HILBI IQ · ONE QUESTION, ANSWERED
Who is responsible when AI touches a patient case?
- Deployer duties
- Signature gate
- Architecture private
Under the AI Act, whoever puts an AI system to work in a professional process carries the duties. Paste a case into a general assistant and the practice owns that. IQ arrives the other way round, as a processor under a written agreement.
Deployer duties
carried by the processor, not by you
Art. 50(4)
transparency recorded on every output
Two ways of working, side by side
The comparison is between two situations, never between named products.
Who is the deployer under the AI Act
A general-purpose assistant used outside the clinical system
To confirmThe practice, by putting the system to use
Hilbi IQ
In forceAllocated in writing, with Hilbi as processor
Contractual relationship for the data
A general-purpose assistant used outside the clinical system
To confirmConsumer terms; usually no Art. 28 agreement
Hilbi IQ
In forceArt. 28 processing agreement per market
Where the data is processed
A general-purpose assistant used outside the clinical system
To confirmDetermined by the vendor's terms; often outside the EU
Hilbi IQ
In forceEU for SK and CZ; India for IN (contractual)
Use for model training
A general-purpose assistant used outside the clinical system
To confirmGoverned by the vendor's terms, changeable
Hilbi IQ
In forceExcluded contractually
Transparency toward the patient
A general-purpose assistant used outside the clinical system
To confirmNothing records that text was machine-generated
Hilbi IQ
In forceArt. 50(4) disclosure carried with the draft
Human oversight
A general-purpose assistant used outside the clinical system
To confirmA habit, not a gate
Hilbi IQ
In forceSignature gate: §21 SK, §12 CZ
Record of what happened
A general-purpose assistant used outside the clinical system
To confirmOutside the record; not auditable by the practice
Hilbi IQ
In forceImmutable trail, exportable by you
What reaches the clinical record
A general-purpose assistant used outside the clinical system
To confirmCopy-paste, unattributed
Hilbi IQ
In forceStructured FHIR R4 resources, signed
In force: applies today and can be evidenced. In progress: under way and dated. Readiness: the position is prepared. To confirm: not established — stated as such, never shown as settled.
What is published, and what is not
Enough to assess responsibility. Not enough to rebuild the system.
- Processing locationIn force
- Stated per market and contractual.
- Legal rolesIn force
- Provider as controller, Hilbi as processor under Art. 28 GDPR, with the AI Act deployer duties allocated in writing.
- Transparency mechanismIn force
- Machine-generated clinical text is disclosed under AI Act Art. 50(4) and carries the clinician who signed it.
- Oversight mechanismIn force
- A signature gate before filing, not a review recommendation.
- Intended purposeIn force
- Generates a structured draft report for clinician review and suggests service codes. It does not diagnose and it does not decide.
- ClassificationIn force
- Assessed against MDCG 2019-11 and AI Act Art. 6(1) on the stated intended purpose, so a reviewer can re-run the assessment.
- Audit evidenceIn force
- What was generated, what was edited, who signed, when: immutable and exportable.
- What is not publishedIn force
- Model routing, prompt construction, retrieval design and the vendor mix are not published. Responsibility can be assessed without them, and publishing them would not make the answer more checkable.
- Independent verificationIn force
- Under agreement a reviewer receives the audit report, the penetration test summary and the sub-processor list.
The follow-up questions
It is not automatically unlawful, but it moves the duties onto the practice: a lawful basis for the disclosure, a processing agreement with whoever receives the data, a transfer basis if it leaves the EU, the AI Act transparency duty toward the patient, and an audit trail the practice does not have. Most practices discover the gap when they are asked to evidence it.
Effective anonymisation takes the processing outside GDPR, but a clinical case narrative is rarely anonymous in practice: the combination of condition, dates and locality re-identifies. Pseudonymised data stays personal data and the duties above still apply.
The clinician who signs is responsible for the record entry, which is exactly why the signature is a gate rather than a suggestion. IQ's part is to produce a draft that is reviewable and to record what was generated and what was changed.
The assessment turns on the stated intended purpose. IQ generates a structured draft report for clinician review and suggests service codes; it does not diagnose and it does not decide. That statement is published so a reviewer can re-run the Art. 6(1) and MDCG 2019-11 assessment rather than take a conclusion on trust.
Because responsibility can be assessed without it. The processing location, the legal roles, the transparency record, the oversight gate and the audit trail are all published and all checkable; the routing and retrieval design are not, and no reviewer needs them to reach a decision.