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Embolie gazeuse cérébrale lors d’une séance d’hémodialyse : aspects médico-légaux : à propos d’une affaire judiciaire 血液透析期间的脑气体栓塞:医学法律方面:关于一个法庭案件
IF 0.2 Q4 MEDICINE, LEGAL Pub Date : 2022-04-01 DOI: 10.1016/j.meddro.2021.10.001
Sarra Gharsellaoui (Résidente en médecine légale) , Amal Ben Daly (Résidente en médecine légale) , Maher Jedidi (Professeur Agrégé en médecine légale) , Khaled Annabi (Résident en médecine légale) , Mohamed Soussi (Résident en Anesthésie réanimation) , Walid Naija (Professeur en anesthésie-réanimation) , Mohamed Ben Dhiab (Professeur en médecine légale)

Air embolism is a serious iatrogenic event, concerning many invasive medical therapies. It is a rare but life-threatening adverse event. We report a case of a cerebral air embolism occurring during a renal replacement therapy. We report the case of a court case analyzed in the Department of Legal Medicine of Farhat Hached University Hospital in Sousse, Tunisia, related to a cerebral gas embolism occurring during a session of renal replacement therapy. Then we discuss the medical liability of the medical team involved in this act. Through a draft organic law (law No. 41/2019 on patients’ rights and medical liability), Tunisian jurisprudence aims at resolving legal claims in the field of medical liability by providing more opportunities for an amicable solution and by guaranteeing an adequate and quick compensation of the damage suffered.

空气栓塞是一种严重的医源性事件,涉及许多侵入性医学治疗。这是一种罕见但危及生命的不良事件。我们报告一例脑空气栓塞发生在肾脏替代治疗。我们报告了在突尼斯苏塞法哈特哈奇大学医院法医学部门分析的一起法庭案件,该案件涉及在肾脏替代治疗期间发生的脑气栓塞。在此基础上,对涉事医疗队的医疗责任进行了探讨。通过一项组织法草案(关于患者权利和医疗责任的第41/2019号法律),突尼斯的法理学旨在通过为友好解决提供更多机会,并保证对所遭受的损害进行充分和迅速的赔偿,来解决医疗责任领域的法律索赔。
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引用次数: 0
Loi de bioéthique du 2 août 2021 : analyse critique des dispositions relatives à l’assistance médicale à la procréation (AMP) 2021年8月2日《生物伦理学法》:对生殖医疗援助条款的批判性分析
IF 0.2 Q4 MEDICINE, LEGAL Pub Date : 2022-04-01 DOI: 10.1016/j.meddro.2021.11.003
Aude Mirkovic (Maître de conférences en droit privé (HDR), auteur de « PMA, un enjeu de société », ed. Artège 2018)

Whereas in France assisted reproductive technology (ART) was intended to respond to pathological infertility or the risk of transmitting a serious disease, the bioethics law of 2 August 2021 opens up technological procreation to fertile couples, to single women and women's couple. Procreation is thus disconnected from the carnal reality of the begetting of a child and is based solely on the will of the adult to realise his or her parental project. This is not without consequences for the rights of the child born of these technologies but also for the meaning of filiation in general.

在法国,辅助生殖技术旨在应对病理性不孕或传播严重疾病的风险,而2021年8月2日的生物伦理法向有生育能力的夫妇、单身妇女和妇女夫妇开放了技术生殖。因此,生殖与生孩子的肉体现实脱节,而完全基于成年人实现其父母计划的意愿。这不仅对这些技术所生的孩子的权利没有影响,而且对一般意义上的亲子关系也有影响。
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引用次数: 0
Analyse du cadre réglementaire des certificats médicaux demandés par une municipalité en 2019 2019年市政当局要求的医疗证明监管框架分析
IF 0.2 Q4 MEDICINE, LEGAL Pub Date : 2022-04-01 DOI: 10.1016/j.meddro.2022.01.002
Mehdi Aber , Yannick Ruelle

Medical certificates have a regular place in general medicine consultation. Since 2011, the french law has highlighted the absence of regulatory support of certain certificates, in particular of public services. The objective of this study was to find out which regulatory texts were based on the medical certificates required by a municipal administration, 8 years after the 2011 rationalization circular?

Material and method

Qualitative study by observation and critical analysis of certificates by literature reviews according to the main PRISMA quality criteria (Preferred Reporting Items for Systematic Reviews and Meta-Analyzes). The first step consisted of the exhaustive collection of the medical certificates provided by the municipality, for the citizens or the employees of the city. The origin of one of the municipal services was the only criterion for inclusion. The second stage consisted in analyzing the certificates according to the law by using databases classified depending on their level, taking their regulatory value into account as a priority. The research equations were constructed with an inductive process as the certificates were collected.

Results

Forty-two certificates were collected and analyzed. Twenty-seven had regulatory support, two of which (not concerned in general medicine) complied with its content. No regulatory support was found for the 15 other certificates. The regulatory vagueness around sports accidents, or even the abuse of authority, are explanations for these certificates without existing or respected regulatory support.

Conclusion

The general practitioner is put in a difficult and ambivalent position. A major institutional commitment should be considered for the rationalization of medical certificates, in particular through medical education, health education for users and law enforcement.

医学证明在普通医学咨询中占有固定的地位。自2011年以来,法国法律一直强调缺乏对某些证书的监管支持,特别是公共服务证书。本研究的目的是找出哪些监管文本是基于2011年合理化通知8年后市政管理部门要求的医疗证明?材料和方法根据PRISMA主要质量标准(系统评价和元分析的首选报告项目)对文献综述证书进行观察和批判性分析的定性研究。第一步是详尽收集市政当局为该市公民或雇员提供的医疗证明。其中一项市政服务的来源是列入的唯一标准。第二阶段是利用按级别分类的数据库依法分析证书,优先考虑其监管价值。在收集证据的同时,用归纳的方法构造了研究方程。结果共收集和分析了42份证书。27个得到了监管部门的支持,其中两个(与普通医学无关)符合其内容。其他15个证书没有得到监管部门的支持。围绕体育事故的监管模糊,甚至滥用权力,都是对这些证书的解释,没有现有的或受尊重的监管支持。结论全科医生处于困境和矛盾的境地。应考虑作出重大的机构承诺,使医疗证明合理化,特别是通过医学教育、对使用者的健康教育和执法。
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引用次数: 0
Protection de la personne Le consentement dynamique : une alternative à la rétraction de publications scientifiques en médecine ? 保护人动态同意:撤回医学科学出版物的替代方案?
IF 0.2 Q4 MEDICINE, LEGAL Pub Date : 2022-04-01 DOI: 10.1016/j.meddro.2021.11.001
Henri-Corto Stoeklé , Côme Bommier , Christian Hervé
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引用次数: 0
Intelligence artificielle et médecine : quelles règles éthiques et juridiques pour une IA responsable ? 人工智能与医学:负责任的人工智能的伦理和法律规则是什么?
IF 0.2 Q4 MEDICINE, LEGAL Pub Date : 2022-02-01 DOI: 10.1016/j.meddro.2021.09.001
Dr Diane de Saint-Affrique (Professeur de droit)

Combining AI and medicine means talking about the medicine of the future, but even more about improving the quality of care. Its fields of application: predictive medicine, precision medicine, decision support, prevention, computer-assisted surgery, robotic support for the elderly, etc. are all related concerns: the possibility of maintaining human contact with the patient, the explicability of the algorithm - the collection of health data - and the improvement of the health care system. AI applications are already improving the quality of care. Its deployment at the heart of the medicine of the future is in constant evolution. To be acceptable and legitimate, the decisions of any algorithm must be understood and therefore explained. Only a good understanding of the diagnoses and therapies proposed by the AI application will allow doctors to discuss with their patients and to explain the possible alternatives. In the opposite case, the doctor risks to dismiss the use of algorithms because he will not be able to justify the decisions which will pose problems in terms of liability research in particular.

将人工智能与医学结合意味着谈论未来的医学,但更多的是关于提高护理质量。它的应用领域:预测医学,精准医学,决策支持,预防,计算机辅助手术,机器人对老年人的支持等都是相关的问题:与患者保持人类接触的可能性,算法的可解释性-健康数据的收集-以及医疗保健系统的改进。人工智能应用已经在提高护理质量。它在未来医学的核心部署是不断发展的。任何算法的决策都必须被理解和解释,才能被接受和合法。只有很好地理解了人工智能应用程序提出的诊断和治疗方法,医生才能与患者讨论并解释可能的替代方案。在相反的情况下,医生冒着拒绝使用算法的风险,因为他将无法证明这些决定是合理的,这些决定尤其会在责任研究方面带来问题。
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引用次数: 0
Recherche sur données : aspects juridiques et éthiques à travers l’expérience de l’hôpital Foch 数据研究:通过福赫医院经验的法律和伦理方面
IF 0.2 Q4 MEDICINE, LEGAL Pub Date : 2022-02-01 DOI: 10.1016/j.meddro.2021.06.003
Elisabeth Hulier-Ammar , Amélie Chioccarello , Pauline Touche , Achille Ivasilevitch , Henri-Corto Stoeklé , Christian Hervé

Health data is the object of covetousness by many actors, of course by the healthcare industry, in particular the drug and medical device industry, by hospitals and research institutes, but also by all types of merchant companies which would like to derive substantial benefits from it. Faced with this phenomenon, the European Commission, within the framework of the replacement of the European Directive on health data of 1995, by the General Data Protection Regulation of 2016 (GDPR) has strengthened the protection of health data which is particularly sensitive data for everyone and, consequently, carrying out studies on health data. Researches that does not involve human beings, improperly called “Data studies”, are closely regulated by the GDPR and, for France, by the Data Protection Act, which has been amended accordingly. This article describes the steps to be taken for the implementation of data studies and what are the rights of participants/patients in the context of these researchs. Ethical vigilance would require that such research be reviewed by an ad hoc committee.

健康数据是许多行为者贪婪的对象,当然包括医疗保健行业,特别是药品和医疗设备行业,医院和研究机构,但也包括希望从中获得实质性利益的各类商业公司。面对这一现象,欧盟委员会在以2016年《通用数据保护条例》(GDPR)取代1995年《欧洲健康数据指令》的框架内,加强了对健康数据的保护,这对每个人来说都是特别敏感的数据,因此开展了健康数据研究。不涉及人类的研究,被不恰当地称为“数据研究”,受到GDPR的严格监管,而法国则受到相应修订的《数据保护法》(Data Protection Act)的监管。本文描述了实施数据研究应采取的步骤,以及在这些研究的背景下参与者/患者的权利。道德上的警惕要求这类研究必须由一个特设委员会进行审查。
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引用次数: 2
Poly Implant Prothèse : en l’absence de responsabilité de l’État, quelle indemnisation possible ? 多种植体假体:在没有国家责任的情况下,可能的赔偿是什么?
IF 0.2 Q4 MEDICINE, LEGAL Pub Date : 2022-02-01 DOI: 10.1016/j.meddro.2021.05.004
Vincent Bouquet (Docteur en droit, Docteur en pharmacie)

With two decisions dated November 16th 2020, the French administrative Highest court (“Conseil d’État”) has compromised the possibility for PIP's victims to demonstrate the deficiency of the National medicines agency (ANSM) in its duty of health control. Those decisions transpose to medical devices already well-established principles, used for other healthcare products. There are of interested because they give the Highest court the opportunity to precisely detail the qualification of the facts. Although the consequences for the victims seem to be only of symbolic value, the scope of the solution is not limited to the liability of the State. By reducing the number of potential liable persons, those decisions also seem to jeopardize the compensation of the victims by the national solidarity funds.

法国行政最高法院(" Conseil d ' État ")于2020年11月16日作出了两项决定,损害了PIP受害者证明国家药品管理局(ANSM)在健康控制职责方面存在缺陷的可能性。这些决定转移到医疗设备已经确立的原则,用于其他医疗保健产品。之所以有兴趣,是因为它们使最高法院有机会精确地详细说明事实的资格。虽然对受害者造成的后果似乎只具有象征意义,但解决办法的范围并不限于国家的责任。由于减少了可能负有责任的人的数目,这些决定似乎也危及国家团结基金对受害者的赔偿。
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引用次数: 0
Le contrôle judiciaire des hospitalisations sans consentement et épidémie de Covid : la fin d’une procédure en trompe l’oeil ? 对未经同意住院和Covid - 19疫情的司法控制:欺骗程序的结束?
IF 0.2 Q4 MEDICINE, LEGAL Pub Date : 2022-02-01 DOI: 10.1016/j.meddro.2021.11.002
Léa Lepoix

Since 2011, the judge of freedoms and detention (JLD) is competent to control care measures without consent. This control, although essential in order to avoid abusive deprivation of liberty, is incomplete. Faced with the health crisis, the shortcomings of this control are more noticeable in a context of violation of the rights of people hospitalized without detriment.

自2011年以来,自由和拘留法官有权在未经同意的情况下控制照料措施。这种控制虽然对避免滥用剥夺自由是必要的,但却是不完整的。面对健康危机,这种控制的缺点在侵犯住院患者权利的情况下更为明显。
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引用次数: 0
Les hydratants et lubrifiants vaginaux – Quel statut pour ce type de produits ? 阴道润肤霜和润滑剂-这类产品的现状是什么?
IF 0.2 Q4 MEDICINE, LEGAL Pub Date : 2021-12-01 DOI: 10.1016/j.meddro.2021.02.001
Céline Couteau , Laurence Coiffard , Catherine Quequet

Vaginal lubricants and moisturizers are products of similar composition used as appropriate to alleviate pathological dryness or facilitate sexual intercourse. The status of this type of product is not clear to some companies who confuse cosmetics and medical devices. With regard to the regulatory definition of cosmetics, it appears that this type of product can in no way be marketed under this status.

阴道润滑剂和保湿剂是适当使用的类似成分的产品,用于缓解病理性干燥或促进性交。一些混淆化妆品和医疗器械的公司不清楚这类产品的地位。关于化妆品的监管定义,这类产品似乎不能在这种状态下销售。
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引用次数: 0
Le déclenchement « sans indication médicale » : regard étonné du juriste 触发“无医学适应症”:法学家惊讶的表情
IF 0.2 Q4 MEDICINE, LEGAL Pub Date : 2021-12-01 DOI: 10.1016/j.meddro.2021.05.001
François Vialla (Professeur de Droit privé et sciences criminelles, Directeur du Centre Européen d’Études et de Recherche Droit & Santé)

Delivery trigger may question obstetrician liability.

分娩诱因可能会质疑产科医生的责任。
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引用次数: 0
期刊
Medecine & Droit
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