In brief. Medical negligence — colpa medica in Italian law — is the legal framework under which patients can seek compensation and, in serious cases, criminal accountability when health-care providers fail to deliver care at the standard required by the profession. Italian law combines a civil compensation track, a criminal track (under art. 590-sexies of the Criminal Code) and an administrative track. The current framework is heavily shaped by Law 24/2017 (“Gelli-Bianco”), which redesigned the system of liability for both doctors and health-care facilities.

Key takeaways

  • Medical negligence in Italy is regulated by Law 24/2017 (Gelli-Bianco) and by art. 590-sexies of the Italian Criminal Code.
  • Patients can pursue civil compensation for damages and, in serious cases, criminal proceedings against the doctor.
  • Health-care facilities (public or private) are liable on a contractual basis (art. 1218 c.c.); the doctor employed by the facility is liable on an extra-contractual basis (art. 2043 c.c.), unless there is a direct private retainer.
  • A mandatory mediation procedure (“ATP conciliativo” ex art. 696-bis c.p.c. or mediation) precedes the civil claim.
  • The statute of limitations differs: 10 years for contractual claims (facility), 5 years for extra-contractual claims (doctor).

What is medical negligence under Italian law?

Medical negligence is the breach of the standard of care that a competent professional should observe in a given clinical situation, when that breach causes harm to the patient. Italian law captures this concept through several layers: the civil liability of the facility for damages, the civil liability of the practitioner, and — in cases involving death or personal injury caused by negligence — the criminal liability of the practitioner under art. 590-sexies of the Criminal Code.

Liability requires four elements: (i) a duty of care owed to the patient; (ii) a breach of that duty (negligence, imprudence, lack of skill, non-compliance with guidelines); (iii) harm to the patient (personal injury, death, deterioration); and (iv) a causal link between breach and harm.

The current framework was reshaped by Law 24/2017 (Gelli-Bianco), which strengthened the role of clinical guidelines and good practices and introduced a partial criminal “safe harbour” for practitioners who followed accredited guidelines.

  • Law 24/2017 (“Gelli-Bianco”) — comprehensive reform of medical liability in Italy.
  • Art. 590-sexies Italian Criminal Code — criminal liability for death or personal injury in health-care; partial exclusion of criminal liability when the practitioner complied with accredited guidelines or good clinical practices, as construed by the Italian Supreme Court (United Sections judgment no. 8770/2018, “Mariotti”).
  • Art. 1218 Italian Civil Code — contractual liability of the health-care facility.
  • Art. 2043 Italian Civil Code — extra-contractual liability of the practitioner (so-called “double track”).
  • Art. 8 Law 24/2017 — mandatory attempt at conciliation before the civil claim.
  • Art. 9 Law 24/2017 — recourse action of the facility against the practitioner.
  • Art. 7 Law 24/2017 — liability allocation between facility and practitioner.
  • Ministerial Decree no. 232/2023 (in force 16 March 2024) — implementing decree on the Gelli-Bianco mandatory insurance system, which made operative the minimum policy requirements and the injured party’s direct action against the insurer.

What kinds of cases qualify as medical negligence?

Italian case law has identified a wide range of situations:

  • Surgical errors: wrong-site surgery, retained foreign objects, operative complications attributable to incorrect technique.
  • Diagnostic errors: missed or delayed diagnosis, misinterpretation of imaging, failure to investigate alarming symptoms.
  • Pharmacological errors: wrong drug, wrong dose, adverse interactions not screened.
  • Birth injuries: complications of pregnancy and delivery, including child medical negligence claims.
  • Informed consent issues: surgery or treatment performed without adequate and complete disclosure of risks and alternatives.
  • Nosocomial infections acquired in hospital, when traceable to organisational defects.
  • Delayed transfer to a more specialised facility when clinically indicated.

The complete framework, including procedural strategy, is presented in the complete guide to medical malpractice in Italy.

How does the civil claim work?

Civil proceedings in medical negligence follow a path designed by Law 24/2017 to encourage early settlement.

Step 1 — Pre-litigation phase. The patient (or their family) collects the medical records, requests a medico-legal expert opinion, and identifies the legal counterparts. A formal letter of claim (“messa in mora”) is sent to the facility and, where appropriate, the practitioner.

Step 2 — Mandatory mediation/ATP. Before filing a civil claim, art. 8 of Law 24/2017 requires either a mediation or a so-called “ATP conciliativo” ex art. 696-bis of the Code of Civil Procedure — an expert opinion procedure aimed at facilitating settlement. The court appoints a neutral expert; the parties may settle on the basis of the opinion.

Step 3 — Civil claim. If conciliation fails, the patient files a civil claim. The facility is sued on a contractual basis (the patient was admitted under a contract of care, even if implicit), with the longer 10-year statute of limitations. The practitioner is sued on an extra-contractual basis under art. 2043 c.c., with a 5-year limitation period (subject to nuances when criminal proceedings are concurrent).

Step 4 — Court-appointed expert. The court appoints a Consulente Tecnico d’Ufficio (CTU) who, in collaboration with a specialist in the relevant clinical area, assesses negligence, causal link and damages.

Step 5 — Judgment and damages. Damages include patrimonial losses (medical expenses, loss of earnings, future care) and non-patrimonial damages (pain and suffering, biological damage, moral damage), liquidated according to standardised tables.

When does medical negligence become a criminal offence?

Criminal liability arises when the negligence causes personal injury (art. 590 c.p.) or death (art. 589 c.p.). Art. 590-sexies of the Criminal Code, introduced by Law 24/2017, provides a partial safe harbour: if the practitioner complied with accredited guidelines or recognised good clinical practices, criminal liability for lack of skill (“imperizia”) is excluded — provided the guidelines were adequate to the specific clinical case.

The exact perimeter of this safe harbour was settled by the United Sections “Mariotti” of 2018, which clarified that the exclusion applies only to negligence by lack of skill (imperizia) of mild degree in the execution phase, not to choices of treatment or in cases of gross negligence.

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.

Criminal proceedings can run in parallel with civil ones. The civil claim can be brought as a parte civile in the criminal proceedings, with procedural advantages but also risks.

What can a patient recover?

Compensation in Italian medical negligence covers a broad set of items:

  • Patrimonial damages: medical expenses (past and future), loss of income, loss of earning capacity, costs of assistance and care.
  • Biological damage (danno biologico): the impairment of psycho-physical integrity, evaluated by medical experts and quantified using tables: art. 7(4) of Law 24/2017 refers to the tables of arts. 138-139 of the Private Insurance Code, and the national single table for major permanent injuries (Presidential Decree 12/2025) applies to events after 5 March 2025; for earlier events courts have generally used the Milan tables.
  • Moral damage (danno morale): suffering and psychological distress.
  • Relational and existential harm: impact on the daily and relational dimension of life, assessed within the single category of non-patrimonial damage.
  • Loss of chance (perdita di chance): in cases where negligence caused the loss of a real probability of better outcomes, even without strict causal link to the harm.
  • Iure proprio damages of relatives in cases of death or severe permanent injury.

For cross-border cases — where the patient is a non-resident or treatment took place in multiple jurisdictions — additional issues of applicable law and jurisdiction arise. Independent legal advice in the specific case is necessary.

Case examples

(Illustrative examples: they do not refer to specific proceedings.)

Case 1 — Cross-border birth injury. A foreign couple delivers a child in an Italian hospital; complications during labour cause permanent disability. The family seeks compensation in Italy on contractual grounds against the facility (10-year limitation period) and on extra-contractual grounds against the obstetrician (5 years). In a case of this kind, counsel coordinates the medico-legal expert opinion, the mandatory conciliation step under Law 24/2017 and, where needed, the cross-border enforcement of the judgment.

Case 2 — Misdiagnosed cancer leading to delayed treatment. A patient is told for months that his symptoms are due to a benign condition. By the time the correct diagnosis is made, the cancer has progressed. The case is built on the loss of chance doctrine: the negligence reduced the probability of recovery, and that lost probability is itself compensable, even without proving certainty of survival in absence of the error.

FAQ

How long do I have to file a claim? For claims against the health-care facility (contractual liability), the statute of limitations is 10 years from the harm. For claims against the practitioner (extra-contractual liability), it is 5 years. The clock starts not from the medical act but from the moment the patient knew or could have reasonably known about the harm and its cause.

Do I have to mediate before going to court? Yes. Art. 8 of Law 24/2017 requires either a mediation procedure or an “ATP conciliativo” ex art. 696-bis c.p.c. before filing a civil claim for medical negligence. It is a condition for the claim to proceed: if it is skipped, the court stays the case and sets a deadline to complete it. The mediation is also an opportunity to settle without prolonged litigation.

Can I claim if the doctor followed guidelines but the outcome was bad? A bad outcome is not by itself proof of negligence. If the doctor followed adequate guidelines and exercised proper care, no liability arises. Liability requires a breach of standard. Italian law recognises that medicine is inherently uncertain. Independent expert opinions are essential to assess whether guidelines were appropriate and properly applied.

What if I am not an Italian resident? Non-resident patients have full standing to bring claims in Italian courts when the treatment took place in Italy. EU regulations (Brussels I bis, Rome II) govern jurisdiction and applicable law for cross-border cases. The firm handles cross-border enforcement and the linguistic dimension of the file.

Is there compensation for the family in case of death? Yes. Family members (spouse, children, parents, in some cases siblings and stable cohabitants) can claim iure proprio damages for moral and existential loss, plus, where applicable, loss of financial support. Quantification follows standardised tables corrected by the specific circumstances.

Talk to the firm

For a confidential consultation on a specific medical negligence file, including cross-border cases, the firm replies within one hour.

ILA — International Lawyers Associates — assists patients and families in medical negligence cases, with a focus on cross-border situations and complex causation issues.

About the Firm

ILA — International Lawyers Associates is an Italian law firm focused on international criminal law and complex litigation, including medical liability with cross-border profiles. Offices in Naples, Milan and Rome and international correspondents in major jurisdictions. The firm is led by Avv. Alexandro Tirelli and operates in Italian, English and Spanish.