Category: 3. Business

Members of the public, clinicians, industry and healthcare providers are being asked to share their views on how AI in healthcare should be regulated, as part of a “Call for Evidence” launched by the Medicines and Healthcare products Regulatory Agency (MHRA) today (18 December 2025).

This will support the work of the newly formed National Commission into the Regulation of AI in Healthcare which brings together global AI leaders, clinicians, regulators and patient advocates and advises the MHRA on the future of health AI regulation.

It is a vital opportunity for all voices, including patients, health professionals, innovators, and the public, to influence the development of a new set of standards and safeguards for how AI is used in healthcare.

The input will help the MHRA to effectively regulate new AI technologies in the NHS and wider healthcare and ensure they support innovation and meet the needs of patients and families. 

The call for evidence seeks to hear from everyone, whether they are familiar with how AI is being used in healthcare or simply have thoughts about what rules should be in place to ensure it is proportionately regulated. 

Key themes include:

·       Modernising the rules for AI in healthcare: Are the current rules for regulating AI in healthcare working, or do they need updating to keep pace with new technology?

·       Keeping patients safe as AI evolves: As AI systems become more advanced and are used in new ways, how can we spot and address any problems quickly, especially with new types of AI that can learn and change over time?

·       Clarifying responsibility: What should the distribution of responsibilities between regulators, companies, healthcare organisations and individuals involved in the use of technology in healthcare look like? 

Chief Executive of the MHRA Lawrence Tallon, who took over the role earlier this year and who has spearheaded the formation of the Commission, said:

AI is already revolutionising our lives, both its possibilities and its capabilities are ever-expanding, and as we continue into this new world, we must ensure that its use in healthcare is safe, risk-proportionate and engenders public trust and confidence.  

The National Commission brings together a host of experts including patients’ groups, clinicians, industry, academics and members from across government. Today we are asking the public to contribute by sharing their thoughts, experiences and opinions.

We want everyone to have the chance to help shape the safest and most advanced AI-enabled healthcare system in the world at this truly pivotal moment.

Professor Alastair Denniston, head of the UK’s Centre of Excellence in Regulatory Science in AI and Digital Health (CERSI-AI) and who chairs the Commission, said: “We are starting to see how AI health technologies could benefit patients, the wider NHS and the country as a whole.

But we are also needing to rethink our safeguards. This is not just about the technology ‘in the box’, it is about how the technology works in the real world.

It is about how AI is used by health professionals or directly by patients, and how it is regulated and used safely by a complex healthcare system such as the NHS.

This call for evidence, and the information it will provide, is so important.

This is everyone’s opportunity to help shape what a future AI-supported healthcare service will look like, and how safety is ensured across the system.

Professor Henrietta Hughes, Patient Safety Commissioner for England and deputy chair of the Commission, said:

Patients bear the direct consequences of AI healthcare decisions, from diagnostic accuracy to privacy and treatment access. 

The lived experience and views of patients and the public are vital in identifying potential risks and opportunities that technologists and clinicians may miss. 

Your views matter and each of us has the opportunity to shape the role AI will play in our lifetime, and for the generations to come. So please let us know through this call for evidence. 

We will listen and incorporate the findings to design safe, fast and trusted systems that truly serve patients and the public.

The Commission’s call for evidence, which runs from Thursday 18 December 2025 to Monday 2nd February 2026, will help ensure AI technologies are safe, effective, and support innovation that benefits patients and the NHS. 

Anyone can take part, with submissions invited from members of the public, patients, medical professionals, technology companies as well as from healthcare providers.

The information gathered will help inform the Commission’s work and help inform its recommendations to the MHRA in 2026.

ENDS

Notes to editors  

1. The link for submission will be live from 9.30am on Thursday 18 ecember 2025 – https://www.gov.uk/government/calls-for-evidence/regulation-of-ai-in-healthcare
2. A survey of the public and NHS staff conducted by the Health Foundation in 2024 found that more than half of the UK public surveyed (54%) and three-quarters of NHS staff surveyed (76%) said they support the use of AI for patient care, and an even greater proportion said they support the use of AI for administrative purposes (61% of the public and 81% of NHS staff surveyed)
3. [Data from the Nuffield Trust shows that](https://www.nuffieldtrust.org.uk/research/how-are-gps-using-ai-insights-from-the-front-line 28% of GPs currently use AI tools in their clinical practice. With GPs emphasising a lack of regulatory oversight of AI as a major concern, as well as misleading or incorrect outputs.
4. The UK AI market is projected to reach £1 trillion by 2035, with health and social care expected to see the largest net job gains.​
5. The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for regulating all medicines and medical devices in the UK by ensuring they work and are acceptably safe.  All our work is underpinned by robust and fact-based judgements to ensure that the benefits justify any risks.
6. The MHRA is an executive agency of the Department of Health and Social Care.
7. For media enquiries, please contact the newscentre@mhra.gov.uk, or call on 020 3080 7651.

The Commission has appointed the 20 members of the new European Innovation Council Board. Among them there are 15 new members and 5 members from the previous EIC Board, whose appointment has been renewed.  

Led by its President, the Board brings together high-level representatives from across the innovation ecosystem, with strong experience and expertise in fields such as academia, entrepreneurship and finance. Its mission is to guide the European Innovation Council (EIC) to become Europe’s go-to instrument for breakthrough innovation and deep-tech scale-ups, maximising impact, channeling resources efficiently and promoting Europe’s strategic autonomy. The Board advises the Commission on the strategy, work programme and thematic portfolios, and may also be asked to provide input on broader innovation policy matters. 

The new members were selected among the 951 applicants who applied to the call for expression of interest, published in April 2025.  

The EIC Board members serve in a personal capacity and are appointed for a two-year term, renewable twice. The first meeting of the renewed Board will take place on 29 January 2026. 

Background  

The EIC is Europe’s flagship innovation programme to identify, develop and scale up breakthrough technologies and game changing innovations. Established under the Horizon Europe  it has a budget of €10.1 billion to support game changing innovations throughout their lifecycle, from early-stage research to proof of concept, technology transfer, and the financing and scale up of startups and small and medium-sized businesses (SMEs).  

The composition of the renewed EIC Board ensures a high level of expertise with strong diversity and balance including: 

• Innovation expertise: bringing together leading researchers, entrepreneurs, corporate executives, ecosystem builders and innovation specialists, with thematic expertise in key EIC priority areas such as digital & artificial intelligence (AI), health & biotech, and the Green Deal & energy transition.
• Gender: a balanced representation of women and men (50:50);
• Geography: new Board members represent 16 nationalities, including 7 coming from Horizon Europe widening countries.  

For more information 

EIC Board Members

EIC Board statements 

1 Executive Summary

1.1 Introduction to the Consultation

1.1.1 This Consultation Analysis Report summarises the responses to the consultation on the Scottish Marine Recovery Fund (MRF) ^[1]. The purpose of the Scottish MRF is to enable resources to be targeted at strategic compensatory measures which best address both plan-level and project-level adverse effects of offshore wind projects, maximising the environmental benefit in Scotland.

1.1.2 Responses to this consultation were collected to inform the design of the Scottish MRF and the relevant United Kingdom (UK) secondary legislation which is required to establish the Scottish MRF and delegate functions to operate and manage it.

1.1.3 The consultation ran for a period of 6 weeks from 19 August 2025 to 30 September 2025. In total 26 responses to the consultation were received and analysed, with 25 responses from organisations (10 Offshore Wind Sector, 6 Public Sector, 6 Environmental Non-Governmental Organisations (NGOs), 2 Other Marine Industries, and 1 Fisheries Sector) and 1 from an individual member of the public.

1.2 Overarching Themes

1.2.1 Consultation Process: Respondents felt that insufficient information and transparency within the consultation documents limited the ability of stakeholders to provide robust and reasoned feedback on details of the proposed Scottish MRF.

1.2.2 Co-benefits of the Scottish MRF: The MRF was viewed as a positive mechanism for integrating various policy goals and achieving wider benefits across economic, environmental and social domains.

1.2.3 Cross-jurisdictional responsibilities: There was a strong emphasis on ensuring effective coordination between the Scottish and the UK Government to avoid duplication and gaps in the implementation of compensation measures and the need for collaborative frameworks to ensure the success of the Scottish MRF.

1.2.4 Integration with existing consenting regimes: Stakeholders frequently raised the theme of aligning the Scottish MRF with existing consenting regimes (Section 36 consents, Marine Licences, Habitats Regulations Appraisals (HRAs) and local authority consent) to maximise its effectiveness.

1.2.5 Fee timelines and payments: The consultation identified the importance of a clear and competitive fee structures for the Scottish MRF.

1.3 Summary of responses by category

Applying to the Scottish MRF

1.3.1 A majority of respondents supported giving developers flexibility in choosing which MRF to apply to, particularly to address cross-border environmental impacts. This flexibility was seen as beneficial for managing compensation across jurisdictions, provided there are clear, transparent criteria and robust protocols for tracking and quantifying impacts. However, concerns were raised about potential risks such as oversubscription, increased administrative burdens, and the possibility of undermining ecological coherence if developers opt for less stringent MRFs. There were also calls to establish a UK-wide register to prevent double funding and ensure compensation is delivered where it is most ecologically meaningful.

1.3.2 There was broad support from the Offshore Wind sector for the Scottish MRF being a voluntary mechanism, particularly for projects in advanced stages, as it allows developers to combine fund-based and bespoke compensatory measures. However, some Environmental NGOs and Public Sector respondents cautioned that a purely voluntary system could lead to underfunding or lack of accountability, and called for proven interventions, independent verification, and clear guidance to ensure the fund’s effectiveness and legal standing.

Funding and Fee Structure

1.3.3 Respondents to the consultation generally supported the introduction of an initial, non-refundable payment to secure access to compensation measures offered by the Scottish MRF, with most agreeing that the MRF operator should allocate measures to projects as needed. While a full cost recovery model was favoured overall, stakeholders offered contrasting views on payment structures: the Offshore Wind Sector advocated for flexible, instalment-based plans to better manage early-stage project risks and cash flow, while Environmental NGOs preferred upfront lump sum payments to guarantee compensation before any environmental harm occurs.

1.3.4 Feedback was divided regarding the proposed 30% adaptive management charge. Many respondents questioned the suitability of a flat fee, suggesting instead a risk-based or tiered approach with clearer justification for the figure. There was broad support for surplus funds to be reinvested in restoration efforts. Stakeholders stressed that the scheme should remain cost-neutral and be designed so as not to deter developer involvement.

Interaction between the Scottish MRF and the UK Government MRF

1.3.5 There was strong support among respondents for the establishment of a Scottish MRF operating independently from the UK Government MRF, with the majority believing this would better align with Scotland’s planning and environmental frameworks. However, some expressed concerns about the complexity and potential inconsistencies that could arise from managing compensation for mobile, cross-border species under separate arrangements, highlighting the need to maintain a coherent UK network of Marine Protected Areas (MPAs) and uphold biodiversity commitments.

1.3.6 Respondents also emphasised the importance of close coordination and alignment between the Scottish and UK MRFs. Key recommendations included shared data, consistent standards, and joint oversight to avoid duplication and ensure effective environmental outcomes. There were calls for clear guidance, transparency in intergovernmental collaboration, and joint agreements to prevent inefficiency.

Impact Assessments

1.3.7 While some stakeholders welcomed the Business Regulatory Impact Assessment (BRIA), several called for greater detail regarding secondary impacts, notably on fisheries, tourism, and island communities. Environmental NGOs and representatives from the Fisheries Sector felt the assessment did not sufficiently address the unique challenges facing islands and fisheries. The Offshore Wind Sector highlighted the potential for compensatory measures to benefit coastal communities and commercial fisheries through long-term ecosystem restoration and noted the potential for improved consenting timelines and cost predictability.

1.3.8 On consumer and community impacts, respondents generally agreed that a Scottish MRF could help lower consumer energy costs if managed effectively, although caution was advised to avoid passing compensation costs to consumers.

General Questions

1.3.9 Responses indicated broad support for establishing a Scottish MRF as a mechanism to streamline offshore wind consenting and deliver strategic compensation measures, with many believing this would help Scotland progress towards its net zero goals. Most respondents agreed the MRF would be beneficial not only for the environment, but also for the people of Scotland and developers, citing advantages such as reduced administrative burdens, improved compliance certainty, and the potential for large-scale, strategic compensation.

1.3.10 However, respondents emphasised that the effectiveness of the Scottish MRF would depend on clear governance, detailed guidance on eligible measures, and careful alignment with UK-wide mechanisms. Concerns were raised regarding cost-effectiveness, transparency, and the need for compensation to be available when required. Stakeholders further stressed the importance of strategic planning, robust stakeholder engagement, and adaptive management to ensure the fund delivers equitable and effective outcomes across sectors.

1.4 Next Steps

1.4.1 Responses to this consultation will inform the design of the Scottish MRF and the relevant UK legislation which will be required to establish the Scottish MRF. Final guidance on all aspects of the draft policy will be developed following this consultation.

1.4.2 The Scottish MRF will open as soon as practicable, subject to completion of all required policy work, the relevant legislation to establish the Scottish MRF being passed by the UK Parliament, and necessary functions to establish and operate a Scottish MRF being delegated to Scottish Ministers.

1.4.3 An approach to monitoring and evaluating the effectiveness of a Scottish MRF is intended to be developed ahead of it coming into operation. The Scottish MRF will be considered against the expectations set out within the draft partial BRIA ^[2], and any associated business case, as part of that process.

1.4.4 The feedback received in relation to the draft partial BRIA, and analysed in this consultation analysis report, will be reflected in the final BRIA.

Australia’s sharemarket has struggled to find a clear direction, as strong performances from iron ore producers helped ballast an energy sector that is on track for its worst week since April.

The S&P/ASX200 crept three points higher on Thursday, up 0.03 per cent, to 8,588.2, as the broader All Ordinaries snatched 1.5 points, or 0.02 per cent, to 8,875.7.

Four of 11 local sectors traded lower, led by slumps in energy (-1.5 per cent) and utilities (-1.1 per cent) stocks, while the real estate and consumer staples rose roughly 0.5 per cent in an underwhelming session for volatility.

The Australian dollar was buying 66.04 US cents, down from 66.19 US cents on Wednesday at 5pm.