We are at the beginning of a rapid digital transformation in the health and social care sector. Digital Health Technologies are becoming intelligent, connected and embedded in everyday care. AI, IoT-enabled devices, and patient wearable devices are changing the way care is provided, yet they are also redefining the nature of clinical risks NHS organisations must be ready to face.
Here we examine some of the novel digital technologies, their risks and opportunities and how a risk-resilient clinical safety framework can be implemented for healthcare providers and health-tech manufacturers.
Emerging Technologies – Defining the Future of Clinical Safety
Over the next decade, clinical risk management will be shaped by three technology pillars:
- Artificial Intelligence (AI)
- Internet of Things (IoT), Health wearables and connected devices
- Electronic Single Patient Record.
These tools hold incredible potential, but only if their risks are controlled with rigorous governance and updated safety processes.
Artificial Intelligence in Health IT
Clinical decision-making is already being enhanced by AI, with efficiencies seen in both administrative and clinical workflows. However, there are other complex risks that AI brings like algorithmic bias, data drift, black-box-decision-making, and false confidence in automated outputs.
Key challenges include:
- Making sure that AI models are trained using representative and safe data.
- Minimising confirmation bias amongst employees, and encouraging them to always trust their own clinical judgement.
- Evaluating AI behaviour in practice to identify drift.
- Ensuring robust data governance processes to ensure patient data remains safe and confidential.
The clinical safety role will become increasingly crucial in the validation, application and post deployment monitoring of AI solutions. Organisations developing AI technologies for use in healthcare must be aware of the relevant quality management and data security standards, including ISO 42001, 27001, BS 30440 and their application alongside DCB 0129 & 0160.
IoT Devices in Clinical Settings
The application of IoT technology within the healthcare sector is rapidly evolving with the adoption of more complex digital solutions and remote patient monitoring services, allowing for the reduction manual admin, seamless automation and early detection of patient deterioration. It is now commonplace to see smart infusion pumps, connected monitors, bed management in real time, and environmental sensors are now commonplace in a modern hospital.
IoT demands Trusts to combine the functions of clinical safety, digital engineering, networking, and cybersecurity into a single governance pipeline. Adopters of these technologies must address common safety challenges, such as:
• Problems with compatibility between devices.
• Connection risk in terms of network failure.
• Cyber risks that may easily turn into patient-safety risks.
• Data quality problems with several data streams that are not standardised.
Wearables and Patient-Generated Data
Wearables, such as smart watches, glucose monitors, blood pressure sensors, and long-term condition trackers can dramatically improve self-management, remote monitoring, and early intervention but they also create new risk questions.
Challenges include:
• Data validation and reliability, as not all wearables are medical-grade.
• Safety implications when clinical staff act on faulty remote data.
• Consent, privacy, and continuous monitoring risks.
• Integrating patient-generated data into EPRs safely and consistently.
Wearables require NHS organisations to evolve from analysing episodic data to managing continuous, high-volume, real-time data flows with clear governance.
Single Patient Record – Nationwide connected care
Benefits of a Single Electronic Patient Record
- Provides a single source of truth for patient information, reducing duplication and improving data accuracy.
- Enables real-time access to comprehensive records, supporting better clinical decision-making and continuity of care.
- Streamlines workflows and reduces administrative burden, improving efficiency across departments.
- Facilitates advanced analytics for population health management and service planning.
- Enhances patient safety by ensuring visibility of allergies, medications, and diagnostic results across all care settings.
Clinical Risk Considerations
- System outages or cyberattacks can disrupt care delivery across the entire organisation due to centralised data.
- Data entry errors or misconfigurations can propagate across all services, amplifying harm.
- Risk of alert fatigue if decision-support tools generate excessive or poorly designed warnings.
- Requires robust governance and clinical safety assurance (e.g., DCB0129/0160 compliance) to mitigate risks.
- Contingency planning is essential to maintain patient safety during downtime or technical failures.
How Emerging Tech Improves Care and Why It Raises New Risks
The next generation of digital health technology will make care more personalised, proactive, and connected. However, the same capabilities can introduce new hazards if unmanaged.
Opportunities
• Earlier clinical insight through predictive analytics.
• Reduced delays through automated workflows.
• Better patient engagement through continuous data.
• Improved diagnostics via AI-enhanced image interpretation.
• More accessible care through remote monitoring.
New Risk Categories
• Algorithmic errors that directly affect clinical decisions.
• Interoperability failures between new and legacy systems.
• Increased complexity in safety cases for multi-vendor ecosystems.
• Heightened reliance on connectivity and cloud-based tools.
• Overwhelming volume of patient-generated data creating noise instead of clarity.
As technology becomes smarter, the safety risks become both less visible and more consequential, which is exactly why NHS organisations must modernise their clinical safety processes now.
What Future-Ready Clinical Risk Management Looks Like
NHS organisations and digital health suppliers will need to evolve from traditional risk assessment models toward a more adaptive, dynamic safety governance approach.
Future-ready clinical safety involves
• Continuous monitoring instead of one-off assessments.
• Real-world validation of AI systems through ongoing performance audits.
• Device and data ecosystem safety cases for interconnected technologies.
• Updated safety training so clinical staff understand AI-assisted workflows.
• Proactive risk modelling for emerging technologies.
• Strong governance aligned with DCB0129/0160, including AI-specific safety documentation.
Clinical safety professionals will need deeper technical literacy, multidisciplinary collaboration, and the ability to manage risk across distributed systems rather than isolated tools.
Practical Recommendations for NHS Organisations and Vendors
To prepare for the next wave of digital transformation, NHS Trusts and digital health suppliers should:
• Introduce AI-specific risk controls such as bias testing, training data audits, explainability reviews and information governance assurances.
• Update clinical risk management frameworks to reflect connected ecosystems rather than individual systems.
• Strengthen relationships between clinical safety officers, cybersecurity teams, and data scientists.
• Implement real-time performance monitoring dashboards for AI and IoT devices.
• Review supplier compliance early during procurement and onboarding.
• Ensure safety cases are continuously updated, not just during implementation.
For a deeper overview of how organisations can build a robust clinical safety foundation, explore the full Clinical Risk
Management service: https://bmsdigitalsafety.co.uk/services/clinical-risk-management/
If your organisation is planning to adopt AI tools, connected devices, or wearable-driven monitoring, now is the time to modernise your clinical safety governance.
Connect with BMS Digital Safety for expert-led guidance on future-ready clinical risk management.
Emerging technology will transform healthcare in a positive way, although this can only happen when it is implemented in a safe manner. The visibility, accuracy, and real-time insight provided by AI, IoT, and wearable devices are unparalleled, but provides new categories of risk that the NHS & manufacturers must mitigate against.
A future proof clinical safety strategy will allow organisations to incorporate innovation alongside governance that supports the provision of safe, compliant and trusted digital healthcare solutions.
Looking to strengthen your organisation’s clinical safety framework for the next generation of digital technology?
Speak to the specialists at BMS Digital Safety and ensure your deployments remain safe, compliant, and future-proof.