In brief. A patient harmed by substandard medical care in Italy has two distinct routes: a criminal route, which targets the personal liability of the doctor or healthcare professional (typically for lesioni personali colpose — negligent bodily harm — or omicidio colposo — negligent homicide), and a civil route, which seeks monetary compensation from the professional and, above all, from the hospital or healthcare facility. The two routes follow different rules on the onere della prova (burden of proof), different time limits and different standards of fault, and they can be pursued in parallel. The framework is shaped by art. 590-sexies of the Italian Criminal Code (codice penale, c.p.) and by the Gelli-Bianco Law (Legge 8 marzo 2017 n. 24).

Two routes, two logics

Italian law treats a single act of malpractice through two largely independent lenses.

The criminal route punishes the individual professional for negligent conduct that caused death or injury. It is driven by the public prosecutor (pubblico ministero) once a denuncia or querela (criminal complaint) is filed, and its purpose is to establish personal criminal responsibility, not to compensate the patient — although the injured party may join the proceedings as a parte civile (civil claimant within the criminal trial).

The civil route is purely compensatory. It is usually directed at the struttura sanitaria (the hospital or clinic), which answers under a contractual standard, and it aims at full recovery of the danno biologico (personal-injury damage), danno patrimoniale (economic loss) and danno morale (non-pecuniary harm).

Because the two routes serve different aims, English-speaking clients are frequently surprised that a criminal acquittal of the doctor does not automatically defeat a civil claim against the hospital — the standards of proof and the defendants are simply not the same.

The criminal route: art. 590-sexies c.p.

The cornerstone is art. 590-sexies del codice penale (responsabilità colposa per morte o lesioni personali in ambito sanitario — negligent liability for death or personal injury in the healthcare setting), introduced by the Gelli-Bianco reform.

The provision sets a special, narrower regime for healthcare professionals: where death or injury results from imperizia (lack of technical skill), criminal liability is excluded if the professional complied with the linee guida (clinical guidelines) accredited under the law, or — absent guidelines — with consolidated buone pratiche clinico-assistenziali (good clinical-care practices), provided those guidelines were adequate to the specific case.

Crucially, this shield covers only imperizia. It does not cover negligenza (carelessness) or imprudenza (recklessness): a surgeon who operates while distracted, or who ignores an obvious warning sign, remains fully exposed. The leading authority is the Court of Cassation, United Sections, judgment Sezioni Unite n. 8770/2018 (sentenza “Mariotti”), which clarified that the exemption applies to non-gross imperizia in the execution phase where adequate guidelines were respected.

Two further points matter as of October 2026. A temporary rule, most recently extended until 31 December 2026 by Decree-Law 200/2025 (converted by Law 26/2026), limits the criminal liability of health-care professionals to gross negligence in situations of serious staff shortage. A broader reform of art. 590-sexies, restricting criminal liability to gross negligence, is contained in a Government enabling bill still before Parliament and is not in force.

A criminal complaint is started by filing a querela — required for negligent bodily harm, including serious injuries — or, for negligent homicide (prosecuted ex officio), a denuncia with the Procura della Repubblica; the querela must be filed within three months of learning of the harm and its possible cause. The prosecutor then opens an investigation, almost always appointing a consulente tecnico (technical consultant) to assess whether the standard of care was breached.

The civil route: contractual vs. extra-contractual liability

The Gelli-Bianco Law drew a sharp line, codified in art. 7 della Legge 24/2017.

  • The healthcare facility (public or private) answers under a contractual standard (responsabilità contrattuale, art. 1218 c.c. — Italian Civil Code, codice civile). This is favourable to the patient: a ten-year limitation period applies and, once the patient has proved the treatment relationship and the causal link between the treatment and the harm, the facility must prove that it performed correctly or that the failure was due to a cause not attributable to it.
  • The individual professional, by contrast, answers under an extra-contractual (tort) standard (responsabilità extracontrattuale, art. 2043 c.c.), unless a direct contract with the patient exists. Here the limitation period is five years and the patient bears a heavier burden of proof.

This deliberate asymmetry channels most claims toward the better-resourced, mandatorily insured hospital, while preserving a route against the doctor personally. For an English-speaking patient, the practical takeaway is that the struttura is usually the primary defendant.

Burden of proof and causation

In every malpractice claim the decisive battleground is nesso di causalità (causal link). The patient must prove, on the civil standard of “più probabile che non” (more likely than not — the balance-of-probabilities test affirmed by Cassazione, Sezioni Unite, n. 581 of 11 January 2008), that the substandard care caused the damage.

In the criminal trial the standard is far stricter: causation must be established “oltre ogni ragionevole dubbio” (beyond reasonable doubt), following the landmark Cassazione, Sezioni Unite, n. 30328/2002 (sentenza “Franzese”). This gap explains why claimants often recover in the civil forum even when no criminal conviction follows.

A mandatory preliminary step in civil claims is the accertamento tecnico preventivo (preventive technical appraisal) under art. 8 della Legge 24/2017 or mediation: the patient must attempt one before filing suit, a condizione di procedibilità (condition of admissibility).

The CTU: the expert at the heart of the case

No medical-negligence case in Italy is decided without the CTU — consulenza tecnica d’ufficio (court-appointed technical expertise). The judge appoints an independent consulente tecnico d’ufficio, typically a forensic doctor (medico legale) flanked by a specialist in the relevant field, as required by art. 15 della Legge 24/2017, which mandates collegial appraisal in malpractice litigation.

The parties appoint their own consulenti tecnici di parte (CTP) to challenge or support the CTU. In practice the CTU report frequently determines the outcome, so the choice of a credible, well-qualified party expert is a strategic decision, not a formality. ILA works with experienced forensic-medicine consultants for clients pursuing or defending these claims.

To understand how the 2017 reform reshaped both routes, see our overview of the Gelli-Bianco Law.

FAQ

Can I bring both a criminal and a civil claim for the same medical error? Yes. The two routes are independent. You may file a criminal complaint and a separate civil action, or join the criminal proceedings as a parte civile to seek compensation within them. A criminal acquittal of the doctor does not automatically bar a civil claim against the hospital, because the standards of proof and the defendants differ.

Who do I sue — the doctor or the hospital? Usually the hospital or clinic is the primary defendant, because under art. 7 of the Gelli-Bianco Law the facility answers on a contractual basis with a ten-year limitation period and a favourable burden of proof. The individual professional answers in tort with a five-year limit. Often both are sued together.

How long do I have to start a claim? Against the healthcare facility, ten years from the harmful event (contractual liability). Against the individual professional, five years (extra-contractual liability). Limitation can run from when the damage became reasonably knowable, so foreign patients should seek advice early.

Speak to the firm

If you believe you or a relative have suffered avoidable harm during medical treatment in Italy, the medical records and timelines matter from day one. Learn more on our medical malpractice page, or contact the firm directly through the Contact page. You can also read about our team and approach.