Navigating the Regulatory Landscape: Governance in the World of Virtual Wards

Virtual Wards have emerged as a promising solution to address the challenges of modern healthcare delivery. In this blog, we explore the pivotal role that governance plays in ensuring compliance with NHS healthcare regulations and ethical standards when implementing Virtual Wards.

2023 saw a significant commitment from NHS England to expand the implementation of virtual wards as part of the Delivery Plan for the restoration of urgent and emergency services. While the challenges faced by the NHS are complex and cannot be solved with a single solution, the implementation of virtual wards presents a practical approach to alleviating some of these issues. By focusing on preventing hospital admissions or facilitating earlier discharges, virtual wards can effectively address the shortage of physical hospital beds.

Virtual Wards leverage technology to provide care and support to patients in their own homes, reducing the need for hospitalisation. While the potential benefits of Virtual Wards are promising, their success relies heavily on navigating the complex regulatory compliance landscape and establishing robust governance protocols. 

What Are Virtual Wards?

Also known as “Hospital at Home” programs, Virtual Wards are a new approach to healthcare delivery that allows patients to receive medical care, monitoring, and support in the comfort of their homes. The increasing burden on healthcare systems, driven by ageing populations and the demand for chronic disease management, has necessitated the need for innovative solutions like Virtual Wards in the UK. 

Virtual Wards are designed to address various healthcare needs, including post-surgery recovery, chronic disease management, and palliative care, among others. They use a combination of digital technologies, telehealth, and remote monitoring devices supported by healthcare professionals to provide comprehensive care to patients outside traditional hospital settings.

These models focus on monitoring patients’ health remotely, providing timely interventions, and enhancing patient outcomes, to help reduce hospitalisation rates, improve patient satisfaction, and achieve cost savings.

The Key Advantages of Virtual Wards

1. Reduced Healthcare Costs: Virtual Wards can significantly reduce the cost of healthcare by minimising hospital admissions and readmissions.
2. Enhanced Patient Experience: Patients benefit from the convenience of receiving care at home, leading to improved satisfaction and adherence to treatment plans.
3. Improved Resource Allocation: By diverting non-critical cases away from hospitals, Virtual Wards free up resources for more acute patients.
4. Prevention of Hospital-Acquired Infections: Keeping patients at home reduces their exposure to hospital-acquired infections, a major concern for many healthcare providers, particularly over the winter months when seasonal flu is on the rise.

According to a study conducted by the Health Foundation, 78% of the general public expressed their willingness to ‘self-monitor their health at home through technology rather than in a hospital.’ This scenario, often associated with a more comprehensive virtual healthcare service, garnered a positive response from a significant majority, while only 13% expressed reluctance.

The Crucial Role of Governance & Compliance for Virtual Wards

Governance Requirements

Several specific actions are required, involving both the lead commissioner and all participating organisations, including third-party tech suppliers, to set up virtual wards in a lawful and secure manner:

1. Design the Model of Care: Some Virtual Wards may be delivered by a single organisation, however multidisciplinary models involving more than one organisation are becoming increasingly common. The operating model and the technical tools selected to support the Virtual Ward will need to take account of any operational complexities, for example staff from multiple organisations who may have varying levels of digital maturity or access to computers and connectivity.
2. The Procurement Process and Due Diligence:
   1. Data Security and Protection Toolkit (DSPT): All organisations involved in the delivery of a Virtual Ward should demonstrate their compliance with the Data Security and Protection Toolkit (DSPT).  This is of particular importance for suppliers as it is necessary to be eligible for an NHS contract. This ensures that organisations with poor IG practices are not awarded contracts.
   2. Digital Technology Assessment Criteria (DTAC) Submission: Complete the DTAC assessment with a specific focus on sections C2 (Data Protection), C3 (Technical Security) and C4 (interoperability), involving input from the ICT lead.
3. Complete a Data Protection Impact Assessment (DPIA): Conduct a DPIA to assess any data protection risks before implementation. Regularly review the DPIA to reflect any service changes. The DPIA should outline the UK GDPR legal basis, controller and processor arrangements and identify any data protection risks associated with the project.
4. NHS Terms and Conditions with a Data Processing Agreement: Consider using the NHS terms and conditions, which can be accompanied by a linked data processing agreement defining allowable data processing. It is always preferable for such an agreement to be incorporated as a schedule within the contract, however in exceptional circumstances it may exist as a standalone document (although it should always be referenced within the contract). Particular attention should be given in circumstances where technology is being procured for use by multiple organisations. For data protection terms to apply and be legally enforceable, contracts should be drafted to ensure they cover all potential users of the technology (which should have been identified as part of steps 1 and 3 above).
5. Prepare a Data Sharing Agreement or Data Processing Contracts (if required): If there will be multiple organisations involved in the operational delivery of a Virtual Ward then the data sharing arrangements will need to be appropriately formalised. The DPIA should identify all parties and clarify the roles and responsibilities of each. If there will be multiple data controllers involved then a Data Sharing Agreement is considered best practice by the Information Commissioner’s Office (ICO). Where organisations will be acting as a data processor on behalf of another, there is a legal requirement to ensure legally binding Data Processing Contracts are established. Depending on existing local arrangements, it may be possible to adopt an existing data sharing framework for shared care records and add an additional schedule or agreement covering data sharing for virtual wards. All organisations participating in the delivery of a Virtual Wards should sign the relevant agreement.
6. Implement a Privacy Notice: Before remote monitoring of a patient begins, ensure that a privacy notice is available for all participating organisations within the virtual ward. This supports transparency and ensures that patients are made aware of the different organisations involved in their care and the roles and responsibilities of each.

Wider Considerations

Effective governance is the cornerstone of any new care model, and Virtual Wards are no exception. While the DTAC establishes a framework to ensure that all healthcare innovations, including the use of Virtual Wards, is implemented and governed effectively, there are wider ethical and safety considerations that should also be adhered to:

1. Beyond Legal Obligations: Decisions regarding patient care, data usage, and resource allocation should prioritise patient wellbeing and equitable access to care, in line with the UK’s ethical standards.
2. Remote Monitoring and Early Intervention: Virtual Wards leverage digital technology for remote patient monitoring. Suppliers must create clear protocols for ensuring timely responses to deteriorating patient conditions and minimising adverse outcomes.
3. Quality Assurance and Continuous Improvement: Regular assessments and feedback loops help identify areas for improvement in clinical safety, ensuring a commitment to continuous learning and development.
4. Data Protection: Safeguarding Patient Privacy: Patient data is the lifeblood of the NHS, and in Virtual Wards, the protection of patient information is critical. Particular care should be given if any patient data is to be used for purposes beyond the direct care of individual patients (e.g. management of health services and systems, service planning and research or service improvement). Any ‘secondary uses’ of patient data should be considered within the DPIA for the project.
5. Privacy Concerns and Patient Trust: Patients’ trust is paramount when it comes to sharing personal health data. Effective data protection measures maintain patient trust in Virtual Wards by safeguarding sensitive information and preserving patient confidentiality.
6. Data Breach Mitigation: Virtual Wards involve the electronic transmission of patient data, which increases the risk of data breaches. Robust cyber security measures minimise these risks and protect patients from potential identity theft or financial fraud. In the event of a cybersecurity breach, a well-defined incident response plan is crucial.
7. Inclusivity in Design: Virtual Ward technologies must be designed with inclusivity in mind, making them accessible to patients with disabilities, while eliminating barriers to care. But it’s also worth bearing in mind that not all patients may be tech-savvy. The provision of digital literacy support ensures patients can effectively navigate Virtual Ward technologies and access care.

The use of confidential patient information is tightly controlled by the NHS, with technology providers required to undergo the rigorous DTAC approval and assurance process. The DTAC ensures that health and care data is managed securely, appropriately, and in compliance with legal standards before access is granted. In this case, health tech suppliers are strictly prohibited from using the information for any purpose other than supporting the virtual ward unless this is explicitly covered within contracts and supported by Privacy Notices.

The future of healthcare delivery

While Virtual Wards hold immense promise for the future of healthcare delivery, offering a wide array of benefits to both patients and healthcare providers, their success hinges on effective governance and unwavering adherence to NHS regulatory compliance and ethical standards. By establishing robust governance frameworks and prioritising patient wellbeing in line with data protection, healthcare organisations and health tech suppliers can successfully provide high-quality care through Virtual Wards, helping to shape the future of healthcare delivery.