The rapid proliferation of digital health technologies in the NHS has ushered in an era of unprecedented potential for improving patient care. However, this technological revolution has also exposed a critical gap in safety assurance practices, particularly concerning the adoption of NHS safety standards DCB0129 and DCB0160.
As we navigate this digital transformation, it is imperative to address the existing shortcomings in clinical risk management practices and learn from patient safety initiatives to create a more robust and secure healthcare ecosystem.
The Current Landscape: Innovation Outpacing Safety Measures
The development of digital health technologies is often driven by innovation rather than an evolutionary approach that prioritises safety. This disconnect has led to an exponential increase in patient risk, as many technologies are deployed without adequate consideration for safety by design or their impact on clinical workflows. The lack of adherence to established safety standards like DCB0129 and DCB0160 further exacerbates this issue, highlighting a systemic failure in prioritising patient and clinical safety.
Lessons from Patient Safety Initiatives
Recent patient safety initiatives, such as the Patient Safety Incident Response Framework (PSIRF) and the introduction of Freedom to Speak Up Guardians, offer valuable insights into improving safety cultures within healthcare organisations. These programs emphasise the importance of open communication, continuous learning, and a proactive approach to identifying and mitigating risks.
The Broken Trust Report: A Call to Action
The Parliamentary and Health Service Ombudsman’s (PHSO) “Broken Trust” report serves as a stark reminder of the need for substantial improvements in patient safety practices. The report underscores that merely having the right framework is insufficient; it requires a fundamental shift in organisational culture and leadership priorities to effect meaningful change.
Regulatory Compliance: A Shared Responsibility
Both manufacturers and healthcare organisations bear the responsibility of investing in people and processes to support regulatory compliance for digital health technologies.
This dual accountability ensures that safety considerations are integrated throughout the development and deployment lifecycle of these technologies.
The shared responsibility model emphasises the critical need for collaboration between manufacturers and healthcare organisations to achieve comprehensive compliance not just compliance with DCB0129/0160 as a box ticking exercise:
Seamless Information Exchange
- Manufacturers provide detailed safety information and user guidance
- Healthcare organisations share real-world usage data and incident reports
Joint Risk Management
- Collaborative approach to identifying and mitigating risks throughout the technology lifecycle
- Shared responsibility for addressing emerging safety concerns
Continuous Improvement
- Feedback loop between users and developers drives ongoing enhancements
- Joint efforts in refining risk management strategies based on real-world evidence
Regulatory Alignment
- Ensures a cohesive approach to meeting regulatory requirements
- Facilitates smoother regulatory approvals and audits
By embracing this collaborative model, both manufacturers and healthcare organisations can more effectively ensure the safety and efficacy of digital health technologies, ultimately leading to better patient outcomes and reduced clinical risk.
Human Factors and Clinical Workflow
One of the most overlooked aspects of digital health technology implementation is its impact on clinical workflows and human factors. Technologies that fail to account for these elements can introduce new risks and inefficiencies, potentially compromising patient safety rather than enhancing it.
The Need for Enforcement and Accountability
To address the lack of awareness and compliance with the NHS safety standards, there is a growing call for introducing penalties for both manufacturers (enforced by NHS England) and healthcare organisations (overseen by the Care Quality Commission). However, this approach presents challenges, particularly when technologies are already in widespread use and their sudden removal could cause more harm than good.
Investing in People and Processes
The NHS Patient Safety Strategy acknowledges that care failings often stem from systemic issues rather than individual incompetence or malice. This realisation underscores the need for substantial investment in people and processes to create a culture of safety that permeates all levels of healthcare delivery.
In Conclusion: A Path Forward
As we continue to embrace digital health technologies, we must ensure that patient safety remains at the forefront of innovation. This requires a multifaceted approach that includes:
- Stricter enforcement of the NHS safety standards with tangible penalties that can be enforced
- Continuous education and training for healthcare professionals in clinical risk management that meets the needs of the individual within their role
- Integration of human factors considerations in technology design is paramount for the successful development of meaningful technologies
- Fostering a culture of open communication and continuous improvement to encourage best practice and What Good Looks Like approaches to implementation
- Collaboration between manufacturers, healthcare providers, and regulatory bodies to achieve better practices that work for all parties in the delivery of safe and effective digital health technologies
By addressing these topics, we can bridge the gap between technological innovation and patient safety, ensuring that digital health transformation and the supporting technologies meet their intended purpose of improving patient outcomes without compromising safety.
