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Offences and defences

Medical negligence as a criminal charge in Italy

by Massimo Romano4 min readupdated 2026-08-05
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Direct answer

Unlike most systems, Italy prosecutes clinical error as a crime and not only as a civil wrong. A statute of 2017 narrowed that exposure: where the practitioner followed accredited guidelines suited to the case, liability for lack of skill is excluded. What remains fully punishable is negligence and imprudence, and that is where these cases are now fought.

The framework

ElementContentSource
Underlying offencesNegligent injury or negligent homicideArts. 590 and 589 Criminal Code
Exclusion of liabilityFor lack of skill, where guidelines were observedArt. 590-sexies Criminal Code
ConditionThe guidelines must be suited to the specific caseStatute of 2017
What remains punishableNegligence and imprudenceGeneral rules on fault
Informed consentRequired, in writing, and recorded in the clinical fileStatute of 2017 on consent
Clinical recordA public document; later alteration is forgeryArts. 476 and 479

The distinction between lack of skill on one side and negligence or imprudence on the other decides these cases. Failing to apply a technique correctly may fall within the exclusion; failing to monitor a patient, failing to read a test result, failing to hand over information at the change of shift does not. Prosecutions are therefore framed around omissions rather than around technique.

Guidelines, and the words that limit them

The exclusion applies where the practitioner observed guidelines published under the statutory system or, failing those, good clinical practice. It carries a condition that does most of the work: the guidelines must be suited to the specificity of the case.

So the argument is rarely about whether a guideline exists. It is about whether this patient, with these comorbidities, at this hour, in this hospital, was a case the guideline covered — and where the answer is no, the exclusion falls away and ordinary rules on fault apply.

Working in a team

Each member of a clinical team answers for their own segment. The principle of reliance means nobody is required to supervise the work of colleagues — until the colleague's error becomes apparent with ordinary diligence, at which point the duty to act revives.

Where the fault lies with more than one person the analysis becomes counterfactual: it is not enough that each made a mistake, it must be shown that correct conduct by that particular person would have avoided the outcome with a high degree of rational credibility. That is the point at which many collective prosecutions dissolve.

  • The actual roster and the composition of the team, which does not always match the formal one.
  • The hourly chronology of every act, note and report.
  • Whether the colleague's error was apparent at the time, not with hindsight.
  • Protocols in force at that facility, not the ideal ones.
  • Organisational conditions: staffing, equipment, workload, which bear on what could be required.

The clinical record, and one fatal mistake

The clinical record is a public document and each entry becomes definitive when it is made. Correcting it afterwards is forgery, even where the corrected content is true, because what the law protects is the genuineness of the document rather than its accuracy.

That charge is intentional, not negligent; it sits outside the protections that apply to clinical fault; and it destroys the credibility of everything else the practitioner says. Errors are corrected by a new, dated and signed entry that leaves the original legible — never by overwriting, and never with correction fluid.

The arrival of a request for a copy of the record is, in most cases, the first sign that proceedings are coming. That is the moment to have it examined, not to reread it.

If you are the patient or the family

The post-mortem, where there is one, is a technical examination in which the family may appoint its own expert, and it cannot be repeated. The position is set out in the guide on investigations following a death, and the rights of injured parties in the guide for victims.

Frequently asked questions

Is medical error a crime in Italy?

It can be. Negligent injury and negligent homicide apply to clinical practice, subject to a statutory exclusion where accredited guidelines suited to the case were followed.

Does following guidelines protect me?

Only for lack of skill, and only where the guidelines were suited to the specific case. Negligence and imprudence remain fully punishable.

Can I correct an entry in the clinical record?

Not by overwriting. Each entry becomes definitive when made, and later alteration is forgery even if the new content is true. Correct with a fresh dated and signed entry.

What does it mean when someone requests the record?

It is usually the first sign that a complaint is coming. That is the moment to have the documentation examined by a lawyer.

If a file has been opened

The clinical record and the appointment of a technical expert decide these cases, and both are urgent. First contact is free and covered by professional privilege.

Reachable 24 hours

Tell me what has happened

First contact is free and covered by professional privilege, at any hour including nights and holidays.

Bar of Naples, admission no. 14553 · Rome · Milan · Naples

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