Consenso Informato Sicuro · In development

Informed consent, verified.

Regulatory compliance, essential data, consistency with the procedure and internal consistency of the document. For doctors and clinics.

What it validates

Regulatory compliance

The consent form contains the mandatory information required by Italian Law 219/2017 and Law 24/2017 (Gelli-Bianco): the nature and purpose of the procedure, the main risks, therapeutic alternatives and the option not to proceed. Each section is checked against the regulatory framework in force.

Essential data present

Patient personal details, doctor identification, date and time the consent was obtained, patient signature and doctor countersignature. Consenso Informato Sicuro flags every missing mandatory field before the document leaves the practice or the organisation.

Consistency with the procedure

Does the signed consent match the procedure actually scheduled? A generic consent does not cover a specific surgical procedure. Consenso Informato Sicuro checks that the subject of the consent is specific, identifiable and consistent with the procedure recorded in the medical record.

Internal consistency of the document

Diagnosis consistent across sections, matching personal details, no anomalous dates (consent must precede the procedure), signatures present and attributable. Five types of inconsistency detected: conflicting data, anomalous dates, missing signatures, contradictory diagnoses, inconsistent references to the procedure.

Corrective suggestions

When validation flags an inconsistency or missing data, Consenso Informato Sicuro proposes a concrete correction. The doctor reads, assesses and decides. Responsibility for the consent always remains with the professional.

A support tool

Structured output (compliant · needs completing · needs review) with specific reasoning. Designed not to slow down the clinical workflow: the doctor gets the check at a point when corrections are still possible.

Priority use cases

Surgical consent: checks before the operation that the document is specific to the scheduled procedure and includes the risks, signatures and date. A generic consent offers no protection in court.
Anaesthetic consent: completeness and consistency check of the anaesthesia form: type of anaesthesia, specific risks, declared allergies, signatures of the anaesthetist and the patient.
Consent for invasive diagnostic procedures: endoscopy, biopsy, arthrocentesis and similar. Checks that the document describes the procedure correctly and that the patient has received adequate information about the risks.
Consent for oncological and chronic treatments: chemotherapy, radiotherapy, biological therapies. Consistency between diagnosis, stated protocol and signed consent; checks on how often renewals are due.
Consent in outpatient and multi-specialty clinic settings: systematic checks on large volumes, applicable to the entire patient flow of a multi-specialty organisation.

Doctor and patient talking before a procedure, with the consent form waiting to be signed

Compliance and data sovereignty

GDPR for health data

Processing compliant with Article 9. Encryption at rest and in transit.

AI Act requirements

Transparency of AI output, an audit trail for every validation, mandatory human review before any action on the document.

Data kept within the European Union

AI processing, storage and backup on EU infrastructure. No transfers outside the EU at any stage.

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Consenso Informato Sicuro is in development. Sign up for updates on availability, or ask to join the pilot.