Call for statutory regulator to oversee use of AI in healthcare

By Cate McCurry, PA

The Government is facing calls to establish a statutory regulator to oversee the use of Artificial Intelligence (AI) in healthcare in Ireland.

A citizens’ jury set out a series of 25 recommendations for health policy-makers on the safe and ethical use of AI in the healthcare system.

They have also advocated for more funding and training to help support the rollout of AI in the sector.

The jury has written an open letter to the Minister for Health Jennifer Carroll MacNeill and to the Minister for Enterprise Peter Burke, calling for a national strategy to chart the course of AI in healthcare over the next five years.

Organised by IPPOSI (Irish Platform for Patient Organisations, Science and Industry), the jury of 24 individuals, representative of the population of Ireland, convened from September to December 2024 to offer the public’s perspective on the complex topic.

Jurors backed the “early, low-risk deployment of high-quality”, human-monitored AI tools in helping alleviate pressures on the healthcare system, in pioneering advances in treatment and care, and in empowering individuals to take a more active role in their own health.

But the jury called for strong regulation, transparent oversight and robust data security.

The citizens’ jury said that the establishment of a statutory regulator would be responsible for developing and enforcing standards for those using AI, including its licensing, data governance and monitoring, as well as imposing penalties for breaches.

It would also publish compliance reports to advance the development of AI technologies in healthcare that were secure, transparent and accountable.

The jury called for the creation of a separate, independent Commissioner for AI in Healthcare to serve as a public-interest watchdog and protect patient rights.

Their role would be to increase public awareness about how AI was being used in healthcare, make recommendations on the use of individuals’ health data by AI, and independently identify opportunities to strengthen compliance with regulatory standards.

The future of using AI in healthcare is widespread, ranging from managing waiting lists, analysing X-rays, to undertaking robotic surgery.

While supporting the automatic enrolment of individual health data for training AI, jurors agreed that people must be clearly informed and given the option to opt out.

The jury also recommended that patients have the right to be informed when AI is involved in their healthcare and, where feasible, be given the choice to receive diagnosis or treatment without AI involvement.

Professor Richard Greene of University College Cork, a member of the independent jury oversight panel, is an obstetrician and gynaecologist by profession, as well as the HSE’s chief clinical information officer.

He said: “As a healthcare professional, I welcome the jury’s strong emphasis on keeping humans at the heart of patient care.

“AI can support us in enhancing decision making and in delivering better outcomes, but it is an aid to healthcare professionals, not a replacement.

“To avoid unintended consequences, its use requires continuous oversight, rigorous evaluation, and clear accountability, with humans firmly in the loop.”

Kim Lennard, a juror from Co Meath, said that as AI became a bigger part of healthcare, there was a role for a “strong, independent regulator”.

“This body should make sure that AI is used responsibly, ethically, and in a way that truly benefits patients – while holding those who misuse it accountable,” she said.

“But regulation is just one piece of the puzzle. We’re also calling for clear policies and laws to protect patient rights and ensure AI in healthcare meets the needs, values, and expectations of the public.”

IPPOSI chairperson Joan Johnston called for work to get under way immediately on the development of a national strategy.

“The citizens’ jury is a truly fascinating process, and these individuals have shown incredible leadership, pragmatism and creativity throughout their deliberations,” she said.

“A statutory regulatory body, backed by independent public oversight, that works to ensure the safeguarding of health data, is a worthy recommendation by the jury, and IPPOSI echoes its call on Government to immediately start work on a national strategy for the future use of AI in healthcare that reflects the priorities set out by jurors.”