The warning focuses on England’s NHS 10 Year Plan, which places digital transformation at the centre of future healthcare delivery. The strategy envisages more care delivered in communities, greater use of remote services and data-driven decision-making, and accelerated adoption of advanced technologies. Yet the researchers say that formal clinical safety assessment is not being consistently monitored or enforced. Under requirements associated with the Health and Social Care Act 2012, digital health technologies are expected to undergo structured risk management in accordance with two national standards: DCB0129, which applies to manufacturers and developers, and DCB0160, which applies to organisations deploying technology in clinical settings.

These standards are designed to identify hazards before a system is used with patients and to control risks throughout its operational life. A clinical safety case should normally describe how a technology might cause harm, the likelihood and severity of possible failures, the safeguards in place, and the evidence supporting its safe use. The process also requires organisations to monitor incidents, reassess risks when software or workflows change, and ensure that staff understand how the technology affects clinical decisions. The researchers say that this system is failing in practice. In an earlier freedom of information survey of 239 NHS trusts and integrated care boards, they identified 14,848 digital health technologies in use. Seventy per cent had no documented safety assurance, while only 17% were reported to be fully assured.

The new analysis examined why compliance was so poor. The researchers reanalysed free-text responses from the original survey and assessed previously unpublished information about the capacity of Clinical Safety Officers, or CSOs. These are clinicians tasked with overseeing the management of risks associated with digital systems used in patient care. Among 211 organisations that provided relevant information between February and March 2025, the average reported deployment was approximately one full-time-equivalent CSO per organisation. However, only 163 organisations supplied data about the number of hours actually devoted to digital clinical safety, making the headline figure difficult to interpret.

The difference between formal staffing levels and real working capacity appeared particularly important. NHS trusts reported an average of 1.3 full-time-equivalent staff, whereas integrated care boards reported less than half a post, or approximately 0.4 full-time-equivalent staff. Written responses suggested that these numbers often overstated the resources available because CSO responsibilities were commonly added to existing clinical or managerial jobs. Twenty-two organisations could not quantify the time allocated to implementing the safety standards. In 11 organisations, the CSO role formed part of a senior executive’s duties, including those of an associate medical director, chief clinical information officer or chief nurse. Senior leadership can give safety work influence, the researchers acknowledge, but it can also place responsibility in the hands of people with the least time to conduct detailed assessments or develop specialist expertise.

The responses also exposed weaknesses in the basic infrastructure needed to understand what technologies are being used. Thirty-seven organisations claimed statutory exemptions from the freedom of information request. Cost and the time required to retrieve information were among the most frequently cited reasons, while others reported that their data were inaccessible or that they had no central register of digital tools. The researchers say these explanations may be valid, but they also point to immature governance. Without a reliable inventory, an organisation cannot easily determine which systems influence diagnosis, treatment, prescribing, triage or patient monitoring, let alone whether those systems have been assessed after updates or changes in clinical use.

Some exemptions raised an additional concern. A number of organisations referred to provisions involving the prevention or detection of crime or health and safety. The researchers interpret this as evidence that some organisations may not understand the specific meaning of clinical safety in digital healthcare. Clinical safety is not limited to cybersecurity, physical security or the prevention of deliberate wrongdoing. It includes unintended clinical consequences such as an algorithm generating systematically biased risk scores, an interface encouraging a prescribing error, an alert system producing so many warnings that clinicians ignore them, or a data integration failure causing information to be assigned to the wrong patient. These hazards can emerge even when a system is functioning exactly as its designers intended.

Thematic analysis identified four mutually reinforcing causes of non-compliance: poor understanding of the standards, immature governance and oversight, ineffective assurance processes, and the treatment of the CSO role as an additional task rather than a professionalised safety function. The researchers describe this as a system-level failure rather than a problem attributable to individual clinicians. If staff lack training, organisations lack technology registers, assurance processes are treated as paperwork, and CSOs have little protected time, each weakness amplifies the others. A clinical risk assessment completed once at the point of procurement cannot provide continuous protection when software is updated, datasets change, workflows are redesigned or a tool is deployed in a new population.

The risk could grow as the NHS adopts technologies that are more complex and more deeply embedded in clinical decisions. Artificial intelligence systems may be trained on data that do not represent every patient group and may perform differently after changes in clinical practice. Genomic tools can produce results whose interpretation depends on evolving scientific evidence, while robotic and automated systems can create new interactions between software, hardware and human operators. The planned shift from hospitals into community and primary care could extend these risks to smaller organisations with fewer specialist resources. At the same time, NHS services increasingly involve private, voluntary and other external providers, creating the possibility of accountability gaps when responsibility for a digital system is divided between a developer, commissioner and frontline service.

The researchers propose stronger oversight by the Care Quality Commission, inclusion of DCB0129 and DCB0160 compliance within the patient-safety section of the NHS Oversight Framework, and a formal career pathway for Clinical Safety Officers based on tiered competencies. They also call for mechanisms to share evidence about common deployment hazards, near misses and clinical incidents across the NHS. Their conclusions are limited by the nature of the data: the survey did not provide the depth or opportunity for clarification available through interviews, and it excluded primary care and adult social care, where compliance remains unknown. Even so, the authors argue that the findings reveal a national gap between the NHS’s ambitions for digital innovation and its ability to control clinical risk. They conclude that England needs a new digital safety architecture combining central assessment, local risk management, professionalised safety expertise, regulatory enforcement and integration of digital governance into routine quality standards. Without it, digital transformation could spread unsafe practices at the same scale and speed as the technologies themselves.

Subject of Research: People

Article Title: Unfit for the future? Revisiting the national cross sectional study of digital clinical safety in England’s NHS to identify drivers of low compliance and implications for the 10 Year Health Plan

News Publication Date: 18-Aug-2026

Web References: https://www.gov.uk/government/publications/10-year-health-plan-for-england-fit-for-the-future

References: BMJ Innovations, DOI: 10.1136/6/bmjinnov-2025-001544

Keywords: NHS digital transformation, clinical safety, digital health, Clinical Safety Officers, DCB0129, DCB0160, artificial intelligence, patient safety, healthcare technology, NHS 10 Year Plan

The study, authored by Keuper, Hek, van Tuyl, and their colleagues, takes a deep dive into the intricacies of what influences patient decisions surrounding consent for sharing their health information electronically. As healthcare systems increasingly adopt digital methodologies, understanding these determinants is pivotal for fostering trust between patients and providers while ensuring that the data exchanged is both secure and ethically managed.

The research delves into several factors contributing to individuals’ willingness to provide consent. Firstly, awareness is a significant determinant. The authors emphasize that many patients remain uninformed about HIE and its benefits. This lack of knowledge creates a barrier, where mistrust can flourish due to the unknowns surrounding data usage and sharing. Educational initiatives are thus paramount in augmenting understanding, which in turn could lead to higher consent rates. Without a robust awareness campaign, the very framework of HIE may struggle to achieve its potential.

Moreover, cultural perspectives and social influences cannot be overlooked. The authors of the study point to varying attitudes toward privacy and data sharing that differ markedly across demographic lines. Factors such as age, socio-economic status, and cultural background shape how individuals perceive the risks and benefits of sharing their health information. For instance, older populations might exhibit heightened caution due to an ingrained respect for privacy, while younger individuals might prioritize convenience over confidentiality.

The role of trust also emerges as a critical theme within the findings. The research outlines how trust in healthcare providers influences consent significantly. Patients who have established relationships with their medical professionals are more likely to consent to data sharing. This underscores the importance of fostering trust through transparency, communication, and responsive care. If patients can believe that their information will not only be protected but also utilized to enhance their care, they may be more inclined to participate in HIE systems.

Equally important is the context of security. In an era plagued by data breaches and cyber threats, ensuring robust security measures is paramount. The study highlights how fears of data misuse or unauthorized access can severely impede consent rates. As the authors elucidate, investment in advanced cybersecurity solutions, coupled with regular audits and a commitment to ethical data management practices, is essential to allay the fears of patients. Only when individuals feel confident that their private information is secure can we hope to see greater participation in HIE initiatives.

Furthermore, the authors bring to light the potential impact of regulatory frameworks on consent. Policies governing data sharing and patient rights can either facilitate or hinder electronic information exchange. For instance, stringent regulations might create layers of complexity for healthcare providers to navigate, inadvertently disincentivizing them from implementing HIE systems. Conversely, clear and supportive legislation can serve as a beacon for healthcare organizations to follow, enabling them to encourage patient participation.

The research additionally examines the implications of personal experiences with healthcare systems on consent. Patients with prior negative interactions—whether through data mishandling or inadequate communication—may exhibit reluctance towards granting consent for HIE. This suggests a pressing need for healthcare institutions to not only rectify past mistakes but also promote a patient-centered approach that prioritizes experiences and feedback.

Moreover, the authors touch on the potential benefits of offering incentives for consent. These might range from improved health monitoring to enhanced personalized care. Such incentives can motivate individuals, especially those skeptical of data sharing, to reconsider their stance. However, this must be approached delicately, ensuring that the incentives align with ethical standards and do not coerce patients into unintended consent.

The study also emphasizes the role of technology in driving consent. Digital tools that allow patients to easily understand and manage their data sharing preferences can empower individuals. User-friendly interfaces that highlight the benefits of electronic health information exchange may effectively bridge the knowledge gap identified in the research. As technology continues to evolve, leveraging these advancements is crucial for fostering an ecosystem where consent is viewed positively.

In conclusion, the observational retrospective study brings to the forefront the multifaceted determinants of consent for electronic health information exchange. By understanding the complex interplay between awareness, trust, cultural attitudes, security, regulation, personal experiences, and technology, stakeholders can effectively shape strategies to encourage patient engagement in HIE. As the digital transformation of healthcare accelerates, ensuring that patients feel safe, informed, and valued in this process is paramount.

Navigating these challenges and improving consent rates is not just about technological advancement but about building respectful, transparent, and ethical relationships with patients. Only through such an approach can we ensure the successful integration of electronic health information exchanges into mainstream healthcare practices, ultimately leading to better patient outcomes and more efficient care delivery systems.

Subject of Research: Determinants of consent for electronic health information exchange

Article Title: Correction: Determinants of consent for electronic health information exchange: an observational retrospective study

Article References:

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