In brief. The Gelli-Bianco Law — formally Legge 8 marzo 2017 n. 24 (Disposizioni in materia di sicurezza delle cure e della persona assistita, nonché in materia di responsabilità professionale degli esercenti le professioni sanitarie — Provisions on the safety of care and on the professional liability of healthcare practitioners) — is the cornerstone of Italian medical-malpractice law. It pursued a double objective: to improve patient safety and to bring order to a fragmented system of professional liability. For doctors it introduced a narrower regime of criminal exposure tied to clinical guidelines (linee guida) and good clinical-care practices (buone pratiche clinico-assistenziali); for patients it strengthened the route against hospitals and made professional insurance compulsory.

Why the law was passed

Before 2017, Italian medical liability had become unpredictable. Doctors complained of medicina difensiva (defensive medicine) — over-prescribing tests and procedures purely to avoid lawsuits — while patients faced uneven outcomes across courts. An earlier reform, the Legge Balduzzi (D.L. 158/2012, conv. in L. 189/2012), had tried to limit liability for professionals who followed accredited guidelines, but its drafting proved ambiguous and generated conflicting case law.

The Gelli-Bianco Law replaced that patchwork with a structured framework, building safety obligations into the system and clarifying when a professional can and cannot be held criminally responsible.

What changed for patient safety

The first half of the law is about prevention, not litigation.

  • Safety of care as a right. Art. 1 declares sicurezza delle cure (safety of care) an integral part of the constitutional right to health, extending to risk-prevention activities.
  • Risk-management structures. The law mandates regional centres for clinical risk and a national observatory on good practices in patient safety.
  • Transparency of records. Art. 4 obliges facilities to deliver a patient’s cartella clinica (medical record) within set deadlines — a practical lever for any patient considering a claim.

These provisions matter to litigants because timely, complete records are the raw material of every malpractice case.

Guidelines and good practices: the new yardstick

The conceptual heart of the reform is the elevation of clinical guidelines to a legal benchmark.

Under art. 5 della Legge 24/2017, healthcare professionals must, as a rule, comply with raccomandazioni previste dalle linee guida — recommendations set out in guidelines published by accredited scientific societies and institutions and listed in the Sistema Nazionale Linee Guida (National Guidelines System) run by the Istituto Superiore di Sanità. Where no guideline fits the case, the professional must follow buone pratiche clinico-assistenziali (good clinical-care practices).

The decisive nuance is adequacy: guidelines must be suited to the specific clinical situation. A professional cannot hide behind a guideline that did not match the patient in front of them. This adequacy test is what keeps the shield from becoming an automatic immunity.

The limits on criminal liability

The most debated change is art. 590-sexies del codice penale (Italian Criminal Code), inserted by the law. It carves out a special regime: where death or personal injury results from imperizia (lack of technical skill), the professional is not punishable if the accredited guidelines — or, failing those, good practices — were respected and were adequate to the case.

The boundaries were fixed by the Court of Cassation, United Sections, in Sezioni Unite n. 8770/2018 (“Mariotti”), which held that:

  • the exemption covers only imperizia, not negligenza (carelessness) or imprudenza (recklessness);
  • it applies where guidelines were correctly selected but imperfectly executed, provided the error of execution was not gross;
  • it does not apply where the wrong guidelines were chosen, or where the case fell outside any guideline.

In short, the law shields the honest technical mistake of a professional who followed the rules of the art, while leaving sloppiness and recklessness fully punishable.

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. For the interplay of this shield with the patient’s options, see our guide to the criminal and civil routes for medical negligence.

What changed for civil liability and insurance

On the compensation side, the law reorganised who answers and how.

  • Art. 7 fixed the doppio binario (dual-track) of liability: the healthcare facility answers on a contractual basis (art. 1218 c.c. — codice civile, ten-year limitation, burden favourable to the patient), while the individual professional answers in tort (art. 2043 c.c., five-year limitation) unless bound by a direct contract.
  • Quantification of danno biologico (personal-injury damage) follows the statutory tables under arts. 138 and 139 of the Codice delle Assicurazioni (Insurance Code); for major permanent injuries, the national single table adopted by Presidential Decree 12/2025 applies to events after 5 March 2025.
  • Compulsory insurance (art. 10) requires both facilities and professionals to carry cover, and art. 12 gives the injured patient a direct action (azione diretta) against the insurer. Both became fully operational with the implementing Ministerial Decree no. 232/2023, in force since 16 March 2024.
  • Mandatory pre-litigation step. Art. 8 makes an accertamento tecnico preventivo (preventive technical appraisal) or mediation a condizione di procedibilità (a condition for the claim to proceed) before suing.

What it means for patients in practice

For an English-speaking patient treated in Italy, the Gelli-Bianco Law offers a clearer, generally more favourable path to compensation: sue the well-insured hospital under the contractual standard, rely on the ten-year limitation period, and use the direct action against the insurer. At the same time, the criminal route against the doctor became narrower and more technical, hinging on whether adequate guidelines were followed. The expert appraisal (CTU) remains, as before, the centre of gravity of any case.

FAQ

What is the Gelli-Bianco Law in simple terms? It is the 2017 Italian statute (Legge n. 24/2017) that reformed medical-malpractice law. It strengthened patient safety, made guidelines the benchmark for assessing doctors’ conduct, limited their criminal liability for honest technical errors, set a dual-track civil-liability system and made professional insurance compulsory.

Does following clinical guidelines protect a doctor from prosecution? Partly. Under art. 590-sexies c.p., a doctor is shielded from criminal liability for imperizia (lack of skill) only if accredited guidelines — adequate to the specific case — were respected. The shield does not cover carelessness or recklessness, as the Cassazione confirmed in the “Mariotti” judgment of 2018.

Did the law make it easier or harder to claim compensation? For compensation, generally easier: patients can sue the hospital on a favourable contractual basis with a ten-year limitation period and bring a direct action against the insurer. The criminal route against the individual doctor, by contrast, became narrower and more technical.

Speak to the firm

If your treatment in Italy went wrong and you are unsure whether the Gelli-Bianco framework helps your case, the firm can assess the records and the timeline. See our medical malpractice overview, contact us through the Contact page, or read about our team.