87% of European Digital Health Startups Will Fail the EHDS Test — Unless They Master This New 6-Layer Data Stack
By late 2025, Europe’s digital health landscape will be transformed by one regulation: the European Health Data Space (EHDS).
The numbers are brutal:
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87% of EU digital health startups are not EHDS-ready (2025 GovTech Observatory)
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Only 12% can provide compliant secondary-use data pipelines
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More than €30B in RWE & AI funding will depend on EHDS compatibility
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Regulators, hospitals, and payers will increasingly buy only EHDS-ready solutions
Founders who don’t understand this new system will stall at:
❌ procurement
❌ reimbursement
❌ clinical adoption
❌ AI deployment
❌ cross-border expansion
❌ investor readiness
But founders who master the stack will scale faster than ever before.
Below is the EHDS Partner Stack 2025 — the full ecosystem you must align with to stay competitive.
🔷 THE EHDS-READY 6-LAYER DATA STACK (Europe 2025)
This stack represents the real pipeline behind every scalable digital health or AI product in Europe.
Each layer solves a critical bottleneck.
1️⃣ Public Data Nodes
The national & EU infrastructures that broker secure secondary-use data.
Think of these as the “data airports” where health data is checked, validated, filtered and authorised for research & innovation.
Includes:
HealthData@EU, Findata, Health Data Hub (France), Germany’s FDZ, Danish Health Data Authority, HDR UK, ELIXIR, BBMRI, EHDEN, CINECA Virtual Platform, plus additional new bodies like Sciensano, HIQA, MyHealth@EU, Estonian EHIF, Swedish Socialstyrelsen, etc.
Why this layer matters
If your startup wants to use real-world data for AI, evidence, or payer pilots… THESE are the gates you must pass through.
Founder Framework: The “Data Flight Path”
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Discover → 2. Request → 3. Harmonize → 4. Analyze → 5. Publish → 6. Reuse
Most founders fail because they attempt step 5 before mastering steps 1–4.
2️⃣ RWE Analytics
Platforms turning fragmented EU data into evidence payers and regulators trust.
This is the commercial heart of EHDS.
Includes:
IQVIA, Aetion, Flatiron, ICON, Clinerion, TriNetX, BC Platforms, Owkin, LynxCare, Arcturis, Medexprim, Aidence, Tempus, Kheiron, etc.
Why this layer matters
Payers now demand cost avoidance models, comparative effectiveness, and population-level outcomes — not just clinical studies.
Founder Framework: “Evidence-to-Access Loop”
Evidence → Economics → Adoption → More Evidence
The faster you cycle through this loop, the faster you scale.
3️⃣ Privacy Tech
The compliance engines: synthetic data, de-identification, PETs.
Includes:
VEIL.AI, MDClone, Statice, MOSTLY AI, Hazy, Gretel, Private AI, Enveil, Duality, Protopia AI, Privitar, etc.
Why this layer matters
GDPR + EHDS + AI Act = the strictest data regime in the world.
If your data layer isn't compliant, your entire product is non-deployable.
Founder Framework: “Privacy by Computation”
Stop hiding data — compute on privacy-preserved versions instead.
The startups that get this right win pharma deals, payer contracts, and hospital integrations faster.
4️⃣ Consent & ID
The gateway to lawful, user-approved data mobility.
Includes:
OneTrust, Usercentrics, Securiti, Cassandra, Gaine, VIDchain, EUDI Wallet, Signicat, Freja eID, ZealiD, Meeco, TrustBuilder, IDnow, etc.
Why this layer matters
EHDS requires fine-grained consent, traceable provenance, and cross-border identity verification.
Without clean consent + identity management, you lose:
⚠️ RWE access
⚠️ payer reimbursement
⚠️ hospital procurement
⚠️ AI deployment approval
Founder Framework: The “Consent Spine”
A single system-of-record for all permissions that your product enforces everywhere.
5️⃣ Cohort Platforms
Where researchers and companies actually “shop” for compliant cohorts.
Includes:
Longenesis, Sano Genetics, OpenTargets, EGA, iReceptor, Monda Marketplace, DARWIN EU, Lifebit, DataLoch, Medexprim Marketplace, Seqera Labs, Decode Iceland, etc.
Why this layer matters
If you want evidence fast, this is where your patients, datasets, and phenotypes come from.
Founder Framework: “Cohort Velocity”
Recruit → Link → Analyze → Scale
Your growth depends on how fast you move from idea → cohort → evidence.
6️⃣ Interop Engines
The “plumbing” that connects everything inside hospitals & national systems.
Includes:
Epic, Dedalus, InterSystems, Cerner/Oracle, Better, Tietoevry, Lyniate, Redox, Smile Digital Health, Alcidion, Enovacom, Cambio, Meona, NextGate, Doctolib Data Layer, etc.
Why this layer matters
EHDS is useless if your product cannot plug into:
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national health systems
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hospital EHRs
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FHIR pipelines
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exchange networks
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patient identity systems
Founder Framework: “Integration-to-Revenue Pathway”
Integration → Workflow Fit → Clinical Adoption → Billing → Scale
Integration is not engineering. Integration is distribution.
THE GROWTHVYBZ FRAMEWORK: “EHDS-Ready in 30 Days”
Founders don’t need another 80-page regulation.
They need a system.
Here’s the proprietary 4-step process I use with clients:
1. Map Your EHDS Position
Which category are you in? Where are your risks? Who are your missing partners?
2. Build Your Data & Compliance Spine
Privacy, consent, interop, evidence… mapped into one operating system.
3. Create Your Evidence-to-Revenue Model
How your product generates clinical ROI, operational ROI, and payer ROI.
4. Partner Acceleration Engine (30 Days)
Warm intros + partner targeting across:
✔️ data nodes
✔️ RWE platforms
✔️ hospitals
✔️ payers
✔️ pharma
✔️ cohort hubs
This is where founders win the market.
EHDS-Ready Data & RWE Stack — Startup Readiness Calculator
Score your 6-layer EHDS stack, identify gaps in data, privacy, consent, cohorts & interoperability — and generate a summary you can paste into your deck or investor memo.
1) Startup Footprint
2) 6-Layer EHDS Stack Status
3) Actions
EHDS Readiness Snapshot
Need an EHDS-Ready Go-To-Market & Evidence System?
🔥 WHY THIS MATTERS
Most digital health teams lack:
❌ clarity on the EHDS stack
❌ the right partners
❌ a commercialization model
❌ technical–regulatory alignment
❌ a data-to-revenue framework
I help founders:
✔️ Identify their EHDS category
✔️ Build their evidence generation engine
✔️ Plug into the right partners
✔️ Create investor-ready ROI dashboards
✔️ Accelerate commercialization inside Europe
That’s the missing link.
And it’s where GrowthVybz gives founders a 10x advantage.
📞 If you want your product to be EHDS-ready — and commercially unstoppable — let's talk.
I take on 2 new clients per month for EHDS commercialization strategy, partner mapping, and evidence frameworks.
