Regulation for AI in healthcare required sooner rather than later

While the potential benefits of artificial intelligence (AI) in healthcare are enormous, there are also a multitude of dangers and risks. This is why regulation is so important.

Late last month, a Citizens’ Jury on the Use of Artificial Intelligence (AI) in Healthcare outlined 25 recommendations for health policymakers on ensuring the safe, ethical, and inclusive use of AI. The jury also addressed an open letter to the Minister for Health and the Minister for Enterprise, Tourism, and Employment on the subject.

Organised by the Irish Platform for Patient Organisations, Science and Industry (IPPOSI), the jury comprised 24 individuals representing Ireland’s population. They convened between September and December 2024 to provide the public’s perspective on this complex issue.

Overall jurors supported the early, low-risk deployment of high-quality, human-supervised AI tools to help ease pressures on the healthcare system.

They found AI could drive innovation in treatment and care and help individuals to take a more active role in managing their health.

However, jurors stressed the need for strong regulation, transparent oversight, and robust data security. To build public trust, one of the jury’s key recommendations is the establishment of a statutory regulator to oversee AI’s utilisation in healthcare. This body would be responsible for setting and enforcing standards, including AI licensing, data governance, and monitoring.

It would also impose penalties for breaches. Additionally, it would publish compliance reports to ensure AI technologies in healthcare remain secure, transparent, and accountable.

To complement this regulatory framework, the jury also called for the appointment of an independent commissioner for AI in healthcare. Such a commissioner would act as a public interest watchdog and protect patient rights. This role would also focus on raising public awareness about AI’s use in healthcare, making recommendations on the handling of individuals’ health data by AI, and independently identifying ways to strengthen compliance with regulatory standards. The commissioner would also manage a complaints process for the public.

The jury highlighted the importance of transparency, patient autonomy, and informed consent. While endorsing the automatic inclusion of individual health data for AI training, they stressed that individuals must be clearly informed and have the option to opt out. In addition, the jury recommended that patients be notified when AI is used in their healthcare and, where possible, be offered the choice to receive diagnosis or treatment without AI.

Among the other recommendations were the call for a public education campaign and a national strategy detailing the role of AI in healthcare. It recommended that this strategy should be published early next year.

Given the pace at which AI is developing, it is vital a regulatory framework and strategy are developed as soon as possible.