EHDS Readiness Score — Methodology

Purpose

The EHDS Readiness Score is a composite index developed by Health Edge to track how prepared each EU Member State is to implement the European Health Data Space Regulation (EU) 2025/327. It is designed to be transparent, reproducible, and updateable over time — each sub-factor maps to a verifiable public source, not an editorial judgment.

The score is not an assessment of policy intent. It measures operational and legislative reality: what has been enacted, designated, built, or connected. Countries are scored on what exists, not what is planned or promised. The single exception is Dimension 6 (Investment & Momentum), where commitments and funding awards are counted as leading indicators of future progress.

Structure

The score is built from six dimensions, each covering a distinct aspect of EHDS readiness. Primary and secondary use of health data are treated as separate categories, reflecting their different legal basis, infrastructure requirements, timelines, and stakeholder audiences.

Tier thresholds

Dimension 1 — Legal & Institutional Foundation (15 pts)

The legislative and institutional bedrock for EHDS implementation. The EHDS is a Regulation (EU 2025/327), not a Directive — it applies directly in all member states and requires no formal transposition. However, member states must take national measures to operationalise it: designating required bodies, enacting any necessary amendments to national health or data laws, and establishing processes that give effect to the Regulation's requirements. This dimension tracks two distinct obligations: the national measures that give the Regulation practical effect, and the designation of the Digital Health Authority — a mandatory primary-use governance body under Article 10 of the Regulation.

Note: D1a is framed as “operationalisation” rather than transposition — the EHDS applies directly, but member states must still designate bodies, amend conflicting national legislation, and establish processes. D1b tracks the Digital Health Authority obligation under Article 10, which is distinct from the Health Data Access Body (HDAB) tracked in D4. Pre-existing national health data acts that already establish a legal basis for secondary use count towards D1c.

Dimension 2 — Primary Use: Infrastructure (20 pts)

Measures operational connection to MyHealth@EU, the EU's cross-border health data infrastructure. Scores reflect actual connection status as published in European Commission monitoring data — not announced plans or commitments.

Note: A country can score full points in this dimension and still score zero in Dimension 3. MyHealth@EU measures cross-border infrastructure; patient empowerment measures domestic patient-facing capability. The two are operationally independent.

Dimension 3 — Patient Rights & Empowerment (15 pts)

Measures whether patients can practically exercise the rights the EHDS Regulation grants them. This spans both primary and secondary use: the right to access their own health data (Articles 5–6), to manage how it is shared, to port it in a structured format, and to opt out of secondary use of their data (Article 48). This is the only dimension that crosses the primary/secondary use boundary, because patient rights under the EHDS are unified — citizens exercise them through a single set of national mechanisms regardless of whether the data use is primary or secondary.

Note: A “comprehensive” patient portal means citizens can access at minimum their medication records, diagnoses, laboratory results, and vaccination history. Data portability carries increased weight in v2.0, reflecting its centrality to the EHDS vision. The secondary use opt-out (D3d) tracks the Article 48 right — separate from primary-use consent management, and politically sensitive as it directly affects the volume of data available for research.

Dimension 4 — Secondary Use: Governance (20 pts)

Measures whether the governance infrastructure for health data access is in place. Under the EHDS Regulation, each Member State must designate at least one Health Data Access Body (HDAB) by March 2027. This dimension distinguishes between formal designation — a political or administrative act — and operational status, where the HDAB is staffed, funded, and processing applications.

Note: “Designated but not yet operational” reflects a common intermediate state in 2025–2026: a country has named an institution in legislation or a government decision, but that institution has not yet begun accepting data access applications.

Dimension 5 — Secondary Use: Data Infrastructure (20 pts)

Measures whether the technical infrastructure for secondary use of health data exists and is accessible to researchers and other eligible users. Governance (Dimension 4) and infrastructure (Dimension 5) are scored independently — a country can have a functioning HDAB without a Secure Processing Environment, and vice versa. This dimension covers both national infrastructure (Secure Processing Environments, data catalogues, access processes) and readiness to participate in the EU-level cross-border infrastructure for secondary use.

Note: An “operational” SPE is one that is live, accessible to approved users, and has processed at least one data access request. A country with an EU-funded SPE project currently in build phase scores 4. HealthData@EU (D5d) is the secondary use equivalent of MyHealth@EU — a cross-border infrastructure enabling researchers to access health data across member states. Most countries score 0–1 in 2026 as the infrastructure is still in pilot.

Dimension 6 — Investment & Momentum (10 pts)

A leading indicator dimension. Countries scoring low across D1–D5 but showing significant investment commitment are more likely to improve than countries with neither infrastructure nor funding. This dimension captures trajectory, not current state — and is the only dimension where commitments and funding awards count, not just delivered outcomes.

Update cadence

Different dimensions change at different rates. Scores are reviewed on the following schedule:

Every score change is logged with a date, the previous value, the new value, and the source that triggered the update. The full change history is available in the tracker.

Versioning and change policy

The methodology is versioned. When sub-factors, point allocations, or tier thresholds change, a new version is published with a dated changelog. Historical scores are retained as assessed under the version in effect at the time of assessment — they are not retroactively recalculated.

This ensures that movements in a country's score over time reflect real-world changes, not methodological drift.

What the score does not measure

Data quality and digitisation rates. The proportion of health records that are digital, structured, and coded is fundamental to practical readiness — but no consistent, cross-country public data source exists. The TEHDAS country factsheets (2023) provide one-off qualitative assessments of data collection and quality for 12 member states, but these are not maintained and cannot be scored on a rolling basis. If a reliable, regularly updated source emerges, data quality will be added as a sub-factor.

EHR system certification and interoperability standards. The EHDS introduces mandatory certification for electronic health record systems, but this obligation falls primarily on EHR vendors, not member states. We track the infrastructure that results from interoperable systems (MyHealth@EU connectivity, patient portals) rather than the certification process itself.

Workforce and institutional capacity. TEHDAS and others find that staff shortages are a binding constraint on EHDS implementation. An HDAB can be designated and nominally operational while critically understaffed. We score existence, not capacity — deeper capacity assessments are covered in Health Edge intelligence reports.

Implementation quality. Legislation of limited quality still scores full points; a technically operational SPE that is inaccessible due to bureaucracy still scores full points. The score tracks whether required elements exist, not whether they work well. The score is a tracking instrument, not an audit.

Comparison with TEHDAS readiness framework

The Joint Action Towards the European Health Data Space (TEHDAS) conducted country visits to 12 member states, assessing data collections, quality, infrastructure, governance, resources, and capacity building. The EHDS Readiness Score is a distinct instrument — TEHDAS produced one-off qualitative assessments; the Readiness Score produces quantitative scores updated on a rolling basis across all 27 member states. Where the two overlap, findings are broadly consistent. Where they diverge, it is because the Readiness Score restricts itself to publicly verifiable factors that can be scored without direct country engagement.