Pub Date : 2022-04-01DOI: 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.
{"title":"Embolie gazeuse cérébrale lors d’une séance d’hémodialyse : aspects médico-légaux : à propos d’une affaire judiciaire","authors":"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)","doi":"10.1016/j.meddro.2021.10.001","DOIUrl":"10.1016/j.meddro.2021.10.001","url":null,"abstract":"<div><p>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.</p></div>","PeriodicalId":41275,"journal":{"name":"Medecine & Droit","volume":"2022 173","pages":"Pages 34-37"},"PeriodicalIF":0.2,"publicationDate":"2022-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"45512915","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2022-04-01DOI: 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.
{"title":"Loi de bioéthique du 2 août 2021 : analyse critique des dispositions relatives à l’assistance médicale à la procréation (AMP)","authors":"Aude Mirkovic (Maître de conférences en droit privé (HDR), auteur de « PMA, un enjeu de société », ed. Artège 2018)","doi":"10.1016/j.meddro.2021.11.003","DOIUrl":"10.1016/j.meddro.2021.11.003","url":null,"abstract":"<div><p>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.</p></div>","PeriodicalId":41275,"journal":{"name":"Medecine & Droit","volume":"2022 173","pages":"Pages 27-33"},"PeriodicalIF":0.2,"publicationDate":"2022-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"42369476","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2022-04-01DOI: 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.
{"title":"Analyse du cadre réglementaire des certificats médicaux demandés par une municipalité en 2019","authors":"Mehdi Aber , Yannick Ruelle","doi":"10.1016/j.meddro.2022.01.002","DOIUrl":"10.1016/j.meddro.2022.01.002","url":null,"abstract":"<div><p>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?</p></div><div><h3>Material and method</h3><p>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.</p></div><div><h3>Results</h3><p>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.</p></div><div><h3>Conclusion</h3><p>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.</p></div>","PeriodicalId":41275,"journal":{"name":"Medecine & Droit","volume":"2022 173","pages":"Pages 21-24"},"PeriodicalIF":0.2,"publicationDate":"2022-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"46768649","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2022-04-01DOI: 10.1016/j.meddro.2021.11.001
Henri-Corto Stoeklé , Côme Bommier , Christian Hervé
{"title":"Protection de la personne Le consentement dynamique : une alternative à la rétraction de publications scientifiques en médecine ?","authors":"Henri-Corto Stoeklé , Côme Bommier , Christian Hervé","doi":"10.1016/j.meddro.2021.11.001","DOIUrl":"10.1016/j.meddro.2021.11.001","url":null,"abstract":"","PeriodicalId":41275,"journal":{"name":"Medecine & Droit","volume":"2022 173","pages":"Pages 19-20"},"PeriodicalIF":0.2,"publicationDate":"2022-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"41617728","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2022-02-01DOI: 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.
{"title":"Intelligence artificielle et médecine : quelles règles éthiques et juridiques pour une IA responsable ?","authors":"Dr Diane de Saint-Affrique (Professeur de droit)","doi":"10.1016/j.meddro.2021.09.001","DOIUrl":"10.1016/j.meddro.2021.09.001","url":null,"abstract":"<div><p>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.</p></div>","PeriodicalId":41275,"journal":{"name":"Medecine & Droit","volume":"2022 172","pages":"Pages 5-7"},"PeriodicalIF":0.2,"publicationDate":"2022-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"49170011","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2022-02-01DOI: 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.
{"title":"Recherche sur données : aspects juridiques et éthiques à travers l’expérience de l’hôpital Foch","authors":"Elisabeth Hulier-Ammar , Amélie Chioccarello , Pauline Touche , Achille Ivasilevitch , Henri-Corto Stoeklé , Christian Hervé","doi":"10.1016/j.meddro.2021.06.003","DOIUrl":"10.1016/j.meddro.2021.06.003","url":null,"abstract":"<div><p>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.</p></div>","PeriodicalId":41275,"journal":{"name":"Medecine & Droit","volume":"2022 172","pages":"Pages 8-14"},"PeriodicalIF":0.2,"publicationDate":"2022-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1016/j.meddro.2021.06.003","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"43459206","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2022-02-01DOI: 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。
{"title":"Poly Implant Prothèse : en l’absence de responsabilité de l’État, quelle indemnisation possible ?","authors":"Vincent Bouquet (Docteur en droit, Docteur en pharmacie)","doi":"10.1016/j.meddro.2021.05.004","DOIUrl":"10.1016/j.meddro.2021.05.004","url":null,"abstract":"<div><p>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.</p></div>","PeriodicalId":41275,"journal":{"name":"Medecine & Droit","volume":"2022 172","pages":"Pages 15-18"},"PeriodicalIF":0.2,"publicationDate":"2022-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1016/j.meddro.2021.05.004","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"42400499","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2022-02-01DOI: 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.
{"title":"Le contrôle judiciaire des hospitalisations sans consentement et épidémie de Covid : la fin d’une procédure en trompe l’oeil ?","authors":"Léa Lepoix","doi":"10.1016/j.meddro.2021.11.002","DOIUrl":"10.1016/j.meddro.2021.11.002","url":null,"abstract":"<div><p>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.</p></div>","PeriodicalId":41275,"journal":{"name":"Medecine & Droit","volume":"2022 172","pages":"Pages 1-4"},"PeriodicalIF":0.2,"publicationDate":"2022-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"41642916","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
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.
{"title":"Les hydratants et lubrifiants vaginaux – Quel statut pour ce type de produits ?","authors":"Céline Couteau , Laurence Coiffard , Catherine Quequet","doi":"10.1016/j.meddro.2021.02.001","DOIUrl":"10.1016/j.meddro.2021.02.001","url":null,"abstract":"<div><p>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.</p></div>","PeriodicalId":41275,"journal":{"name":"Medecine & Droit","volume":"2021 171","pages":"Pages 120-122"},"PeriodicalIF":0.2,"publicationDate":"2021-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1016/j.meddro.2021.02.001","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"47376635","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2021-12-01DOI: 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。
{"title":"Le déclenchement « sans indication médicale » : regard étonné du juriste","authors":"François Vialla (Professeur de Droit privé et sciences criminelles, Directeur du Centre Européen d’Études et de Recherche Droit & Santé)","doi":"10.1016/j.meddro.2021.05.001","DOIUrl":"10.1016/j.meddro.2021.05.001","url":null,"abstract":"<div><p>Delivery trigger may question obstetrician liability.</p></div>","PeriodicalId":41275,"journal":{"name":"Medecine & Droit","volume":"2021 171","pages":"Pages 103-119"},"PeriodicalIF":0.2,"publicationDate":"2021-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1016/j.meddro.2021.05.001","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"47566569","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}