“Move fast and break things” – Silicon Valley’s famous mantra revolutionised social media and transformed how we connect online. But in healthcare, where technology decisions directly impact patient safety, the stakes are fundamentally different.
NHS organisations today face significant pressure to accelerate digital transformation, particularly in areas like virtual wards and remote monitoring. While these innovations offer exciting possibilities for patient care, they also require careful consideration of safety and regulatory requirements – balancing the drive for progress with our fundamental responsibility to protect patients.
The current landscape
The NHS is making remarkable progress in transforming patient care through virtual wards, providing hospital-level care in people’s homes through a combination of technology and face-to-face care. With a national target of 40-50 virtual ward ‘beds’ per 100,000 people and the potential for more than 50,000 monthly admissions, these innovations are reshaping healthcare delivery across every integrated care system.
The opportunity and challenge
Virtual wards represent an essential element in the NHS’s urgent and emergency care recovery plan, offering personalised care choices and alternatives to hospital admission. Already well-established for acute respiratory infections and frailty, they’re expanding into new areas such as heart failure care and children and young people’s services.
As these services scale rapidly across the country, it’s essential to ensure that the technologies enabling this transformation meet appropriate safety and regulatory standards. This isn’t just about compliance – it’s about supporting NHS organisations in delivering safe, effective care in new ways.
The regulatory framework
To support the safe deployment of virtual ward technologies, several key standards work together. These standards help ensure patient safety and service quality:
- ISO 27001 enables organisations to protect sensitive information and maintain data security across their virtual ward services. This is crucial when handling patient data across multiple care settings.
- ISO 13485 gives regulatory requirements for medical device quality management systems. It ensures that virtual ward technologies meet safety and performance standards throughout their lifecycle.
- BS EN 62304 deals with medical device software and helps manufacturers demonstrate compliance with the relevant regulatory requirements. This is essential for the software platforms that power virtual ward services.
- ISO 14971 applies to the risk management of medical devices and provides a framework for identifying and mitigating potential risks in virtual ward implementations.
- DCB0129 is designed to help manufacturers of health IT software evidence the clinical safety of their products through systematic risk assessment and management processes.
- DCB0160 is intended to help NHS organisations ensure clinical safety when implementing and using health IT systems in their virtual ward services.
Building trust in virtual ward services
Quality standards and regulations play a vital role in building confidence in virtual ward services among patients, clinicians, operational teams and system leaders.
For successful implementation, NHS organisations should:
- Conduct thorough regulatory compliance reviews of existing technology solutions
- Verify that remote monitoring platforms meet current and future medical device standards
- Implement comprehensive data security measures aligned with ISO 27001
- Establish and maintain robust clinical safety protocols
Regularly assess and update safety measures as services develop
Looking forward
As virtual wards continue to expand and evolve, with new pathways being added and evidence growing, maintaining strong regulatory compliance will help ensure these innovative services can scale safely and effectively. This supports NHS England’s vision of providing more personalised, convenient care while maintaining high safety standards.
Conclusion
Unlike Silicon Valley’s ‘move fast and break things’ mindset, healthcare innovation demands higher standards. By choosing partners which understand both regulation and innovation, NHS organisations can deliver virtual ward services that transform care safely.