{"title":"Regulating algorithmic care in the European Union: evolving doctor-patient models through the Artificial Intelligence Act (AI-Act) and the liability directives.","authors":"Barry Solaiman,Abeer Malik","doi":"10.1093/medlaw/fwae033","DOIUrl":"https://doi.org/10.1093/medlaw/fwae033","url":null,"abstract":"This article argues that the integration of artificial intelligence (AI) into healthcare, particularly under the European Union's Artificial Intelligence Act (AI-Act), poses significant implications for the doctor-patient relationship. While historically paternalistic, Western medicine now emphasises patient autonomy within a consumeristic paradigm, aided by technological advancements. However, hospitals worldwide are adopting AI more rapidly than before, potentially reshaping patient care dynamics. Three potential pathways emerge: enhanced patient autonomy, increased doctor control via AI, or disempowerment of both parties as decision-making shifts to private entities. This article contends that without addressing flaws in the AI-Act's risk-based approach, private entities could be empowered at the expense of patient autonomy. While proposed directives like the AI Liability Directive (AILD) and the revised Directive on Liability for Defective Products (revised PLD) aim to mitigate risks, they may not address the limitations of the AI-Act. Caution must be exercised in the future interpretation of the emerging regulatory architecture to protect patient autonomy and to preserve the central role of healthcare professionals in the care of their patients.","PeriodicalId":49146,"journal":{"name":"Medical Law Review","volume":"1 1","pages":""},"PeriodicalIF":1.7,"publicationDate":"2024-09-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142219969","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"The short-lived verdict in Le Page v Center for Reproductive Medicine: why 'personhood' matters in the regulation of assisted reproductive technologies.","authors":"Edward R Grant","doi":"10.1093/medlaw/fwae020","DOIUrl":"10.1093/medlaw/fwae020","url":null,"abstract":"","PeriodicalId":49146,"journal":{"name":"Medical Law Review","volume":" ","pages":"399-409"},"PeriodicalIF":1.8,"publicationDate":"2024-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141421544","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Sara A Attinger, Ian Kerridge, Cameron Stewart, Isabel Karpin, Siun Gallagher, Robert J Norman, Wendy Lipworth
{"title":"Money matters: a critique of 'informed financial consent'.","authors":"Sara A Attinger, Ian Kerridge, Cameron Stewart, Isabel Karpin, Siun Gallagher, Robert J Norman, Wendy Lipworth","doi":"10.1093/medlaw/fwae015","DOIUrl":"10.1093/medlaw/fwae015","url":null,"abstract":"<p><p>In recent years, concerns about the financial burdens of health care and growing recognition of the relevance of cost to decision making and patient experience have increasingly focused attention on financial 'transparency' and disclosure of costs to patients. In some jurisdictions, there have been calls not only for timely disclosure of costs information, but also for 'informed financial consent'. However, simply putting the 'financial' into 'informed consent' and invoking an informed consent standard for cost information encounters several ethical, legal, and practical difficulties. This article will examine the viability and desirability of 'informed financial consent', and whether it is possible to derive ideas from traditional informed consent that may improve decision making and the patient experience. We argue that, while there are important legal, ethical, and practical challenges to consider, some of the principles of informed consent to treatment can usefully guide financial communication. We also argue that, while medical practitioners (and their delegates) have an important role to play in bridging the gap between disclosure and enabling informed (financial) decision making, this must be part of a multi-faceted approach to financial communication that acknowledges the influence of non-clinical providers and other structural forces on discharging such obligations.</p>","PeriodicalId":49146,"journal":{"name":"Medical Law Review","volume":" ","pages":"356-372"},"PeriodicalIF":1.8,"publicationDate":"2024-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11347940/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140899874","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Michael Holmes v Poeton Holdings Ltd [2023] EWCA Civ 1377: a necessary clarification for a non 'de minimis' discussion in causation.","authors":"Patricia de Moraes Paisani Matthey Claudet","doi":"10.1093/medlaw/fwae024","DOIUrl":"10.1093/medlaw/fwae024","url":null,"abstract":"","PeriodicalId":49146,"journal":{"name":"Medical Law Review","volume":" ","pages":"410-420"},"PeriodicalIF":1.8,"publicationDate":"2024-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141477784","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Mediating disputes under the Mental Capacity Act 2005: relationships, participation, and best interests.","authors":"Jaime Lindsey, Chris Danbury","doi":"10.1093/medlaw/fwae014","DOIUrl":"10.1093/medlaw/fwae014","url":null,"abstract":"<p><p>This article analyses the use of mediation to resolve mental capacity law disputes, including those that arise in the healthcare context. It draws on original empirical data, including interviews with lawyers and mediators, and analysis of a mediation scheme, to argue that mediation has the potential to be an effective method of resolution in mental capacity law. It highlights the relationship benefits of mediation while acknowledging the challenges of securing P's participation and best interests. The final section of the article considers how mediation can operate in one of the most challenging healthcare environments, the Intensive Care Unit. The article emphasizes that the challenges we see in mediation are not unique and exist across the spectrum of Court of Protection practice. Therefore, the article concludes that mediation may be used effectively but the jurisdiction would also benefit from a clearer regulatory framework in which it can operate.</p>","PeriodicalId":49146,"journal":{"name":"Medical Law Review","volume":" ","pages":"336-355"},"PeriodicalIF":1.8,"publicationDate":"2024-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11347943/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141421593","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"France's constitutional right to abortion: symbolism over substance.","authors":"Zoe L Tongue","doi":"10.1093/medlaw/fwae019","DOIUrl":"10.1093/medlaw/fwae019","url":null,"abstract":"","PeriodicalId":49146,"journal":{"name":"Medical Law Review","volume":" ","pages":"392-398"},"PeriodicalIF":1.8,"publicationDate":"2024-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141181398","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"A health-conformant reading of the GDPR's right not to be subject to automated decision-making.","authors":"Hannah B van Kolfschooten","doi":"10.1093/medlaw/fwae029","DOIUrl":"10.1093/medlaw/fwae029","url":null,"abstract":"<p><p>As the use of Artificial Intelligence (AI) technologies in healthcare is expanding, patients in the European Union (EU) are increasingly subjected to automated medical decision-making. This development poses challenges to the protection of patients' rights. A specific patients' right not to be subject to automated medical decision-making is not considered part of the traditional portfolio of patients' rights. The EU AI Act also does not contain such a right. The General Data Protection Regulation (GDPR) does, however, provide for the right 'not to be subject to a decision based solely on automated processing' in Article 22. At the same time, this provision has been severely critiqued in legal scholarship because of its lack of practical effectiveness. However, in December 2023, the Court of Justice of the EU first provided an interpretation of this right in C-634/21 (SCHUFA)-although in the context of credit scoring. Against this background, this article provides a critical analysis of the application of Article 22 GDPR to the medical context. The objective is to evaluate whether Article 22 GDPR may provide patients with the right to refuse automated medical decision-making. It proposes a health-conformant reading to strengthen patients' rights in the EU.</p>","PeriodicalId":49146,"journal":{"name":"Medical Law Review","volume":" ","pages":"373-391"},"PeriodicalIF":1.8,"publicationDate":"2024-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11347939/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141972176","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"How should we decide how to treat the child: harm versus best interests in cases of disagreement.","authors":"David Archard, Emma Cave, Joe Brierley","doi":"10.1093/medlaw/fwad040","DOIUrl":"10.1093/medlaw/fwad040","url":null,"abstract":"<p><p>Where parents seek treatment for their young child that healthcare professionals cannot agree to, the High Court can determine what is in the child's best interests. Some activists and academics seek change to impose threshold criteria that would bolster the decision-making rights of parents and reduce deference to clinicians and the courts. We defend the best interests standard against arguments that a higher threshold of 'significant harm' should apply. We do so from ethical, legal, and clinical perspectives. The matter is of significant moral and practical importance, especially in light of the divergence of academic opinion, the burgeoning number of cases coming before the courts and recent case law and statutory attempts to effect change. We begin by disputing ethical claims that a significant harm threshold is preferable to the best interests standard, and then we set out jurisprudential and practical arguments that demonstrate the imprudence of a significant harm threshold and defend the established yardstick of best interests.</p>","PeriodicalId":49146,"journal":{"name":"Medical Law Review","volume":" ","pages":"158-177"},"PeriodicalIF":1.7,"publicationDate":"2024-05-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11132700/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138488857","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Heritable human genome editing: correction, selection and treatment.","authors":"Rosamund Scott","doi":"10.1093/medlaw/fwae003","DOIUrl":"10.1093/medlaw/fwae003","url":null,"abstract":"<p><p>Heritable human genome editing (HHGE) to correct a nuclear gene sequence that would result in a serious genetic condition in a future child is presented as 'treatment' in various ethics and policy materials, and as morally preferable to the 'selection' practice of preimplantation genetic testing (PGT), which is subject to the disability critique. However, whether HHGE is 'treatment' for a future child, or another form of 'selection', or whether HHGE instead 'treats' prospective parents, are now central questions in the debate regarding its possible legalisation. This article argues that the idea of 'treatment' for a future child is largely a proxy for 'seriousness of purpose', intended to distinguish HHGE to avoid serious genetic conditions from less obviously justifiable uses; that HHGE is best understood, and morally justified, as a form of 'treatment' for prospective parents who strongly desire an unaffected genetically related child and who have no, or poor, options to achieve this; that HHGE would be morally permissible if consistent with that child's welfare; that legalisation is supportable with reference to the right to respect for private and family life under Article 8 of the European Convention on Human Rights; and that HHGE is morally distinguishable from PGT.</p>","PeriodicalId":49146,"journal":{"name":"Medical Law Review","volume":" ","pages":"178-204"},"PeriodicalIF":1.7,"publicationDate":"2024-05-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11132701/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140186067","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Case Comment-JJ v Spectrum Community Health: When Medical Paternalism Meets Prisoners' Dignity.","authors":"Angelika R Reichstein","doi":"10.1093/medlaw/fwae005","DOIUrl":"10.1093/medlaw/fwae005","url":null,"abstract":"","PeriodicalId":49146,"journal":{"name":"Medical Law Review","volume":" ","pages":"248-254"},"PeriodicalIF":1.7,"publicationDate":"2024-05-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140194881","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}