The provision and deployment of Digital Health Systems within the NHS can deliver substantial benefits to patients through the timely provision and availability of clinical information to those healthcare professionals that are responsible for administering and managing care. However, it must be recognised that failure, design flaws or incorrect use of such systems has the potential to cause harm to those patients that the system is intending to benefit.
Ensuring patient safety and data security in healthcare is paramount. This includes complying with various regulations set forth by governing bodies within digital health. Regulatory compliance is a critical aspect that digital health manufacturers and healthcare organisations must navigate to maintain the highest standards of care and reduction in risk of harm to patients.
Understanding Regulatory Compliance
Regulatory compliance refers to adhering to a set of guidelines, rules, and standards established by the NHS and other relevant external authorities. These regulations encompass a wide range of areas, including patient safety, data privacy and security, medical device usage, and more.
The primary goal of regulatory compliance is to ensure that healthcare services are delivered safely, efficiently, and ethically supported by digital health systems.
The Digital Technology Assessment Framework (DTAC) provides the means to assess digital health systems and their compliance with a number of standards and regulations that are encompassed into five categories:
- Clinical Safety
- Data Protection
- Technical Security
- Interoperability
- Usability and Accessibility
Key Components of Digital Health Regulatory Compliance within the NHS
Patient/Clinical Safety: DCB0129 Clinical Risk Management: its Application in the Manufacturer of Health IT Systems ensures that patient safety is upheld through proper procedures, processes, and digital health system usage. This safeguards patients from avoidable harm or errors. Medical devices used in healthcare settings must adhere to specific regulations to guarantee their safety and efficacy. In the UK this means complying with the UK MDR 2002 (UKCA)
Data Protection: Protecting patient information is of utmost importance. Regulations such as General Data Protection Regulation (GDPR), Data Security and Protection Toolkit and ISO27001 dictate how clinical information should be collected, stored, and processed securely.
Technical Security: Technical security, also known as cybersecurity, refers to the measures and practices implemented to protect digital health systems, networks, data, and digital assets from various cyber threats, attacks, and unauthorised access. It encompasses a wide range of strategies and technologies designed to ensure the confidentiality, integrity, and availability of digital resources.
Cyber Essentials is one of the requirements in relation to technical security. Cyber Essentials helps you to guard against the most common cyber threats and demonstrate your commitment to cyber security.
Interoperability: Interoperability refers to the ability of digital health systems, devices, applications, or components to work together and exchange information in a safe and effective manner. In the context of technology and information systems, interoperability ensures that disparate systems can communicate, share data, and perform tasks collaboratively, even if they are developed by different vendors or have different functions.
Application Programme Interfaces (API) are used to support interoperability with other systems and should adhere to best practice and guidance.
Usability and Accessibility: Usability refers to the ease with which users can interact with a digital health system, or service to achieve their goals efficiently and effectively. A usable design is intuitive, user-friendly, and minimises the cognitive load required to complete tasks. Usability is often evaluated through user testing, user feedback, and observation of user behaviour.
Digital health manufacturers need to be aware of the NHS service standard which helps address the differing needs of the health service users when delivering digital services into healthcare.
Accessibility focuses on designing products, services, and digital content in a way that ensures they are usable by people with disabilities. This involves making adjustments to accommodate individuals who might have visual, auditory, motor, or cognitive impairments. Accessibility aims to provide equal access and opportunities for all users, regardless of their abilities.
NHS Regulatory Compliance is an Essential Pillar of Healthcare Operations.
Adherence to these regulations ensures patient safety, data security, and overall quality of care. Working collaboratively with the Clinical Safety Officer and your digital team will help you navigate the regulatory compliance process, allowing you to focus on what truly matters: delivering high quality clinical services while safeguarding the well-being of patients.
