A new era for healthcare
Artificial intelligence (AI) is ushering in a new era, with the potential to reshape the world as we know it. In healthcare, it’s already starting to have an impact.
AI can support earlier diagnosis and reduce the administrative burden on clinicians, giving them more time to focus on patient care.
For patients, this could mean faster answers, more personalised treatment, and a healthcare system that responds better to their needs.
As Patient Safety Commissioner, my role is to ensure patient voices are heard and acted on, particularly as new technologies like AI are introduced. Through the National Commission into the Regulation of AI in Healthcare, we are working with partners across the system to explore both the opportunities and the challenges this brings.
Leading voices
The National Commission brings together leading voices from healthcare, academia, industry and government to advise on a clear and trusted approach to regulating AI in healthcare. Regulation is essential: it protects patients while allowing innovation to grow.
The Commission meets regularly to discuss key issues and create space for open, cross‑sector conversations. At its core is a simple idea: the future of healthcare, and the role of AI within it, should be shaped by a wide range of voices. Bringing those voices together helps build shared understanding, ownership and confidence across the system.
Hearing the voices of patients
This work needs all of us. It must be shaped not only by government, experts and industry, but with patients and the public at the centre of how AI is introduced into healthcare.
That commitment has guided the Commission’s work from the outset. An open Call for Evidence received over 770 responses before closing in February, with a third coming from patients and the public. This level of engagement shows how strongly patients and the public want to be included as partners in the regulation of AI in healthcare.
In the Call for Evidence, we heard from patients, patient groups and charities, alongside healthcare professionals, researchers and industry. Together, these perspectives painted a detailed picture of both the potential benefits of AI and the risks that must be addressed.
What we heard
A clear message emerged: trust is central. This means trust in the technologies themselves, in how they are used, and in the systems that govern them.
There is strong support for reform of the current regulatory approach. People want meaningful change, but not a complete overhaul. This reflects confidence in parts of the existing system, alongside a need to strengthen and adapt it as technologies evolve.
Concerns were raised about how AI medical devices are monitored once they are in use. Safety does not stop at approval. Ongoing monitoring, transparency and the ability to respond quickly when risks emerge are essential.
There is also uncertainty about liability, this means who is responsible if something goes wrong as AI becomes more involved in clinical decision‑making. Addressing this will be vital for protecting patients, supporting clinicians and building trust, and will require collaboration across the system.
Across all of this, there is strong support for innovation that is matched with strong safeguards, clear accountability and transparency. These are the foundations for building trust and confidence in how AI is developed, regulated and used in practice, including for the ultimate users - patients and the public. Getting this right is essential to ensuring these technologies can be introduced safely and effectively to deliver meaningful improvements in patient care.[1][2]
Deepening engagement
Alongside the Call for Evidence, a wider programme of engagement is underway to ensure a broad range of voices shape the Commission’s work.
The MHRA has worked closely with patients and communities, including those often left out of these conversations, such as people with learning disabilities, carers and young people, in partnership with National Voices. It has also supported in‑depth public discussion sessions delivered by The Health Foundation with Ipsos MORI, and consultations with its Patient and Public Community.
These discussions show that people are more comfortable with AI supporting clinicians, for example by reducing administrative burden, than making high‑stakes decisions independently. There is strong emphasis on human oversight, transparency, and evidence that these technologies work safely for everyone.
Across all engagement, a consistent picture emerges trust is central to whether the benefits of AI in healthcare can be realised.
Working together across the system
The Commission’s work is supported by four working groups bringing together expertise across health systems, technology, devolved nations and government.
As Chair of the Health Systems Working Group, my focus has been on ensuring AI is used in ways that include the patient’s perspective. This means taking a patient‑centred view of how technologies are designed, implemented and overseen in everyday healthcare settings.
Alongside this, the MHRA has led sector roundtables involving over 30 organisations and 117 clinicians and representatives from across the healthcare system. These sessions bring together those developing, using and supporting AI, ensuring the Commission’s recommendations are grounded in real‑world experience and focused on what matters most to patients.
Continuing the conversation
These voices are shaping the future of AI regulation and deployment in healthcare, but the conversation must remain open. That is why I will be hosting an Ask Me Anything session on Wednesday 20 May. This will be an open public webinar where patients and the public can hear directly from the Commission’s leadership.
I will be joined by the Chair of the National AI Commission and the Chief Executive of the MHRA. Together, we will share more about our work and respond to the issues that matter most to patients and the public. We want to hear from you so please register and submit your questions in advance.
The National Commission’s recommendations are on track to be published this summer. They will be shaped by the collective insight of many voices, because the future of AI regulation in healthcare will not be shaped by one voice, but by many.
[1] The Health Foundation, AI in health care must earn the public’s confidence, finds that the public prioritises safety, strong evidence, human oversight and clear safeguards over speed or economic opportunity, highlighting the importance of building trust and confidence in how AI is used in healthcare.
[2] Tony Blair Institute for Global Change, What the UK Thinks About AI, highlights the role of public trust in shaping how AI is received.