News
The invisible infrastructure of patient safety and why digital governance matters
By Misbah Mahmood, CXIO & Clinical Safety Officer, Bradford District Care Trust, (Former digital midwife at Leeds Teaching Hospitals and long-standing K2/HHA customer and collaborator)
Across the NHS, digital governance is frequently misunderstood.
It is often seen as a bureaucratic necessity or a technical, administrative process that becomes invisible once a system goes live or as a barrier to innovation when services are under pressure to change quickly.
However, digital systems do far more than document care. They shape how care is delivered, how risk is identified and interpreted, and how clinical decisions are made.
When systems are well designed and well governed, they support clinical judgement and safe practice.
When they are not, the impact is felt directly at the bedside, as illustrated by recent concerns over an AI discharge summary tool trialled at Chelsea and Westminster.
Here, unresolved questions about regulatory status and assurance exposed the consequences of deploying clinically influential technology without sufficient clarity or oversight.
In maternity services in particular, care is complex, unpredictable, and deeply dependent on context. Rapid decision making and information continuity across settings are essential.
As digital systems increasingly influence day-to-day practice, the way they are designed, governed, and used can either reinforce safe care or quietly undermine it.
Digital governance distinguishes technology that protects women and babies from technology that introduces hidden risk.
The myth of “invisible infrastructure”
When people hear the word “governance”, they often think of forms, meetings and compliance. For clinicians, it can feel like a tick box exercise that sits in the way of getting things done.
But governance decisions show up at the most critical moments of care, often without being named as such.
As clinicians, we instinctively understand safety in physical terms. If a blood pressure machine stops working, that’s immediately recognised as a patient safety issue. It gets escalated, reported and fixed.
But for a long time, digital issues have not been treated the same way. Slow systems, unreliable access, or inability to view the EPR were often accepted as “just one of those things”. Yet the impact on safety can be just as significant.
If you can’t see the record, you can’t see the risks. If you can’t trust the system, you start working around it.
Electronic patient records are no longer passive repositories of information. They influence what clinicians notice, how quickly they escalate concerns and what decisions they make.
That means the way these systems are governed, and how they are designed, tested and introduced, has direct consequences for patient safety.
A good example of this is central foetal monitoring. Used well, it can support situational awareness. But without clear governance and shared understanding, it can also create a false sense of security.
Being explicit that central monitoring does not replace bedside assessment or escalation is essential. If staff assume “someone else is watching”, the technology has unintentionally weakened safety.
Why safe digital infrastructure matters more than ever in maternity
Maternity care is non‑linear. Risk changes rapidly, and plans change, as women move between community and hospital settings.
Many digital systems are built around rigid templates and linear workflows that do not reflect this reality. When systems don’t fit practice, practice adapts.
Parallel notes, paper diaries, and reliance on free text are not resistance to digital tools; they are practical responses to keep care safe.
Operational realities add further challenge. Community midwives work across geography with unreliable connectivity, making offline access a safety requirement rather than a technical convenience.
Systems that support secure offline working reduce rushed documentation and missed safety checks.
Misbah Mahmood
On the labour ward, pressures intensify. Emergencies escalate quickly and staff are often fatigued. Here, usability becomes inseparable from safety.
Systems that add unnecessary steps increase cognitive load precisely when attention must remain on the patient. At four in the morning, design can either support safe decision‑making or work against it.
When the safest decision is saying “not now”
Digital governance is as much about preventing unsafe change as enabling innovation. Not every system that is technically ready is clinically ready.
Introducing change during periods of strain, limited training, or inadequate testing increases risk.
Pausing a rollout is rarely comfortable as delivery pressures create momentum to proceed. Effective governance, however, gives organisations permission to prioritise safety over speed.
Delaying implementation to allow further testing or clinical engagement often leads to safer adoption and greater staff trust.
Saying “not now” is not resistance to change. It is a mature safety response, as introducing change at the wrong time can cause harm that is far harder to undo.
Co‑design, not configuration: new models for supplier partnerships
Safe digital transformation depends on genuine partnership between NHS teams and suppliers, with shared responsibility for clinical risk.
Effective collaboration starts early, with meaningful clinical involvement, transparency about system constraints, and shared understanding of risk.
It continues through testing in real clinical environments and shared accountability for safety outcomes after go‑live.
Working with Harris Health Alliance and the K2 maternity tool made these conversations more effective.
Responsiveness to safety feedback was faster, and small design changes, such as surfacing critical risk information or adding validation checks to reduce error under fatigue, had significant impact on usability and safety.
Every change, however minor it appears, is a clinical safety decision. Digital governance provides the structure to recognise this and ensure changes are designed and implemented accordingly.
People, process and technology are an interdependent system
Technology does not fail in isolation. Risk emerges when people, processes, and digital systems are misaligned. Even the most sophisticated EPR will struggle if staff are unsupported, processes have not evolved, or workflows do not reflect clinical reality.
Technology can also obscure risk by embedding unsafe or outdated practices into systems that appear efficient when governance focuses only on technical delivery.
Effective digital governance recognises that patient safety depends on the interaction between people, processes, and technology.
Skills, confidence, and behaviours matter, as do evidence‑based, consistent processes and systems that are usable, reliable, and aligned with real clinical work.
Safety improves when these elements are deliberately aligned and governance focuses on learning rather than blame.
Design matters and systems must be fast, predictable, and forgiving of human fatigue. The same principle is evident in data quality.
A yes/no field relating to cord prolapse produced alarming figures due to human factors rather than practice.
Introducing a simple validation check prompting confirmation improved data quality and reduced risk by addressing system design, not individual behaviour.
This is digital governance in practice. It is recognising where design and reality collide and fixing the system rather than blaming clinicians.
From invisible to essential
Digital governance should no longer be invisible. It must be recognised, valued, and treated as a core component of patient safety.
That means involving clinical safety expertise from the outset, listening to frontline concerns, designing for real-world conditions, and being willing to pause when something does not feel safe.
The absence of incidents does not mean the absence of risk; often, it means the system has not yet failed under the wrong circumstances.
Maternity services, with their complexity and sensitivity, have much to teach the wider NHS about safe digital transformation.
When governance is shared, practical, and grounded in real clinical experience, digital systems can genuinely support safer care and not just record it.
Yoga and omega-3 supplements may be as effective as talking therapies for pregnancy depression, a major review suggests.
Globally, nearly one in three pregnant women experience depression, but most receive no treatment.
When support is available, women are often directed towards talking therapies such as cognitive behavioural therapy, or CBT, and mindfulness.
CBT is a structured talking therapy that helps people identify and change patterns of thought and behaviour affecting their mental health.
The review examined 115 clinical trials involving more than 12,000 participants across 30 countries.
It found that yoga, massage, omega-3 supplements and bright light therapy were broadly as effective as talking therapies at reducing depression symptoms during pregnancy.
Bright light therapy involves controlled exposure to bright light and is sometimes used to treat mood conditions.
The findings point to the importance of social support and increased connection, as all these approaches offer some element of contact or guided support.
Led by King’s College London, the research brought together trial evidence across every type and format of treatment for antenatal depression under a common framework.
Antenatal depression is depression that occurs during pregnancy.
The study was conducted as part of HappyMums, a European consortium led by the University of Milan that aims to improve mental health support during pregnancy and after birth.
Carmine Pariante, professor of biological psychiatry, said: “This is the most comprehensive analysis of treatments for depression in pregnancy ever conducted, and the findings should prompt a rethink of how we support women during this critical period.
“The evidence is clear that there is no single best approach. What matters is that women have access to a range of options, and that clinicians feel equipped to offer them.”
The researchers said yoga and omega-3 supplements could be legitimate treatment options, rather than stopgaps, for women on waiting lists or those who struggle to access mental health support.
However, the studies differed considerably in design, sample size and how results were measured, so the findings should be interpreted with care.
The team said non-psychological approaches could help women cope with long waits for care without ruling out other treatments alongside them.
Digital and online interventions, including apps and telephone-based support, were also found to be as effective as face-to-face treatment.
Researchers said this could affect how antenatal depression is managed, particularly for women who cannot travel or face long waits for in-person care.
The team found no randomised controlled trials of pharmaceutical treatments for antenatal depression, despite antidepressants being widely prescribed for depression outside pregnancy.
A randomised controlled trial is a study in which participants are randomly assigned to different treatment groups, allowing researchers to compare outcomes more fairly.
Evidence for drug treatment during pregnancy therefore relies on indirect research rather than trials carried out during pregnancy, reflecting long-standing caution around testing medicines in pregnant populations.
NICE guidelines recommend antidepressants for moderate to severe depression in pregnancy, while evidence from outside formal pregnancy trials suggests they can be safe and effective.
However, the researchers said trials are still needed, particularly for women who cannot access or engage with other forms of support.
Riddhi Laijawala, trial manager and PhD student, said: “Depression in pregnancy is common, but it is not inevitable, and it is treatable. What this review shows is that the options available to women are broader than many people realise.
“A yoga class, music therapy, or an online programme may not sound like clinical treatment, but the evidence suggests they can make a real difference, and for many women they may be easier (and quicker) to access than a course of therapy.”
Depression during pregnancy affects an estimated 28.5 per cent of pregnant people worldwide, but only around one in five receives appropriate and timely treatment.
The team said closing this treatment gap should be a priority for health systems because the condition can affect both parent and child.
The HappyMums project is supported by the European Union’s Horizon Europe research and innovation programme.
Type 2 diabetes is rising among women in their 20s in England, with experts warning of a worrying increase since the Covid pandemic.
The rise has largely occurred since the pandemic and is closely linked to increasing obesity levels, according to an analysis of NHS data from 2011 to 2024.
The condition is serious and can lead to severe complications, including heart attacks and strokes.
Diabetes UK said it tends to be more aggressive when it develops at a younger age, raising the risk of serious complications and shorter lives.
The charity said early diagnosis is vital for people at risk to help prevent long-term organ damage.
The condition can sometimes be put into remission through healthy eating and maintaining a healthy weight, without relying on glucose-lowering medicines.
Researchers said newer obesity treatments, including GLP-1 injections and pills, may also help alongside healthy eating advice.
About 90 per cent of the six million people living with diabetes in the UK have type 2 rather than type 1, or insulin-dependent, diabetes.
The risk increases with age, and older adults still account for the largest proportion of new diagnoses.
However, NHS England estimates suggest that 12,000 people under 30 are now living with the condition, with women making up more of the younger cases.
Common symptoms include feeling very tired, urinating more often than usual and feeling thirsty all the time.
Researchers at Imperial College London analysed NHS data from the English National Diabetes Audit to examine trends over time.
The figures showed that cases are falling slightly among older adults, who still account for the largest share of new diagnoses.
However, diagnoses are increasing rapidly among people under 40, with some of the sharpest rises among women aged 20 to 29.
Body mass index at diagnosis has also been rising more quickly among younger adults than in older age groups, pointing to obesity as a likely factor.
Body mass index, or BMI, is a measure of obesity based on a person’s height and weight.
Separate NHS data for England shows obesity rates have worsened since the pandemic, with nearly one in three people now affected.
The largest increases over time have been among younger adults.
Between 2019 and 2025, new obesity cases rose by 16 per cent among people aged 20 to 29 and by almost 20 per cent among those aged 30 to 39.
Rates fell among adults aged 60 to 79 over the same period.
Lead researcher Dr Shivani Misra said: “We think that the earlier onset of severe obesity in young people is increasing their type 2 diabetes risk in early life and pulling down their age at diagnosis.
“This is really worrying given the poor health outcomes from early-onset type 2 diabetes.”
Misra said much of the discussion about rising rates among younger people had focused on ethnic minority groups, which have traditionally been considered at higher risk.
However, the new data suggests the trend extends well beyond those communities.
She added: “We now see that incidence is also increasing in white populations too, showing that this public health challenge is broadening across the generations.”
Diabetes UK said better follow-up care is also needed for mums-to-be diagnosed with gestational diabetes during pregnancy because it raises the risk of developing type 2 diabetes after childbirth.
Some studies have suggested that the risk of developing the condition may also increase after being ill with Covid, although the evidence remains inconclusive.
AstraZeneca’s breast cancer drug Etcamah has been approved in the EU as part of a combination treatment for advanced disease.
The European Commission acted on a positive opinion from the Committee for Medicinal Products for Human Use, the Cambridge, England-based drug maker said.
The decision followed positive results from the Serena-6 phase III trial, which showed a 56 per cent reduction in the risk of disease progression in advanced oestrogen receptor-positive breast cancer.
A phase III trial is a large, late-stage study used to assess a treatment’s safety and effectiveness before wider regulatory approval.
Oestrogen receptor-positive breast cancer is a form of the disease that can grow in response to the hormone oestrogen.
Etcamah, whose generic name is camizestrant, was tested in combination with a cyclin-dependent kinase 4/6 inhibitor.
Known as CDK4/6 inhibitors, these medicines block proteins that help cancer cells grow and divide.
AstraZeneca said the Etcamah combination has also been approved in Japan, the UAE and Saudi Arabia based on the Serena-6 trial results.
The company said breast cancer remains the leading cause of cancer death among women in Europe, with more than 140,000 deaths and more than 540,000 patients diagnosed in 2024.
AstraZeneca shares were down 0.6 per cent at 12,628 pence in London on Thursday.
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