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Fixed-fee fact-finding · EU AI Act

A clearer first pass for healthcare AI in Europe.

For U.S. health-tech companies and healthcare AI vendors considering current or planned EU/EEA activity. Oathmesh helps clarify the system facts and regulatory touchpoints worth discussing next.

The fixed fee and payment instructions are agreed before booking. Share business and system context only—never patient details or medical records.

EU AI Act · first-pass assessment

A bounded fact-finding brief

From system context to useful next questions.

Context reviewed

  • Intended use
  • System and data
  • Users and oversight
  • EU/EEA activity and role

Written first-pass summary

Findings, touchpoints, assumptions, and open questions.

Working output is agreed in scope. This is not legal advice or a compliance determination.

What we review

A focused look at the facts around one system.

Fit depends on your product purpose, intended healthcare use, and current or planned EU/EEA activity. The first conversation helps decide whether this bounded assessment is the right next step.

  1. 01

    Intended healthcare use

    The workflow, purpose, and output the system is designed to support.

  2. 02

    System and data context

    Relevant system characteristics and the kinds of data involved.

  3. 03

    Users and oversight

    Who uses or relies on the output, and where human review fits.

  4. 04

    EU/EEA activity

    Current or planned market activity and the timing or markets in view.

  5. 05

    Value-chain role

    Your role in developing, providing, deploying, importing, or distributing the system.

This is an initial fact-finding scope, not an eligibility decision or a final determination about whether a law applies.

What you receive

A concise written summary for the next discussion.

Within the agreed scope, Oathmesh records factual findings and relevant regulatory touchpoints so your team can organize open questions and prepare for a discussion with qualified counsel.

  • Factual findings from the agreed context
  • Relevant regulatory touchpoints
  • Assumptions and open questions
  • Suggested next steps for discussion with qualified counsel

A clear request path

Fit and terms are discussed before anything is booked.

  1. 01

    Share business and system context

    Use the request form to describe the product and intended healthcare workflow.

  2. 02

    Discuss fit and agree the scope

    Oathmesh will follow up to discuss fit, format, and the boundaries of the first pass.

  3. 03

    Confirm the fixed fee before booking

    The fixed fee and payment instructions are agreed before work is booked. There is no on-site checkout.

Good context makes the request useful

Describe the business, product, system, and workflow. Do not submit patient details, medical records, or sensitive health information.

Request an assessment

Informational fact-finding

Clear boundaries are part of a useful first pass.

The assessment is informational fact-finding. It is not legal advice, a legal opinion, a compliance determination, or a certification.

It does not imply attorney review or formal legal sign-off. Any attorney involvement and its limits would need to be stated in the agreed scope. Discuss legal questions with qualified counsel.

For U.S. healthcare AI teams planning EU/EEA activity

Start with the facts. Agree the work before booking.

Send business and system context only. Oathmesh will discuss fit, scope, format, fixed fee, and payment instructions with you before a booking is made.

Request an assessment