The expansion is particularly critical for the estimated 70% of countries that report weak or inadequate regulatory systems for health products. By broadening the prequalification programme for medical devices, WHO aims to improve equitable access to technologies such as male and female condoms, intrauterine devices (IUDs), and computer-aided detection software for tuberculosis (CAD-TB). As part of this transition, the prequalification of condoms and IUDs has been transferred from the United Nations Population Fund (UNFPA) to WHO. Additionally, male circumcision devices have been integrated into this broader framework to support voluntary medical services that can reduce the risk of HIV acquisition in men by approximately 60%.

Dr. Sylvie Briand, WHO Chief Scientist and Assistant Director-General a.i. for Health Systems, Access and Data, stated: “Everyone, everywhere, should be able to rely on medical devices that are safe, effective and meet high standards of quality. By expanding WHO prequalification, we are strengthening confidence in these essential health products and helping countries expand equitable access to the technologies people need to protect and improve their health.” The inclusion of CAD-TB software also introduces artificial intelligence-driven digital health technology into the programme, facilitating earlier detection and treatment in high-burden countries.

Known as the Manchester Sandbox, the programme provides a structured environment where innovators, healthcare professionals, and regulators can assess new technologies in real-world clinical conditions. The initiative was officially launched at MFT’s Oxford Road Campus in Manchester, bringing together representatives from the regulatory, NHS, industry, and research sectors.

The programme is expected to initially focus on AI-enabled medical devices, with the broader aim of generating robust evidence on their safety, effectiveness, and suitability for deployment within NHS care pathways. The Manchester Sandbox also intends to explore regulatory approaches that can keep pace with increasingly sophisticated medical technologies as they continue to evolve.

Faster Access to Innovation for Patients

Health Innovation Minister James Frith commented at the launch, stating: “Manchester is leading the way in getting the best new technologies into the hands of local patients faster, from AI models that can identify people at risk sooner to innovative treatments that could transform NHS care.”

The MHRA noted that the programme will enable emerging technologies to be assessed at an earlier stage, while also helping developers understand the evidence requirements needed to support their adoption within healthcare systems. For NHS healthcare technology stakeholders, including NHS organisations themselves, the sandbox is designed to offer greater insight into how new solutions perform in live operational environments and how they could realistically be integrated into existing services.

At the launch event, several technologies were highlighted as examples of the innovation the programme aims to support. These included wearable devices and AI-powered Ambient Voice Technology — the latter of which is already being used in active patient care settings.

The MHRA and MFT confirmed that learnings gathered through the Manchester Sandbox will be shared more broadly to support the safe and informed adoption of innovative technologies across the wider NHS. A roundtable is also planned, bringing together regulators, NHS organisations, innovators, researchers, and patient and public representatives to identify further opportunities for the programme.

The MHRA is expected to invite medical device developers to submit expressions of interest for the next phase of the sandbox. The partnership forms part of wider efforts to accelerate healthcare innovation while maintaining appropriate regulatory oversight, reinforcing the commitment to responsible development of NHS healthcare technology across the United Kingdom.

The National Commission into the Regulation of AI in Healthcare, established by the Medicines and Healthcare products Regulatory Agency (MHRA) in September 2025, arrived at its recommendations following an extensive evidence-gathering process involving more than 12,000 stakeholders — including clinicians, healthcare leaders, industry representatives, and technology developers.

Broad Public Support, With Clear Conditions

The commission’s findings revealed broad public support for AI in healthcare, though that support comes with clear conditions. Stakeholders consistently called for strong safety standards, meaningful human oversight, and greater transparency about when and how AI is being used in patient care. These three pillars form the backbone of the commission’s regulatory thinking.

Professor Alastair Denniston, NHS consultant and Chair of the National Commission into the Regulation of AI in Healthcare, stated: “We innovate because we believe tomorrow’s healthcare can be better than today’s. But any new innovation — including AI — needs to earn its place and earn our trust. These technologies need to show that they are safe, effective and bring benefits to patients, staff and the wider NHS, without leaving people behind.”

He added: “Over the past year we have heard from more than 12,000 people, including patients, carers, clinicians and the technologists building AI tools. One message came through clearly: people are open to AI improving their care, but only if it is safe, overseen by humans, and if they know when it is being used.”

Staged Authorisations: The ‘L-Plates’ Approach

On the matter of faster access to safe and effective AI, the commission recommends that the MHRA introduce staged authorisations for new AI models — a process it likens to ‘L-plates’ for learner drivers. Under this approach, new AI models would be deployed under close supervision with tight guardrails, allowing them to demonstrate real-world safety and performance before being granted fuller authorisation.

The commission stated that this staged approach is designed to give UK patients world-first access to promising new models, while ensuring risk is carefully controlled at every step of the process.

Continuous Real-World Monitoring Throughout the Device Lifecycle

The commission also recommends that AI-enabled medical devices be subject to continuous, real-world monitoring throughout their lifecycle, rather than evaluation at a single point in time. This recommendation reflects the evolving nature of AI technologies after they are deployed.

According to the commission, this approach would help ensure that as AI systems learn and adapt, patients remain protected and regulators retain the visibility to act quickly if problems emerge. AI-enabled medical devices present a unique regulatory challenge precisely because their behaviour can change post-deployment — making ongoing oversight a critical component of responsible AI deployment.

Public Access to Device Safety Information

Another key element of the commission’s recommendations is a provision for members of the public to easily search for information about the safety of specific AI-enabled medical devices, including any adverse incidents. The intent is to give the public “clear, accessible information” they can trust — making safety data on AI-enabled medical devices more transparent and readily available.

Strengthened Enforcement Powers for the MHRA

The commission also recommends granting the MHRA stronger enforcement powers, enabling the agency to “act decisively” in cases where AI systems “fall short of the standards patients expect.” These enhanced powers are intended to ensure that AI healthcare regulation carries meaningful authority — and that patients are protected when systems underperform or fail to meet required standards.

MHRA Chief Executive Officer Lawrence Tallon responded to the recommendations: “We have heard clearly about the opportunities of AI to speed up and improve care, and to release more of clinicians’ time for the essentially human aspects of their work with patients. We will only realise those opportunities if we have a modern, dynamic regulatory framework that accelerates safe adoption, protects patients and commands public and professional confidence. I am so grateful to the many people who contributed to this expert commission to set out the roadmap ahead.”

With the commission’s work now complete, the UK government and the MHRA will carefully consider its recommendations, with a formal response to follow in due course.

Context: Prior Policy Consultation and Current Regulatory Framework

The commission’s recommendations on safe AI rollout follow an earlier ‘policy-shaping’ consultation on AI healthcare regulation, published in June 2026. In the United Kingdom, AI in healthcare is currently regulated under the nation’s medical device regulation (MDR), with the technology classified under the designations of software-as-a-medical-device (SaMD) or AI-as-a-medical-device (AIaMD).

The consultation revealed that 50% of respondents believed the existing regulatory framework needed substantial revision, while 21% called for a complete overhaul. Key areas of concern included safety, performance standards, data governance, and privacy.

International Regulatory Developments

The MHRA is not the only regulatory body seeking industry input on AI. The United States Food and Drug Administration (FDA) also issued a call for stakeholder feedback on the use of generative AI in medical devices in August. That same month, the FDA and the MHRA announced plans for a more collaborative approach to shaping the future of healthcare regulation, with AI a key focus of that partnership — signalling growing international alignment around responsible AI deployment in clinical settings.

The current dialogue is anchored in the findings of the BRICS Health Track Technical Working Group 4 (TWG-4), which identifies the lack of interoperable data systems as a primary constraint to seamless health service delivery. By establishing common standards for information exchange, member nations aim to overcome challenges such as large and diverse populations, rural-urban disparities, and stretched health workforces. The transition toward integrated and people-centric healthcare delivery makes the adoption of a robust digital health infrastructure an essential tool for ensuring that clinical information follows the patient throughout their medical history, rather than remaining trapped in institutional silos.

Scalable Infrastructure and Responsible AI Governance

India has provided a scalable blueprint for this digital transformation, having already created more than 940 million Ayushman Bharat Health Account (ABHA) IDs. This foundation for digital identity has enabled the registration of more than one million healthcare professionals and over 500,000 health facilities into a unified network. Furthermore, the system currently facilitates secure access to more than one billion digital health records. These metrics demonstrate the practical feasibility of managing high-volume data to support continuity of care across complex national health landscapes.

The integration of advanced analytics is being guided by India’s Strategic Framework for AI in Healthcare, which establishes the parameters for responsible AI adoption. This framework focuses on strengthening healthcare delivery while ensuring ethics, transparency, safety, and citizen trust. By aligning these AI governance protocols with interoperable data standards, BRICS countries are working to ensure that new technologies can effectively address the rising burden of chronic and non-communicable diseases. The collective focus remains on fostering mutual learning and shared innovation to achieve universal health coverage through a connected and data-driven medical ecosystem.

HHS Secretary Robert F. Kennedy, Jr. emphasized the importance of individual data control in a formal statement, noting: “Americans deserve secure, timely access to their health records. We are strengthening TEFCA to put patients in control of their health information, improve care coordination, and ensure health data moves securely where it is needed. Access to your own health records is a fundamental right.” This administrative push comes as healthcare technology leaders and more than 75 health systems expressed concerns regarding bad actors potentially exploiting the system. Critics have argued that the current reliance on self-attestation and decentralized monitoring is insufficient to prevent the unauthorized monetization of patient data under the guise of the treatment pathway. Consequently, the new contract with Alliance Global Tech Inc. includes a baseline year of approximately $1.28 million to establish centralized scrutiny and verify compliance among participants.

Beyond network monitoring, the administration is intensifying its stance against information blocking, with potential penalties reaching $1 million per violation for developers and the loss of Medicare payments for providers. Thomas Keane, M.D., National Coordinator for Health IT, informed HIMSS26 attendees in March that the department has received over 1,500 complaints via its specialized portal. Highlighting the clinical necessity of these rules, Chris Klomp, HHS Chief Counselor and Director of the Center for Medicare, stated: “Seamless interoperability is essential for quality care; health records must flow easily between providers and patients. When critical health information is blocked or withheld, patients suffer the consequences. We are fully committed to using every appropriate regulatory and policy tool available to root out information blocking and protect patients’ right to access their own health data.” If behaviors indicating fraud or criminal activity are identified, the ONC plans to refer cases to the Department of Justice, the HHS Office of Inspector General, or the HHS Office for Civil Rights for further investigation. Through these combined efforts, the administration aims to facilitate a more robust health record exchange while protecting the legal rights of individuals to access their information securely.

The framework has received support from healthcare policy specialists and stakeholders within the medtech sector, who believe it could help NHS purchasing decisions better account for the long-term benefits and impact of healthcare technologies. Chris Whitehouse, Director of Health and MedTech Policy at Whitehouse Communications, which advises medical device suppliers, said: “For many years, procurement decisions across parts of the NHS have too often been driven primarily by upfront cost.” While the framework establishes a new direction for procurement practices, industry observers note that its success will depend on how effectively it is adopted across NHS organisations and integrated into existing decision-making processes.

Attention will also be required in areas such as procurement culture and stakeholder engagement to ensure the intended benefits are realised. Whitehouse emphasised that policy changes alone would not be enough to transform purchasing practices, stating: “Changing procurement frameworks on paper is relatively straightforward. Changing behaviours and cultures that have developed over many years is much harder,” he said. A central feature of the framework is the earlier involvement of clinicians in procurement discussions, recognising their insight into how technologies perform in real-world healthcare environments and how they influence patient care.

The framework further underlines the importance of patient experience as a measure of value. NHS organisations are encouraged to consider how technologies affect factors such as independence, dignity and quality of life when assessing procurement options. Through this outcomes-focused model, value-based procurement for Medical Device assessment aims to support more informed purchasing decisions while aligning procurement practices with broader healthcare objectives across the NHS.

The decision follows findings that equated the daily time savings to roughly five weeks per staff member each year. Health Innovation and Safety Minister Preet Kaur Gill said: “Every day, doctors, nurses and other healthcare professionals spend valuable time on administrative tasks that take them away from patients.” She added: “By rolling out Microsoft Copilot across the NHS, we can reduce that burden, free up clinicians’ time and help staff focus on what they do best, caring for patients.” Rob Thompson, Chief Digital, Data and Technology Officer at NHS England, said: “The potential to save clinical staff nearly a day’s worth of admin time every fortnight could be a gamechanger for patients.” He added: “We’re making sure every pound is spent on cutting waiting times and boosting care through the Plan for Change and 10 Year Health Plan.”

The deployment will support a range of operational and administrative functions across NHS England. Ward clerks will use the technology for patient discharge processes, rota planning and bed management, while medical secretaries will apply it to meeting documentation and template creation. Administrative teams in HR, finance and procurement will also use the platform, and management groups will employ it to prepare board papers and briefings. NHS England will additionally gain access to Copilot Studio, enabling individual NHS Trusts to build customized AI agents for workflow automation, including support for helpdesk operations, complaints handling, freedom of information requests and financial processing. Agent 365 will provide governance controls to ensure those agents comply with organizational security requirements.

Microsoft UK and Ireland CEO Darren Hardman said: “By rolling out Microsoft 365 Copilot at scale, NHS teams can cut through everyday admin and spend more time where it matters most.” He added: “Bringing AI safely into the flow of healthcare will help ease pressures, improve productivity, and support better decision-making across the health service.” NHS England serves approximately 56 million people and employs around 1.4 million staff, making this one of the largest enterprise AI deployments undertaken by a healthcare organization. The structured onboarding programme will run for 12 months and is intended to support adoption across the health system while providing a large-scale example of AI implementation in public healthcare.

For decades, patient data across the NHS has remained siloed across dozens of disconnected systems GP records, hospital trusts, mental health providers, and community care teams each holding separate, often incompatible records. The result has been persistent gaps in care, repeated diagnostic tests, and clinical decisions made without full visibility of a patient’s history.

The NHS single patient record initiative directly addresses this fragmentation. Under the proposed model, authorised healthcare professionals would be able to access a comprehensive, real-time view of a patient’s medical history, medications, diagnoses, allergies, and previous care interactions regardless of which part of the system that patient has previously engaged with.

The consolidated record is intended to bring together information currently scattered across primary, secondary, and community care settings. This includes GP records, hospital discharge summaries, diagnostic results, prescribed medications, and relevant social care data. Clinicians treating a patient in an emergency, for example, would no longer need to rely on incomplete information or wait for records to be manually transferred.

The NHS federated data platform is expected to play a key role in enabling this infrastructure. Rather than creating a single centralised database, the federated model allows data to remain within local systems while still being accessible in a joined-up way addressing both technical and governance concerns around data centralisation.

A key aspect of the plans involves giving patients greater agency over their own health information. The proposals include mechanisms for individuals to view their own records and, where appropriate, control how their data is shared across care settings. This reflects growing expectations around transparency and data rights within the public sector.

Data security and consent frameworks are central to the implementation design. NHS England has indicated that robust safeguards would govern who can access records and under what circumstances, with strict audit trails and access controls built into the system architecture.

From a healthcare operations standpoint, a functioning single patient record system carries substantial implications for NHS efficiency. Duplication of tests and procedures a known cost driver within the health service could be reduced significantly if clinicians have immediate access to prior results. Clinical handovers between teams and care settings, frequently a point of risk in patient safety terms, would also benefit from more complete and consistent information sharing.

The NHS digital transformation agenda has placed data interoperability at its core, and the single patient record represents one of the most tangible expressions of that direction. Healthcare modernisation at this scale requires not only technological investment but also changes in clinical workflow, staff training, and cross-organisational data agreements.

NHS England is progressing the initiative as part of its wider data and digital strategy. While a full national rollout will take time, the direction of travel is clearly set toward a more connected, data-driven health system. Integrated care systems across England are expected to play a role in the local delivery of this programme, given their remit to coordinate care across providers within defined geographies.

For healthcare industry executives and system leaders, the advancement of the NHS single patient record signals a concrete shift in how the health service intends to manage patient data moving from a fragmented, institution-by-institution model toward one built around the patient journey as a whole.

The NHS federated data platform and the broader push for healthcare modernisation reflect a system-level commitment to making patient data work harder, more safely, and more equitably across the entire care continuum.

In preparation for the rollout, the European Medicines Agency has scheduled an online information session on 24 April 2026. The session will outline key elements of the Breakthrough Devices framework and address practical considerations for stakeholders intending to participate. This step is expected to help manufacturers better understand procedural requirements and align early with regulatory expectations.

The pilot draws from the recently adopted MDCG 2025-9 guidance issued by the Medical Device Coordination Group. It also aligns with broader regulatory revisions proposed by the European Commission in December 2025, which introduced new provisions under Article 52a of the Medical Devices Regulation and Article 48a of the In Vitro Diagnostic Regulation. These updates aim to formalise a future framework for breakthrough medical technologies within the EU.

Positioned as a strategic move, the programme reinforces efforts to foster an innovation-oriented regulatory landscape across Europe. To secure a breakthrough designation, manufacturers must seek an opinion from the agency’s expert panels, with additional guidance and application templates expected ahead of the launch. The pilot also supports wider objectives tied to public health priorities, ensuring that advanced medical technologies entering the EU market continue to meet stringent quality, safety, and performance benchmarks. The Breakthrough Devices pilot is therefore expected to play a defining role in shaping future regulatory processes while strengthening confidence in high-impact innovations. The Breakthrough Devices pilot further underlines the EU’s commitment to balancing innovation with robust oversight.

With the expanded funding, AI Airlock is expected to scale its operations and support the development of sustainable regulatory pathways for AI-driven medical technologies. Delivered through collaboration between MHRA, DHSC, the NHS AI Team, and Team AB, the programme aligns with broader government strategies, including the AI Opportunities Action Plan, the Regulatory Action Plan, the 10-Year Health Plan, and the Life Sciences Sector Plan.

Commenting on the development, James Pound, Executive Director, Innovation and Compliance, said:
“Securing this multi-year funding boost marks a pivotal moment for AI Airlock and for the safe and responsible advancement of AI in healthcare.
The programme has already shown how collaborative, real-world testing can uncover regulatory challenges early and help innovators bring high-quality, safe technologies to patients faster.
This additional investment will allow us to scale up and ultimately strengthen our ability to ensure that AI-powered medical devices can reach patients safely, efficiently and with the confidence of robust regulatory oversight.”

The AI Airlock programme has evolved steadily since its pilot launch in 2024, followed by a second phase in 2025 that broadened its scope. Early findings highlighted new regulatory complexities associated with AI medical devices, particularly around risk management, accuracy, and the need to anchor model outputs in verified clinical data. It also underscored the importance of explainability in AI systems to strengthen clinician trust, alongside the necessity for continuous post-market monitoring to detect performance shifts or over-reliance.

Building on these insights, the second phase has examined specific regulatory challenges, including AI-powered diagnostic tools, pre-determined change control plans (PCCPs), and evolving use cases of AI systems. The programme has tested a wide spectrum of technologies such as large language models, voice-enabled tools, and advanced diagnostics targeting cancer and rare diseases. Outputs from this phase, including reports and case studies, are expected in Summer 2026 and will guide the design of phase three. Findings are also feeding into the National AI Commission’s work on shaping future regulatory frameworks. As AI Airlock expands, it continues to play a central role in strengthening collaboration between regulators and industry, supporting safe innovation while maintaining a robust and future-ready regulatory environment for medical devices.