Product and intended use
Describe the healthcare workflow, the system’s purpose, and the output it is intended to provide.
EU AI Act applicability assessment
A focused first pass for healthcare AI vendors evaluating the EU market.
For US health-tech and healthcare AI vendors considering current or planned EU/EEA activity. Share the business and product context behind your system to request an applicability assessment.
Request an assessment
Share business and system context only. Do not submit patient details, medical records, or sensitive health information.
Fit and review context
Start with the product facts that shape the question.
The request frames a first conversation around your system, its intended healthcare use, and your EU/EEA plans. Include relevant data, users, and oversight context in your description so the assessment request has useful boundaries.
System, data, and oversight context
Share relevant system and data context, who uses or relies on its outputs, and where human oversight fits.
EU/EEA activity and value-chain role
Explain current or planned EU/EEA activity and your role in the healthcare AI value chain.
The request form collects product and intended-use details, EU/EEA market activity, and value-chain role. Keep any additional context at the system or workflow level.
Working output
A written first-pass summary to support your next conversation.
The working deliverable is a concise summary of the submitted scope, assumptions, open questions, and suggested next steps for qualified counsel. The exact scope and format should be agreed before work begins.
- A written first-pass summary of the submitted system and use context
- The assumptions and open questions identified from that context
- Suggested next steps for discussion with qualified counsel
Attorney review and legal boundary
Informational assessment, with the limits stated clearly.
This assessment is informational. It is not legal advice or a legal opinion, and it does not imply that an attorney has reviewed your submission or its output. Any attorney involvement, if included, and its limits must be stated in the agreed scope. Confirm legal questions with qualified counsel.
Request an assessment
Share business and product context to start.
No patient details, medical records, or sensitive health information. The request form is for business and system context only.