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NHS & HealthTech Assurance

NHS & HealthTech Governance: DSPT, DTAC and Clinical Safety

A buyer-ready evidence base across DSPT, DTAC, clinical safety and the other requirements NHS buyers and care organisations expect.

The problem is often not a single missing document. It is fragmented responsibility across safety, privacy, cyber and procurement evidence.

View relevant evidence — View Relevant Evidence

Find your starting point

Which problem are you solving?

Preparing to sell into the NHS. The product is ready, but the assurance position is fragmented or incomplete — see NHS DTAC Readiness below.

Clinical safety needs specialist support. DCB0129, DCB0160, hazard management or Clinical Safety Officer capability is required.

A procurement deadline is approaching. Evidence needs prioritising without creating unsupported claims.

A technology is being deployed. The care organisation must assess supplier evidence and local clinical risk.

Free resource: NHS HealthTech Assurance Playbook — supplier and deployer responsibilities across DSPT, DTAC, DCB0129 and DCB0160.

Free tool: DTAC Evidence Preparation Matrix — the evidence each DTAC form question may call for.

Service family

Explore NHS & HealthTech governance services

Grouped by how you need to engage. DTAC readiness has its own page; clinical safety and procurement support are scoped directly.

Prepare and strengthen evidence ahead of NHS buyer or procurement scrutiny.

When organisations engage us

Signals that it is time to act

  • Preparing to sell into the NHS

    The product is ready, but the assurance position is fragmented or incomplete.

  • DTAC evidence is incomplete

    Responses exist, but supporting evidence or controls need strengthening.

  • Clinical safety needs specialist support

    DCB0129, DCB0160, hazard management or CSO capability is required.

  • A procurement deadline is approaching

    Evidence needs prioritising without creating unsupported claims.

  • A technology is being deployed

    The care organisation must assess supplier evidence and local clinical risk.

  • The product has materially changed

    New functionality, integrations, AI or context may affect existing assurance.

Scope

Integrated assurance — with clear professional boundaries

IG-Smart can support
HealthTech governance, DTAC readiness and gap analysis, digital clinical-safety consultancy, DCB0129/DCB0160 assurance support, CSO services where appropriately scoped, privacy and information-governance assurance, NHS procurement readiness, cyber governance coordination, evidence development, remediation oversight and continuing assurance.
Not implied by default
NHS approval or endorsement, accredited certification, medical-device regulatory approval, DTAC “certification”, guaranteed procurement success, legal opinions outside professional scope, full penetration testing unless commissioned, software-development responsibility, or guaranteed compliance.

Relevant evidence

Selected NHS and health-sector engagements

Published engagements involving AI HealthTech NHS-standards governance, national NHS information governance advice, DSPT readiness and health and care data governance.

  • Named client · Healthcare / NHS

    Royal Brompton & Harefield NHS Foundation Trust

    Three-year managed service: Information Governance, data quality, Payment by Results, trust-wide information security and clinical systems safety, reporting to the board-level SIRO

    Three-year managed IG, data quality, security & clinical systems safety service · reporting to the board-level SIRO

    View the evidence: Royal Brompton & Harefield NHS Foundation Trust

  • Named client · Technology / SaaS / RegTech

    Clini-Hub

    Embedded governance and clinical-safety support since start-up

    NHS AI Toolkit, DSPT, DTAC and clinical-safety governance from start-up

    View the evidence: Clini-Hub

  • Named client · Healthcare / NHS

    NHS England

    Strategic data-privacy and data-sharing advisory

    National privacy-by-design framework · multiple national workstreams

    View the evidence: NHS England

  • Named client · Higher Education / Research

    UCL

    IG audit, improvement plan, training and physical-security audit

    Helped shape and focus the final DSPT submission

    View the evidence: UCL

Explore all case studies →Request HealthTech Assurance Evidence →

Your IG-Smart team

Specialist expertise, coordinated around your requirement

Subject-matter expertise is paired with a clear client and programme contact from initial scoping through delivery.

  • Subject-matter expert

    Michael Abtar

    LLB (Hons), PG.Dip.Law, Cert. DPO

    View profile

  • Subject-matter expert

    Himanshu Desai

    MSc, MBA, MRPharmS

    View profile

  • Subject-matter expert

    Shaista Peart

    BA (Hons), CIPP/E

    View profile

  • Client & programme contact

    Julia Andrade

    BA

    Coordinates scope, practitioners, delivery and stakeholder communication.

    View profile

Buyer decisions

Questions before you engage

What is HealthTech governance?

The accountability, decision-making, controls and evidence through which a digital-health supplier or care organisation manages the safety, privacy, security, interoperability and procurement requirements that apply to a technology — and keeps them current as it changes.

What is DTAC?

The Digital Technology Assessment Criteria: a common NHS approach for assessing digital-health technologies across clinical safety, data protection, technical security, interoperability, and usability and accessibility.

What is the difference between DCB0129 and DCB0160?

DCB0129 covers clinical risk management in the manufacture of health IT systems. DCB0160 covers clinical risk management by health and care organisations deploying and using them. They are related but not interchangeable.

Who needs a Clinical Safety Officer?

Organisations within scope of DCB0129 or DCB0160 need a suitably qualified and experienced clinician acting as Clinical Safety Officer to oversee clinical-risk management. Specific requirements are set by the standards.

How does DSPT relate to DTAC?

DSPT is organisational assurance over data security and information governance. DTAC assesses a specific technology. One does not substitute for the other, though evidence may overlap.

Can IG-Smart prepare or review DTAC evidence?

Yes. IG-Smart can assess existing evidence, identify gaps, help build the underlying evidence and review responses so they can be substantiated.

Related insight: DSPT, DTAC, DCB0129 and DCB0160: How NHS HealthTech Governance Fits Together

Ready to move forward?

Need to make your HealthTech assurance position clearer and more defensible?

Not sure which service applies? Find the Right Service

  • Still defining your requirement?

    Discuss HealthTech Assurance

    Discuss the requirement, risk, scope and the right engagement model with an experienced practitioner.

    Discuss HealthTech Assurance

  • Have a defined scope, tender or RFP?

    Submit a HealthTech Requirement

    Share a defined requirement, RFP, tender, statement of work or existing scope for senior review.

    Submit a HealthTech Requirement

  • Procurement or supplier assurance

    Prepare for Procurement Review

    Access company, security and assurance information for supplier review, with controlled evidence available on request.

    Open Trust Centre