Call for better regulation of AI-based medical products

Artificial neuron in concept of artificial intelligence. Wall-shaped binary codes make transmission lines of pulses and/or information in an analogy to a microchip. Neural network and data transmission.

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.