EHDS Compliance Services

Become EHDS-ready fast and unlock the value of your health data.

DataArt helps healthcare, MedTech, and Life Sciences organizations transform fragmented health data into interoperable, research-ready, and monetizable assets. Our modular approach supports both primary use (interoperability and cross-border exchange) and secondary use (research, Real-World Evidence, AI).

Why Does Your Business Need EHDS Compliance Services?

The European Health Data Space (EHDS) is a framework that sets unified standards for secure health data sharing, interoperability, and advanced analytics across the healthcare sector in Europe. This regulation is reshaping how organizations share, use, and monetize health data, introducing requirements for data formats, consent management, governance, and cross border exchange. By 2028, all healthcare and life sciences organizations operating in Europe must comply, making early adoption critical for regulatory readiness and a competitive edge. Get ahead of the curve and fast-track compliance with DataArt’s modular, AWS native EHDS enablement accelerators.

End-to-End EHDS Enablement Workflow

EHDS Readiness Assessment

Identify gaps and define a clear roadmap
We identify technical, regulatory, and data governance gaps across both primary and secondary use cases. By using AWS-native reference architectures and accelerator-driven models, we deliver a prioritized roadmap that links regulatory requirements to tangible business outcomes, including faster Real-World Evidence generation, AI adoption, and cross-border data exchange, while reducing EHDS compliance timelines by up to 50%.
EHDS Compliance · Data Holder · Data Consumer

Accelerated non-FHIR → FHIR Transition

Enable primary use and interoperability
We streamline the transformation of legacy healthcare formats such as HL7v2, CDA, and proprietary schemas into FHIR, ensuring interoperability and participation in EHDS primary-use ecosystems. We use DataArt’s AILA accelerator, powered by agentic AI on Amazon Bedrock, for rapid, automated data mapping and prebuilt pipelines to cut integration costs by up to 60%. The result is scalable, production-ready FHIR pipelines that support digital health applications and compliant cross-border data exchange.
Primary Use · FHIR · Data Holder

FHIR → OMOP Transformation

Empower secondary use and analytics
DataArt enables the seamless conversion of interoperable FHIR data into research ready OMOP datasets. Our approach combines AI assisted terminology mapping, prebuilt transformation pipelines, and integration with Databricks and the Aidbox FHIR Server (including SQL on FHIR capabilities). The result is standardized, high quality datasets that reduce research preparation time by up to 70% and support faster clinical trial feasibility.
Secondary Use · OMOP · Data Holder · Data Consumer

EHDS-Compliant Data Marketplace

Make data discoverable, governed, and reusable
We help organizations create a secure, governed, and discoverable data marketplace aligned with EHDS and HealthDCAT AP standards. We leverage a data catalog built on AWS SageMaker and AI-powered metadata enrichment to track lineage and ownership for transparent data usage. This enables self-service access, strong governance, and faster data discovery, reducing access time by up to 80% and improving compliance, transparency, and audit readiness.
Secondary Use · Data Governance · Data Holder · Data Consumer

Quick Access to EHDS Data Insights

Accelerate Real-World Evidence and study feasibility
DataArt delivers ready-to-use analytics environments and standardized datasets for faster study feasibility and Real-World Evidence analysis. Integration with Amazon QuickSight enables intuitive data exploration and automated reporting. By combining secure data governance with real-time insights capabilities, we help organizations reduce the time to research findings by up to 60%, empowering them to design better studies, accelerate recruitment, and make data-driven decisions with confidence.
Secondary Use · AI Analytics · Data Consumer.

EHDS Data as a Product

Scale trusted data access across the organization
We empower healthcare and life sciences organizations to scale compliant secondary data use through secure, AWS-native Trusted Research Environments (TREs). DataArt’s AI Lakehouse Accelerator (AILA) enables automated data ingestion, transformation, and orchestration using agentic AI on AWS. With end-to-end mapping from non-FHIR to FHIR to OMOP, built-in auditability, and support for cross-border data sharing, businesses gain a sustainable data product framework that enables Real-World Evidence generation, monetization, and AI innovation.
Secondary Use · Infrastructure · Data Consumer

How DataArt Supports EHDS Readiness and Business Value

We help our clients reach full EHDS compliance for tangible business results.

30–50%

Reduce EHDS compliance timelines by 30–50% while directing investments toward high value outcomes such as Real World Evidence, AI, and cross border data exchange.

40-60%

Cut integration costs by 40–60% and accelerate FHIR adoption from months to weeks with AI driven mapping and prebuilt pipelines.

50–70%

Accelerate delivery of research ready datasets by 50–70%, enabling faster feasibility studies, patient recruitment, and generation of Real World Evidence.

60–80%

Reduce data discovery and access time by 60–80% while enhancing compliance, transparency, and audit readiness.

40–60%

Unlock insights 40–60% faster with standardized datasets and pre configured analytics environments that simplify exploration and decision making.

Reduce infrastructure costs

With prebuilt AWS native platforms that enable secure, compliant secondary use of health data in controlled environments aligned with EHDS standards.

Our Clients

Start Your EHDS Journey

Contact DataArt today and accelerate your path to EHDS compliance.

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