Generic placeholder image

Current Pharmaceutical Biotechnology


ISSN (Print): 1389-2010
ISSN (Online): 1873-4316

Research Article

New Rules on Patient’s Safety and Professional Liability for the Italian Health Service

Author(s): Sara Albolino, Tommaso Bellandi, Simone Cappelletti, Marco Di Paolo, Vittorio Fineschi*, Paola Frati, Caterina Offidani, Michela Tanzini, Riccardo Tartaglia and Emanuela Turillazzi

Volume 20, Issue 8, 2019

Page: [615 - 624] Pages: 10

DOI: 10.2174/1389201020666190408094016

Price: $65


Background: The phenomenon of clinical negligence claims has rapidly spread to United States, Canada and Europe assuming the dimensions and the severity of a pandemia. Consequently, the issues related to medical malpractice need to be studied from a transnational perspective since they raise similar problems in different legal systems.

Methods: Over the last two decades, medical liability has become a prominent issue in healthcare policy and a major concern for healthcare economics in Italy. The failures of the liability system and the high cost of healthcare have led to considerable legislative activity concerning medical malpractice liability, and a law was enacted in 2012 (Law no. 189/2012), known as the “Balduzzi Law”.

Results: The law tackles the mounting concern over litigation related to medical malpractice and calls for Italian physicians to follow guidelines. Briefly, the law provided for the decriminalisation of simple negligence of a physician on condition that he/she followed the guidelines and “good medical practice” while carrying out his/her duties, whilst the obligation for compensation, as defined by the Italian Civil Code, remained. Judges had to consider that the physician followed the provisions of the guidelines but nevertheless caused injury to the patient.

Conclusion: However, since the emission of the law, thorny questions remain which have attracted renewed interest and criticism both in the Italian courts and legal literature. Since then, several bills have been presented on the topic and these have been merged into a single text entitled “Regulations for healthcare and patient safety and for the professional responsibility of healthcare providers”.

Keywords: Medical liability, patient safety, risk management, Italian law 24/2017, quality of health care, malpractice claims.

Graphical Abstract
Albolino, S.; Tartaglia, R.; Bellandi, T.; Bianchini, E.; Fabbro, G.; Forni, S.; Cernuschi, G.; Biggeri, A. Variability of adverse events in the public health-care service of the Tuscany region. Intern. Emerg. Med., 2017, 12(7), 1033-1042.
Di Landro, A.R. Criminal law as a response to medical malpractice: pluses and minuses-comparing Italian and U.S. experiences. Med. Law, 2012, 31, 221-263.
Association of Insurance Companies. Association of Insurance Companies (ANIA) Executive Summary 2015-2016.. Insurance/2015-2016/ANIA-Italian-Insurance-2015- 16.pdf (Accessed January 19, 2018).
Association of Insurance Companies. Association of Insurance Companies (ANIA) Executive Summary 2012-2013.. images/agenas/monitor/quaderno/pdf/14_indagine_sui_modelli_ regionali_sinistri.pdf (Accessed January 19, 2018).
Di Marzo, C. Medical malpractice: The Italian experience. Chic. Kent Law Rev., 2012, 87, 53-77.
Traina, F. Medical malpractice: The experience in Italy. Clin. Orthop. Relat. Res., 2009, 467, 434-442.
Elli, L.; Tenca, A.; Soncini, M.; Spinzi, G.; Buscarini, E.; Conte, D. Defensive medicine practices among gastroenterologists in Lombardy: Between lawsuits and the economic crisis. Dig. Liver Dis., 2013, 45, 469-473.
Catino, M.; Celotti, S. The problem of defensive medicine: Two Italian surveys. Stud. Health Technol. Inform., 2009, 148, 206-221.
Magnavita, N.; Fileni, A.; Mirk, P.; Magnavita, G.; Ricci, S.; Cotroneo, A.R. Malpractice claims in interventional radiology: Frequency, characteristics and protective measures. Radiol. Med. , 2013, 118, 504-517.
Panella, M.; Rinaldi, C.; Leigheb, F.; Donnarumma, C.; Kul, S.; Vanhaecht, K.; Di Stanislao, F. The determinants of defensive medicine in Italian hospitals: The impact of being a second victim. Rev. Calid. Asist., 2016, 31, 20-25.
Amaral Garcia, S.; Bertoli, P.; Grembi, V. Does experience rating improve obstetric practices? Evidence from Italy. Health Econ., 2015, 24(9), 1050-1064.
Italian law 189/2012. 11/10/012G0212/sg (Accessed January 19, 2018).
Voultsos, P.; Casini, M.; Ricci, G.; Tambone, V.; Midolo, E.; Spagnolo, A.G. A proposal for limited criminal liability in high-accuracy endoscopic sinus surgery. Acta Otorhinolaryngol. Ital., 2017, 37(1), 65-71.
Vincent, C.; Batalden, P.; Davidoff, F. Multidisciplinary centres for safety and quality improvement: learning from climate change science. BMJ Qual. Saf., 2011, 20, i73-i78.
Nuti, S.; Tartaglia, R.; Niccolai, F. Rischio clinico e sicurezza del paziente: modelli e soluzioni nel contesto internazionale; Il Mulino: Bologna, 2007.
Bellandi, T.; Albolino, S.; Tartaglia, R.; Bagnara, S. Human Factors and Ergonomics in Patient Safety Management. In Human Factors and Ergonomics in Health Care and Patient Safety,, 2nd ed.;; CRC Press Taylor & Francis Group: Boca Raton, 2012.
Bellandi, T.; Albolino, S.; Tomassini, C. How to create a safety culture in the healthcare system: the experience of the Tuscany Region. Theor. Issues Ergon. Sci., 2007, 8(5), 495-507.
Bagnara, S.; Tartaglia, R. Patient safety: An old and a new issue. Theor. Issues Ergon. Sci., 2007, 8(5), 365-372.
Graham, R.; Mancher, M.; Wolman, D.M.; Greenfield, S.; Steinberg, E. Clinical practice guidelines we can trust; National Academies Press: Washington, DC, 2011.
Italian Ministry of Health, Decree 15 July 1997, “Transposition of European Union Guidelines on good clinical practice for clinical trials”.. (Accessed January 19, 2018).
European Union Network for Patient Safety and Quality of Care (PaSQ).. (Accessed January 19, 2018).
Wetterneck, T.B.; Pak, M.H. Using clinical practice guidelines to improve patient care. WMJ, 2005, 104(3), 30-33.
Rotter, T.; Kinsman, L.; James, E.; Machotta, A.; Gothe, H.; Willis, J.; Snow, P.; Kugler, J. Clinical pathways: Effects on professional practice, patient outcomes, length of stay and hospital costs. Cochrane Database Syst. Rev., 2010, 17CD006632
Medves, J.; Godfrey, C.; Turner, C.; Paterson, M.; Harrison, M.; MacKenzie, L.; Durando, P. Systematic review of practice guideline dissemination and implementation strategies for healthcare teams and team-based practice. Int. J. Evid.-Based Healthc., 2010, 8, 79-89.
Grimshaw, J.M.; Thomas, R.E.; MacLennan, G.; Fraser, C.; Ramsay, C.R.; Vale, L.; Whitty, P.; Eccles, M.P.; Matowe, L.; Shirran, L.; Wensing, M.; Dijkstra, R.; Donaldson, C. Effectiveness and efficiency of guideline dissemination and implementation strategies. Health Technol. Assess., 2004, 8, 1-72.
Hakkennes, S.; Dodd, K. Guideline implementation in allied health professions: A systematic review of the literature. Qual. Saf. Health Care, 2008, 17, 296-300.
Ivers, N.; Jamtvedt, G.; Flottorp, S.; Young, J.M.; Odgaard-Jensen, J.; French, S.D.; O’Brien, M.A.; Johansen, M.; Grimshaw, J.; Oxman, A.D. Audit and feedback: Effects on professional practice and healthcare outcomes. Cochrane Database Syst. Rev., 2012, (6)CD000259
Baker, R.; Camosso-Stefinovic, J.; Gillies, C.; Shaw, E.J.; Cheater, F.; Flottorp, S.; Robertson, N.; Wensing, M.; Fiander, M.; Eccles, M.P.; Godycki-Cwirko, M.; van Lieshout, J.; Jäger, C. Tailored interventions to address determinants of practice. Cochrane Database Syst. Rev., 2015, (4)CD005470
Baskerville, N.B.; Liddy, C.; Hogg, W. Systematic review and meta-analysis of practice facilitation within primary care settings. Ann. Fam. Med., 2012, 10, 633-636.
Brusamento, S.; Legido-Quigley, H.; Panteli, D.; Turk, E.; Knai, C.; Saliba, V.; Car, J.; McKee, M.; Busse, R. Assessing the effectiveness of strategies to implement clinical guidelines for the management of chronic diseases at primary care level in EU Member States: a systematic review. Health Policy, 2012, 107, 168-183.
Flodgren, G.; Parmelli, E.; Doumit, G.; Gattellari, M.; O’Brien, M.A.; Grimshaw, J.; Eccles, M.P. Local opinion leaders: Effects on professional practice and health care outcomes. Cochrane Database Syst. Rev., 2011, 10CD000125
Di Sanzo, M.; Cipolloni, L.; Borro, M.; La Russa, R.; Santurro, A.; Scopetti, M.; Simmaco, M.; Frati, P. Clinical applications of personalized medicine: A new paradigm and challenge. Curr. Pharm. Biotechnol., 2017, 18(3), 194-203.
La Russa, R.; Fineschi, V.; Di Sanzo, M.; Gatto, V.; Santurro, A.; Martini, G.; Scopetti, M.; Frati, P. Personalized medicine and adverse drug reactions: The experience of an Italian Teaching Hospital. Curr. Pharm. Biotechnol., 2017, 18(3), 274-281.
Borro, M.; Gentile, G.; Cipolloni, L.; Foldes-Papp, Z.; Frati, P.; Santurro, A.; Lionetto, L.; Simmaco, M. Personalised healthcare: The DiMA clinical model. Curr. Pharm. Biotechnol., 2017, 18(3), 242-252.
Lohr, K.N.; Eleazer, K.; Mauskopf, J. Health policy issues and applications for evidence-based medicine and clinical practice guidelines. Health Policy, 1998, 46, 1-19.
Sonnenberg, A.; Boardman, C.R. Costs of Fear. Am. J. Gastroenterol., 2013, 108, 173-175.
Kachalia, A.; Little, A.; Isavoran, M.; Crider, L.M.; Smith, J. Greatest impact of safe harbor rule may be to improve patient safety, not reduce liability claims paid by physicians. Health Aff. (Millwood), 2014, 33, 59-66.
Kachalia, A.; Mello, M.M. Breast cancer screening: conflicting guidelines and medicolegal risk. JAMA, 2013, 309, 2555-2556.
Mehlman, M.J. Medical practice guidelines as malpractice safe harbors: Illusion or deceit? J. Law Med. Ethics, 2012, 40, 286-300.
Samanta, A.; Mello, M.M.; Foster, C.; Tingle, J.; Samanta, J. The role of clinical guidelines in medical negligence litigation: A shift from the Bolam standard? Med. Law Rev., 2006, 14, 321-366.
AGREE Collaboration. Development and validation of an international appraisal instrument for assessing the quality of clinical practice guidelines: The AGREE project. Qual. Saf. Health Care, 2003, 12, 18-23.
Balshem, H.; Helfand, M.; Schünemann, H.J.; Oxman, A.D.; Kunz, R.; Brozek, J.; Vist, G.E.; Falck-Ytter, Y.; Meerpohl, J.; Norris, S.; Guyatt, G.H. GRADE guidelines: 3. Rating the quality of evidence. J. Clin. Epidemiol., 2011, 64, 401-406.
Schünemann, H.J.; Wiercioch, W.; Brozek, J.; Etxeandia-Ikobaltzeta, I.; Mustafa, R.A.; Manja, V.; Brignardello-Petersen, R.; Neumann, I.; Falavigna, M.; Alhazzani, W.; Santesso, N.; Zhang, Y.; Meerpohl, J.J.; Morgan, R.L.; Rochwerg, B.; Darzi, A.; Rojas, M.X.; Carrasco-Labra, A.; Adi, Y.; AlRayees, Z.M.; Riva, J.; Bollig, C.; Moore, A.; Yepes-Nuñez, J.J.; Cuello, C.; Waziry, R.; Akl, E.A. GRADE Evidence to Decision Frameworks for adoption, adaptation and de novo development of trustworthy recommendations: GRADE-ADOLOPMENT. J. Clin. Epidemiol., 2017, 81, 101-110.
Guyatt, G.H.; Oxman, A.D.; Kunz, R.; Vist, G.E.; Falck-Ytter, Y.; Schunemann, H.J. What is actuality of evidence and why is it important to clinicians? BMJ, 2008, 336, 995-998.
Kung, J.; Miller, R.R.; Mackowiak, P.A. Failure of clinical practice guidelines to meet institute of medicine standards: Two more decades of little, if any, progress. Arch. Intern. Med., 2012, 172, 1628-1633.
Laine, C.; Taichman, D.B.; Mulrow, C. Trustworthy clinical guidelines. Ann. Intern. Med., 2011, 154, 774-775.
Qaseem, A.; Forland, F.; Macbeth, F.; Ollenschläger, G.; Phillips, S.; van der Wees, P. Board of Trustees of the Guidelines International Network. Guidelines International Network: Toward international standards for clinical practice guidelines. Ann. Intern. Med., 2012, 156, 525-531.
US Office of Technology Assessment. Impact of Legal Reform on Medical Malpractice Costs.. (Accessed January 19, 2018).
Grilli, R. Toward the efficacy of clinical appropriateness: national program for guidelines. Epidemiol. Prev., 2000, 24, 54-56.
Grilli, R.; Taroni, F. Guidelines: Several principles of the National Program. Recenti Prog. Med., 2000, 91, 341-343.
Mele, A.; D’Angelo, F.; Della Seta, M.; Lacorte, E.; Laricchiuta, P.; Morciano, C.; De Masi, S. National Guidelines System: The Italian experience. Epidemiol. Prev., 2014, 38, 53-58.
Keyhani, S.; Kim, A.; Mann, M.; Korenstein, D. A new independent authority is needed to issue National Health Care guidelines. Health Aff. (Millwood), 2011, 30, 256-265.
National Institute for Health and Care Excellence. The Guidelines Manual; National Institute for Health and Care Excellence; NICE: London, 2012.
Poolman, R.W.; Verheyen, C.C.; Kerkhoffs, G.M.; Bhandari, M.; Schunemann, H.J. International Evidence-Based Orthopedic Surgery Working Group. From evidence to action: Understanding clinical practice guidelines. Acta Orthop., 2009, 80, 113-118.
Avrahan, R. Clinical Practice Guidelines: The Warped Incentives in the U.S. Healthcare System. Am. J. Law Med., 2011, 37, 7-40.
Tzeel, A. Clinical practice guidelines and medical malpractice. Physician Exec., 2002, 28, 36-39.
Rosoff, A.J. Evidence-based medicine and the law: The courts confront clinical practice guidelines. J. Health Polit. Policy Law, 2001, 26, 327-368.
Nonino, F.; Liberati, A. Essential requirements for practice guidelines at national and local levels. Neurol. Sci., 2004, 25, 2-7.
Franzini, L.; Giannoni, M. Determinants of health disparities between Italian regions. BMC Public Health, 2010, 10, 296-306.
Wahid, N.N.; Moppett, S.H.; Moppett, I.K. Quality of Quality Accounts: transparency of public reporting of never events in England. A semi-quantitative and qualitative review. J. R. Soc. Med., 2016, 109, 190-199.
Austin, J.M.; McGlynn, E.A.; Pronovost, P.J. Fostering transparency in outcomes, quality, safety, and costs. JAMA, 2016, 316, 1661-1662.
Kachalia, A. Improving patient safety through transparency. N. Engl. J. Med., 2013, 369, 1677-1679.
Kumpunen, S.; Trigg, L.; Rodrigues, R. Public reporting in health and long-term care to facilitate provider choice., http://www. (Accessed January 19, 2018).
Pross, C.; Averdunk, L.H.; Stjepanovic, J.; Busse, R.; Geissler, A. Health care public reporting utilization - user clusters, web trails, and usage barriers on Germany’s public reporting portal BMC Med. Inform. Decis. Mak., 2017, 17, 48.
Bellandi, T.; Tartaglia, R.; Forni, S.; D’Arienzo, S.; Tulli, G. Adverse events in cardiac surgery, a mixed methods retrospective study in an Italian teaching hospital. J. Eval. Clin. Pract., 2017, 23, 839-847.
Le Grand, J. The other invisible hand: delivering public services through choice and competition; Princeton University Press: Princeton, 2007.
Baxter, K.; Glendinning, C.; Greener, I. The implications of personal budgets for the home care market. Public Money & Manag., 2011, 31, 91-98.
Marshall, M.N.; Shekelle, P.G.; Leatherman, S.; Brook, R.H. The public release of performance data: What do we expect to gain? A review of the evidence. JAMA, 2000, 283, 1866-1874.
Fung, C.H.; Lim, Y.W.; Mattke, S.; Damberg, C.; Shekelle, P.G. Systematic review: The evidence that publishing patient care performance data improves quality of care. Ann. Intern. Med., 2008, 148, 111-123.
Shekelle, P.G.; Lim, Y.W.; Mattke, S.; Damberg, C. Does public release of performance results improve quality of care? A systematic review; The Health Foundation: London, 2008.
Ketelaar, N.A.; Faber, M.J.; Flottorp, S.; Rygh, L.H.; Deane, K.H.; Eccles, M.P. Public release of performance data in changing the behaviour of healthcare consumers, professionals or organisations. Cochrane Database Syst. Rev., 2011, (11)CD004538
Victoor, A.; Delnoij, D.M.; Friele, R.D.; Rademakers, J.J. Determinants of patient choice of healthcare providers: A scoping review. BMC Health Serv. Res., 2012, 12, 272.
Turillazzi, E.; Neri, M. Medical error disclosure: From the therapeutic alliance to risk management: The vision of the new Italian code of medical ethics. BMC Med. Ethics, 2014, 15, 57.
D’Errico, S.; Pennelli, S.; Colasurdo, A.P.; Frati, P.; Sicuro, L.; Fineschi, V. The right to be informed and fear of disclosure: sustainability of a full error disclosure policy at an Italian cancer centre/clinic. BMC Health Serv. Res., 2015, 15, 130.
Italian Ministry of Health. Guidelines for the Management and Communication of Adverse Events in Health, 2011.
Yahanda, A.T.; Lafaro, K.J.; Spolverato, G.; Pawlik, T.M. A systematic review of the factors that patients use to choose their surgeon. World J. Surg., 2016, 40(1), 45-55.
Sinaiko, A.D.; Eastman, D.; Rosenthal, M.B. How report cards on physicians, physician groups, and hospitals can have greater impact on consumer choices. Health Aff. (Millwood), 2012, 31(3), 602-611.
Findlay, S.D. Consumers’ interest in provider ratings grows, and improved report cards and other steps could accelerate their use. Health Aff. (Millwood), 2016, 35(4), 688-696.
World Health Organization Minimal Information Model for Patient Safety.. information_model/en/ (Accessed January 29, 2018).
European Union PaSQ Joint Action Patient Safety and Quality of Care. (Accessed January 29, 2018).
Italian Supreme Court, Section IV, Judgment n. 4391, 2012.
Italian Supreme Court, Section V, Judgment n. 33136, 2011.
Italian Supreme Court, Section IV, Judgment n. 34729, 2011.
Italian Supreme Court, Section IV, Judgment n. 23146,. 2012.
Italian Supreme Court, Section IV, Judgment n. 16237,. 2013.
Italian Supreme Court, Section IV, Judgment n. 16237,. 2013.
Garner, B.A. Black’s Law Dictionary, 9th ed; Thomas West: New York, 2009.
Cheshire, W.P.; Hutchins, J.C. Professionalism in court: The neurologist as expert witness. Neurol. Clin. Pract., 2014, 4, 335-341.
Jones, O.D.; Wagner, A.D.; Faigman, D.L.; Raichle, M.E. Neuroscientists in court. Nature, 2013, 14, 730-736.
Bal, B.S. The expert witness in medical malpractice litigation. Clin. Orthop. Relat. Res., 2009, 467, 383-391.
Pegalis, S.E. Medical Malpractice: The Art of Advocacy When Engaging in The” Battle of the Experts. Am. J. Trial Advocacy, 1999, 23, 2.
Johnston, J.C.; Sartwelle, T.P. The expert witness in medical malpractice litigation: through the looking glass. J. Clin. Neurol., 2013, 28, 484-450.
Kesselheim, A.S.; Studdert, D.M. Role of professional organizations in regulating physician expert witness testimony. JAMA, 2007, 298, 2907-2909.
American Medical Association. AMA expert witness testimony policy H-265.994..
American Medical Association. AMA expert witness testimony policy E-9.07..
Camilleri, M.; Parke, D.W. 2nd. Perspective: Conflict of interest and professional organizations: considerations and recommendations. Acad. Med., 2010, 85, 85-91.
Foster, R.S. Conflicts of interest: recognition, disclosure, and management. J. Am. Coll. Surg., 2003, 196, 505-517.
Schunemann, H.J.; Osborne, M.; Moss, J.; Manthous, C.; Wagner, G.; Sicilian, L.; Ohar, J.; McDermott, S.; Lucas, L.; Jaeschke, R. An official American Thoracic Society Policy statement: managing conflict of interest in professional societies. Am. J. Respir. Crit. Care Med., 2009, 180, 564-580.
American Thoracic Society, Ethics and Conflict of Interest Committee and the Documents Development and Implementation Committee.. (Accessed January 29, 2018).
Larriviere, D.; Williams, M.A.; Sagsveen, M. Regulating physician expert witness testimony. JAMA, 2008, 299, 1667.
Hartz, A.J.; Green, M. Regulating physician expert witness testimony. JAMA, 2008, 299, 1667-1668.
Bellandi, T.; Tartaglia, R.; Sheikh, A.; Donaldson, L. Italy recognises patient safety as a fundamental right. BMJ, 2017, 357, 2277.

Rights & Permissions Print Export Cite as
© 2022 Bentham Science Publishers | Privacy Policy