The National Health Service at work in Portsmouth, a mobile immunisation van,, has reduced the risk of diphtheria cases from 776, twenty years ago to 1 in 1950. Local doctors gave more than 37,000 various injections. Pic: 1951 (Photo by Popperfoto via Getty Images/Getty Images)

Discover how the NHS Innovator Passport and MedTech Compass are reshaping the pathway for medical technologies, diagnostics, and digital health innovations in the UK. These new frameworks enable faster, evidence-based adoption within the NHS, linking regulatory approval, real-world evidence, and reimbursement. Odelle Technology guides innovators through this process, helping them secure clinical validation, market access, and sustainable NHS integration. Explore how the NHS Innovator Passport and MedTech Compass accelerate the adoption of medical devices, diagnostics, and digital health tools in the UK. Odelle Technology supports innovators with evidence generation, HTA alignment, and reimbursement strategies for faster NHS integration. Discover how the NHS Innovator Passport and MedTech Compass will revolutionise healthcare innovation, enabling the evidence-based adoption of medical, diagnostic, and digital health tools across the UK with Odelle Technology.

Executive Summary: What the NHS Innovator Passport Means for Adoption & Reimbursement (2025)

On 2 July 2025, the UK Department of Health and Social Care (DHSC) and NHS England launched the Innovator Passport, a transformative digital validation framework powered by MedTech Compass. The NHS Innovator Passport and MedTech Compass mark a fundamental transformation in how healthcare innovation is evaluated, financed, and adopted across the UK health system. These frameworks create a unified, evidence-based pathway connecting clinical validation, real-world data (RWD), and reimbursement readiness, enabling faster access for safe and effective medical devices, diagnostics, and digital health technologies.

Through a combination of scientific rigour, economic modelling, and regulatory precision, Odelle Technology helps innovators navigate this new ecosystem, aligning with NICE, NHS England, and HTA expectations to convert credible evidence into sustainable NHS adoption. As the UK moves quickly towards using data to drive innovation based on results, the Innovator Passport is more than just a way to get approval; it serves as a strategic guide for entering the market, getting paid, and

1. Policy Context and Purpose Policy Context (2025): Where the Innovator Passport Fits in NHS Strategy & NICE HTA

The Innovator Passport is part of a larger policy evolution that builds upon:

The NHS Long Term Plan (2019–2029) aims to integrate digital and precision medicine.
The UK Life Sciences Vision (2021) aims to enhance the pathways from research to market.
The Accelerated Access Collaborative (AAC) aims to facilitate the swift adoption of proven technologies.
The NICE Health Tech Evaluation (HTE) and Early Value Assessment (EVA) aim to establish a connection between evidence generation and expedited NHS access.
Health Innovation Network England (HINE)—the new national body coordinating 15 regional Health Innovation Networks (HINs), formerly known as Academic Health Science Networks (AHSNs).

2. System Architecture: How the Passport Works: How the Innovator Passport Works: MedTech Compass, IDs & Cross-Trust Adoption

The Innovator Passport is integrated into MedTech Compass, a national digital platform hosted in Leeds. Once a product receives validation from one NHS organisation, it is assigned a unique Innovator Passport ID.

All other NHS Trusts and Integrated Care Boards (ICBs) can adopt the technology without repeating assessments, enabling national scalability based on a single verified evidence base.

Governance Framework

Entity	Role
DHSC	The strategy, funding, and policy alignment are focused on the Life Sciences Vision.
NHS England	Clinical governance, national rollouts, policy enforcement
Health Innovation Network England (HINE)	National coordination and stakeholder engagement
Regional HINs	Identify innovations, facilitate validation studies, and liaise with ICBs
MedTech Compass (NHSD Leeds)	Digital infrastructure for validation and evidence sharing
NHS Trusts & ICBs	Validation hubs are conducting clinical, economic, and operational checks.

Authoritative sources:

3. The Scientific Evaluation Framework for reimbursement: Clinical Evidence, RWE, BIA/ICER, DTAC & Governance Sign-off

Each submission to MedTech Compass is scored against structured, evidence-based criteria.

Domain	Evidence Type	Key Requirements	Evaluation Level
Clinical Impact	This includes RCTs, cohort studies, and real-world data (RWD).	Measurable patient benefit (mortality, QoL, LOS)	Level I–III
Economic Value	Cost-consequence, BIA, ICER, QALY	Cost-effectiveness and budget feasibility	Level I–III
Operational Fit	Workflow simulation, interoperability data	Proven ease of adoption and digital integration	Level I–III
Safety & Compliance	MHRA, CE/UKCA, GDPR, DPIA.	Full regulatory and safety conformity	Pass/Fail
Governance Sign-off	CIO, MDSO, Procurement, Exec Board	Official institutional validation	Mandatory

4. Implementation Pathway: Step-by-Step: From HIN Nomination to MedTech Compass Upload & Passport Issuance

Step	Description	Estimated Duration
1. Identify Innovation	The Regional Health Innovation Network (HIN) or the Integrated Care Board (ICB) nominates a specific technology.	1 month
2. Build an evidence pack.	RCTs, RWE, BIA, workflow, usability studies	2 months
3. Trust Assessment	VAC Panel + CIO + MDSO + Procurement review	2 months
4. Upload to MedTech Compass	Structured digital submission	1 month
5. Passport-issued	Unique ID and system visibility	1 month
6. National Adoption	Evidence reused across NHS organisations	2+ months

5. National Rollout Timeline Timeline to National Scale (2025–2027): Milestones & What to Prepare Now

Q3 2025: Policy Announcement
Q4 2025: Technical Specification & Governance Finalisation
Q1–Q2 2026: Pilot Trust Assessments
Q3 2026: MedTech Compass Completion
Q4 2026–Q1 2027: National Rollout
Q2 2027 onward: Enforcement and Scaling

6. Why It Matters: Scientific and Economic Rationale: Why It Matters: Faster Evidence Translation, £ Savings, VBHC & SME Growth

Accelerates translation of science into care — reduces the 17-year evidence adoption lag.
Prevents duplicated assessments, saving the NHS an estimated £700 million annually.
Promotes real-world validation, rewarding innovators for post-market evidence generation.
Aligns with Value-Based Healthcare (VBHC) principles — ensuring measurable outcomes per cost.
Strengthens the UK’s life sciences economy through faster market access for SMEs.

Comparable frameworks include:

Biomarker Qualification (EMA/FDA) for centralised evidence reuse.
AI Algorithm Auditability (NHSX, 2023) ensuring safety and explainability.
Digital Therapeutics Evidence Standards (NICE, 2024) for patient-centric applications.

7. Practical Guide for Companies: Action Plan for Innovators: Build the Evidence Pack, Win VAC, Go National

Engage Early with a HIN or ICB: Identify a regional partner to nominate your innovation.
Develop a Robust Evidence Pack: Include clinical, operational, and economic validation data.
Secure Trust Governance Approval: Gain VAC/Innovation Panel endorsement.
Upload to MedTech Compass: Ensure structured data format compliance.
Plan for National Scale: Use MedTech Compass analytics to monitor adoption and engagement.

8. Common Pitfalls and How to Avoid Them: Top Rejection Reasons & Fixes: Weak BIA, Missing DPIA, Poor Interop, Overclaims

Risk	Mitigation
Weak BIA or Cost Model	Commission NHS-compliant Budget Impact Analyses early
Missing DPIA or MHRA evidence	Engage compliance experts pre-submission
Limited interoperability testing	Validate via FHIR/API data exchange before upload
Overstated clinical claims	Align communications strictly with peer-reviewed data

9. Odelle Technology: Your Partner for Passport Readiness

At Odelle Technology, we specialise in helping medtech, diagnostics, and digital health innovators prepare for Innovator Passport submission and MedTech Compass inclusion.

Our Expertise

Evidence Development & Real-World Studies – Aligning outcomes with NHS decision-maker priorities.
Health Economics & Outcomes Research (HEOR) – Building BIA, CUA, and cost-consequence models.
Governance and Compliance Audits – Ensuring VAC, CIO, and MDSO sign-off readiness.
Digital Submission Structuring – Creating Compass-ready data packs (metadata, CSV/XML templates).
Stakeholder Engagement – Connecting innovators with Trusts, ICBs, and regional HINs.
How to Build a Budget Impact Analysis for NHS Submission
NICE Early Value Assessment (EVA): What Evidence You Need
DTAC Checklist: Data, Cyber & Interoperability for NHS Digital
RWE Design for UK Devices & Diagnostics (2025)

Visit www.odelletechnology.com for NHS and EU reimbursement insights.

Frequently Asked Questions (FAQ)

Q1. What is the NHS Innovator Passport?

The NHS Innovator Passport is a structured framework introduced by NHS England to accelerate the safe, evidence-based adoption of new medical, diagnostic, and digital health technologies. It aligns regulatory clearance, clinical evidence, and reimbursement planning to help innovators reach patients faster.

Q2. Does the Innovator Passport replace NICE evaluations?

No. It complements NICE’s technology appraisal and evidence-based guidance processes. The Passport streamlines pre-NICE engagement, allowing innovators to prepare early evidence and economic models that meet NICE and NHS commissioning requirements.

Q3. Who can apply for the Innovator Passport?

Both SMEs and large MedTech, diagnostic, and digital health companies are eligible. The Passport was designed to make NHS entry more accessible to smaller innovators with limited regulatory or health-economic resources.

Q4. How do companies apply for the NHS Innovator Passport?

Applications are submitted via the MedTech Compass digital platform, managed by NHS England. Innovators complete a structured application outlining their regulatory status, intended use, clinical evidence, economic rationale, and proposed NHS value proposition. Initial screening determines alignment with NHS strategic priorities.

Q5. What information must be included in an application?

To be eligible for assessment under the NHS Innovation Passport or MedTech Compass framework, applicants must submit a comprehensive evidence and documentation package that demonstrates clinical need, patient benefit, safety, and economic value within NHS settings. The submission serves as both a regulatory dossier and a strategic market access plan, allowing NHS England, NICE, and regional decision-makers to evaluate readiness for adoption, reimbursement, and scale-up.

1. Clinical Need and Patient Benefit

Applicants must provide a concise but data-driven summary of:

The unmet clinical need the technology addresses (e.g., diagnostic delay, readmission rates, or workforce inefficiencies).
The application should also outline the target patient population and the expected measurable clinical outcomes, such as mortality reduction, improved mobility, and faster triage.
There is evidence that the technology aligns with the priorities of the NHS Long Term Plan (2025–2035), which include early diagnosis, chronic disease management, and the reduction of health inequalities.

Including NHS burden-of-disease data, or NICE-recognized clinical gap statistics, greatly improves application strength and SEO visibility for healthcare stakeholders searching for “NHS unmet clinical need innovation.”

2. Regulatory Certification and Device Classification

Applicants must confirm the product’s regulatory status:

Valid CE marking (EU MDR/IVDR), UKCA marking, or compliance under MHRA transitional rules (up to June 2030).
Applicants must provide the device classification (e.g., Class I–III or A–D for IVDs) along with the supporting Declaration of Conformity.
Details of the Notified Body or Approved Body, plus UK Responsible Person (UKRP) registration with MHRA.
Regulatory transparency demonstrates readiness for NHS procurement and NICE evaluation.

3. Evidence of Safety, Quality, and Clinical Performance

Applications must include:

Clinical evaluation reports compliant with ISO 14155, ISO 14971, and GCP standards.
Post-Market Surveillance (PMS) and Post-Market Clinical Follow-Up (PMCF) data for CE-marked or UKCA devices.
This includes any available NHS site evaluation data, adverse-event monitoring, or usability assessments.
Demonstrating compliance with MHRA vigilance requirements strengthens credibility and speeds review.

4. Real-World Evidence (RWE) or Clinical Trial Data

The evidence should be contextualised for NHS use:

The NHS should contextualise published or ongoing randomised controlled trials (RCTs), registry studies, or observational RWE datasets.
The data should demonstrate a measurable impact on NHS Key Performance Indicators (KPIs) such as length of stay (LOS), bed occupancy, ED reattendance, or ICB expenditure.
There is evidence to support the quality, reproducibility, and representativeness of the data for UK healthcare populations.

5. Proposed NHS Adoption and Implementation Model

Applicants must define:

The applicant must specify the intended use setting, which could be primary care, secondary care, diagnostics, or community health.
The integration model within NHS pathways must include alignment with HRG codes, ICB commissioning, and year-of-care bundles.
The model has implications for resources such as staffing, workflow impact, and interoperability requirements.
The model has the potential to align with Innovation and Technology Payment (ITP) or Value-Based Procurement (VBP) schemes.

Well-defined adoption models improve evaluation speed and link directly to reimbursement feasibility.

6. Economic and Cost-Impact Evidence

The NHS places significant weight on demonstrating affordability and long-term value:

The NHS uses methods such as Budget Impact Analysis (BIA), Cost-Consequence Modelling (CCM), or ICERs to demonstrate economic efficiency in comparison to the standard of care.
The NHS uses cost tables or ICB-level projections to demonstrate system savings.
There is evidence of a positive impact on workforce capacity, throughput, or a reduction in treatment burden.

7. Data Governance, Cybersecurity, and Interoperability

Strong emphasis is placed on compliance with NHS Digital standards:

DPIA, GDPR compliance statement, and Data Security and Protection Toolkit (DSPT) certification.
Interoperability with NHS systems using FHIR APIs, SNOMED CT, and OpenEHR standards.
Confirmation of ISO 27001 and DCB0129/DCB0160 compliance for clinical risk management.

Digital health and AI-driven innovators should also demonstrate conformance with DTAC and NHS AI Regulation Service readiness.

8. Supporting Attachments and Documentation

Typical appendices include:

Executive summary and abstract
Regulatory certificates and Notified Body documentation
Clinical trial or RWE summary tables
Economic model overview (Excel or PDF)
DPIA, DSPT, and interoperability evidence
Letters of support from NHS sites, AHSNs, or academic collaborators

Q6. What does the application cost?

There is no formal application fee for the passport. However, innovators must fund their evidence generation, data collection, and economic evaluation. Early investment in health-economic modelling, RWE generation, and market-access planning (e.g., via Odelle Technology) significantly improves success rates. The NHS Innovation Passport assessment process typically takes 8 to 16 weeks, depending on the completeness of the submission, quality of clinical and economic evidence, and alignment with NHS strategic priorities. The process is overseen by the MedTech Compass digital platform, which standardises evidence review, stakeholder engagement, and progress tracking.

1. Stage 1 – Application Submission and Triage (Weeks 0–2).

Once submitted via the MedTech Compass portal, applications undergo an initial eligibility and completeness review.

Key checks include regulatory status (UKCA/CE marking), safety documentation, data governance compliance (GDPR, DSPT, DPIA), and readiness for evaluation.
Technologies demonstrating potential NHS benefit — such as addressing workforce efficiency, early diagnosis, or health inequality reduction — advance rapidly.
Incomplete or poorly structured submissions may face early rejection or requests for clarification.

2. Stage 2 – Technical and Evidence Review (Weeks 2–8)

The second phase focuses on clinical, technical, and economic validation:

NICE advisors or NHS evaluators assess the quality of evidence against ISO 14155, GCP, and the NICE Evidence Standards Framework (ESF).
Real-world evidence (RWE) and postmarket data are analysed to confirm clinical effectiveness, safety, and reproducibility.
Health-economic modelling (Budget Impact Analysis, Cost-Consequence Analysis, or ICER assessment) is reviewed for consistency with NHS reference costs, ICB budgets, and HRG tariffs.

During this phase, close alignment with NICE Early Value Assessment (EVA) or HealthTech Evaluation (HTE) frameworks can shorten timelines.

3. Multi-Agency Review and Validation (Weeks 8–12)

At this stage, applications undergo multi-agency coordination:

NHS England’s Digital Transformation Directorate, Health Innovation Network England (HIN), Office for Life Sciences (OLS), and NICE jointly validate findings.
Procurement and commissioning readiness are reviewed to ensure the innovation fits into existing NHS structures— including Integrated Care Board (ICB) payment routes and value-based procurement mechanisms.
If evidence gaps are identified, applicants may be invited to participate in pilot evaluations within NHS Trusts to generate missing data.

4. Stage 4 – Decision, Feedback, and Pathway Mapping (Weeks 12–16)

Successful applicants receive a formal recommendation for onboarding to the NHS Innovation Passport and potential entry into the Innovation Service Directory.
Feedback includes a pathway-to-reimbursement roadmap, outlining future engagement with NICE, ICBs, or NHS Supply Chain.
Technologies that align strongly with NHS Long Term Plan (2025–2035) priorities—such as digital transformation, chronic disease management, and workforce optimisation often proceed faster to pilot or commissioning.

5. Accelerated Pathways

Highly validated innovations addressing national NHS priorities or public-health crises (e.g., antimicrobial resistance (AMR), cancer diagnostics, and AI-based triage) may be fast-tracked, reducing timelines to as little as 6–8 weeks if all regulatory and economic evidence is in place.

⏱️ Typical Timeline Summary

Stage	Duration	Key Milestones
1. Submission & Triage	0–2 weeks	Eligibility check, regulatory & data compliance
2. Evidence Review	2–8 weeks	NICE & NHS evaluation of clinical, RWE, and economic data
3. Multi-Agency Validation	8–12 weeks	Cross-body review with HIN, OLS, MHRA, ICB procurement input
4. Decision & Roadmap	12–16 weeks	Feedback, pilot preparation, reimbursement mapping

Q7. How long does the assessment process take?

Typical timelines range from 8 to 16 weeks, depending on the completeness of the submission and the level of evidence provided. Early alignment with NHS policy priorities and NICE guidance can shorten review times.

Q8. What is the MedTech Compass, and how does it relate to the Passport?

The MedTech Compass is the digital infrastructure underpinning the Passport. It tracks each innovation’s progress from regulatory clearance through clinical evaluation and procurement, ensuring visibility, transparency, and data consistency across the NHS. The NHS MedTech Compass is the central digital infrastructure and data governance platform that underpin the NHS Innovation Passport program. Developed by NHS England’s Digital Transformation Directorate, it provides an end-to-end system for tracking, evaluating, and scaling innovative medical technologies, diagnostics, and digital-health solutions across the NHS in England.

1. Purpose and Core Function

The MedTech Compass is a safe online platform where inventors, NHS Trusts, and evaluators can handle all parts of the innovation process, from getting approval to testing in real-life settings and getting paid for it.
It ensures:

Transparency – every technology’s progress is logged from early evaluation to national rollout.
Data consistency – information is standardised across Integrated Care Systems (ICSs), Health Innovation Networks (HINs), and NHS procurement teams.
Interoperability – alignment with NHS Digital frameworks such as DTAC (Digital Technology Assessment Criteria), FHIR, SNOMED CT, and DSPT standards.

2. Relationship with the NHS Innovation Passport

The MedTech Compass is the digital backbone of the Innovation Passport. It connects innovators directly with:

NICE (Early Value Assessment and HealthTech Evaluation) teams for structured evidence review.
MHRA for regulatory status tracking (CE/UKCA compliance, PMS, PMCF data).
Office for Life Sciences (OLS) for policy alignment under the UK Life Sciences Vision and MedTech Strategy (2023–2030).
Through this linkage, the Passport leverages Compass data to monitor outcomes, measure cost-effectiveness, and inform reimbursement and procurement decisions.

3. Support for Evidence, Reimbursement, and Adoption

The MedTech Compass enables the NHS to:

Integrate real-world performance metrics into NICE HTA and ICB budget impact models.
Track readiness for Innovation and Technology Payments (ITP), Year-of-Care bundles, and Value-Based Procurement pilots.
Provide a national view of technologies progressing from pilot to tariff inclusion, ensuring evidence aligns with HRG, OPCS, and ICD-10 coding frameworks.

4. Benefits for Innovators and the NHS

End-to-end visibility: real-time dashboards showing progress through evaluation, reimbursement, and adoption stages.
Data integrity: harmonised evidence collection across Trusts and ICSs.
Faster market access: integrated sign-off with NICE, NHS England, and regional procurement teams.
Reduced duplication: one digital route replaces multiple disconnected submission processes.

5. Governance and Oversight

The platform is governed jointly by NHS England’s Digital Transformation Directorate, Health Innovation Network England (HIN), Office for Life Sciences (OLS), and NICE, ensuring coherent policy, regulatory, and reimbursement alignment.

Q9. Who governs the MedTech Compass framework?

NHS England’s Digital Transformation Directorate and Health Innovation Network England (HIN) jointly oversee governance, supported by the Office for Life Sciences (OLS) and NICE. This multi-agency model ensures alignment between evidence, reimbursement, and adoption. The NHS MedTech Compass is jointly governed by NHS England’s Digital Transformation Directorate and Health Innovation Network England (HIN), the national organisation connecting regional innovation hubs across the NHS. Oversight and policy alignment are further supported by the Office for Life Sciences (OLS) and the National Institute for Health and Care Excellence (NICE), creating an integrated, multi-agency governance structure.

This coordinated model ensures that:

Innovation evidence, reimbursement, and adoption remain fully aligned across NHS England, NICE, and OLS priorities.
Clinical safety, regulatory compliance, and data governance follow NHS Digital standards and the Data Security and Protection Toolkit (DSPT).
NICE synchronises its Health Technology Assessments (HTA) and Early Value Assessments (EVA) with OLS’s MedTech Strategy and Life Sciences Vision.
Regional Health Innovation Networks (HINs) and Integrated Care Systems (ICSs) serve as delivery partners, facilitating pilots, generating evidence, and promoting system-wide adoption.

By connecting policy, evaluation, and procurement under one governance umbrella, the MedTech Compass framework provides a clear pathway from regulatory approval to real-world deployment and reimbursement integration within NHS payment systems.

Q10. What evidence is required for passport approval?

Applicants must demonstrate clinical safety, effectiveness, and economic value. Accepted evidence includes:

Randomised or controlled studies (ISO 14155-compliant);
Real-world evidence (RWD/RWE) from NHS or registry sources;
Post-Market Clinical Follow-Up (PMCF) data for CE-marked devices;
Comparative economic analyses demonstrating system-wide benefit.

To qualify for the NHS Innovation Passport, innovators must present a robust package of clinical, safety, regulatory, and economic evidence. The goal is to prove that the technology is safe, effective, and cost-efficient in UK healthcare settings— meeting both NICE and MHRA expectations.

1. Clinical Safety and Effectiveness Evidence

Applicants must demonstrate that the product performs safely and effectively compared with the current standard of care. Accepted forms of evidence include:

Randomised controlled trials (RCTs) and prospective clinical studies are compliant with ISO 14155:2020 and ICH-GCP standards.
Comparative observational studies or pragmatic trials conducted in NHS hospitals or integrated-care environments are also acceptable forms of evidence.
Systematic reviews or meta-analyses validate device or diagnostic performance against recognised clinical endpoints.
CE-marked or UKCA-marked device documentation showing conformity assessment, risk-management files, and usability studies.

2. Real-World Evidence (RWE) and Registry Data

The NHS strongly supports UK-based RWE, especially where outcomes relate to length of stay (LOS), readmissions, diagnostic turnaround times, or workforce efficiency.
Examples include:

Registry or audit datasets from NHS Trusts, Integrated Care Systems (ICSs), or Academic Health Science Networks (AHSNs).
Post-market surveillance (PMS) and post-market clinical follow-up (PMCF) data demonstrating performance consistency over time.
Digital-health usage analytics compliant with GDPR, DPIA, and DTAC standards.
Real-world comparator studies show measurable improvements in patient outcomes, accessibility, or cost savings.

3. Health, economic, and Reimbursement Evidence

To support NHS adoption and reimbursement, applicants must demonstrate clear economic value using established modelling frameworks.

Cost-Consequence Analysis (CCA) and Budget Impact Analysis (BIA) mapping savings across ICB or hospital-trust budgets.
Incremental Cost-Effectiveness Ratio (ICER) demonstrating QALY gains aligned with NICE thresholds (£20–30 k per QALY).
Pathway impact models illustrate how the technology alleviates pressure on primary care, ED admissions, or bed utilisation.
Productivity metrics, such as improved clinician throughput, reduced repeat diagnostics, or enhanced population-health outcomes, are key indicators of the technology’s effectiveness.

4. Regulatory and Quality Documentation

Applicants must include:

Evidence of CE/UKCA certification, MHRA registration, and a valid Declaration of Conformity.
Copies of ISO 13485 quality-management certification and relevant biocompatibility, electrical-safety, or cyber-security test reports.
DPIA and Data Security and Protection Toolkit (DSPT) confirmation for digital and AI-enabled systems.

5. Best-Practice Tip for Applicants

High-scoring submissions combine international validation with UK-specific RWE and economic modelling. Collaborating early with NICE, Health Innovation Networks (HINs), or Odelle Technology helps structure evidence to meet NHS tariff, ICB commissioning, and HTA expectations.

Q11. Can companies without a UKCA marking apply?

Yes, if the product holds CE certification under EU MDR or IVDR and meets MHRA transitional rules. However, full UKCA compliance will be required for permanent NHS procurement and reimbursement approval. Yes. Companies without UKCA marking can still apply for the NHS Innovation Passport, provided their technology holds valid CE certification under the EU Medical Device Regulation (MDR 2017/745) or In Vitro Diagnostic Regulation (IVDR 2017/746) and complies with the MHRA’s transitional arrangements. These rules enable continued market access for CE-marked products in Great Britain during the current transition period.

1. Current Regulatory Position (2025–2030 Transition Window)

The MHRA (Medicines and Healthcare Products Regulatory Agency) permits CE-marked devices to remain on the UK market until 30 June 2030 under the transitional framework.
Manufacturers must maintain valid certification from an EU-designated Notified Body, ensuring ongoing post-market surveillance, clinical evaluation, and risk-management documentation.
Devices imported into Great Britain must have a UK Responsible Person (UKRP) registered with the MHRA.

2. When UKCA Marking Will Be Required

While CE marking currently satisfies entry criteria for NHS pilots and early innovation pathways, UKCA marking will be required for:

Permanent NHS procurement, national framework contracts, and sustainable reimbursement inclusion (e.g. HRG tariffs, ICB commissioning, and NICE adoption).
NHS Supply Chain listings or bulk purchasing under the Value-Based Procurement framework.
Digital Health Technologies (DHTs) that undergo NICE evaluation and seek system-wide scale-up.
Applicants are therefore encouraged to begin UKCA transition planning early, aligning with MHRA’s upcoming Future Regulations for Medical Devices guidance.

3. Regulatory Equivalence and Evidence Expectations

During the transition, CE-marked products must still demonstrate:

Technical and clinical equivalence to UKCA-ready standards.
Compliance with ISO 13485, ISO 14971, and ISO 14155 (for clinical investigation).
Valid Post-Market Surveillance (PMS) and Post-Market Clinical Follow-Up (PMCF) data meeting MHRA expectations.
NHS evaluators may request confirmation of conformity documentation, vigilance history, and risk-management reports to ensure patient safety before pilot authorisation.

4. Implications for Reimbursement and NICE Evaluation

Technologies that rely solely on CE marking can:

Participate in NHS Innovation Service pilots, NICE Early Value Assessments (EVA), or Health Innovation Network demonstrations.
Generate UK real-world evidence (RWE) while transitioning to UKCA certification.
However, full UKCA compliance is mandatory for NICE HealthTech Evaluation Programme (HTE) submissions and national tariff reimbursement approval.

5. Best Practice for Non-UKCA Applicants

To strengthen an application, companies should:

Reference alignment with MHRA guidance on international recognition and EU–UK regulatory convergence frameworks.

Provide evidence of CE certification validity, Notified Body audit reports, and PMS/PMCF data.

Identify a UK Responsible Person (UKRP) and confirm MHRA registration status.

Outline a UKCA transition plan, demonstrating intent and timeline for compliance.

Q12. How does the Passport support reimbursement?

The Passport links evidence generation directly to NHS payment frameworks — including Year-of-Care bundles, Innovation Payments, and Integrated Care Board (ICB) funding routes. This ensures that technologies demonstrating measurable clinical and economic benefit can secure sustainable reimbursement. The NHS Innovation Passport is designed not only to accelerate adoption but also to bridge the crucial gap between evidence generation and reimbursement. By aligning clinical data, health-economic evidence, and care-pathway integration with NHS funding structures, the Passport ensures that validated innovations can achieve sustainable, scalable payment mechanisms across the health system.

1. Direct Alignment with NHS Payment Frameworks

The Passport connects innovators with the NHS’s evolving Value-Based Procurement and Payment by Results (PbR) ecosystem, including:

Year-of-Care Payment Bundles: For long-term care models (like diabetes, COPD, and heart disease), this allows technologies that show overall efficiency or cost savings to be included directly in the bundled payments.
Innovation and Technology Payments (ITP): Central NHS England programmes that temporarily reimburse novel technologies while long-term tariff adjustments are being considered.
Integrated Care Board (ICB) Budgets: The Passport supports alignment with ICB commissioning priorities, helping technologies demonstrate savings across population health management, prevention, and urgent-care services.

2. Facilitating Entry into National and Local Tariff Systems

For medical devices, diagnostics, and digital tools, reimbursement depends on correct coding and tariff alignment. The Passport helps innovators link evidence outputs to:

The Passport assists innovators in linking evidence outputs to Healthcare Resource Groups (HRGs) and the National Tariff Payment System (NTPS) for secondary care reimbursement.
OPCS-4 and ICD-10 codes for procedure and diagnostic classification, ensuring hospital activity can be captured and paid.
EBM (Enhanced Service) and QOF (Quality and Outcomes Framework) indicators in primary care, supporting adoption through Primary Care Networks (PCNs).
Community-based reimbursement codes within Locally Enhanced Services (LES) or Integrated Neighbourhood Teams (INTs) for digital or diagnostic tools supporting home or outpatient care.

3. Early Health-Economic Validation

Passport applicants receive feedback from NICE, NHS England, and ICB finance teams on how to structure:

Cost-Consequence Models (CCMs) to show multi-stakeholder benefits (hospital, GP, commissioner).
Budget Impact Analyses (BIA) to quantify financial implications at the system level.
Incremental Cost-Effectiveness Ratios (ICERs) relative to existing care pathways, using NHS reference costs and HRG tariffs.
This early validation shortens the time between clinical validation and payment inclusion.

4. Support for Digital and Diagnostic Reimbursement Routes

For digital health and diagnostics innovators, the Passport aligns evidence with:

Digital Technology Assessment Criteria (DTAC) for data security and interoperability.
NICE Digital Health Technologies (DHT) Evidence Standards Framework, paving the way for local ICB reimbursement or inclusion in procurement frameworks.
The OPCS/HRG groupers’ tariffs for pathology and radiology facilitate the integration of diagnostic innovations into existing payment schedules.
Companion diagnostics and IVDs entering MaaS (Managed Access Agreements) or conditional reimbursement models, where ongoing RWE supports long-term tariff creation.

5. Integration with NHS Procurement and Value-Based Funding

By linking reimbursement readiness with procurement policy, the Passport gives SMEs and innovators visibility in:

NHS Supply Chain catalogues, regional ICS procurement hubs, and value-based procurement pilots.
NHS Commercial Medicines Unit (CMU) and Health Innovation Networks (HINs) for price-volume negotiation.
Innovation service adoption maps, ensuring reimbursement data supports system-wide purchasing and scale-up.

6. Pathway to Sustainable Reimbursement

The ultimate aim of the Passport is to move innovations from short-term pilots or ITP funding into permanent reimbursement streams—through HRG tariff inclusion, ICB-level commissioning, or national tariff adjustments. Technologies demonstrating measurable clinical effectiveness, cost savings, and workforce efficiency can be embedded as standard NHS practice under long-term payment structures.

Q13. What are the benefits for SMEs?

SMEs gain structured access to NHS expertise, pilot opportunities, data partnerships, and early HTA feedback. The Passport effectively reduces entry barriers by connecting innovators to NICE, MHRA, and NHS procurement teams at an earlier stage. Small and medium-sized enterprises (SMEs) are at the heart of the UK Life Sciences Vision and the NHS Innovation Passport programme. The passport offers SMEs a structured, accelerated route into the NHS— helping them navigate complex reimbursement, evidence, and procurement pathways that traditionally block early-stage innovators.

1. Early Engagement with Key NHS and Regulatory Bodies

Through the Passport, SMEs gain direct, coordinated access to:

NHS England and the MedTech Directorate for early pilot identification and evaluation support.
NICE (National Institute for Health and Care Excellence) provides Early Value Assessment (EVA) and health-economic guidance.
MHRA (Medicines and Healthcare Products Regulatory Agency) for regulatory alignment and advice on clinical-evidence expectations under UKCA and EU MDR.
This integrated engagement allows SMEs to align regulatory and reimbursement strategies early, reducing time to adoption.

2. Access to Real-World Testing and Pilot Opportunities

The Passport connects SMEs with Integrated Care Systems (ICSs), NHS Trusts, and Health Innovation Networks (HINs) willing to host real-world evidence (RWE) studies and demonstration pilots.
This helps SMEs:

Validate clinical and economic outcomes in NHS settings.
Generate data for Health Technology Assessment (HTA) and Budget Impact Analysis (BIA).
Strengthen business cases for inclusion in NHS procurement catalogues or ICS innovation pipelines.

3. Health-Economic and Reimbursement Support

Participating SMEs receive early feedback on cost-effectiveness modelling, ICER thresholds, and budget impact — critical for NICE and NHS England approval.
This early insight helps innovators design pricing strategies, reimbursement codes (HRG, CCSD, OPCS), and cost-consequence analyses aligned with ICB (Integrated Care Board) decision frameworks.

4. Improved Data Partnerships and Digital Readiness

The Passport facilitates partnerships that allow SMEs to access NHS datasets, registries, and digital infrastructure (via MedTech Compass).
It also supports alignment with NHS Digital standards, including:

DTAC (Digital Technology Assessment Criteria) for interoperability and cybersecurity.
DPIA and DSPT for patient-data compliance.
FHIR and SNOMED CT for data integration and interoperability.

5. Reduced Market Entry Barriers and Enhanced Credibility

By providing a single-entry route, the Passport simplifies the process of introducing new medical devices, diagnostics, and digital tools into the NHS.
Successful participation gives SMEs:

Recognition as a vetted, NHS-aligned supplier — significantly boosting credibility with both public sector buyers and private investors.

Visibility within the NHS Innovation Service directory, helping secure procurement interest and investor confidence.

Access to innovation funding schemes such as SBRI Healthcare, Innovate UK Smart Grants, and NHS Innovation Accelerator (NIA).

Q14. What role does Odelle Technology play?

Odelle Technology supports innovators through evidence generation, health-economic modelling, and reimbursement strategy — ensuring submissions align with NICE, ICS, and HTA standards. Odelle translates clinical data into the language of NHS decision-making, accelerating adoption and funding approval.

Q15. How is patient data managed within the Innovator Passport process?

The NHS Innovation Passport and NHS Innovation Service both require good management of patient data. All applicants must demonstrate full compliance with the UK General Data Protection Regulation (UK GDPR), the Data Protection Act 2018, and the NHS Data Security and Protection Toolkit (DSPT). The Passport framework ensures that any use of patient information within innovation pilots, registries, or real-world evidence (RWE) programmes meets the highest standards of privacy, transparency, and accountability.

1. Legal and Regulatory Compliance

The UK GDPR and Data Protection Act 2018 set the legal basis for processing personal health data, requiring demonstrable lawful grounds, data minimisation, and purpose limitation.
Before any patient data can be processed, all projects must get a Data Protection Impact Assessment (DPIA) approved by the NHS Trust or Integrated Care System (ICS) that is hosting them.
Where data crosses organisational or regional boundaries, applicants must establish data sharing agreements (DSAs) consistent with NHS digital guidance and information governance (IG) best practices.

2. NHS Information Governance Standards

Compliance with the NHS Data Security and Protection Toolkit (DSPT) is mandatory, confirming that systems, staff, and suppliers meet required cybersecurity and data-handling benchmarks.
For digital health technologies and AI tools, conformity with NHS Digital’s DCB0129 and DCB0160 clinical-risk management standards is required to ensure data integrity and patient safety.
Data storage and processing must occur in environments certified to ISO 27001 or equivalent security standards, with encryption applied both in transit and at rest.

3. Real-World Evidence and Registry Data Governance

When innovators collect real-world evidence (RWE) or add to NHS registries, they must:

Align with NHS Digital or ICS-led data-sharing protocols to safeguard patient confidentiality.
Whenever possible, use pseudonymised or anonymised datasets to minimise the risk of re-identification.
Clearly define data ownership, stewardship, and retention policies in accordance with NHS Information Governance (IG) frameworks.
Provide transparency to patients through consent statements or public notices describing data use, storage duration, and rights to withdraw.

4. Integrated Care System (ICS) Data-Sharing Frameworks

The Passport encourages innovators to partner with Integrated Care Systems (ICSs) that operate secure Shared Care Records (ShCR). These frameworks:

Enable responsible data exchange between primary, secondary, and community care providers.
Support analytics for population health management, outcome measurement, and equity monitoring.
Require all technology partners to adhere to NHSX Information Governance Principles and Digital Health and Care Wales/NHS England interoperability standards (e.g., FHIR and SNOMED CT).

5. Best Practice for Innovators

To strengthen an application, innovators should:

Include evidence of DSPT completion, DPIA approval, and cybersecurity certifications.
Demonstrate integration with ICS data environments or NHS-approved cloud providers.
Provide a Data Governance Statement outlining data flows, anonymisation processes, and patient-consent mechanisms.
Reference adherence to GDPR Article 9(2)(j) for scientific research and Article 32 for security of processing.

Q16. What are common reasons for application rejection?

Rejections often stem from insufficient evidence, unclear NHS value propositions, poor data governance, or a lack of alignment with NHS priorities such as workforce optimisation, chronic disease management, or health inequalities. Applications to the NHS Innovation Service, NICE Early Value Assessment (EVA), or Innovator Passport programmes are frequently rejected or delayed due to a combination of scientific, economic, and operational shortcomings. Common reasons include:

Lack of alignment with key evaluation domains such as clinical effectiveness, safety, usability, adoption feasibility, and system benefit.

Insufficient or Weak Clinical Evidence

Lack of peer-reviewed studies, real-world evidence (RWE), or comparative data against standard of care.

Over-reliance on pilot or single-site data that fails to demonstrate scalability or generalisability across NHS settings.

Unclear NHS Value Proposition

Failure to clearly articulate how the technology delivers measurable benefits in line with NHS Long Term Plan priorities — such as reduced bed occupancy, improved patient throughput, or enhanced health equity.

Absence of clear links between clinical outcomes and financial impact (e.g., cost savings, productivity gains, or workforce efficiencies).

Poor Data Governance and Interoperability

There is a lack of adherence to the NHS Data Security and Protection Toolkit, DCB0129/DCB0160 clinical safety standards, and the GDPR requirements.

Lack of integration capability with EHR systems (e.g., EMIS, Cerner, Epic) or poor data flow documentation.

Limited Health Economic Modelling

Incomplete Budget Impact Analysis (BIA) or Cost-Consequence Modelling (CCM) that fails to quantify savings to commissioners or providers.

Ignoring the importance of regional Integrated Care Board (ICB) budget frameworks and cost-pressure reporting.

Lack of Alignment with NHS Strategic Priorities

Technologies that do not support the NHS’s 10-Year Plan objectives, such as workforce optimisation, chronic disease management, population health, or health inequalities reduction.

Weak connection to policy initiatives like Value-Based Procurement, Digital Health and Care Plan (2024), or the Innovation for a Purpose framework.

Inadequate Stakeholder Engagement

Failure to demonstrate early engagement with ICS/ICB decision-makers, Health Innovation Networks (HINs), or AHSNs (Health Innovation England).

Lack of clinician champions or patient-reported outcomes (PROs) supporting adoption.

Regulatory or Classification Gaps

Misalignment between MHRA regulatory status and claimed indications (e.g., absence of UKCA/CE marking for intended use).

Missing documentation around post-market surveillance, PMCF/PMCFR plans, or safety risk assessments.

Poor Application Quality or Narrative Structure

Unclear writing, missing attachments, inconsistent terminology, or poor mapping to the NHS template structure.

Q17. How does the Passport align with NHS Long Term Plan priorities?

The Passport supports digital transformation, earlier diagnosis, and integrated care – key pillars of the NHS Long Term Plan (2025–2035). It prioritises innovations that improve productivity, reduce wait times, and deliver measurable health gains for the population. The NHS Innovation Passport is strategically aligned with the NHS Long Term Plan (2025–2035) and the NHS Digital Health and Care Strategy, ensuring that innovations contribute directly to the system’s key transformation pillars: digital transformation, early diagnosis, integrated care, and workforce sustainability.

1. Driving Digital Transformation

The Passport accelerates adoption of digital health technologies, AI-driven diagnostics, and remote monitoring platforms that improve productivity and efficiency across NHS care pathways.
It supports the NHS’s ambition to create a digitally connected healthcare ecosystem, interoperable with Electronic Health Records (EHRs) such as EMIS, Cerner, Epic, and SystmOne, enabling seamless data sharing, population health analytics, and evidence-based decision-making.

2. Supporting Earlier Diagnosis and Preventive Care

Aligned with the Early Diagnosis and Prevention Framework, the Passport favours technologies that detect diseases sooner, reduce unnecessary hospital admissions, and promote proactive care for conditions such as cardiovascular disease, cancer, diabetes, respiratory illness, and mental health.
Innovations that shorten diagnostic turnaround times or enhance triage accuracy are prioritised for evaluation and potential scale-up.

3. Advancing Integrated and Personalised Care

Integration across Integrated Care Systems (ICSs) and Integrated Care Boards (ICBs) is central to the NHS Long Term Plan. The Passport enables cross-sector collaboration between primary care, secondary care, and community services, fostering data-driven continuity of care and reducing fragmentation.
Technologies supporting personalised medicine, patient-reported outcome measures (PROMs), and shared decision-making fit directly within this model.

4. Boosting Productivity and Workforce Capacity

The Passport champions innovations that deliver measurable efficiency gains — reducing waiting lists, streamlining clinical workflows, and freeing up clinician time through automation, virtual triage, and AI-assisted documentation.
By addressing NHS workforce pressures, it contributes to sustainable service delivery and value-based healthcare outcomes.

5. Reducing Health Inequalities and Improving Population Health

A major long-term plan objective is to tackle regional and socioeconomic health disparities. The Passport encourages adoption of technologies proven to improve access, especially in underserved communities, and those that demonstrate measurable population health impact.

Q18. Can academic innovators or NHS trusts apply?

Yes. Academic institutions, NHS Trusts, and spin-outs developing regulated innovations can apply either independently or in partnership with industry. We particularly encourage collaborations that combine clinical leadership with industrial scalability. Yes. The NHS Innovation Passport actively welcomes applications from academic institutions, NHS Trusts, Integrated Care Systems (ICSs), and spin-outs developing regulated healthcare innovations. The initiative is designed to accelerate the translation of research and early-stage technologies into scalable solutions that deliver measurable value across the NHS.

1. Eligible Applicants

Universities and Academic Health Science Centres (AHSCs) conduct translational research, clinical validation, or early-stage trials.
NHS Trusts, Foundation Trusts, and ICSs implementing new digital, diagnostic, or therapeutic technologies in real-world settings.
University spin-outs and SMEs bringing AI-driven diagnostics, digital therapeutics (DTx), MedTech, or in-vitro diagnostics (IVDs) to market.
Joint academic–industry collaborations seeking to co-develop evidence, generate real-world data (RWD), and test business models for NHS scale-up.

2. Benefits for Academic and Clinical Applicants

Accelerated pathway to NHS adoption: Successful applicants can access centralised evaluation support through NICE, NHS England’s Innovation Service, and Health Innovation Networks (HINs).
Projects receive help in gathering evidence by using NHS data, real-world evidence frameworks, and early guidance on health economics to improve future submissions for health technology assessments or the list of products for patient reimbursement.
Visibility and credibility: Recognition via the Passport enhances institutional reputation, attracting further funding, partnerships, and cross-regional adoption.

3. Encouraged Collaboration Models

We particularly prioritise applications that combine clinical leadership, academic rigour, and industrial scalability.
Examples include:

Examples include the implementation of co-development pilots between NHS Trusts and MedTech firms.
University–industry partnerships validating AI algorithms using NHS datasets.
Integrated clinical trials where academic units lead study design while industry partners manage regulatory and commercial execution.

4. Alignment with NHS Research and Innovation Strategy

The Passport supports the NHS Research and Innovation for Improvement and Growth Framework (2024), promoting closer ties between academia, the NHS, and the life sciences sector.
It underpins the government’s UK Life Sciences Vision, which calls for faster translation of academic discoveries into NHS practice— particularly in priority areas such as cancer, cardiovascular disease, mental health, antimicrobial resistance (AMR), and digital health integration.

Q19. Is international evidence accepted?

Yes, provided it meets recognised regulatory and methodological standards (ISO14155, GCP, or equivalent). However, the NHS prioritises UK-based real-world evidence and economic models that reflect domestic care pathways and tariff structures. Yes. The NHS Innovation Passport and NICE Early Value Assessment (EVA) will consider international clinical and real-world evidence (RWE) as long as the studies meet accepted regulatory and methodological standards like ISO 14155 (Good Clinical Practice for medical device trials), ICH-GCP, or similar guidelines.

However, while global data can support safety and performance claims, UK-specific evidence remains essential for demonstrating system relevance, economic value, and real-world impact within NHS care pathways.

1. Accepted Forms of International Evidence

Peer-reviewed clinical studies conducted in the EU, US, or OECD countries adhere to recognised ethical and regulatory standards.
Data from post-market surveillance (PMS) or post-market clinical follow-up (PMCF) collected according to EU MDR or FDA 21
Health-economic evaluations (like cost-utility or cost-consequence analyses) that use widely accepted methods such as CHEERS 2022 or

2. How International Data Should Be Adapted for NHS use.

To maximise acceptability, international evidence should be contextualised for the UK market by:

We should map foreign clinical pathways to their equivalents in the NHS, such as translating US outpatient workflows into NHS community or integrated-care models.
Adjusting cost parameters to reflect NHS reference costs, HRG/DRG tariffs, and ICB budgets.
The process involves referencing NICE or NHS England clinical guidelines to demonstrate alignment with current UK practice standards.
Validating data quality and reproducibility in line with NHS Digital and MHRA data governance requirements.

Example:
If a diagnostic device has been validated in German university hospitals under ISO 14155, the applicant should present supplementary data demonstrating how those outcomes translate to NHS laboratories, turnaround times, and cost structures (e.g., comparing InEK DRG to NHS GHS tariff models).

3. When International Evidence Alone Is Not Enough

Applications based solely on foreign data often fail when they lack:

Engagement with NHS sites, Health Innovation Networks (HINs), or Integrated Care Systems (ICSs) for validation.
Adaptation of outcomes to UK population health needs, e.g., differences in disease prevalence, comorbidities, or health inequalities.

4. Best Practice: Combine Global and UK Real-World Evidence

The strongest submissions blend international validation with UK-based pilot data, ensuring both scientific credibility and NHS relevance. This dual approach supports subsequent NICE HealthTech Evaluation or Early Value Assessment (EVA), strengthening reimbursement and adoption potential.

Q20. Where can innovators find further guidance?

Detailed guidance is available via the NHS England MedTech Compass portal and the Office for Life Sciences website. For tailored strategic, regulatory, and reimbursement support, innovators can contact Odelle Technology, specialists in evidence generation and NHS market access. Innovators seeking to navigate the NHS Innovation Passport, NICE Early Value Assessment (EVA), or wider NHS market-access pathway can access a range of official and expert resources that provide technical, regulatory, and strategic guidance.

1. Official NHS and Government Resources

NHS England – MedTech Compass Portal
The MedTech Compass is the NHS’s central digital platform for innovators. It offers:
- Application forms and templates for the NHS Innovation Service and Innovation Passport.
- Step-by-step guidance on evidence requirements, regulatory readiness, and adoption pathways.
- Access to resources on DTAC (Digital Technology Assessment Criteria), DCB0129/0160 clinical safety standards, and data governance frameworks.
- Contact channels for regional Health Innovation Networks (HINs) and Integrated Care Systems (ICSs) supporting local pilots.
Office for Life Sciences (OLS)
The Office for Life Sciences provides policy and funding guidance for MedTech, digital health, and diagnostics.
- Information on innovation programmes such as the NHS Innovation Accelerator (NIA), Small Business Research Initiative (SBRI Healthcare), and Life Sciences Vision.
- Updates on national priorities, including value-based procurement, AI in healthcare, and UK Life Sciences Investment Zones.
NICE (National Institute for Health and Care Excellence)
- Guidance on HealthTech Evaluation, Digital Health Evaluation, and Evidence Standards Framework (ESF).
- Access to NICE advice services for early scientific engagement and evidence mapping.
- Current MedTech Innovation Briefings (MIBs) and EVA guidance documents relevant to diagnostics, digital tools, and medical devices.

2. Regional and Academic Support Networks

Health Innovation Networks (HINs) / Health Innovation England – regional bodies that connect innovators to NHS sites for evaluation and adoption.
Academic Health Science Networks (AHSNs) and NIHR MedTech and In Vitro Diagnostics Co-operatives (MICs) – offer support with study design, evidence generation, and clinical validation.
Catapult Centres (e.g., HealthTech Catapult, Digital Catapult) – provide regulatory testing environments and support for data interoperability and cybersecurity readiness.

3. Expert Consultancy Support for Evidence and Market Access

For innovators requiring tailored strategic support across evidence generation, health-economic modelling, and reimbursement, Odelle Technology provides end-to-end guidance.
Odelle specialises in:

Designing real-world evidence (RWE) programmes for NHS and NICE submissions.
Odelle specialises in the development of cost-consequence, budget impact, and cost-utility models that are in line with UK tariff structures and ICB/ICS decision frameworks.
Advising on reimbursement coding (HRG, CCSD, OPCS/ICD-10), pricing strategy, and adoption readiness.
Aligning innovations with NHS Long Term Plan (2025–2035) priorities and value-based healthcare objectives.

Contact Odelle Technology for expert guidance:
www.odelletechnology.com | ✉️ info@odelletechnology.com

11. Glossary of Terms

AHSN – Academic Health Science Network
Regional innovation organisations that identify, evaluate, and scale health technologies across England. Now integrated into Health Innovation Network England (HINE) to align innovation with NHS priorities and accelerate evidence-based adoption.

AMR – Antimicrobial Resistance
A global health challenge and NHS strategic priority. Many diagnostics and digital tools supported by the Innovator Passport aim to reduce inappropriate antibiotic use and strengthen AMR stewardship.

BIA – Budget Impact Analysis
A key health-economic model assessing the financial consequences of adopting a technology within the NHS. Required for reimbursement submissions and integral to NICE and ICB decision-making.

CCG – Clinical Commissioning Group (Legacy)
Replaced by Integrated Care Boards (ICBs) in 2022. Still referenced in older guidance and cost-impact models; ICBs now hold commissioning power for NHS innovation funding.

CCSD – Clinical Coding and Schedule Development Group
The private-sector equivalent of NHS coding governance, relevant for technologies entering independent healthcare reimbursement pathways in the UK.

CE / UKCA Marking
Regulatory conformity marks showing compliance with EU MDR or UK MDR safety, performance, and quality standards — essential before applying for the Innovator Passport or NHS procurement.

CER – Clinical Evaluation Report
A core regulatory document summarising clinical data for medical devices. It feeds into Post-Market Clinical Follow-Up (PMCF), NICE submissions, and RWE generation plans.

CIO – Chief Information Officer
Senior NHS executive responsible for digital infrastructure, cybersecurity, and data compliance. Often a key stakeholder during MedTech Compass onboarding and digital-health integrations.

CNIL – Commission Nationale de l’Informatique et des Libertés
France’s data-protection authority. Mentioned frequently in European RWE contexts and in Odelle’s multi-country strategies for data governance alignment.

CPP – Comité de Protection des Personnes
French ethics committee overseeing clinical studies. Included for innovators conducting multi-jurisdiction PMCF in France alongside NHS adoption.

DAF – Digital Assessment Framework
The NHS England framework that evaluates digital technologies for interoperability, cybersecurity, usability, and data protection — linked to MedTech Compass and DTAC compliance.

DPIA – Data Protection Impact Assessment
Mandatory under UK GDPR for processing patient data. Required for all digital health tools or registries included in the Innovator Passport or MedTech Compass submission.

DTAC – Digital Technology Assessment Criteria
National baseline standards for digital-health adoption in the NHS, covering clinical safety, cybersecurity, interoperability, and usability. All MedTech Compass innovations must meet DTAC before procurement.

EBM – Evidence-Based Medicine
The scientific foundation of the Innovator Passport: combining clinical data, RWE, and economic analysis to guide NHS adoption decisions.

EMA – European Medicines Agency
The EU body responsible for medicine regulation. Its RWE guidance influences how post-market data are collected and interpreted in NHS and UKCA contexts.

G-DRG – German Diagnosis-Related Group System
Germany’s hospital reimbursement model. Included for innovators seeking European market comparisons in Odelle Technology’s reimbursement analyses.

GDPR – General Data Protection Regulation (UK GDPR)
The legal framework governing personal data use. All Innovator Passport and MedTech Compass data submissions must comply with GDPR principles and NHS Data Security Standards.

HAS – Haute Autorité de Santé
The French health-technology assessment (HTA) agency. Relevant for EU-wide innovators aiming to expand from the NHS pathway into continental reimbursement frameworks.

HIN – Health Innovation Network
Regional bodies (formerly AHSNs) that help identify, evaluate, and spread promising innovations across local NHS systems.

HINE – Health Innovation Network England
The national coordination of all HINs, providing strategic oversight of innovation, evaluation, and adoption under NHS England’s MedTech Compass programme.

HTA – Health Technology Assessment
A multidisciplinary evaluation of clinical effectiveness, safety, cost-effectiveness, and organisational impact. HTA alignment is central to NICE appraisals, Innovator Passport success, and NHS reimbursement.

ICB – Integrated Care Board
Regional NHS commissioning bodies responsible for funding and implementing innovations. ICBs evaluate Budget Impact Analyses (BIAs) and determine whether technologies progress from pilot to routine use.

ICER – Incremental Cost-Effectiveness Ratio
A key output of cost-utility analysis expressing the additional cost per Quality-Adjusted Life Year (QALY) gained. Used by NICE and ICBs to assess economic value.

ICS – Integrated Care System
Partnerships between NHS organisations, local authorities, and voluntary groups to deliver joined-up care. ICSs are often the first adopters of technologies approved under the Innovator Passport.

IFU – Instructions for Use
Regulatory document defining a device’s intended purpose and safe operation. Updates to the IFU often stem from Post-Market Clinical Follow-Up (PMCF) results.

LOS – Length of Stay
A hospital-based outcome measure used in BIAs and RWE analyses to quantify efficiency gains or cost savings associated with new technologies.

MDSO – Medical Device Safety Officer
A nominated NHS professional overseeing device safety incidents and compliance. MDSOs frequently support MedTech Compass risk assessments and safety reporting.

MHRA – Medicines and Healthcare Products Regulatory Agency
UK regulatory authority responsible for licensing medicines and medical devices. Its collaboration with NICE and NHS England underpins the Innovator Passport’s validation framework.

MDR – Medical Device Regulation (EU) 2017/745
European legislation governing medical device safety and performance. CE-marked devices under MDR can enter the UK via MHRA transitional arrangements before UKCA certification.

NICE – National Institute for Health and Care Excellence
The UK’s leading HTA authority, assessing the clinical and cost-effectiveness of health technologies. The Innovator Passport interfaces directly with NICE’s Early Value Assessment (EVA) and HealthTech Evaluation (HTE) programmes.

OLS – Office for Life Sciences
Joint UK Government–NHS initiative that funds innovation and coordinates policies for life-science growth, including the Innovator Passport and MedTech Compass.

PMCF – Post-Market Clinical Follow-Up
A regulatory process under EU MDR and UK MDR ensures ongoing safety and performance monitoring for medical devices in real-world use. PMCF data often feed NHS RWE submissions.

QALY – Quality-Adjusted Life Year
A measure of health outcome combining life expectancy and quality of life. Used by NICE and NHS England to determine cost-effectiveness thresholds for technology reimbursement.

RWE – Real-World Evidence
Clinical evidence derived from real-world data (RWD) such as electronic health records, registries, or claims databases. A cornerstone of the Innovator Passport’s evidence-generation model.

RWD – Real-World Data
Raw, patient-level information collected outside controlled trials. Structured and analysed to produce RWE supporting regulatory and reimbursement decisions.

VAC – Value and Access Committee
Internal NHS or industry body evaluating whether an innovation demonstrates sufficient value-based healthcare (VBHC) outcomes to justify reimbursement and adoption.

VBHC – Value-Based Healthcare
A healthcare model focusing on outcomes that matter to patients relative to cost. The Innovator Passport integrates VBHC principles to prioritise technologies that improve quality and efficiency.

Year-of-Care Tariff (YOC)
A bundled payment model covering a full care pathway rather than isolated procedures — used in NHS reimbursement of chronic disease and digital health innovations.

ZIN – Zorginstituut Nederland
The Dutch HTA body is included to highlight European parallels with the NHS Innovator Passport in evaluating evidence and cost-effectiveness.

12. References (Harvard Style)

Department of Health and Social Care (DHSC), 2025. Innovator Passports set to accelerate cutting-edge NHS care. [online] Available at: https://www.gov.uk/government/news/innovator-passports-set-to-accelerate-cutting-edge-nhs-care [Accessed 3 Nov 2025].

Digital Health, 2025. DHSC to launch Innovator Passport to accelerate tech adoption. [online] Available at: https://www.digitalhealth.net/2025/07/dhsc-to-launch-innovator-passport-to-accelerate-tech-adoption/ [Accessed 3 Nov 2025].

Health Innovation Network England, 2024. New HIN structure to deliver innovation at scale. [online] Available at: https://www.healthinnovationengland.org.uk [Accessed 3 Nov 2025].

HTWorld, 2025. NHS to introduce passport for medical tech adoption. [online] Available at: https://www.htworld.co.uk/news/digital-health/nhs-to-introduce-passport-for-medical-tech-adoption/ [Accessed 3 Nov 2025].

Mantra Systems, 2025. A New Era for NHS Innovation: Innovator Passports. [online] Available at: https://mantrasystems.com/articles/innovator-passports-cut-red-tape-and-speed-up-access-to-medtech [Accessed 3 Nov 2025].

NHS Confederation, 2025. NHS welcomes new Innovator Passports. [online] Available at: https://www.nhsconfed.org/news/nhs-confederation-welcomes-new-innovator-passports [Accessed 3 Nov 2025].

Porter, M.E. and Teisberg, E.O., 2020. Redefining Health Care: Creating Value-Based Competition on Results. Harvard Business Review Press.

Author:
Steven Haken – Managing Director, Odelle Technology
📍 www.odelletechnology.com

#NHSInnovation #HealthTech #MedTechCompass #HealthInnovationNetwork #DigitalHealth #ValueBasedHealthcare #NICE #RWE #HEOR

External Resources

NICE HealthTech Evaluation Programme

NHS England – Innovation and Technology

Health Innovation Network England – National Portal

UK Government Life Sciences Vision

MHRA Medical Device Regulatory Updates

Key Statistics

Average NHS innovation adoption time: 17 years (The Health Foundation, 2023)
Annual duplication cost in NHS procurement: ~£700 million
Estimated time saved with Innovator Passport: 8–12 months per technology
Target national rollout completion: Q2 2027

How to win an NHS Innovator Passport.