BMS Digital Safety leverages expert knowledge in clinical risk management. We effectively guide clinicians through the DCB and DTAC compliance requirements.
Digital Technology & Assessment Criteria
DTAC is embedded in the procurement procedures of NHS organisations.
It applies to digital health technologies used within the NHS and social care environments.
DTAC ensures these technologies meet national standards in five key areas: Clinical Safety, Data Protection, Technical Security, Interoperability, Usability & Accessibility.
Introduced in 2021 by NHSX (now part of NHS England), the Digital Technology Assessment Criteria (DTAC) serves as a national baseline for assessing digital health technologies.
It is mandatory for all digital health technologies supplied to the NHS, including initial pilots and medical devices, and focuses significantly on legislative compliance.
While the NHS and other organisations cannot issue DTAC certification, experienced professionals can ensure that all standards are met.
DTAC Components
DCB0129 documentation and clinical safety officer services ensure health IT systems are safe for use. Clinical Safety Officers manage clinical risks and oversee compliance with safety standards.
The Data Security and Protection Toolkit (DSP Toolkit) helps organisations comply with GDPR and other regulations. It ensures personal information is handled securely and correctly.
Cyber Essentials certification helps organisations protect against common cyber threats. It involves implementing technical controls to safeguard data and systems.
Interoperability allows seamless sharing and use of patient information across different systems. It improves patient outcomes and ensures efficient communication between healthcare providers.
Digital accessibility standards ensure that digital services are accessible to everyone, including those with disabilities. The NHS follows the Web Content Accessibility Guidelines (WCAG) to meet high accessibility standards.
DCB 0129
DCB0129 is designed to help digital health manufacturers demonstrate the clinical safety of their products.
It is a mandatory requirement in England, Wales & NI.
DCB0129 is part of the Digital Technology Assessment Criteria (DTAC).
Clinical Safety standards, mandated under section 250 of the Health & Social Care Act 2012, are governed by DCB0129 and DCB0160.
These standards apply to Health IT, including software, apps, and middleware, used within Health & Social Care environments.
Their primary aim is to ensure the safe deployment, use, and ongoing maintenance of these products or systems.
Compliance requires certain activities to be completed designed to mitigate potential hazards that could lead to patient harm – especially related to patient demographics, clinical information, diagnostics, and other health-related data that influence patient pathways, choices, or decisions regarding health and care
DCB 0160
DCB0160 requires health organisations to establish a framework for managing clinical risks associated with the implementation or alteration of digital health systems, as outlined in the DCB0129 documents.
This framework is applicable to entities involved in the deployment, usage, maintenance, or decommissioning of Health IT systems.
Clinical Safety standards, mandated under section 250 of the Health & Social Care Act 2012, are governed by DCB0129 and DCB0160. These standards apply to Health IT, including software, apps, and middleware, used within Health & Social Care environments.
Examples of organisations required to complete DCB 0160 include GP practices, hospital trusts, Integrated Care Boards (ICBs), councils, social care facilities, care homes, and more.
The CSO is a registered clinician who has received appropriate training in clinical risk assessment and holds a relevant professional registration.
They are responsible for overseeing clinical risk activities within an organisation, and to effectively carry out this role, the CSO requires support and collaboration from the entire product team.