Digital Clinical Safety Strategy
Published 17 September 2021
Dr Natasha Phillips, Chief Nursing Information Officer and Director of Patient Safety
Safety is everyone's responsibility. As a nurse, I know very well the importance of delivering safe care and what it looks like when everyone contributes to a culture of safety. I also know that while we aim to provide the safest care every day, safety is not just a product of our individual actions. It is the result of the environments we work in, the tools we have at our disposal and the culture around us. This means that delivering safe care requires a concerted effort across all health and care professionals, patients and the public. More than ever, it also requires a dedicated focus on digital technologies, which are increasingly integral to our health and care service.
I have seen first hand the risk that digital can present, but I have also witnessed it transform pathways, support staff and save lives. Right now we have a responsibility to ensure that the digital technologies that surfaced with such vigour during the pandemic not only have a positive legacy, but are sustained and improved upon for patients, carers and families. We need to ensure the safety of digital health technologies, but beyond that, we need to employ these technologies as solutions to safety challenges.
Through this Digital Clinical Safety Strategy, we provide a collaborative national direction towards the enhanced safety of digital technologies that is fit for the future. We pave a path towards using these digital tools to counter some of our greatest challenges to patient safety. Empowering staff with the knowledge and skills to ensure safety will help us build a culture where safety is at the heart of all that we do. I look forward to implementing this strategy, working across the system and seeing patient safety truly be everyone’s responsibility.
Professor Jonathan Benger, Chief Medical Officer, NHS Digital
The implementation of effective digital technologies has huge potential to improve safety in health and care, however this potential has not been fully realised to date. Digital technologies can enhance safety by ensuring that critical information is provided in a timely way, and by automating processes to make them more efficient while reducing the risk of error. It is also essential that digital innovation is delivered safely, and does not lead to unintended harms.
This addition to the National Patient Safety Strategy, focusing on digital technologies and presented to the same principles and structure, is highly welcome. It is also timely in a post-pandemic landscape in which NHS clinicians and the patients and public they serve have come to rely more than ever before on the digital delivery of health and care.
I am hugely grateful to colleagues in NHS Digital and all our partner organisations who have contributed to the design and delivery of this for the NHS, and who strive tirelessly to enhance and assure digital safety in healthcare. This new strategy, and the national commitments it contains, will complement and support their work as we collaborate across the system to reduce avoidable harm in the NHS.
Dr Aidan Fowler, National Director of Patient Safety
There are two really important concepts in relation to digital systems and patient safety.
First, how do we make sure that the digital systems we use work safely? With greater use of IT, AI and other digital systems, the function of which is a mystery to many, how do we make sure these do not harm patients? For example, we have seen several incidents related to algorithms recently which have the potential to affect the care of thousands of patients.
The second thing is how we use digital systems to help us keep patients safe and harness the huge potential of such approaches to help us provide safer clinical care whether by facilitating the recording of information or for monitoring or supporting decisions and much more.
This strategy, especially as the style is so well aligned with the Patient Safety Strategy, is a really helpful part of continuing our digital clinical safety journey.
The Digital Clinical Safety Strategy is a joint publication between NHSX, NHS Digital and NHS England and NHS Improvement. It is an addendum to the NHS Patient Safety Strategy, outlining the case for improved digital clinical safety across health and social care.
The aim of the strategy is twofold.
- To improve the safety of digital technologies in health and care, now and in the future.
- To identify, and promote the use of, digital technologies as solutions to patient safety challenges.
In other words, digital clinical safety is about making sure the technologies used in health and care are safe, and then using those technologies to improve patient safety.
Part 1 provides an introduction to patient safety and defines digital clinical safety. It summarises the evidence base behind this strategy and it explains the regulatory and policy context for the strategy.
Part 2 sets out the Digital Clinical Safety Strategy. It directly links to the NHS Patient Safety Strategy, mirroring its structure, which highlights ‘Insight, Involvement and Improvement’, as three strategic priorities for safer systems and safer cultures. Actions are outlined for each of these three areas. The strategy specifies 23 actions, which can be summarised as five national commitments.
National commitments for digital clinical safety
- Collect information about digital clinical safety, including from the Learn from patient safety events (LFPSE) service and use it to improve system-wide learning.
- Develop new digital clinical safety training materials and expand access to training across the health and care workforce.
- Create a centralised source of digital clinical safety information, including optimised standards, guidelines and best practice blueprints.
- Accelerate the adoption of digital technologies to record and track implanted medical devices through the Medical Devices Safety Programme.
- Generate evidence for how digital technologies can be best applied to patient safety challenges.
Part 3 explains how this strategy will be delivered and updated, with a focus on patient safety and digital health networks.
This strategy establishes what is needed for digital technologies to enable safety across health and care and how that can be prioritised nationally and delivered with a range of stakeholders. This strategy’s objectives support the wider NHS Patient Safety Strategy’s aim to build safer systems and safer cultures.
PART 1: Introduction and strategic alignment
Across health and care systems internationally, patient safety is a cornerstone of quality (National Academies of Sciences, Engineering and Medicine, 2018). Unsafe care is still among the leading causes of death worldwide (Kruk et al., 2018). While the NHS is seen as a leader in patient safety, rates of harm across services remain unacceptably high, and cross sector commitment is needed to establish open and transparent safety cultures.
Delivering the safest care for our patients, service users and families, and designing the safest systems for our staff, are ambitions that need to respond to the evolving nature of the health and care system. Given the prominence of digital technologies, and their essential role in clinical care delivery, it is important to ensure their safety both in design, commissioning and use. It is also crucial that digital technologies be optimised to support safety and reduce errors. The potential for digital technologies to enhance safety in areas such as prescribing, record keeping and data driven health and care is widely evidenced (Avery et al., 2012; Bates et al., 1998). However, digital technologies that are not designed and deployed with safety in mind have the potential to harm patients. Ensuring that rapidly evolving digital systems do not cause or contribute to adverse events is also a system-wide priority.
‘Digital clinical safety’ refers to the avoidance of harm to patients and staff as a result of technologies manufactured, implemented and used in the health service. It is important across digital systems’ lifecycles and is part of a culture of patient safety focused on learning from best practice and speaking up about emerging risks.
Case for change
Evidence from a safety perspective
The NHS Patient Safety Strategy explains that improving patient safety will have profound benefits for patients and reduce costs across the health system,
“....Getting this right could save almost 1,000 extra lives and £100 million in care costs each year from 2023 to 2024. The potential exists to reduce claims provision by around £750 million per year by 2025.” NHS Patient Safety Strategy (NHS England and NHS Improvement, 2019).
Six types of events (hip fracture, death in low mortality treatment groups, pressure ulcers, sepsis, blood clots and central line infections) account for 36,000 healthy life years lost each year in England. The cost of common adverse events in England is equivalent to 2,000 GPs or 3,500 hospital nurses each year (OECD, 2017). This evidence is supported by Baroness Cumberlege’s First Do No Harm report, which exposed the need to improve the response to harmful side effects associated with certain medicines and medical devices.
The role of digital as an enabler to patient safety has been emphasised on a global level by the World Health Organisation’s (WHO) Patient Safety Action Plan. The interplay between human behaviour and systems drives patient safety, and in the NHS, reducing the burden of harm described above and meeting the outcomes outlined in the NHS Patient Safety Strategy will be dependent on digital clinical safety. It will depend on technologies being both safe and appropriately applied to major safety challenges facing patients, staff and the public.
Evidence from a digital perspective
Across safety-critical industries, digital technologies are considered in terms of their opportunity to enhance safety and their potential to disrupt it. Evidence demonstrates the power of digital to support safety. Scanning technologies and programmes like Scan4Safety, that use barcodes to track data and devices, have reduced device and patient identification errors (Scan4Safety report, 2020). Digital interventions like pharmacist-led information technology intervention for medication errors (PINCER) have been effective in reducing such medication errors (Avery et al., 2012). More recently, remote monitoring technologies are demonstrating the potential to recognise early signs of deterioration, an important factor in preventing harm (Clarke, 2020). More generally, the evidence base for electronic health records (EHR) supports many aspects of safety in terms of record keeping and reliable and shared access to information. However, as the use of these digital technologies increases and new EHRs continue to replace older versions, new safety risks emerge during transitions and periods of implementation. Evidence suggests these risks can be kept to a minimum, but securing safety during transition periods will continue to be a key feature of digital clinical safety (Barnett, 2016).
The evidence base for these technologies is expanding, as is their routine use. The COVID-19 pandemic has accelerated the use of digital technologies in health and care, and subsequently increased the interest in digital clinical safety. For instance, the use of online consultation systems in primary care doubled during the early stages of the pandemic to 600,000 requests per week (NHS England and NHS Improvement, 2021), digital prescriptions rose from 72% to just over 90%, and repeat prescriptions ordered via the NHS App increased by 495% in one year (NHS Digital, 2021). From a public perspective, survey results show that 97% of UK adults who had received NHS care for any health condition since the pandemic started used technology in their interaction with the health service, and 60% of those used it in a new way or more than before (Horton et al., 2021).
While digital health technologies have been available before, the pervasiveness of their use represents a fundamental change. This rapid acceleration has placed a focus on the role of digital technologies in delivering care and surfaced a public and professional interest in their safety. It is evident that as digital systems become increasingly integral to care delivery, there is a further need to understand their safety, but also how care can be delivered safely without them, or during periods of system downtime. Evidence demonstrates that disruption caused by downtime can cause delays and confusion, which could present safety risks (Larson, 2019).
Further understanding the impact of digital technologies and issues like downtime requires a clear and efficient mechanism for capturing information about when digital technologies contribute to risk or harm.
Studies have attempted to quantify harm associated with digital systems by applying natural language processing of safety incidents reported into the NHS’s national incident repository, the National Reporting and Learning System (NRLS). This is currently being replaced with the Learn from patient safety events (LFPSE) service. In an examination of 13,738,411 patient safety incidents recorded over more than a decade in England and Wales, 2,627 individual events were identified as related to failures in health IT. Of these 2,627 incidents, 75% were amenable to improvement (Martin et al., 2019).
However, these figures should be treated with caution. Underreporting of patient safety incidents is a complex problem that obscures what is known about harm caused as a result of digital systems (Mayer et al., 2016; Sari et al., 2007). Incident reporting systems have not historically captured comprehensively digital clinical safety information or indicate the influence digital systems have in the NHS. However, greater emphasis on digital systems and technologies in the LFPSE taxonomy, as compared to the NRLS, will be valuable as digital systems become more central to care delivery and will allow for insights into a greater number of associated events.
In the NHS there is an established national infrastructure for incident reporting, which is set to be further strengthened with the LFPSE. It will provide a front door for safety reporting, with data and intelligence shared across national organisations in the background to support a culture of national learning. It is important to promote use of the LFPSE service, expand its capacity for capturing and relaying information about digital technologies, and ensure it is aligned to other reporting mechanisms to support a comprehensive risk management and learning system.
Digital clinical safety is not simply about recording harm reactively, it is also about learning and preventing it proactively. Evidence suggests that better clinical integration and local configuration of digital information systems will help identify safety problems and pre-empt harm in both acute and primary care (Avery et al., 2020; Hogan and Sherlaw-Johnson, 2020). It is equally important to capture and share this information for proactive learning, within a systems approach to safety that aims to resolve the issues at source wherever possible.
The role for technology in harm prevention is typified in communication tools, as explained by the Healthcare Safety Investigation Branch’s (HSIB) national investigation of nosocomial spread of COVID-19 in hospitals. The HSIB also recommended that: