Frequently asked questions
Public answers to understand participation, Data Products, access, privacy, AI, governance and next steps.
General overview
What is EDGE/DM?
EDGE/DM is a governed data space for medical-device innovation. It enables organisations to discover, publish and request access to Data Products under clear rules.
Is EDGE/DM a data download portal?
No. The public website shows descriptions and documentation. Access to data, services or endpoints requires review and usage conditions.
What is a Data Product?
A Data Product is a reusable asset packaged with metadata, usage conditions, evidence, governance information and access rules.
Participation
What happens after a participation request?
The team reviews the organisation role, purpose, eligibility and appropriate pathway: provider, user, technology partner, research, governance or integration.
Do organisations need to be consortium members?
Participation may be limited to eligible organisations, pilots or reviewed requests. The website starts the conversation without promising automatic access.
Can startups or SMEs participate?
Yes, they can express interest if their work fits publication, use, validation, AI, integration or governance of Data Products.
Data Products & catalogue
Are catalogue Data Products always available?
Not necessarily. An entry may be a pilot, under governance review or available only to eligible participants.
What types of Data Products can be published?
Datasets, benchmarks, inference services, AI services, validation workflows, evidence packs and traceability resources.
Can a provider update or remove a Data Product?
Yes, the model should support updates, evolution or removal under participation rules and traceability.
Access, privacy & usage conditions
Does EDGE/DM expose personal health data publicly?
No. The public website should not expose sensitive data. It shows descriptions, conditions and documentation.
Who decides whether access is granted?
Access should be evaluated against declared purpose, requester role, Data Product restrictions and governance rules.
Which uses are normally prohibited?
Re-identification, unauthorised redistribution, use outside the agreed purpose, model extraction or unapproved clinical use.
AI collaboration
Can an AI service be a Data Product?
Yes. A model, inference service, AI agent or evaluation workflow can be treated as a Data Product if it includes purpose, limits, evidence and conditions.
Is EDGE/DM intended for clinical diagnosis?
Not as a general public promise. Any clinical use would require a specific approved and evidenced framework.
Can participants collaborate without moving raw data?
Yes, the approach may include federated patterns, inference services or controlled evaluation without uncontrolled data movement.
Governance & European alignment
Which governance artefacts are used?
Rulebook, participation agreement, Data Usage Agreement/Policy, evidence records, access decisions and traceability.
What does European alignment mean?
It means EDGE/DM is presented in line with European data-space and health-data governance principles, without claiming undocumented certification.
Does alignment mean certification?
No. Public communication should distinguish alignment, formal compliance and certification.
Value models
Can Data Products be monetised?
EDGE/DM is exploring sustainable value models for participants, such as governed access, validation, benchmarking, AI services or evidence services, always under agreements, conditions and traceability.
Next steps
Where should I start?
Use the participation request page if you want to publish, request access or collaborate. Use contact for general questions.
Where can I download documentation?
The Resources page provides public PDF documents in Spanish, English and French.
Interested in joining EDGE/DM?
Tell us whether you want to publish, request access, collaborate technically or explore governance. The EDGE/DM team can review your interest and guide the next step.