Prime Highlights-
- MHRA sets out ten findings pushing for a proportionate, lifecycle-based approach to AI regulation in healthcare.
- Report finds strong backing for major regulatory reform as AI use grows across healthcare.
Key Facts-
- Findings call for shared responsibility across the system for ongoing AI post-market surveillance.
- Report urges retaining human oversight and boosting training to protect patient and public trust.
Background-
The Medicines and Healthcare products Regulatory Agency has laid out ten conclusions from a report looking at how artificial intelligence should be regulated across healthcare.
The findings follow a call for evidence launched late last year, gathering evidence on how AI is currently used in practice and the regulatory hurdles it brings.
Among the key findings, the report points to a clear demand for a proportionate, lifecycle-based approach to regulation, with strong support for major regulatory reform.
Respondents also agreed that AI systems will need ongoing post-market surveillance, with that responsibility spread across the healthcare system so every individual and institution knows its part.
Healthcare providers want clear rules on who is responsible. Patients and the public want the current gaps fixed. The report also asks for clearer rules on liability. It says humans must stay in charge of clinical decisions, and AI tools must stay open and easy to understand as they spread across health settings.
Data access and use sit at the core of AI’s growing role in healthcare, the report finds. It also calls for stronger training and better AI literacy among healthcare staff, along with improved incident reporting and learning systems to keep patient and public trust intact.
Alastair Denniston, who chairs the National Commission into the Regulation of AI in Healthcare, said AI’s growing footprint in healthcare will touch everyone. He pointed to real benefits on offer, from better quality and speed to convenience and safety, but cautioned that regulators and the wider health system need to actively step up, making sure governance keeps up with the risks and rewards these new technologies bring.
