Question 1

Who is the assessment for?

Accepted Answer

The fixed-fee fact-finding assessment is intended for US health-tech companies and healthcare AI vendors considering current or planned EU/EEA activity. Whether it fits a particular system depends on its product purpose and intended use, relevant system and data context, who uses or relies on its outputs, human oversight, EU/EEA activity, and your value-chain role. Submit a service request to discuss fit; this is not an eligibility determination.

Question 2

What information should we include in the request?

Accepted Answer

Share business and system context: the product and intended healthcare use, relevant system and data context, who uses or relies on the output, where human oversight fits, your current or planned EU/EEA activity, and your role in the value chain. Keep details at the product, system, or workflow level. Do not submit patient details, medical records, or sensitive health information.

Question 3

What does the first-pass assessment include?

Accepted Answer

The working deliverable is a concise written first-pass summary of the submitted system and use context, the assumptions and open questions identified from that context, and suggested next steps for discussion with qualified counsel. The exact scope and format are agreed before work begins.

Question 4

What is the fixed fee, and when is it confirmed?

Accepted Answer

The assessment is offered on a fixed-fee basis, but a numeric fee is not published here. Submit the service request to discuss fit; Oathmesh will confirm the fixed fee and payment instructions with you before booking. The request form is not an on-site payment or checkout flow.

Question 5

How do we request the assessment?

Accepted Answer

Use the service request form to share your business and product context. Oathmesh can then discuss fit and agree the scope, format, fixed fee, and payment instructions with you before work is booked. Do not include patient details, medical records, or sensitive health information in the form.

Question 6

Is this legal advice, a compliance certification, or attorney review?

Accepted Answer

No. The assessment is informational fact-finding; it is not legal advice or a legal opinion and does not certify compliance. It does not imply that an attorney has reviewed your submission or the output. Any attorney involvement, if included, and its limits must be stated in the agreed scope. Confirm legal questions with qualified counsel.

Question 7

Can the EU AI Act matter to a company based in the United States?

Accepted Answer

A US location alone does not settle whether the Act applies. As of 9 October 2026, Article 2 covers, among others, providers placing AI systems on the EU market or putting them into service regardless of where they are established, and providers or deployers located outside the EU when the system’s output is used in the Union. The relevant role, market activity, intended use, and other facts matter, so this answer does not determine whether the Act applies to your system; discuss that question with qualified counsel.

Question 8

Which AI Act application dates should healthcare AI teams know?

Accepted Answer

As of 9 October 2026, the Act generally applies from 2 August 2026. Under Regulation (EU) 2026/1744, Chapter III Sections 1–3, except Article 6(5), apply from 2 December 2027 to systems classified as high-risk under Article 6(2) and Annex III, and from 2 August 2028 to systems classified as high-risk under Article 6(1) and Annex I. Healthcare AI is not automatically high-risk. Intended use, the system’s role, applicable product legislation, and other classification facts matter; classification questions should go to qualified counsel.

Question 9

When do the AI Act’s Article 50 transparency obligations apply?

Accepted Answer

As of 9 October 2026, the Commission says Article 50 applies from 2 August 2026. It describes a limited transition only for the Article 50(2) marking and detection obligation for AI-generated content for systems placed on the market before 2 August 2026; providers of those systems must meet that obligation from 2 December 2026. This limited transition does not extend to every Article 50 transparency duty.

Question 10

Is the Commission’s high-risk classification guidance final?

Accepted Answer

As of 9 October 2026, the Commission still describes its high-risk classification guidance as draft. Its consultation closed on 23 July 2026, and the Commission says it expects to adopt final guidance by the end of 2026. That is the Commission’s stated expectation, not a guarantee; the guidance’s status may change. Check the Commission source for updates, and treat the draft as non-final.

Assessment questions, answered plainly.

Scope, fee, legal boundaries, and current dates.

Start with business and system context.