Overview
The UK healthcare sector is anticipated to face several significant challenges in 2025 and 2026, with multiple regulatory and legislative shifts aimed at addressing systemic issues, improving healthcare quality, and adapting to technological advancements.
Written by Suzanne Ash
Government Oversight and NHS Governance:
A major legislative trend is the expansion of the Secretary of State’s powers over the NHS. Proposed changes would allow the health secretary to have veto authority over certain local appointments to integrated care systems (ICSs) and intervene in local NHS service reconfigurations.
While intended to provide more responsive governance, these shifts have raised concerns about potential politicisation of healthcare decision-making and are expected to influence how local health systems operate and prioritise services.
Integrated Care Systems (ICS):
ICSs, which represent a structural shift toward more collaborative, locally focused healthcare, are set to become central to NHS England’s operations. However, with the expansion of central government oversight, the autonomy of these systems may be tested, affecting how effectively they can tailor services to local needs.
Medical Device Regulations:
The Medicines and Healthcare products Regulatory Agency (MHRA) is set to implement a new regulatory framework for medical devices, with a phased approach that includes stricter quality management, enhanced post-market surveillance, and new classifications for certain devices, including software as a medical device (SaMD).
This overhaul, which aligns partially with the EU Medical Devices Regulation, will introduce new requirements such as unique device identifiers (UDI) and strengthened documentation protocols to improve patient safety and market oversight.
SaMD
In 2025, the UK’s regulation for Software as a Medical Device (SaMD) is set to evolve as part of a broader reform of the medical device framework led by the Medicines and Healthcare products Regulatory Agency (MHRA).
The key changes will include new SaMD-specific guidance that addresses areas such as defining intended use, managing change control, and adverse incident reporting.
Additionally, the MHRA is working on developing best practices for AI as a Medical Device (AIaMD), introducing good machine learning practices, and launching an “AI Airlock” regulatory sandbox to support innovation and safety testing for AI-based health solutions.
The MHRA’s roadmap for 2024-2025 also outlines updates that align the UK’s SaMD regulations with international standards, particularly around cybersecurity for medical software, quality management systems, and unique device identification (UDI).
As the MHRA plans to introduce new post-market surveillance and risk classification requirements, manufacturers of SaMD and AIaMD products will face additional responsibilities and potential up classification for current low risk SaMD. These changes are intended to create a more resilient regulatory environment that prioritises patient safety while fostering MedTech innovation.
With regulation expected to be stricter from 2025, with tougher compliance requirements on the legal manufacture, NHSE recently went out to tender to contract assessment, review and strengthening of their software medical device products’ testing, validation and technical documentation to bring the products in line with the expected requirements of the amended regulation.
Clinical Safety Standards
In 2025, several changes to clinical safety standards in the UK will impact digital health technologies and IT systems, particularly under the NHS’s DCB0129 standard.
DCB0129, which ensures risk management and safety protocols are in place for digital health systems, is currently under review by NHS England, with updates anticipated following a public consultation in late 2024 to early 2025.
This review is expected to strengthen requirements around clinical risk management, aiming to address newly identified safety issues in electronic patient record (EPR) systems and other healthcare technologies. Emphasis will be on ensuring that these standards account for evolving risks and are consistently applied in digital health applications across NHS organisations.
Additionally, there is an increasing push for standardised documentation and streamlined compliance processes.
New platforms are emerging to help digital health providers maintain continuous compliance with DCB0129. These tools provide structured templates for clinical safety documentation, enabling faster updates and approvals, which should help reduce compliance costs and improve efficiency in safety reviews but will still require close, in-house management and approval.
Moreover, NHS England is promoting digital clinical safety training and expanding access to clinical safety officers (CSOs) to ensure adequate safety oversight in all digital implementations.
These updates reflect a stronger regulatory focus on patient safety and streamlined compliance in response to rising digital health adoption within the NHS, as well as concerns about safety lapses linked to digital system errors in recent years.
Data Protection
The UK is set to make several adjustments to its data protection framework in 2025.
The Data Protection and Digital Information Bill (DPDI), which builds on the UK GDPR, aims to simplify data compliance, promote business innovation, and maintain high data security standards. Key updates focus on several aspects:
- Data Use and Legitimate Interests: The Bill proposes exemptions from extensive assessments for certain uses, such as national security and public interest, allowing more flexibility in data processing while reducing administrative tasks for businesses.
This update could broaden the “legitimate interests” basis for data processing, making it easier for organisations to use data without explicit consent in some cases, especially for essential services like national security or emergency response.
- Automated Decision-Making: Changes in the scope of Article 22 will allow more widespread use of automated decision-making (like AI-driven profiling) by limiting restrictions to cases involving sensitive personal data. This means companies may have more freedom to deploy AI systems for decision-making, though it raises concerns about individual rights.
- Expanded Regulatory Framework: The Information Commissioner’s Office (ICO) may transform into an “Information Commission,” with a new structure like the Financial Conduct Authority. This change is expected to increase governmental oversight in data protection operations and shift some decision-making power over policies and practices to government agencies.
- Cookie Consent and PECR Compliance: The Bill intends to ease consent requirements for analytics cookies and similar tools, especially for first-party analytics, reducing the burden of repetitive cookie prompts. Additionally, penalties for breaches of the Privacy and Electronic Communications Regulations (PECR) are expected to increase, aligning with GDPR fine levels, while expanding enforcement on spam emails and texts.
- Interoperability and Data Sharing: In healthcare, the Bill aims to facilitate better interoperability between health systems by standardizing information infrastructure, allowing smoother data flows between entities like GP surgeries and hospitals.
These updates signal a shift toward a more streamlined and innovation-friendly approach, with adjustments to facilitate practical data use across sectors. However, these changes also raise concerns about data protection adequacy agreements with the EU, as the UK must maintain “essentially equivalent” protection standards to continue seamless data exchanges with the EU under its adequacy decision.
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