Datum accelerator

Datum for healthcare.

Datum accelerates the deployment of the clinical data operating model — with a FHIR-first Clinical Common Data, SNOMED CT and LOINC integration, and a regulatory framework ready for GDPR Art. 9, ENS high level and EHDS.

Standards
HL7 FHIR R4
SNOMED CT · LOINC · ICD-10
RGPD Art. 9 · ENS alto
Ley 41/2002 · EHDS
DAMA Healthcare
The problem

Clinical data is rich in content and poor in governance.

Hospitals and healthcare groups generate valuable data at every interaction. The problem is not volume — it is fragmentation, semantic inconsistency and the lack of a model that makes it usable.

01
Systems that don't communicate

HIS, LIS, RIS, EMR… each system generates data in different formats. Without an integration model based on standards, a complete clinical view of the patient is unattainable.

02
Inconsistent clinical data

Different codings for the same diagnosis, out-of-range values undetected, fragmented records. Clinical data quality directly impacts patient safety.

03
Data that cannot be reused

Without common semantics or traceability, clinical data is barely reusable for research, trials or advanced analytics. The data's potential is trapped in the systems.

04
GDPR and ENS in healthcare environments

Health data is especially sensitive. Data governance, access control, traceability and anonymisation are regulatory and ethical requirements that need a model, not just technology.

Sector architecture

How Datum is structured for healthcare.

Datum's architecture extends for healthcare with two explicit sector layers: a Clinical Common Data aligned with HL7 FHIR and a Business Layer focused on regulatory traceability, clinical indicators and population analytics. We don't reinvent the architecture — we specialise it for clinical data.

CATALOGSBusiness cataloguesClinical · Analytics · Research · Operations · ManagementBUSINESSClinical & regulatory Business LayerClinical indicators · Cohorts · Quality of care · Population analyticsCDM_CLINClinical Common Data (HL7 FHIR)Patient · Encounter · Observation · Condition · Procedure · MedicationRequestCDMCommon Data (core Datum)Practitioner · Facility · Product · cross-cutting operationsOPOperationalHarmonised, historised and traceable technical dataLANDINGLanding (RAW)HIS · LIS · RIS · EMR · devices · external sources

What it means for a hospital or healthcare group

01
Clinical Common Data — FHIR as first-class citizen

Core clinical entities (patient, encounter, observation, diagnosis, procedure, medication) are modelled from day one aligned with HL7 FHIR R4. There is no intermediate step of translating a generic CDM into the clinical world — the layer exists with that semantics.

02
Business Layer — certifiable clinical indicators

Quality of care indicators, research cohorts and population analytics aggregates are not local spreadsheets. They are governed data products, with lineage back to source and access controls specific to health data.

03
Explicit layer separation — governance by level

Each layer has its own ownership: IT owns Landing and Operational, the Data Office governs Common Data and Business, and the clinical business consumes from the catalogues. Health data security is applied by design at every level, not as a final patch.

Regulatory scope

What we address with Datum — and what we don't.

Health data is special category data and requires the highest level of protection. We honestly distinguish which frameworks Datum covers as a technical foundation, which we partially align with and which are out of scope.

Covered by Datum

Datum provides the real technical foundation (governance, lineage, classification, ownership, clinical data access traceability).

GDPR · Art. 9
Special category data
Classification of health data as special category, traced legal basis, defined ownership and auditable use registry.
ENS
National Security Framework (high level)
Technical and access controls aligned with Spanish ENS high level: encryption, segregation, activity logging and data continuity.
LOPDGDD
Spanish Data Protection Act
Subject rights (access, rectification, erasure) executable on governed data with lineage and traceability.
Law 41/2002
Patient autonomy and clinical record
Clinical record governance: integrity, retention, professional access and patient consultation — on top of a traceable data layer.
EHDS
European Health Data Space
Readiness for primary and secondary use of health data: catalogue, FHIR metadata, consent and access controls.

Partially aligned

Datum enables conformance; final certification or validation belongs to specific bodies.

HL7 FHIR
Clinical interoperability
We cover the semantic model and FHIR resource publication. Certifying FHIR connectors as a product is not in scope.
ISO 13606
Electronic health record
We enable semantic interoperability with archetypes. CEN/ISO 13606 certification of a specific system is the manufacturer's responsibility.

Out of scope

We do not replace medical device or clinical decision frameworks. Let's be clear.

MDR / IVDR
Medical device · medical software
If software is part of diagnosis or clinical decision, MDR/IVDR certification is the device manufacturer's responsibility.
Clinical validation
Models on health data
Datum provides the governed data; clinical validation of a predictive model is the responsibility of the medical team and ethics committee.
How Datum supports the clinical data pyramid
Secondary use and analyticsCohorts · Research · EHDSDatumAnonymisation · governed data products · traceabilitySemantic interoperabilityHL7 FHIR · SNOMED CT · ICD-10DatumFHIR-first model · terminologies · versioned mappingsResilience and securityENS high · DORA (applies)DatumContinuity · encryption · least privilege · auditingGovernance and traceabilityGDPR Art. 9 · LOPDGDD · Law 41/2002DatumOwnership · lineage · consent · use logging
Sector standard

HL7 FHIR as the semantic map of clinical data.

HL7 FHIR (Fast Healthcare Interoperability Resources) is the most widely adopted clinical interoperability standard internationally. It defines a set of Resources representing universal clinical concepts. We use it as the semantic reference to design Datum's Clinical Common Data.

Why FHIR matters in clinical data governance

01
Universal clinical semantics

FHIR R4 defines more than 140 Resources representing clinical concepts recognised by any hospital system in the world: Patient, Encounter, Observation, Condition, Procedure… It is the common language of clinical data.

02
Foundation for the Clinical CDM

It lets us structure the healthcare CDM aligned with how clinical systems actually operate, instead of inventing a proprietary model incompatible with the ecosystem.

03
Integrated terminologies

It complements with SNOMED CT (clinical), LOINC (laboratory), ICD-10/11 (diagnoses) and ATC (medications). Datum integrates those terminologies as governed metadata of the Clinical CDM.

04
EHDS and secondary use

The European Health Data Space requires structured, traceable and interoperable clinical data. A FHIR-first CDM is the most direct way to be ready for primary and secondary use without reworking the architecture.

FHIR Resources we cover in Datum's Clinical CDM

We don't cover all 140+ FHIR Resources. We cover the ones that support critical clinical data for care, quality, research and reporting.

Clinical CDMCommon DataFHIR-firstPATIENTPatientENCOUNTEREncounterOBSERVATIONObservationCONDITIONConditionPROCEDUREProcedureMEDICATIONMedicationRequestDIAGNOSTICREPORTDiagnosticReportORGANIZATIONOrganization
PATIENT
Patient
Patient, identifiers, demographics, contact.
ENCOUNTER
Encounter
Clinical episode, admission, consultation, emergency.
OBSERVATION
Observation
Vital signs, clinical results, assessments.
CONDITION
Condition
Diagnoses, clinical problems, medical history.
PROCEDURE
Procedure
Surgical procedures, examinations.
MEDICATION
MedicationRequest
Prescription, dispensing, administration.
DIAGNOSTICREPORT
DiagnosticReport
Lab, imaging and pathology reports.
ORGANIZATION
Organization
Facility, service, functional unit.
HL7 FHIR is not a physical data model. It is a semantic resource model. Datum translates those resources into real Clinical Common Data structures, aligned with FHIR but optimised for the hospital ecosystem (HIS, LIS, RIS, analytics) and local regulatory requirements (ENS, GDPR, Law 41/2002).
What Datum activates

Data capabilities designed for the healthcare context.

01
Clinical architecture with FHIR and mCODE

Design of integration models based on HL7/FHIR and mCODE to standardise, connect and govern clinical data with real interoperability.

02
Clinical data governance

Ownership model, policies and quality adapted to the healthcare context: clinical entities, codings, diagnosis and procedure traceability.

03
Platform for advanced analytics

Event-driven architecture (Kappa) and clinical data catalogue to enable precision analytics, research and predictive models with a governed foundation.

04
Anonymisation and access control

Design of privacy policies, pseudonymisation and access control for clinical data per GDPR, ENS and AEPD guidelines for healthcare environments.

Healthcare experience

Governed clinical architecture in precision oncology.

Featured case

"Governed clinical data under FHIR and mCODE to activate precision analytics in oncology"

Definition of data strategy and Data-Driven architecture under DAMA, with Kappa architecture based on Confluent Cloud, HL7/FHIR/mCODE meta-modelling and data governance with Collibra.

Results with Datum · unattributed ranges
reduction in data teams while maintaining coverage
performance improvement in governed pipelines
for the first data capability in production
Another sector?
Every sector has its own regulatory and semantic context. Explore the other industry solutions.
Next step

Accelerate Datum in your healthcare organisation.

An initial assessment identifies the starting point, pilot domain and deployment model that fit best.