Regulating AI in healthcare: a moving target

The debate about AI in healthcare is no longer on whether we should use it but on the conditions under which staff and patients can trust it. The UK’s National Commission into the Regulation of AI in Healthcare,1 set up in response to the government’s commitment to make the NHS the most AI enabled health system in the world, drew a consistent message from patients, clinicians, providers, industry, and regulators: AI can improve care and productivity, but only in a regulatory system proportionate to risk, capable of learning over time, and explicit about transparency and accountability. With the NHS moving from small pilots to system-wide use,2 it is unclear whether regulatory capacity and infrastructure can keep pace.Small scale trials of AI supported systems in controlled environments—for example, when staffing levels and documentation practices are fixed by the study protocol—do not match postmarket implementation environments, such as busy hospitals.3 A regulatory…