EHDS and Lab Data Portability in Europe

The European Health Data Space (EHDS) is the most ambitious legislative initiative of the European Union in the field of digital health. Approved in its final form by the European Parliament and the Council, the EHDS establishes a legal framework for access to and portability of electronic health data across member states, explicitly including lab test results.

For healthcare organizations, laboratories, and technology providers, the EHDS represents both a regulatory challenge and a strategic opportunity. This article analyzes the aspects of the EHDS most relevant to lab data and what organizations need to do to prepare.

What is the EHDS

Context and objectives

The EHDS was born from a realization: despite the fact that GDPR established the right to personal data portability (Art. 20), the reality is that electronic health data remains largely trapped within the systems where it is generated. A patient moving from Spain to Germany cannot easily transfer their lab results from one healthcare system to another.

The main objectives of the EHDS are:

• Primary use: give citizens control over their electronic health data and guarantee its portability across member states.
• Secondary use: create a regulated framework for the reuse of health data for research, innovation, and public health policy purposes.
• Interoperability: establish common standards and technical specifications for health data exchange across the EU.

Scope for lab data

The EHDS establishes priority categories of electronic health data that must be interoperable and portable. Lab results are explicitly included as one of the priority categories, alongside:

• Patient summary records
• Electronic prescriptions and dispensations
• Medical imaging reports
• Hospital discharge reports

For lab results, the EHDS specifies that they must be exchangeable using recognized international standards, with explicit reference to LOINC as the standard vocabulary for test coding and FHIR as the exchange standard.

Primary use: lab data portability

Citizen rights

The EHDS grants European citizens enhanced rights over their electronic health data:

• Free electronic access: citizens will have immediate access to their electronic health data, including lab results, in electronic format and at no cost.
• Cross-border portability: lab data must be transferable between healthcare systems of different member states in an automated manner.
• Access control: citizens will be able to decide who accesses their data and restrict access to specific professionals or services.

Exchange format

The EHDS establishes that lab data must be exchanged in a European Electronic Health Record Exchange Format (EEHRxF). This format is based on implementation profiles developed by the EU eHealth Network, which in turn rely on the FHIR R4 standard and terminologies such as LOINC and SNOMED CT.

In practice, this means that a lab result generated in Spain must be readable, interpretable, and processable by a healthcare system in France, Germany, or any other member state, provided both systems implement the European exchange format.

{
  "resourceType": "Observation",
  "code": {
    "coding": [
      {
        "system": "http://loinc.org",
        "code": "2345-7",
        "display": "Glucose [Mass/volume] in Serum or Plasma"
      }
    ]
  },
  "valueQuantity": {
    "value": 95,
    "unit": "mg/dL",
    "system": "http://unitsofmeasure.org",
    "code": "mg/dL"
  },
  "referenceRange": [{
    "low": {"value": 70, "unit": "mg/dL"},
    "high": {"value": 100, "unit": "mg/dL"}
  }]
}

This FHIR Observation resource with LOINC coding and UCUM units is readable by any compatible system, regardless of the country of origin or destination.

MyHealth@EU

The technical infrastructure for cross-border portability is channeled through MyHealth@EU, the digital platform connecting national contact points for eHealth. As the EHDS is implemented, MyHealth@EU will expand its services to include lab result exchange, in addition to the electronic prescription and patient summary services already operational in several member states.

Secondary use: lab data reuse

Data access framework

The EHDS creates a regulated framework for access to health data for secondary use purposes. "Health Data Access Bodies" in each member state will manage access requests from researchers, pharmaceutical companies, regulatory bodies, and other legitimate applicants.

Aggregated and anonymized lab data will be usable for:

• Medical and epidemiological research
• Drug and medical device development
• Evidence-based public health policies
• Training and validating healthcare AI systems
• Official health statistics

Anonymization requirements

For secondary use, lab data must be anonymized or, at minimum, pseudonymized before being made available. The EHDS establishes specific requirements to ensure data cannot be re-identified, which is particularly relevant for lab data that, when combined with other sources, could potentially identify the patient.

Implications for labs and hospitals

Laboratory information systems (LIS)

Laboratories will need to ensure their information systems generate results in a format compatible with the EEHRxF. In practice, this means:

• Mandatory LOINC coding: all lab results must be coded with LOINC. Laboratories still using proprietary internal codes will need to implement LOINC mapping.
• UCUM units: numerical values must use standardized UCUM units.
• FHIR interface: LIS systems must be capable of exporting results in FHIR R4 format according to European profiles.

Digitizing paper reports

A particular challenge for EHDS implementation is the volume of lab reports that are still generated or transmitted in paper or unstructured PDF format. These reports must be digitized and structured to meet EHDS portability requirements.

OCR technology specialized in medical documents, like that offered by MedExtract, is a key piece of this puzzle. A pipeline that extracts data from PDF reports, maps them to LOINC codes, and generates FHIR R4 resources conforming to the EEHRxF converts unstructured documents into portable, EHDS-compliant data.

Implementation timeline

The EHDS establishes a gradual implementation timeline:

• Phase 1 (2 years after entry into force): member states designate national digital health authorities and data access bodies.
• Phase 2 (4 years): implementation of access and portability rights for priority data categories, including lab results.
• Phase 3 (6 years): full implementation, including the secondary use framework and cross-border infrastructure.

Healthcare organizations should plan their adaptation well in advance, especially regarding LOINC coding of lab results and FHIR interface implementation.

Implications for technology providers

Certification and conformity

The EHDS will establish certification requirements for EHR systems and laboratory information systems. Providers will need to demonstrate that their systems meet the EEHRxF technical specifications, including correct implementation of European FHIR profiles.

Extraction APIs and conformity

Providers of lab data extraction APIs like MedExtract will need to ensure their outputs conform to the EEHRxF. This includes:

• Correct LOINC mapping for all extracted analytes
• Generation of FHIR R4 resources conforming to European profiles
• Use of standardized UCUM units
• Provenance metadata identifying the data source and extraction method

Market opportunities

The EHDS creates a pan-European market for health data interoperability solutions. Providers offering lab data extraction, structuring, and coding capabilities will have a significant competitive advantage, as many healthcare organizations will need these capabilities to meet EHDS deadlines.

Relationship between EHDS and GDPR

The EHDS does not replace GDPR: it complements it with healthcare sector-specific requirements. GDPR legal bases for processing health data continue to apply, but the EHDS adds:

• Specific portability obligations for health data
• Technical interoperability requirements
• A regulated framework for secondary use with additional safeguards
• National digital health authorities with supervisory powers

Organizations that already comply with GDPR for health data processing have a solid foundation, but will need to adapt their technical systems to meet the EHDS format and interoperability requirements.

How to prepare

Assessing the current situation

The first step is to assess the organization's current situation:

• Are lab results coded with LOINC?
• Can the LIS export data in FHIR R4 format?
• Are there paper or PDF reports that need digitizing?
• Is there a data processing agreement with technology providers?

Action plan

Based on the assessment, a typical action plan includes:

1. LOINC mapping: implement mapping from internal codes to LOINC for all analytes.
2. FHIR interface: implement or update the LIS FHIR interface according to European profiles.
3. Digitization: implement an extraction pipeline for paper/PDF reports, like the Python pipeline using the MedExtract API.
4. GDPR compliance: review and update data protection measures.
5. Training: train staff on new workflows and requirements.

Conclusion

The EHDS will transform the health data landscape in Europe by making lab result portability across member states a reality. For healthcare organizations, preparing for the EHDS starts today: implementing LOINC coding, adopting FHIR R4 interfaces, and digitizing unstructured reports are steps that benefit the organization regardless of the regulatory timeline, by improving interoperability, data quality, and operational efficiency.

Solutions like MedExtract, which transform unstructured lab reports into coded, standards-compliant data, will be fundamental pieces of the EHDS ecosystem, enabling organizations to bridge the gap between their current workflows and the portability and interoperability requirements the EHDS will make mandatory.