu la Matibabu, ambalo litahitaji kutoa miongozo ya wazi juu ya matumizi sahihi ya AI.""" Mashirika ya ulinzi wa matibabu yanaweza kuhitaji kuwa tayari kutokana na kuongezeka kwa idadi ya wagonjwa wanaopewa maamuzi na mapendekezo yaliyotengenezwa na AI. Tume ya Ubora wa Huduma (CQC) ya Hospitali na Kliniki inapaswa kuzingatia jinsi mifumo ya AI itaathiri ubora wa huduma, na NHS Digital kuchukua jukumu katika usimamizi wa hatari. Lakini ripoti hiyo iliyoagizwa na NHS imegundua kuwa AI haiwezekani kuchukua nafasi ya madaktari katika siku zijazo na kwamba daktari wanapaswa badala yake kufundishwa katika sayansi ya data na dawa. Ripoti hiyo ilitoa mapendekezo saba, na ya kwanza ni kwamba wanasiasa na watunga sera wanapaswa kuepuka kufikiria kwamba AI itatatua matatizo yote yanayokabili mfumo wa afya wa Uingereza. Usalama wa wagonjwa lazima ufuatwe, na madaktari wa siku zijazo watahitaji kuwa na ujuzi wa kutumia teknolojia ya AI. Takwimu zinapaswa kugawanywa kwa wingi kati ya wale wanaokidhi viwango vya habari na utawala, na inapaswa kuwa kwa serikali kuamua ni kwa wingi gani inashirikiwa. Pia kuna haja ya "kuungana juu ya udhibiti" na watoa huduma za AI wanapaswa kudhibitiwa kama kila bidhaa nyingine ya huduma ya afya. "Kama ilivyo na sekta ya dawa, leseni na usimamizi wa baada ya soko ni muhimu na mbinu zinapaswa kuendelezwa kuondoa mifumo isiyo salama", waandishi wa ripoti walisema. AI inapaswa kutumika kupunguza, sio kuongeza usawa wa afya, ripoti hiyo iliongeza.