Executive summary
The market for digital health in the UK is maturing rapidly, and with it, the regulatory and assurance requirements. NHS buyers must now ensure all new tools comply with the DTAC (Digital Technology Assessment Criteria), while manufacturers must provide clinical safety cases under DCB0129/0160. For novel AI as a Medical Device (AIaMD), the MHRA’s AI Airlock and NICE’s Early Value Assessment (EVA) pathway are creating new, structured routes to market that demand robust evidence.
This complex landscape has fuelled the rise of a new sector of specialist UK advisory firms. These consultancies help innovators and NHS organisations navigate four key areas: (1) regulatory & assurance, (2) strategy & transformation, (3) data & analytics, and (4) market access. This article maps this new ecosystem.
It also introduces iatroX Insights, our new advisory and research partnership arm. Unlike "pure-play" consultancies, iatroX operates a live, UK-centric clinical platform (UKCA/MHRA-registered) and can generate unique, first-party, opt-in clinician usage insights to help partners de-risk adoption and build a powerful evidence case.
Why advisory is booming: the UK assurance & adoption gap
The path to NHS adoption is no longer just about having a great product; it's about having verifiable proof of its safety, compliance, and value.
- The procurement baseline: The DTAC is the national "front door" check for NHS buyers. Any tool, even for a pilot, is expected to have a DTAC pack ready (NHS Transformation Directorate).
- Regulatory novelty: The MHRA AI Airlock provides a supervised "sandbox" for novel AIaMD, allowing developers and regulators to test products in a real-world setting and de-risk evidence generation before a full-scale launch (GOV.UK).
- Fast-track evidence: The NICE EVA pathway accelerates the assessment of digital and medtech tools, allowing for conditional "use while evidence is generated" in high-need areas (NICE).
This "assurance stack" is complex. It creates a critical need for specialist navigators who can speak the languages of clinical safety, regulatory law, and NHS delivery.
Capability map: four jobs to be done
We can map the advisory landscape into four main capabilities:
A) Regulatory, safety & assurance This is the foundational layer: preparing DTAC readiness packs, authoring DCB 0129 (manufacturer) and DCB 0160 (deployer) clinical safety cases, and navigating the UKCA/MHRA route-to-market.
- Typical partners: Safehand (focused on DCB 0129/0160 compliance), Hardian Health (specialising in SaMD/AIaMD regulation and NICE ESF).
B) Strategy & transformation (provider-side) This focuses on helping NHS organisations implement change. It includes digital strategy, patient flow optimisation, EPR support, and designing user-centred services.
- Typical partners: Ethical Healthcare, Channel 3 Consulting, TPXimpact.
C) Data & analytics This is the technical work of building data pipelines (often FHIR-based), supporting FDP integration, and running the analytics and modelling to prove impact.
- Typical partners: Edge Health, Methods Analytics.
D) Market access & HEOR (vendor-side) This helps vendors get their product paid for. It involves building an evidence strategy, navigating pricing and reimbursement, and facilitating engagement with NICE.
- Typical partners: Mtech Access / Petauri Evidence.
Product-led partners (AI implementation) This is a new hybrid model. iatroX operates as a product-led partner. We provide our own UKCA-marked, MHRA-registered clinical AI platform—with its UK guideline grounding—and use our Insights division to complement consulting teams, ensuring AI is deployed safely and its adoption is informed by real clinician behaviour.
Who’s who: exemplar firms & what they’re known for
- Curistica: A clinical innovation consultancy known for its AI education and adoption programmes for clinical teams.
- Safehand: A specialist consultancy focused purely on DCB 0129 and DCB 0160 clinical safety compliance, testing, and training.
- Hardian Health: A regulatory strategy firm with deep expertise in SaMD/AIaMD, guiding companies through CE, UKCA, and FDA pathways.
- Ethical Healthcare: An NHS-born digital transformation consultancy with a strong "from the NHS, for the NHS" ethos.
- Channel 3 Consulting: An established NHS digital change partner, focusing on large-scale programmes, patient flow, and policy.
- Edge Health: A health analytics and modelling firm known for its evidence-led transformation projects and AI evaluations.
- Methods Analytics: A large data science and AI delivery partner for the public sector and NHS-linked programmes.
- Mtech Access (Petauri Evidence): A market access and health economics (HEOR) consultancy, recognised as a NICE META facilitating organisation.
- BJSS (now part of CGI): A large-scale technical delivery partner that has worked on major national assets like the NHS App and Spine.
- TPXimpact: A user-centred design and digital services firm that works extensively with the NHS.
- iatroX Insights: A product-led partner. We provide our UKCA-marked clinical AI platform, combined with advisory services on safety, validation, and adoption, uniquely informed by aggregated, anonymised data from our live clinician community.
How to brief and buy: a due-diligence checklist
- Map your need: Are you buying Assurance (DTAC/DCB), Transformation (workflow), Data (analytics), or Market Access (HEOR)?
- Ask for proof: Request evidence of alignment with UK frameworks. Ask for example DCB 0129/0160 safety cases, experience with the NICE EVA pathway, and a clear understanding of the MHRA AI Airlock.
- Check interoperability fluency: Your partner must be fluent in FHIR, CDS Hooks, SMART on FHIR, and the governance of the Federated Data Platform (FDP).
- Insist on outcome-based contracts: Define the deliverable (e.g., "a passed DTAC pack," "a signed-off DCB0160 safety case") and avoid open-ended, time-based billing where possible.
- Demand governance artefacts: Your contract should include the delivery of a DPIA, clear clinical safety ownership, and auditable governance for any AI deployment.
What “good” looks like in delivery
- National-scale digital delivery: Look for partners with a proven track record of delivering on major national programmes, such as BJSS's work on the NHS App.
- Analytics in the NHS: Look for firms that publish their data-engineering and modelling insights, using this as a proxy for their technical strength (e.g., Edge Health).
- Market access depth: Look for formal recognition, such as Mtech Access's status as a NICE META facilitating organisation.
- Education & change: Look for partners who address the "human factor" of adoption with credible training programmes (e.g., Curistica's AI training).
- AI product-led partnership: Look for platforms with existing UKCA/MHRA credentials and a UK-guideline knowledge base (e.g., iatroX) when you need a compliant product and adoption support.
Case vignettes
- Ambient scribing rollouts: A Trust needs to deploy an AI scribe. It must follow NHS England guidance, complete a DTAC, and write a DCB0160. An assurance partner like Safehand can be brought in to manage this process and ensure the vendor's DCB0129 is robust.
- AI dermatology pathways: An ICS wants to pilot a new AI-powered skin cancer triage tool. An evaluation partner like Edge Health can design the real-world evidence study to meet the stringent criteria of a NICE EVA.
- Differential-support pilots: A vendor with a novel diagnostic AI (AIaMD) needs to get it to market. A regulatory advisor like Hardian Health can guide them through the application process for the MHRA AI Airlock.
What We Do: The iatroX Insights Difference
| Capability | What “Good” Looks Like | How iatroX Insights Delivers | | :--- | :--- | :--- | | Clinical Safety Case | A DCB0129/0160 signed by a CSO | We provide expert, accredited CSO services. | | Procurement Assurance| A completed, robust DTAC pack | We manage the gap-analysis and evidence collation. | | Validation & Evidence | A clear NICE EVA-ready plan | We can co-design validation studies using anonymised, aggregated insights and opt-in feedback from our live clinician platform. | | AI Strategy | A safe, compliant adoption roadmap | We pair our advisory service with our own UKCA-marked clinical AI tool to accelerate your journey. |
Calls to action
- For NHS buyers/ICSs: Shortlist advisory partners across the four key areas (safety, evaluation, transformation, data). For any AI pilot, require a clear plan for generating usage evidence, not just compliance documents.
- For innovators: Align your product to DTAC and DCB0129 from day one. Build a NICE EVA-ready evidence plan. To accelerate your product-market fit and validation, consider working with a platform-led partner like iatroX Insights.