- Domain
- Health data exchange
- Active version
- R4 (stable) · R5 (2023)
- Description
- HL7 standard for clinical data exchange via REST/JSON API. Technical backbone of Mon Espace Santé and France's CI-SIS.
- Regulatory links
- HIAPP, HDS, CI-SIS
About this guide
Your processes run through tools that don’t talk to each other: messaging, spreadsheets, CRM, ERP, LIMS, cloud storage, industry software. This guide explains how to connect them, which standards to use in healthcare and life sciences, and how to choose or build the right connector.
It is for leaders, IT managers and business teams who want to eliminate re-keying and make their data usable, including by AI.
Contents
Chapter 1
Making data flow
Your tools make each person more efficient. Your losses happen between them: an order received by e-mail and re-keyed into a spreadsheet, a test result copied into a report, a patient record rebuilt from three systems. Each break costs time and produces incomplete or inconsistent data.
A connector links two systems so information flows without re-keying: it is entered once, at the source, then passed on to where it is needed. Connecting your teams’ tools rather than replacing them is often the fastest way to digitize a process.
Interoperability is also the condition for AI: without accessible, structured and comparable data, every model stays locked in a silo.
Chapter 2
Standards and regulatory frameworks
Two notions complement each other without overlapping:
- Interoperability standards define the how: the format, syntax and meaning of the data exchanged.
- Regulatory frameworks define the what and the why: legal obligations, governance, audit.
The same project can therefore fall under the GDPR, a framework, while using FHIR R4, a standard, to exchange patient data. Regulatory frameworks often reference or require standards. The "Regulatory compliance" guide details the frameworks; this one focuses on how data flows.
Chapter 3
Three families of connectors
Business activities: agnostic connectors
Everyday tools, whatever the industry. They carry the routine exchanges of processes: notifying a team, filing a document, updating a tracking sheet, finding a customer, placing an order, archiving files or querying a database.
Healthcare and life sciences: standards
In healthcare, exchanges rely on shared formats and terminologies, often required by partners or authorities: patient records, imaging, clinical trials, lab results. Chapter 4 presents them one by one.
Other industries: custom connectors
Manufacturing, finance, services: every industry has its own software, files and instruments. When no standard connector exists, our team builds it, from the software’s API, its exports or its files.
Chapter 4
Healthcare standards
Nine standards shape data exchange in healthcare and life sciences: formats and APIs, messaging, data models, terminologies and clinical data.
| Standard | Type | Organization |
|---|---|---|
| FHIR R4 / R5 | Format / API | HL7 International |
| CDISC (SDTM / ADaM / CDASH) | Clinical data | CDISC |
| DICOM | Data format | NEMA / WG-DICOM |
| HL7 v2 | Messaging | HL7 International |
| OMOP CDM | Data model | OHDSI |
| openEHR | Data model | openEHR Foundation |
| CI-SIS | Format / National profiles | ANS (France) |
| SNOMED CT | Terminology | SNOMED International |
| LOINC | Terminology | Regenstrief Institute |
- Domain
- Clinical trials / regulatory submissions
- Active version
- SDTM 1.8 · ADaM 2.1
- Description
- Family of standards for clinical trial data collection (CDASH), submission (SDTM) and analysis (ADaM). Quasi-mandatory for FDA and EMA regulatory submissions.
- Regulatory links
- FDA 21 CFR, GCP / ICH E6, EMA
- Domain
- Medical imaging
- Active version
- PS 3.x (2024)
- Description
- Universal standard for storing, transmitting and displaying medical images (MRI, CT, X-ray). Includes patient metadata linked to images.
- Regulatory links
- ISO 13485, MDR/IVDR, FDA 21 CFR 820
- Domain
- Hospital messaging
- Active version
- v2.8 (2014)
- Description
- Dominant point-to-point messaging standard in hospital information systems. Widely used despite its age; gradual migration to FHIR underway.
- Regulatory links
- CI-SIS, HIAPP
- Domain
- Observational / real-world data
- Active version
- v5.4
- Description
- Common data model for harmonising large-scale observational healthcare data. Used by OHDSI for pharmacovigilance and real-world evidence studies.
- Regulatory links
- RGPD, GCP / ICH E6
- Domain
- Structured clinical patient record
- Active version
- Release 1.1
- Description
- Open clinical modelling architecture, separating the reference model (data) from archetypes (clinical semantics). Adopted in several European countries for EHR systems.
- Regulatory links
- HIAPP, CI-SIS
- Domain
- French health IS interoperability
- Active version
- 2024.01
- Description
- ANS national framework defining FHIR, IHE and HL7 profiles adapted to the French context. Mandatory reference for services integrating Mon Espace Santé.
- Regulatory links
- HIAPP, HDS, FHIR R4
- Domain
- Clinical coding
- Active version
- Release 2024-07
- Description
- World-leading clinical terminology (>350,000 concepts). Used to code diagnoses, procedures, drugs and findings in an interoperable way.
- Regulatory links
- FHIR R4/R5, CI-SIS, OMOP CDM
- Domain
- Lab results & clinical observations
- Active version
- 2.78 (2024)
- Description
- Universal standard identifying laboratory tests and clinical measurements (>100,000 codes). Natural complement to SNOMED CT for lab results.
- Regulatory links
- FHIR R4/R5, CDISC, OMOP CDM
Chapter 5
Choosing and building a connector
A good connector is decided from the process, not from the tool. A few questions are enough to frame it:
- Direction and frequency: does data flow one way or both, in real time or in batches?
- Source of truth: which system prevails when two values differ?
- Identifiers and terminologies: how do you recognize the same customer, patient or sample from one system to another?
- Security and access: who may read and write, with which secrets and permissions?
- Traceability: is every exchange logged, for audits and to understand an error?
- Regulated context: is the connector part of a computerized system that must be validated (GAMP 5, Annex 11)?
Our approach: map data flows during the diagnostic, connect existing tools rather than adding more, and build the connector that is missing. Connectors fit into the digitized processes: they inherit their audit trail and access management.
Chapter 6
Where to start
Start with the process that costs the most in re-keying. List the tools it runs through, the information passed from one to the next and the people who copy it: you have the list of your first connectors.
The Express Process Diagnostic maps your processes and data flows in ten days and hands you a costed action plan, prioritized by gain.
Let’s talk about your constraints
Terminus 2π · Digital process first. AI at the core.
Website: terminus2pi.com · E-mail: [email protected]
LinkedIn: linkedin.com/company/terminus-2pi
Standard versions are indicative and change over time: check the version required by your partners and authorities. Healthcare standards catalogue after a synthesis published by Gencovery in 2025, reviewed and extended by Terminus 2π.