Understanding NHS DTAC and DSPT
One of the primary requirements for NHS-compliant software is adherence to the NHS Digital Technology Assessment Criteria (DTAC). This framework ensures digital health solutions are safe, effective, and interoperable with NHS systems. It evaluates solutions across five key areas: clinical safety, data protection, technical security, interoperability, and usability/accessibility. DTAC certification is often necessary for software to be procured and used by NHS organisations.
Closely related is the NHS Data Security and Protection Toolkit (DSPT), a self-assessment tool that enables organisations to measure and improve their data security practices. Compliance with DSPT is a prerequisite for accessing NHS patient data and integrating with NHS digital services. It aligns with the UK General Data Protection Regulation (UK GDPR) and mandates robust data governance policies.
Clinical Safety: Meeting DCB 0129 Requirements
For software that impacts clinical decision-making or patient care, adherence to DCB 0129 is essential. This standard requires the implementation of a Clinical Safety Case, overseen by a designated Clinical Safety Officer (CSO). It involves risk assessments to identify potential hazards and mitigation strategies to ensure that software does not compromise patient safety. Developers must document clinical risk management processes and demonstrate ongoing monitoring and review procedures.
Cybersecurity Standards: Cyber Essentials and Beyond
Given the sensitivity of health data, compliance with Cyber Essentials is a fundamental requirement for NHS digital services. This government-backed certification ensures basic security measures are in place to protect against common cyber threats. In addition to Cyber Essentials, NHS-compliant software must often meet Cyber Essentials Plus, which includes external audits and penetration testing.
Further security measures include ensuring software aligns with the National Cyber Security Centre (NCSC) guidelines, particularly concerning secure coding practices, vulnerability management, and network security. Developers should also implement ISO 27001 standards for information security management where possible.
Data Protection and Privacy: Adhering to UK GDPR
Any digital health solution handling patient data must comply with UK GDPR and the Data Protection Act 2018. These regulations mandate strict controls over data collection, processing, storage, and sharing. Key principles include data minimisation, purpose limitation, and ensuring patient consent where necessary.
Software developers must also conduct Data Protection Impact Assessments (DPIAs) to identify potential risks to personal data and mitigate them effectively. Ensuring compliance with NHS Information Governance (IG) policies is crucial for managing patient data responsibly.
Authentication and Identity Management
Ensuring secure and seamless authentication is a critical requirement for NHS digital services. For patient-facing applications, integration with NHS Login is often required. NHS Login provides a secure and standardised authentication mechanism, allowing patients to access services using verified credentials.
For clinician-facing applications, authentication must align with NHS Care Identity Service 2 (CIS2). This system enables role-based access control for healthcare professionals, ensuring that only authorised individuals can access sensitive patient records. Developers must implement multi-factor authentication (MFA) and robust identity verification processes.
Interoperability with NHS Systems
To facilitate data exchange and seamless workflows within NHS infrastructure, software must be interoperable with key NHS systems, including the Spine, HL7 FHIR-based APIs, and other electronic patient record (EPR) systems. Compliance with NHS interoperability standards ensures digital tools can communicate effectively with existing platforms, enhancing efficiency and patient care.
Accessibility and Usability Standards
Digital health solutions should be accessible to all users, including those with disabilities. Compliance with Web Content Accessibility Guidelines (WCAG) 2.2 AA ensures software is usable by individuals with visual, hearing, motor, and cognitive impairments. Additionally, applications should be designed with user-centred design (UCD) principles to improve usability for both patients and clinicians.
Conclusion
Developing NHS-compliant software requires adherence to a comprehensive set of standards covering clinical safety, data protection, cybersecurity, authentication, and interoperability. By ensuring compliance with frameworks such as DTAC, DSPT, DCB 0129, Cyber Essentials, and UK GDPR, digital health innovators can create solutions that are secure, effective, and aligned with NHS requirements. Understanding and implementing these standards from the outset will enhance the likelihood of successful NHS adoption and ultimately contribute to better patient care.