OpenEHDS is being developed as a neutral, non-commercial foundation initiative focused on turning EHDS from a legal framework into practical, reusable technical reality.

Mission

OpenEHDS is built on the belief that EHDS infrastructure must be:

• interoperable by design
• privacy-preserving by default
• operationally realistic
• publicly understandable

The initiative also creates a neutral space for dialogue between public institutions, regulators, patient organizations, researchers, and technology stakeholders through open discussion, workshops, and co-creation of reference architectures.

Scope

OpenEHDS focuses primarily on EHDS secondary use of electronic health data, where regulatory, technical, and organizational complexity is highest.

The scope includes the full secondary-use lifecycle:

• dataset preparation for approved secondary-use cases
• controlled access based on data permits
• operation in secure processing environments
• auditable and transparent lifecycle governance

Controlled data mediation layer

EHDS does not create unrestricted data federation. It establishes permit-based access that is limited by purpose, time, and full auditability.

In practice, this means a controlled data mediation layer is unavoidable.

OpenEHDS defines this layer explicitly as:

a data mediation layer constrained by data permit scope and enforcing access policies

OpenEHDS explicitly addresses this reality as a controlled data mediation layer that:

• is not a central data lake
• is not a permanent data repository
• is not a commercial data platform

It is a temporary, controlled data assembly and processing layer required for:

• creating datasets according to approved data permits
• enforcing opt-out rules, purpose limitation, and legal exceptions
• pseudonymization, anonymization, filtering, and aggregation
• operating within secure processing environments
• ensuring complete logging, auditing, and controlled data deletion after permit expiry

EHDS does not remove this layer - EHDS formally defines, constrains, and enforces it.

What OpenEHDS builds

Open reference components and architecture patterns, including:

• permit-aware dataset assembly engines
• policy enforcement modules for purpose limitation, opt-out, and legal exceptions
• connectors across health data holders, health data access bodies, and secure processing environments
• audit, logging, and data lineage capabilities
• temporary-data lifecycle mechanisms, including TTL and controlled deletion
• interoperability mappings and transformations aligned with EHDS, FHIR, and future implementing acts

These components are designed to be:

• deployed by health data access bodies
• deployed by trusted health data holders
• adapted to national EHDS implementations
• reused as reference architectures in public procurement

What OpenEHDS does not do

• does not act as a health data access body
• does not host or monetize medical data
• does not operate secure processing environments
• does not replace national or EU governance institutions

OpenEHDS is an enabler, not a system operator.

Governance, neutrality, and trust

OpenEHDS operates as a foundation based on:

• a transparent governance model
• open contribution processes
• public documentation and decision transparency
• clear separation from commercial exploitation of outcomes

The initiative aims to be:

• a credible partner for public institutions
• practical support for healthcare organizations
• a trusted reference point for regulators
• a practical toolset for technology providers

Why OpenEHDS is needed

EHDS provides a legal framework, but not implementation simplicity.

Without shared, open, and auditable components:

• member states will rebuild similar solutions from scratch
• fragmentation will be recreated under a new label
• smaller organizations will be excluded by cost and complexity
• trust in EHDS can be weakened by opaque or closed implementations

OpenEHDS exists to turn EHDS from a legal framework into shared technical reality. It also helps close the EHDS knowledge gap through open educational resources and stakeholder dialogue.

Open source presence

• GitHub organization: Open-EHDS on GitHub