Medical error disclosure in the Italian healthcare context: A delicate balance between ethical obligations and the principle of non-self-incrimination

Surprisingly, Italian legal doctrine and jurisprudence never systematically address the medical error disclosure issue. The topic of medical error communication represents a non-negligible profile of interest, relating to the possible detrimental effects on doctors who accuse themselves of conduct that does not comply with the lex artis. The effects of error disclosure on the effectiveness of insurance guarantees in civil and administrative liability are particularly relevant, as are the implications for ethical liability. Although the burden of reporting an error falls within the wide range of informative duties doctors hold, it still seems far from having found a factual statement in clinical practice, especially in Italy. This applies whether the error has a marginal or significant impact on the patient’s health. The reasons lay in a very contradictory legal framework. Doctors tend with increasing ease not to comply with their information obligation – especially in cases where fulfilling this duty means admitting a personal, professional error – to preserve the integrity of their professional images. This article aims to offer a brief overview of that topic in the context of Italian healthcare.     

浅谈建立医疗意外保险制度

在我国司法实践中,对医疗意外的损害赔偿主要通过公平责任原则来处理,但是,这种责任分配模式对医患双方都有很大的局限性,不利于医疗纠纷的处理。尽快建立医疗意外保险制度,切实维护医患双方的合法权益,是解决此类纠纷的一个出口。该文从医疗意外保险的必要性出发,探讨应怎样设立医疗意外保险,保险的具体运作模式、保险赔付以及保险赔偿责任的范围等。     

L’expert judiciaire et l’irresponsabilité pénale. Débats et controverses au cours du temps et questions contemporaines

IntroductionSince the creation of the Société Médico-Psychologique, an accumulation of discussions at the national level has resulted in legislative changes, which concern people with mental disorders. Public opinion has now become a stakeholder, prompting us, as judicial experts, to address criminal irresponsibility. The authors wish to give an account of the evolution of the ideas and professional practices in alienism and forensic psychiatry regarding criminal liability, irresponsibility, and the evolution of legislative measures in this realm.MethodsTo do so, they rely on the use of their forensic psychiatric and medico-psychological expertise, which has been effective for many years and remains relevant today, as well as on their clinical and theoretical research activities. The methodology is based on the analysis of language and the critical approach of historical and clinical epistemology.Forensic IssuesThey are examined taking into account the cultural and scientific context from the middle of the 19th century to the beginning of the 21st century. Criminal responsibility and irresponsibility are ancient principles codified in Roman law by Marcus Aurelius and which evolved with the political, social and religious conjunctions of each epoch. Whether the reason given for the recognition of criminal irresponsibility is referred to as madness, degeneration, insanity, dementia, psychic abnormality or discernment, it has always been the subject of research by physicians, alienists, and then psychiatrists. The authors analyze the role of the dissemination of the debates from the creation of the Annales Médico-Psychologiques (in 1843) and of the Société Médico-Psychologique (in 1852), illustrating them with some famous cases in specialized literature. The importance of forensic discussions at the Société Médico-Psychologique animated the end of the nineteenth century and the first part of the twentieth century, contributing to the enrichment of psychiatric semiology and to the opening up of new research, notably methodological. This will lead to an evolution of the conceptions relative to what induces the criminal act and will no longer limit irresponsibility to a diagnosis of insanity or dementia ; the study of psychic functioning will be put forward with the notion of discernment and those of self-control of one's actions. If numerous theoretical debates within the profession have fueled “expert disputes” sometimes disqualifying the role of experts, they remained, however, in the medical and judicial field. Over the past decade, these issues have been broadened to include societal debates around issues related to dangerousness and recidivism. This has become a dominant theme in scientific gatherings, before the eruption into the criminal field, of the increasing role played by victims and victims’ associations. Law No. 92-683 of 22 July 1992 introduced into the Penal Code Article 122-1 (1994 Penal Code) replacing Article 64, by inserting the notions of alteration or abolition of discernment. This distinction has given rise to new difficulties and tensions in expert practice ; the law came into force in 1994. During the 2000s, a series of high-profile homicides involving people with serious mental disorders, sometimes carried out in a recidivist situation, hit the headlines in France. This resulted in a shift in public opinion that led to the law of 25 February 2008 on criminal irresponsibility. The law put an end to the judicial dismissal of cases on the grounds of criminal irresponsibility, by introducing other provisions in the form of security measures (judicial supervision and detention of security). This law creates new interferences between legal procedural issues and psychiatric practice ; it also emphasized the importance of the role of experts by creating new missions, including the expertise of dangerousness. The movement linked to the consideration of the place of victims has been accentuated, both by the objective of obtaining a judgment for the perpetrator of the acts, and by the solicitation of their participation in the successive phases of the procedure. We have recently moved on to questions and controversies about the lack of accountability leading to the law of 24 January 2022. The current article 122 did not specify the origin of the psychic disorder causing the abrogation of discernment, which was interpreted by the Minister of Justice as “a legal void”, which must be “filled with urgency”. Title I states: “Provisions limiting criminal irresponsibility in cases of mental disorder resulting from self-induced psychoactive substances”. All these new provisions, as well as the creation of new incriminations and qualifications, certainly engender debates between magistrates and experts, but they are above all part of a concern of the public authorities about the necessity of setting up “provisions limiting criminal liability in the case of mental disorder”. The interpretation of the contribution of the law to a criminal act remains complex, according to the authors, in terms of psychopathological and etiopathogenic research. Within the context of expert practice, this new law will make it necessary to add new questions for the current missions, and it can only result in an increase in the complexity of these missions and in a risk of confusion in the answers.ConclusionThe authors show that the question of criminal liability does not solicit the same questions and problems in the judicial field (the point of view of the forensic psychiatrist, during the expert examination) or in the societal field with the confrontation with all the representations that are attached both to madness and to the passage to the criminal act, which since the beginning of the twentieth century involves other emerging disciplines. From their point of view, the assertion that a psychic disorder can be of such severity so as to affect the free will and discernment of the perpetrator of a criminal act at the time of the offence, must remain within the domain of psychiatry, even if the new law of 24 January 2022, through several of its provisions, would attempt to eliminate this necessity.     

La dermatología y sus aspectos médico-legales: seguridad clínica y dermatología

Clinical safety and medical liability are first-order concerns in today's medical practice. It is important to understand the circumstances under which medical acts fail to live up to the accepted standard of care and to recognize the impact that malpractice claims have on physicians. Practitioners must also grasp the concept of medical error, studying malpractice claims in order to identify the areas where improvement is needed. The risk of accusations of malpractice in dermatology is comparatively low, both in Spain and worldwide. However, a great variety of clinical scenarios in dermatology can potentially give rise to a claim, and malignant melanoma is most susceptible to risk. Dermatologists should know which actions during clinical consultation merit particular attention and care. Clinical practice carries inherent risk of malpractice claims, but taking certain recommended precautions can prevent them.     

The 2017 deregulation of pharmacies in Italy: Introducing non-pharmacist ownership

Italy is the last European country to adopt policies on the liberalization of pharmacy ownership. In August 2017, the Italian government approved the law n. 124 (annual market and competition law), despite the opposition of some stakeholders. This law extended the ownership of pharmacies to non-pharmacist business partners. Law n. 124 is an important turning point for pharmacists in Italy and could lead to a general reorganization of the Italian pharmaceutical system. As has already happened in several European countries, the removal of barriers to pharmacy ownership incentivizes finance companies and pharmaceutical wholesalers to make significant investments in this sector, leading to the emergence of commercial pharmacy chains. The future of community pharmacies is uncertain and is closely linked to the fate of the current government. However, progressive polarization between independent pharmacies and pharmacies that are part of chains can already be observed.     

Abolition du discernement : état des lieux des pratiques des experts psychiatres dans l’ouest de la France

ObjectivesThe goal of this study was to determine the characteristics of subjects considered to be criminally irresponsible due to abolition of judgment pursuant to article 122-1, 41 of the French Penal Code.Materials and methodsThis retrospective study gathered every forensic assessment in 2016 that concluded in criminal irresponsibility from eight forensic psychiatrists practicing in the west of France. We proceeded to study the frequency of abolitions, the socio-demographic characteristics of the subjects, the psychiatric pathologies as defined by the DSM-5, the crimes committed, the clinical justifications and the conclusions of the forensic psychiatrist concerning the potential forced hospitalisation of the subject, the psychiatric dangerousness, curability and the ability to readapt of the subject.ResultsThirty-eight assessments out of the 763 collected concluded in abolition of judgment, a frequency of 4.98%. The subjects suffered from a schizophrenia spectrum disorder or a paranoid delusional disorder (85.2%). The most present clinical elements were paranoid delusions of persecution (23.1%), from intuitive, interpretative, hallucinatory or mental automatism mechanisms (39.7%) and dissociative syndrome (10.7%). Subjects with abolished judgment weren’t always considered dangerous (for 34.3% of individuals) even if a schizophrenia diagnosis was correlated (f = 0.03). Forced hospitalisation was proposed in 50% of assessments and associated with the conclusion of dangerousness (f = 0.01).ConclusionsSchizophrenia spectrum disorders or paranoid delusional disorders are the most common pathologies in forensic psychiatric assessments concluding in abolition of judgment.     

Dangerosité psychiatrique et responsabilité pénale atténuée : à propos de la condamnation à la réclusion à perpétuité d’un schizophrène auteur d’un homicide sexuel sadique

The second paragraph of article 122-1 of the French Criminal Code provides for a reduced penalty in criminal matters (Court of Assizes) when the offender is suffering at the time the act is committed from a mental disorder that reduces his liability. This legal provision is not always respected, as shown by the sentencing to life imprisonment of a chronic psychotic patient who committed a sexual homicide (sadistic rape). The Court of Assizes found that the great dangerousness of this schizophrenic, with a multiple criminal record and who had refused his treatment, justified his conviction, while the psychiatric expertise concluded that he should benefit from a reduction on his criminal liability. The sentence was passed without the level of severity of his mental state having been verified by a new expert. The author therefore questions the “ethical” nature of this court decision which, albeit legal, is contrary to the spirit of the law. There was no appeal against the sentence.     

儿童遗传性压迫易感性周围神经病的临床、肌电图与基因特征(附1例报告)

目的探讨儿童遗传性压迫易感性周围神经病(HNPP)的临床、EMG与基因特点。方法报道基因诊断明确的1例HNNP,并结合文献分析HNPP的临床、EMG与基因特点。结果患儿,女,11岁8个月,于入院10 d前运动后出现左足麻木,不能背屈,查EMG提示多发性周围神经源性损害。患儿父亲及伯父有类似病史。患儿基因检查示chr17:14095421~15458636杂合缺失,大小1363.2kb,诊断HNPP。结论轻微牵拉或压迫后出现肢体无力患儿,及早进行EMG检查,对于周围神经损害广泛而肢体麻痹局限,且有类似家族史的患儿,应注意HNPP,并进行基因检查。     

医生对医疗责任保险的认知和需求调查——以广州某三甲综合医院为例

目的:调查医生对医责险的认知与需求,为医责险在我国的进一步发展提供政策建议。方法:对广州某三甲综合医院医生进行分层随机抽样调查,同时对相关部门负责人及个别医生进行访谈。结果:风险越高的科室,对医责险的认知越高,工龄越长的医生,对医责险越了解;医责险受到医生的普遍支持,需求意愿强烈,但对保费承担主体及分担意见差异较大。讨论:医生对医责险仍缺乏足够的认知,有效宣传较缺乏;医责险的构建模式仍比较模糊,政府主导能力及市场运作能力严重不足。建议:加大宣传力度并优化流程,提高医责险的认知度和参与度,完善医责险具体内容,加强监管,探索建立适合我国国情的医责险发展模式。     

Patient blood management implementation in light of new Italian laws on patient's safety

The present work aims to analyze the impact - from legal and medical perspective - of the recent Italian legislative provisions on the subject of healthcare safety, and how these affect current transfusion practices, also in light of the accumulation of evidence deriving from the implementation of the Patient Blood Management (PBM) program.The scientific evidence shows that PBM is a bundle of care that improves patient outcomes including mortality and morbidity, improves the quality of life of patients and the population, reduces healthcare costs and decreases consumption of blood components. These aspects should be largely sufficient to carry out an urgent implementation of PBM in Italian hospitals. However, it is now also possible to indicate a further incentive for implementation which is made up of medico-legal aspects and is characterized by the need to decrease the intrinsic risks of the use of blood products so as to protect doctors and hospitals from possible future medico-legal disputes regarding adverse transfusion events that could be effectively avoided.