Architecture design + Sprint 0 delivery. Fixed price. 4–5 weeks.
Connecting to EU EHR systems via FHIR R4/R5 is deceptively complex. Authentication flows, EU IPS profiles, GDPR consent frameworks and European Health Data Space requirements all interact in ways that stall engineering teams who haven't done it before.
Integration blockers this package removes:
No FHIR architecture — ad-hoc integration leads to GDPR / EHDS compliance gaps
SMART on FHIR auth flows misunderstood — EU EHR access fails on first attem
GDPR Article 9 special category data and consent not designed in from the start
EU IPS / base profile mapping done incorrectly — downstream data quality issues
Architecture scope — what we design and build in this engagement
FHIR Data Model & Resource Mapping
FHIR R4/R5 Architecture Design
FHIR resource selection and profile mapping (Patient, Observation, Encounter, MedicationRequest, DiagnosticReport, DocumentReference)
EU International Patient Summary (EU IPS) profile mapping
European Health Data Space (EHDS) secondary use alignment
Custom resource extensions where standard profiles don't cover your use case
Smart on FHIR & Authentication
SMART on FHIR Auth Architecture
SMART on FHIR v1/v2 launch sequences (EHR launch, standalone launch)
OAuth 2.0 / OpenID Connect scopes — patient-level and system-level
EU EHR vendor registration (Epic EU, Intersystems HealthShare, Agfa ORBIS), Token refresh, session management, and secure credential storage design
GDPR - Compliant Data Architecture
GDPR / Special Category Data Architecture
Special category health data classification (GDPR Article 9)
GDPR-compliant cloud infrastructure — EU data residency (AWS EU, Azure EU, GCP)
Consent management design — explicit consent flows for FHIR data access
Audit logging — FHIR AuditEvent, IHE ATNA, and NIS2 access trail
EHR Connectivity & Sprint 0
EHR Integration & Sprint 0 Delivery
Epic EU FHIR sandbox connection and test environment setup
Intersystems HealthShare / Agfa ORBIS FHIR endpoint configuration
Sprint 0: working FHIR client — read/write to at least one EHR endpoint
Engineering team handover: runbooks, ADRs, and integration test suite
What you receive at the end of the engagement
FHIR Architecture Blueprint
Full architecture document covering FHIR resource design, SMART auth flows, GDPR data handling patterns, and EU EHR connectivity decisions. Includes ADRs (Architecture Decision Records) for every major technical choice.
Working Sprint 0 Codebase
A running FHIR integration codebase — authenticated connection to at least one target EHR (Epic or Cerner), with read/write for key resources, full test suite, and CI/CD pipeline ready for your team to extend.
GDPR Data Architecture Document
Special category data classification, GDPR-compliant cloud architecture diagram, consent management design, audit logging, and EU data residency decisions — ready for your DPO, legal team, and enterprise customer review
Engineering Runbooks & Handover
Step-by-step integration runbooks, SMART on FHIR launch sequence diagrams, environment setup guides, and a 60-minute technical handover session with your engineering leads.
We need 30 minutes to explore how to accelerate your project.
Lock in your assessment.
Pricing — fixed fee with 20% discount
Standard Package
EUR 21,500/ Standard Price
€17,200
Package Scope
FHIR R4/R5 resource design and EU IPS / EU base profile mapping
SMART on FHIR v1/v2 auth architecture (Epic / Cerner /standalone)
GDPR-compliant cloud data architecture and special category data design
Social media management
EHR sandbox setup + working Sprint 0 codebase delivery
Architecture Blueprint, GDPR document, runbooks and handover session
Engagement details
Typical timeline
Kick-off, EHR sandbox access, architecture scoping
FHIR resource design, SMART auth architecture, GDPR data model
Sprint 0 development — EHR connection + core resource CRUD
Integration testing, runbook authoring, GDPR doc preparation
Final review, handover session, CI/CD pipeline handoff
Who this is for
Digital health companies integrating with EU EHR systems via FHIR
Health data platform teams building for European Health Data Space (EHDS)
CROs and hospital/clinic integration teams new to FHIR R4/R5
Companies preparing for EU interoperability mandates (XDS, IHE, EHDS)
Medtech and digital therapeutics teams needing EHR data access for MDR Art. 83
Terms
All prices are fixed fees excluding VAT.
Every engagement includes:
30-min discovery call
Written scope
Senior QA/RA review
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