# HEALTH & DIGITAL EXPERTISE — Health & Digital Expertise | Health Factory

Canonical URL: https://healthfactory.io/en/expertise-health-digital/

> **BLUF Executive Summary** : Our Digital Health Expertise practice guides manufacturers, hospitals, and startups through medical-grade software architecture, French ANS national standard integration (Mon Espace Santé, CI-SIS, ProSanté Connect, MSSanté), HL7 FHIR hospital interoperability, and operational readiness for HDS hosting, healthcare GDPR, and EU MDR 2017/745 regulations.

## Execution Dossier — Stages 2 to 4 — Digital Health Architecture, ANS/FHIR Interoperability & HDS (2 to 6 months)
### Target B2B Actors
- **MedTech & Healthcare Manufacturers** (`?acteur=industriels-sante`) : Validate hospital ergonomics, ward or OR integration, and EU MDR 2017/745 readiness prior to scale-up.
- **MedTech & Digital Health Startups** (`?acteur=startups`) : Cross the clinical valley of death: access hospital trial sites, prove real-world utility, and prepare market access (PECAN / CNAM).
- **Hospitals & Clinics** (`?acteur=hopitaux-cliniques`) : Streamline patient-caregiver workflows, reduce administrative burden, and structure hospital living-lab experimentation.
- **Big Pharma** (`?acteur=big-pharma`) : Move beyond molecule-only models to deploy "Beyond the Pill" care pathways adopted by clinicians and patients.

### Concrete Phase Deliverables
- Phase 1 — Architecture Audit & Regulatory Qualification: Health data flow map, SaMD qualification analysis (MDCG 2019-11), and DPIA/HDS pre-framing.
- Phase 2 — Digital Health Engineering & Interoperability: Application build, HL7 FHIR / EHR connectors, and ANS national teleservice integration (INS, ProSanté Connect, MSSanté).
- Phase 3 — HDS Production Rollout & Handover: Deployment on HDS-certified infrastructure, IEC 62304 technical documentation, and team handover.

### Go / No-Go Stage-Gate Criteria
- Regulatory scope and security architecture approved by DPO and CISO.
- CI-SIS interoperability test completion and zero critical findings in security audit.
- Clinical production sign-off and live activation across partner healthcare facilities.

### Verified Partner Proofs
- **Agence du Numérique en Santé (ANS)** (National Digital Health Authority) : Alignment with the French national digital health doctrine (Mon Espace Santé, CI-SIS, ProSanté Connect, MSSanté).
- **InterSystems & Medasys** (HL7 FHIR Interoperability & Hospital Information Systems) : Integration of digital health workflows and HL7 FHIR streams into hospital information systems (HIS / EHR).
- **Medtronic & GE Healthcare (MedTech)** (Global MedTech & Medical Device Manufacturers) : Field experimentation and ergonomic validation of medtech solutions in hospital environments.
- **Assurance Maladie (CNAM)** (National Public Payer & Care Pathways) : Health-economic evidence structuring and integration into national reimbursement pathways.

### Regulatory & Interoperability Checkpoints
- **HDS (ISO 27001)** (Health Data Hosting (HDS Certification Readiness)) : Health data flow matrix, environment isolation blueprint, and HDS hosting SLA alignment.
- **RGPD / CNIL Santé** (Healthcare GDPR & CNIL Reference Methodologies (MR-001 / MR-004)) : DPIA pre-framing, processing registry, and patient consent workflow specification.
- **UE MDR 2017/745 & DMN** (Digital Medical Device (SaMD) & EU MDR 2017/745 Qualification) : SaMD qualification memo, clinical usability test protocol, and technical file readiness checklist.
- **Doctrine ANS / CI-SIS** (ANS National Doctrine: Mon Espace Santé, CI-SIS, ProSanté Connect & MSSanté) : ANS Convergence compliance matrix and national teleservice integration roadmap.
- **HL7 FHIR / IHE** (HL7 FHIR Hospital Interoperability & EHR/HIS Connectors) : FHIR profile specifications, HL7 v2 mapping, and end-to-end HIS integration test plan.
- **PECAN / LPPR / CNAM** (Early Reimbursement Access (PECAN) & Remote Monitoring Pathways) : Real-world evidence collection protocol (PROMs / PREMs / caregiver workflow impact).

## Detailed Sections
### AN INTERNATIONAL NETWORK OF EXPERTS
Succeeding in digital health requires mastering medicine, software engineering, healthcare law, UX design, and entrepreneurship simultaneously. Health Factory connects your project with top specialists across Europe and North America.
### TECHNICAL EXPERTISE (ARCHITECTURE, HDS, SECURITY, AI)
From distributed architectures to high-security systems handling sensitive health records (cryptography, anonymization, HDS compliance), our technical experts guide your engineering decisions.

Our team has also built pioneering medical applications including Résurgences, Docteur Gratis, and toubib.co.
### LEGAL & REGULATORY EXPERTISE
Navigate GDPR, medical confidentiality, health data hosting (HDS), intellectual property, and Software as a Medical Device (SaMD / CE marking) requirements from day one.
### MEDICAL & CLINICAL EXPERTISE
Backed by world-renowned medical advisors (including Prof. Jacques Marescaux, founder of IRCAD and IHU Strasbourg) and practicing clinicians, we ensure clinical relevance and seamless workflow integration.
### UX / UI & SERVICE DESIGN EXPERTISE
In healthcare, poor usability leads to immediate clinician burnout or patient non-adherence. Our designers craft intuitive, accessible, and empathetic user experiences.
### ENTREPRENEURIAL & BUSINESS MODEL EXPERTISE
Build sustainable business models (hospital B2B, pharma B2B2C, institutional reimbursement), prepare fundraising, and accelerate go-to-market execution.