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Abstract

Digital health adoption in the National Health Service (NHS) remains fragmented despite significant technological advances and substantial government investment in innovation initiatives. Many promising digital solutions fail to progress beyond pilot phases, with implementation remaining inconsistent across trusts despite national strategies including the 2022 digital health and social care plan. This Viewpoint examines the principal obstacles to digital health commercialisation within the NHS, focusing on regulatory complexity, organisational fragmentation, limited financial capacity and cultural resistance to change. We review existing support mechanisms including the Digital Technology Assessment Criteria (DTAC), NHS Innovation Accelerator and Clinical Entrepreneur Programme, highlighting their strengths and persistent limitations. To accelerate adoption, we propose two key reforms: formalising DTAC as a mandatory national standard with subsidised compliance pathways for small and medium-sized enterprises, and establishing a national ‘innovation passport’ that harmonises DTAC, Medicines and Healthcare products Regulatory Agency and procurement requirements into a single, transferable assessment. These reforms, complemented by strengthened procurement coordination and cultural change initiatives, could create a more predictable pathway for digital innovation while maintaining rigorous patient safety standards and enabling equitable access to validated digital health tools across the NHS.

Keywords

Digital health NHS regulation DTAC innovation adoption health policy commercialisation SMEs

Introduction

Digital health adoption in the NHS (National Health Service in the UK) remains fragmented and more measured than technological advances warrant.¹ The UK has invested in initiatives to support entrepreneurship and accelerate digital health innovation, yet many promising digital health solutions often fail to progress beyond pilot phases.^2,3 Recent national strategies, including the government's plan for digital health and social care (2022)⁴ and the Hewitt Review of integrated care systems (2023),⁵ have reinforced the urgency of accelerating digital adoption and reducing fragmentation, yet implementation remains inconsistent across trusts.⁶ Four interconnected factors may help explain this gap: regulatory complexity, organisational fragmentation, limited financial capacity and cultural resistance to change.⁷ Addressing these barriers is essential to creating an enabling environment for digital health technologies (DHTs) and ensuring patients benefit equitably from advances in digital care. In this article, we use the term DHTs to refer to software-based or digitally enabled health interventions across all the National Institute for Health and Care Excellence (NICE) Evidence Standards Framework (ESF) tiers. In this Viewpoint, we examine the principal obstacles to digital health commercialisation across all tiers of DHTs within the NHS. We focus on the full pathway from regulatory approval through health technology assessment and reimbursement decisions to procurement and adoption – distinct but interconnected stages where procurement and adoption present particularly substantial barriers. We review existing mechanisms designed to overcome these obstacles and propose strategies to streamline regulation, support small and medium-sized enterprises (SMEs), while strengthening system-wide adoption.

Regulatory approval, assessment and procurement barriers

Regulatory fragmentation represents one of the earliest and most significant obstacles for DHT developers.⁷ The Digital Technology Assessment Criteria (DTAC), the national baseline criteria in the United Kingdom used by healthcare organisations during procurement and due diligence, plays a central role in shaping the regulatory environment for digital technologies.⁸ Although DTAC is intended to provide assurance that products meet essential standards, the recent NHS England review highlighted a lack of clarity in how DTAC should be applied and acknowledged the burden it places on suppliers.⁸ The DTAC does not constitute formal regulatory approval but rather establishes baseline standards that inform local procurement and commissioning decisions.

Compliance is resource-intensive and poses particular challenges for SMEs that lack dedicated regulatory expertise.⁷ Inconsistent standards across England, Wales and Scotland further compound uncertainty for developers.⁹ Moreover, overlapping requirements between the DTAC, the Medicines and Healthcare products Regulatory Agency (MHRA) and NICE ESF can delay clinical evaluation and implementation.¹⁰ Third-party validation, often required for DTAC compliance,⁸ adds further cost and time⁷. Collectively, these demands may inadvertently deter smaller firms and slow the introduction of valuable DHTs.^7,11

The NICE plays a central role in assessing DHTs through its ESF, which categorises technologies into three tiers based on functionality and risk: Tier A (system services), Tier B (communicating and managing health, including wellness and self-management apps) and Tier C (treating or diagnosing, including clinical decision-support and treatment tools).¹² Evidence requirements appropriately scale with tier level and clinical risk, with Tier C DHTs requiring the most robust clinical effectiveness evidence. While this tiered approach aims to provide proportionate regulation, overlapping requirements between NICE ESF, DTAC and MHRA pathways continue to create complexity and duplication, particularly for smaller developers who must navigate multiple assessment processes simultaneously.

Beyond initial approval, practical integration presents further challenges. Even when digital innovations demonstrate potential, embedding them into NHS care pathways remains challenging.¹³ Many digital therapeutics and platforms are designed for narrow clinical functions, making integration into complex care systems difficult. Misalignment between product design and service delivery undermines clinical utility and scalability. Although platforms such as the NHS G-Cloud aim to facilitate procurement, their accessibility and interoperability with frontline systems remain limited.¹⁴ As a result, digital solutions often operate in parallel to existing workflows, increasing rather than reducing clinician burden. For DHTs to succeed, products must be designed with NHS service models in mind, and procurement mechanisms must prioritise integration and interoperability over isolated adoption.^15,16

Digital health technologies typically move from initial concept through pilot trials at local trusts, securing regulatory approval from MHRA where applicable, demonstrating DTAC compliance, undergoing third-party validation, and then navigating local procurement processes.¹⁵ Each step adds administrative and financial burden, particularly for small and SMEs, creating bottlenecks that slow adoption.¹⁷ Even after regulatory approval, fragmented procurement across trusts further delays scaling.⁷ Collectively, these regulatory approval, assessment and procurement hurdles represent a primary barrier to the timely commercialisation of DHTs in the NHS.¹⁸ These overlapping regulatory demands risk excluding high-potential DHTs from smaller firms.¹⁹

Organisational and structural barriers to adoption

The NHS is not a single organisation but a network of hundreds of trusts, each with independent procurement and governance responsibilities.^20,21 Each trust operates under its own governance framework, meaning DHTs often require separate approvals across multiple bodies. This structural fragmentation may contribute to administrative duplication and can slow the diffusion of digital solutions across the system. This structural fragmentation typically requires DHTs to secure approval repeatedly across trusts,⁷ with each body often reassessing clinical safety, data protection,²² and value-for-money evidence.²¹ The resulting duplication appears to increase administrative burden and may delay diffusion of digital solutions.²³ Limited interoperability between digital infrastructures compounds inefficiencies and can introduce patient safety risks.¹⁵ Centralised initiatives – such as the national digital programmes in Wales – illustrate both the opportunities and challenges of coordinated approaches: while standardisation can improve integration, variations in rollout and local uptake across health boards may restrict adaptability and slow overall adoption.²⁴ Without cohesive national frameworks, adoption of digital technologies may remain inconsistent and slow.²⁵

Financial constraints further hinder innovation. Daytoday operational pressures appear to leave little flexibility for investment in emerging technologies that lack established evidence within NHS settings.⁶ Obsolete IT infrastructure exacerbates this challenge, with many trusts lacking the hardware or digital maturity required to implement new tools.⁶ For innovators, obtaining pilot or validation funding is reported to be difficult without exposing individual trusts to financial risk.^17,18 Existing support mechanisms, including the NHS Innovation Accelerator, provide valuable opportunities but are limited in scale and competitiveness.²⁶ Short-term budget cycles may also prioritise immediate service demands over long-term transformation, potentially leaving digital health innovations with deferred benefits underfunded.²⁷ Addressing these structural and financial constraints will be critical to enabling a more agile, learning-oriented NHS capable of adopting and sustaining digital innovation.

The challenge of evidence generation for DHTs is compounded by their rapid iteration cycles. Digital health technologies often update much faster than traditional medical devices – sometimes monthly – meaning new versions may enter the market before sufficient evidence has been collected on earlier iterations.²⁸ This creates tension between traditional evidence requirements and the reality of digital innovation. Conditional approval pathways, sometimes termed ‘coverage with evidence development’, offer a potential solution by allowing controlled market entry for promising DHTs while requiring ongoing evidence collection.²⁹ Germany's Digital Health Applications (DiGA) framework exemplifies this approach, granting temporary reimbursement while manufacturers generate real-world evidence.³⁰ The predicate device concept, adapted for DHTs, could allow substantially equivalent updated versions to leverage evidence from earlier iterations, reducing duplication while maintaining safety oversight.³¹ Such mechanisms must balance timely access to innovation with robust patient protection, ensuring that early adoption does not compromise safety or effectiveness standards.

Cultural barriers to adoption

Risk aversion, rooted in patient safety mandates, plays an essential protective role but may sometimes impede adoption of DHTs with emerging evidence bases.³² The system's deeply ingrained risk aversion – rooted in its responsibility to protect patients – appears to often favour established solutions over emerging digital approaches.³³ While caution is justified and patient safety must remain paramount, overly rigid application of traditional evidence frameworks designed for pharmaceuticals may slow adoption of DHTs where evidence generation follows different timelines and methodologies. Appropriate risk management requires frameworks that account for the unique characteristics of digital technologies, including their iterative development cycles and capacity for post-market surveillance and real-world evidence collection. Leadership within many trusts lacks commercial and entrepreneurial expertise, potentially limiting capacity to assess and integrate innovative business models.³⁴ At the operational level, few formal roles exist to champion digital health innovation, leaving these initiatives under-resourced.³⁵ Developing a culture that balances safety with curiosity and experimentation is essential. Leadership training, protected time for digital innovation and workforce development programmes can help shift attitudes towards safe but proactive adoption.³⁶ Without deliberate cultural and structural change, clinically sound and cost-effective DHTs will not reach patients equitably across the NHS.

Current initiatives to support digital health innovation and commercialisation

Multiple initiatives address specific barriers, but gaps remain. The NHS has implemented multiple initiatives to address barriers to digital health innovation, ranging from regulatory guidance to cultural support programmes. Table 1 summarises the key initiatives, outlining their primary objectives, strengths and limitations. This overview provides a snapshot of how existing efforts target specific challenges such as regulatory compliance, organisational fragmentation and support for SMEs.

Table 1.

Summarises the main initiatives, their aims, strengths and limitations.

Initiative	Purpose	Strengths	Limitations (with evidence)
NHS Commercial Framework	Standardises procurement and contract negotiation within NHS digital and IT buying.	Provides guidance on framework agreements to help simplify procurement and reduce duplication.³⁷	Procurement in the NHS remains fragmented across organisations and bureaucratic, making navigation difficult for suppliers- especially SMEs.^38–41
DTAC	Provides baseline criteria for clinical safety, data protection, interoperability and technical assurance.	Encourages adoption of best practice and supports patient safety by setting minimum assurance standards for digital technologies used in the NHS.^42,43	Compliance requires substantial evidence and documentation (meeting safety, security, interoperability and accessibility standards), which can be burdensome for developers.^8,44–46
NICE Evidence Standards Framework (ESF)	Provides tiered assessment framework for DHTs based on functionality and clinical risk.	Risk-proportionate approach with three tiers allows appropriate evidence requirements for different technology types.¹²	Despite tiered structure, overlap with DTAC and MHRA requirements creates duplication; developers must still navigate multiple pathways even when NICE tier is established.¹²
MHRA Innovative Licensing and Access Pathway (ILAP)	Accelerates regulatory review and pathways to market entry for innovative medicines and related products.	Provides structured early engagement with the regulator to streamline approval processes, offering coordinated advice from MHRA, NICE and NHS partners.^47–49	Regulatory acceleration does not guarantee NHS adoption or broad system uptake on its own – the original ILAP (2021–2024) lacked sufficient NHS involvement to support timely adoption, a key barrier the 2025 relaunch aims to address.^50–52
Clinical Entrepreneur Programme (CEP)	Supports NHS staff in developing innovation skills and enterprise capabilities.	Builds intrapreneurship culture within NHS by training staff and connecting them to mentors and networks, providing commercial skills and knowledge.^53–55	While it supports individual digital health innovators through education, mentoring and networking, it does not directly offer any funding or grants for innovations, nor does it guarantee their adoption in the NHS; systemic adoption barriers remain.^41,56,57
NHS Innovation Accelerator (NIA)	Scales evidencebased innovations across the NHS and supports innovators.	Provides visibility, mentorship and structured support to innovators.^26,58	Highly competitive selection and systemic scaling barriers (complex commissioning and implementation pathways) limit how many innovations spread widely.²⁶
Integrated Digital Application Programme (IDAP)	Supports adoption of existing innovations where uptake is low through accelerated access pathway for medical devices.	Attempts to bridge the gap between innovation readiness and realworld use by providing integrated regulatory and access pathway support.^59–61	Still early stage (pilot launched September 2023) with unclear, consistent impact on widespread adoption across the NHS – persistent structural barriers remain.^41,59
Digital transformation plans (trust roadmaps)	Locallevel digital modernisation in trusts.	Tailored digital strategies reflect local needs and priorities.⁶²	Trusts face systemic constraints such as limited digital skills, legacy IT systems and coordination gaps, leading to inconsistency and duplication.⁶²
Thirdparty DTAC validation services	Independent verification that a digital product meets DTAC criteria.	Adds credibility and trust for adopters by independently confirming compliance.^42,43,63	Independent validation requires time and cost outlay – especially burdensome for SMEs seeking NHS adoption, with penetration testing, code reviews and certifications requiring significant investment.^44,46,63

Despite these initiatives, fragmentation and risk aversion continue to limit adoption.⁷ The Clinical Entrepreneur Programme and NHS Innovation Accelerator support individual innovators but appear unable to fully overcome duplication across trusts.³³ The Innovative Licensing and Access Pathway accelerates regulatory approval but does not guarantee clinical diffusion.⁶⁴

Recommendations for innovation support

Addressing barriers to DHT adoption and commercialisation within the NHS requires reforms that promote consistency, reduce duplication and enable equitable participation. Two complementary strategies could achieve these aims.

The first is to formalise the DTAC as a mandatory national standard for digital technologies entering the NHS. Although DTAC is currently advisory and distinct from regulatory approval, it widely functions in practice as a de facto procurement requirement.^8,46 Making compliance explicit would provide clarity for both innovators and commissioners, while maintaining standards for patient safety, data protection and clinical effectiveness. To avoid disadvantaging SMEs, DTAC implementation should be supported through a tiered or subsidised validation pathway. Multiple funding mechanisms exist to support digital health innovation in the NHS, including the NIHR Invention for Innovation (i4i) programme, Small Business Research Initiative Healthcare and NHS England innovation funding streams.⁶⁵ A centralised innovation support fund building on these existing mechanisms could underwrite compliance costs for early-stage companies, ensuring that high-potential DHTs are not excluded by financial or administrative barriers.

The second suggested reform is a national ‘innovation passport’ – a harmonised, single-entry assessment aligning DTAC, MHRA and NHS procurement requirements. Digital health technology developers currently face repetitive evidence submissions across multiple bodies and trusts, resulting in duplication and delay. A unified dossier, reviewed centrally by NHS England or a designated authority, would create a transferable credential recognised across all trusts. This approach would streamline regulatory processes, accelerate scale-up and strengthen consistency while maintaining rigorous safety and quality oversight.^64,66

International frameworks offer valuable lessons for streamlining DHT assessment. The DiGA Fast-Track process demonstrates how accelerated pathways can support market entry for lower-risk DHTs while maintaining safety standards through conditional reimbursement with ongoing evidence collection.⁶⁷ Similar approaches in France (Mon Espace Santé) and Belgium (mHealthBelgium) emphasise early dialogue between developers and regulators.^68,69 Mutual recognition agreements between countries could reduce duplication of assessment efforts, allowing DHTs approved in comparable regulatory environments to enter the NHS pathway more efficiently. The European Commission's proposed European Health Data Space aims to facilitate cross-border interoperability and recognition.⁷⁰ While international collaboration warrants further exploration, such mechanisms must ensure equivalence of safety standards and contextual relevance to NHS service delivery models. These international models demonstrate how conditional approval and coverage with evidence development can accelerate access while maintaining safety oversight. The NHS should explore similar mechanisms that allow promising DHTs to enter controlled use while collecting real-world evidence, rather than requiring complete evidence packages upfront. This approach must be carefully governed to ensure patient protection remains central, with clear triggers for removal if evidence fails to materialise or safety concerns emerge.

Together, these reforms align regulatory efficiency with clinical priorities. Embedding DTAC and an innovation passport within coordinated procurement frameworks would create a predictable, streamlined pathway for digital adoption, enabling clinicians to access validated tools faster while maintaining rigorous patient safety oversight.⁷¹ The reforms should be complemented by targeted interventions addressing the organisational, financial and cultural dimensions of digital adoption: establishing joint procurement consortia at integrated care system level; mandating interoperability standards; dedicating pilot funding with clinical outcome tracking; developing board-level digital leadership capacity; and aligning innovation assessment with Integrated Care System digital roadmaps.^72–74

Conclusion

Fragmented regulatory pathways and organisational silos constrain digital health adoption in the NHS despite strong evidence for clinical and economic benefit. Existing initiatives have demonstrated feasibility; systemic reforms are now needed to scale impact. Formalising DTAC with proportionate support for SMEs, alongside the creation of a national regulatory ‘innovation passport’, could reduce duplication, enhance transparency and accelerate procurement. Embedding these reforms within coordinated procurement frameworks and culture change strategies would foster a more predictable and supportive environment for digital development. Aligning regulatory efficiency with clinical priorities will enable the NHS to translate DHTs into faster patient access to validated tools, strengthening both clinical outcomes and system sustainability.

Footnotes

ORCID iDs

Yousef Yousef

Jacob Keast

Hajira Dambha-Miller

Contributorship

YY, JK and HDM jointly conceived the article and contributed to the analysis and interpretation of the literature. YY drafted the initial version of the manuscript. JK and HDM critically revised the manuscript for intellectual content. All authors read and approved the final manuscript.

Funding

The authors disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: This study is independent research funded by the National Institute for Health Research, NIHR Programme Development Grants (NIHR206431 – ‘Developing and optimising an intervention prototype for addressing health and social care need in multimorbidity’). The views expressed in this article are those of the authors and not necessarily those of the NHS, the National Institute for Health Research or the Department of Health and Social Care.

Declaration of conflicting interests

The authors declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Data availability

No primary data were collected or analysed for this study. All materials cited are publicly available sources.

Disclaimer

The views expressed in this publication are those of the authors and not necessarily those of the NHS, the NIHR or the Department of Health and Social Care.

Guarantor

YY.

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Streamlining regulation to Unlock Digital Health Innovation in the NHS