Product and intended use
Describe the product purpose, intended healthcare use, workflow, and output the system is meant to provide.
EU AI Act applicability assessment
A focused first pass for healthcare AI vendors evaluating the EU market.
A bounded, informational first pass for U.S. health-tech companies and healthcare AI vendors considering current or planned EU/EEA activity. Share the business and product context behind your system to discuss fit.
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. Product purpose, intended use, relevant system and data context, people using or relying on outputs, human oversight, EU/EEA activity and markets, and value-chain role are discussion prompts, not an eligibility determination.
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 markets, 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 deliverable is one concise written first-pass summary of the submitted system and intended-use context, factual findings and relevant EU AI Act touchpoints, assumptions and open questions, and suggested next steps for qualified counsel. The exact scope and format should be agreed before work begins.
- One concise written first-pass summary of the submitted system and intended-use context
- Factual findings and relevant EU AI Act touchpoints, with assumptions and open questions
- Suggested next steps for discussion with qualified counsel
Attorney review and legal boundary
Informational assessment, with the limits stated clearly.
This bounded first pass is informational only. It is not legal advice, a legal opinion, or legal conclusions; it does not decide whether the EU AI Act applies or assign a final classification; and it is not an audit or certification. Attorney review is not implied. Any attorney involvement and its limits must be described in the agreed scope. Confirm legal questions with qualified counsel.
Read the EU AI Act assessment FAQBuyer fit
Could this first pass fit your EU/EEA plans?
For U.S. health-tech companies and healthcare AI vendors considering current or planned EU/EEA activity. Fit depends on product purpose and intended healthcare use; relevant system and data context; people using or relying on outputs; human oversight; EU/EEA activity and markets; and value-chain role. These are discussion prompts, not an eligibility determination.