Artificial intelligence in healthcare: why not apply the medico-legal method starting with the Collingridge dilemma?

Technology has greatly influenced and radically changed human life, from communication to creativity and from productivity to entertainment. The authors, starting from considerations concerning the implementation of new technologies with a strong impact on people's everyday lives, take up Collingridge's dilemma and relate it to the application of AI in healthcare. Collingridge's dilemma is an ethical and epistemological problem concerning the relationship between technology and society which involves two approaches. The proactive approach and socio-technological experimentation taken into account in the dilemma are discussed, the former taking health technology assessment (HTA) processes as a reference and the latter the AI studies conducted so far. As a possible prevention of the critical issues raised, the use of the medico-legal method is proposed, which classically lies between the prevention of possible adverse events and the reconstruction of how these occurred.The authors believe that this methodology, adopted as a European guideline in the medico-legal field for the assessment of medical liability, can be adapted to AI applied to the healthcare scenario and used for the assessment of liability issues. The topic deserves further investigation and will certainly be taken into consideration as a possible key to future scenarios.

Emerging post-Dobbs liability concerns for providers handling embryos.

PURPOSE OF REVIEW: This review outlines novel, emerging legal risks for in-vitro fertilization (IVF) providers and patients. RECENT FINDINGS: This article reviews recent antiabortion legal developments that create novel legal risks to IVF. This article examines new potential liability for the handling or managing of embryos, and threats to safe, efficient, standard-of-care practice of IVF. It reviews established US and international judicial and regulatory frameworks based on scientifically grounded recognition of IVF embryos as deserving of 'special respect', and finds this approach to be an alternative for law and policy makers. SUMMARY: Defining life as 'beginning at fertilization' (or 'conception') or otherwise embracing 'embryonic personhood' creates emerging legal vulnerabilities and concerns for IVF patients and professionals who handle embryos and threatens standard-of-care IVF. Internationally and domestically established, scientifically grounded understandings of IVF embryos, rather than religious beliefs, should be the basis for legal frameworks that accord appropriate - but not unlimited - protections to IVF embryos. This article presents this framework as an alternative to the current path being embraced by some US policymakers and courts, as a means of protecting the rights of patients, providers and the families they create.

Risk management and empirical study of the doctor-patient relationship: based on 1790 litigation cases of medical damage liability disputes in China.

BACKGROUND: Compensation for medical damage liability disputes (CMDLD) seriously hinders the healthy development of hospitals and undermines the harmony of the doctor-patient relationships (DPR). Risk management in the DPR has become an urgent issue of the day. The study aims to provide a comprehensive description of CMDLD in China and explore its influencing factors, and make corresponding recommendations for the management of risks in the DPR. METHODS: This study extracted data from the China Judgment Online - the official judicial search website with the most comprehensive coverage. Statistical analysis of 1,790 litigation cases of medical damage liability disputes (COMDLD) available from 2015 to 2021. RESULTS: COMDLD generally tended to increase with the year and was unevenly distributed by regions; the compensation rate was 52.46%, the median compensation was 134,900 yuan and the maximum was 2,234,666 yuan; the results of the single factor analysis showed that there were statistically significant differences between the compensation for different years, regions, treatment attributes, and trial procedures (P < 0.05); the correlation analysis showed that types of hospitals were significantly negatively associated with regions (R=-0.082, P < 0.05); trial procedures were significantly negatively correlated with years (R=-0.484, P < 0.001); compensat- ion was significantly positively correlated with years, regions, and treatment attributes (R = 0.098-0.294, P < 0.001) and negatively correlated with trial procedures (R=-0.090, P < 0.01); regression analysis showed that years, treatment attributes, and regions were the main factors affecting the CMDLD (P < 0.05). CONCLUSIONS: Years, regions, treatment attributes, and trial procedures affect the outcome of CMDLD. This paper further puts forward relevant suggestions and countermeasures for the governance of doctor-patient risks based on the empirical results. Including rational allocation of medical resources to narrow the differences between regions; promoting the expansion and sinking of high-quality resources to improve the level of medical services in hospitals at all levels; and developing a third-party negotiation mechanism for medical disputes to reduce the cost of medical litigation.

Liability of Health Professionals Using Sensors, Telemedicine and Artificial Intelligence for Remote Healthcare.

In the last few decades, there has been an ongoing transformation of our healthcare system with larger use of sensors for remote care and artificial intelligence (AI) tools. In particular, sensors improved by new algorithms with learning capabilities have proven their value for better patient care. Sensors and AI systems are no longer only non-autonomous devices such as the ones used in radiology or surgical robots; there are novel tools with a certain degree of autonomy aiming to largely modulate the medical decision. Thus, there will be situations in which the doctor is the one making the decision and has the final say and other cases in which the doctor might only apply the decision presented by the autonomous device. As those are two hugely different situations, they should not be treated the same way, and different liability rules should apply. Despite a real interest in the promise of sensors and AI in medicine, doctors and patients are reluctant to use it. One important reason is a lack clear definition of liability. Nobody wants to be at fault, or even prosecuted, because they followed the advice from an AI system, notably when it has not been perfectly adapted to a specific patient. Fears are present even with simple sensors and AI use, such as during telemedicine visits based on very useful, clinically pertinent sensors; with the risk of missing an important parameter; and, of course, when AI appears "intelligent", potentially replacing the doctors' judgment. This paper aims to provide an overview of the liability of the health professional in the context of the use of sensors and AI tools in remote healthcare, analyzing four regimes: the contract-based approach, the approach based on breach of duty to inform, the fault-based approach, and the approach related to the good itself. We will also discuss future challenges and opportunities in the promising domain of sensors and AI use in medicine.

Doctors, FIRs, and Arrest in Alleged Medical Negligence Cases in India: Demystifying the Legal Tenability.

The relationship between a doctor and a patient is a contract, retaining the essential elements of the tort. Modern medical practice has evolved alongside the court of law to regulate the conduct of doctors and hospitals to reduce litigations of medical negligence. Lately, Indian patients have become more aware of their rights and the Consumer Protection Act. This awareness encourages patients to litigate and seek the help of redressal forums to mitigate their loss/injury in cases of medical negligence. Though there is a rise in complaints of medical negligence filed against doctors and hospitals, these allegations are often frivolous. The specter of litigation constantly looms over medical practitioners, who frequently struggle to defend themselves in a court of law, causing undue anxiety and anguish. Thus, a doctor can be considered the second victim in a medical negligence case. Lack of awareness regarding their legal rights and pertinent laws coupled with contradictory actions of the law enforcement agencies while handling alleged medical negligence cases worsens a doctor's trepidation. Hence, this article attempts to raise awareness among medical professionals, which will thereby allay undue fear while facing an allegation.

[Quality indicators artificial intelligence]. / Qualitätsindikatoren künstliche Intelligenz.

The ability of some artificial intelligence (AI) systems to autonomously evolve and the sometimes very limited possibilities to comprehend their decision-making processes present new challenges to our legal system. At a European level this has led to reform efforts, of which the proposal for a European AI regulation promises to close regulatory gaps in existing product safety law through cross-sectoral AI-specific safety requirements. A prerequisite, however, would be that the EU legislator does not only avoid duplications and contradictions with existing safety requirements but also refrains from imposing exaggerated and unattainable demands. If this were to be taken into consideration, the new safety requirements could also be used to specify the undefined standard of care in liability law. Nevertheless, challenges in the context of provability continue to remain unresolved, posing a risk of rendering the legal protection efforts of the aggrieved party ineffective. It remains to be seen whether the EU legislator will address this need for reform with the recently proposed reform of product liability law by the Commission.

[Criminal liability of practitioners. Patient consent as a justification ?] / Responsabilité pénale du médecin. Le consentement du patient comme fait justificatif ?

The medical world brings together the divergent interests of healthcare professionals and patients, and a balance between the two is always necessary to establish and maintain a relationship of trust and to ensure that the healthcare system functions properly. Conflicts do arise, however, particularly when patients feel that their rights have not been respected by health professionals, in which case the latter may be held liable, particularly under criminal law. However, there are justifications that practitioners can use to avoid any liability : in particular, the patient's consent, and it is up to the professional to prove this.

Le monde médical mêle les intérêts parfois divergents des professionnels de la santé et des patients, un équilibre entre les deux étant toujours nécessaire à la création et au maintien d'une relation de confiance ainsi qu'au bon fonctionnement du système de santé. Il arrive toutefois qu'un conflit apparaisse, notamment lorsque le patient estime que ses droits n'ont pas été respectés par le praticien, auquel cas la responsabilité ­ en particulier pénale ­ de ce dernier peut être engagée. Or, il existe des faits justificatifs que le professionnel de la santé peut invoquer, pouvant lui permettre de se libérer de tout chef de responsabilité : c'est le cas notamment du consentement du patient, à charge pour le praticien d'en apporter la preuve.

A Review of Professional Liability in IR: Sweeping the Mines.

Medical professional liability (MPL) is becoming a substantial issue in interventional radiology (IR), with both impact on health care costs and negative psychological effects on physicians. MPL presents special challenges within IR because of the field's complex and innovative therapies that are provided to a diverse group of patients and complicated by the off-label use of devices and drugs that is pervasive in the field. This review discusses the principles and practices to avoid and manage MPLs that are specific to the field of IR.

A case of intrauterine fetal death related to furcate cord insertion: a brief review of the literature and professional liability considerations.

The furcate insertion of the umbilical cord is an uncommon abnormality, often asymptomatic, potentially dangerous, or lethal for the fetus and the mother. This report shows the case of a healthy 29-year-old patient, at 37 weeks of gestation, admitted to the hospital two days before the due date because of the appearance of uterine contractions; clinical exams were regular. The following day, no fetal movements were perceived, a cardiotocography was performed, showing the absence of fetal heartbeat. A dead fetus was delivered. Autopsy showed furcate insertion of the umbilical cord and the rupture of the umbilical vessel, which caused fetal hemorrhagic shock. Furcate insertion still remains mostly undiagnosed and rarely it can be identified prenatally (only three cases are reported in literature). Future research, mainly in forensic fields, could improve the knowledge about this condition, helping prenatal diagnosis and providing warnings that can prevent similar deaths in the future.

The Impact of Malpractice Damage Caps on C-section Rates and Alternative Approaches.

About half of the states in the United States have had noneconomic damage caps in place for at least 8 years. National aggregate data shows that women are just as likely to give birth by cesarean section (C-section) in states with damage caps as in ones without. For the most recent year studied, the national C-section rate for births in states with damage caps was 33.04% compared with a 32.10% ratefor births in states without caps. Other initiatives (malpractice insurance reform, accessible public disclosure of hospital C-section rates, and improved compensation for vaginal delivery) should be considered to reduce C-section rates.

Judicial and legislative practice and related suggestions on off-label drug use in China.

BACKGROUND: Off-label drug use exists widely in medical practice and is also an area which easily triggers controversy between patients and medical institutions. Previous studies have identified the reasons why off-label drug use long exists. However, there is no multidimensional analysis on real judicial precedents about off-label drug use. This study aimed to investigate the dispute points on off-label drug use based on real cases in China, and proposed suggestions based on newly-leased Physicians Law. METHODS: Our study is a retrospective study with all the 35 judicial precedents on off-label drug use extracted from China Judgments Online from 2014 to 2019. This study mainly used the methods of statistical analysis, inferential analysis, exemplification, literature summarization and comparative analysis. RESULTS: According to the analysis of the 35 precedents of jurisdictions from 11 different aspects, it can be seen that the second-instance and retrial rates of this kind of cases are high, and the disputes between patients and medical institutions are fierce. In judicial practice of off-label drug use, medical institutions are determined whether to bear civil liability according to the constituent elements of medical tort liability: the rate of medical institutions' bearing liability for off-label drug use is not high, and medical institutions are not directly identified as infringing acts and they don't bear tort liability. The clear provisions about off-label drug use in Law of the People's Republic of China on Physicians which was implemented in March 2022 confirm this at the legislative level. CONCLUSIONS: By analyzing the current judicial practice of China's off-label drug use cases, and summarizing the dispute points between medical institution and patients, the constituent elements of tort liability, and the rules of evidence etc., suggestions are proposed to further regulate off-label drug use and promote safe and rational drug use.

How patient autonomy drives the legal liabilities of medical practitioners and the practical ways to mitigate and resolve them.

This paper discusses the rapidly evolving healthcare risk landscape and considers how emerging trends-such as advancement of medical technology, cyber security, pandemic risks, increasing prevalence of noncommunicable health conditions, and the shift towards patient autonomy-are shaping the nature of liabilities faced by doctors and healthcare professionals. Then it discusses practical ways to mitigate clinical risks and resolve the medico-legal claims or inquiries that arise while addressing the role that indemnity providers should play.

How Much Information is Enough? Understanding the Alabama Supreme Court's Expansion of the Causation Standard in Failure to Warn Claims.

This RCD analyzes the Alabama Supreme Court's recent answer to two certified questions sent to the court from the Eleventh Circuit. The questions involved whether a pharmaceutical company's duty to warn included a duty to provide instructions about how to properly mitigate for warned of risks, and if the pharmaceutical company had such a duty could a plaintiff recover if their physician would have prescribed the same drug but just changed their monitoring scheme. The Alabama Supreme Court answered both questions in the affirmative, expanding the causation standard in failure to warn claims.

Who Is a Health Care Provider?: Statutory Interpretation as a Middle-Ground Approach to Medical Malpractice Damage Caps.

Debates over the effectiveness, constitutionality, and fairness of medical malpractice damage caps are as old as the laws themselves. Though some courts have struck down damage caps under state constitutional provisions, the vast majority hesitate to invalidate malpractice reform legislation. Instead, statutory interpretation offers a non-constitutional method of challenging the broad scope of damage caps without fully invalidating legislative efforts to curtail "excessive" malpractice liability. This Note examines the term "health care providers" in construing malpractice reform laws and identifies two predominant forms of statutory interpretation that state courts apply. In doing so, this Note offers recommendations for courts and legislatures to best balance the goals of the malpractice reform movement with patients' interests in recovery for medical injuries.

The Causes of Minor Suicide: How the Restatement Approach to Foreseeability & Scope of Liability Fails to Act as a Deterrent.

Suicide is one of the most common causes of death among individuals younger than eighteen years old. While psychological and social sciences continue to study the causes of the increasing prevalence of suicide in children and teens, the law largely continues to treat suicide as an isolated event. This Note tracks the historical treatment of suicide both under tort and criminal law, supporting the shift away from the traditional view of suicide towards one that more closely aligns with the growing understanding of the many factors that can contribute to a minor's suicide. Ultimately, this Note argues that many minor suicides should be treated as foreseeable, allowing actions in tort.

Lessons from Re Teo: Unconventional Practice and the National Law.

This section explores the decision of the New South Wales Professional Standards Committee, in Re Teo [2023] NSWMPSC 2. The case provides insights into how the Health Practitioner Regulation National Law Act 2009 (Qld) regulates practitioners who practise outside of conventional practice. The section compares the decision to similar cases and then concludes with a proposal that an express policy on unconventional practice is needed in Australia.

The Standard of Care Test Revisited: Competing Approaches to Defining Competent Profession Practice in Australia.

This section examines the recent decision of the New South Wales Court of Appeal in Dean v Pope [2022] NSWCA 260. The decision settles a long-running dispute in New South Wales about the test for the standard of care under s 5O of the Civil Liability Act 2002 (NSW). That provision was introduced following the medical indemnity crisis of the early 2000s and provided for a modified Bolam test to protect professionals from claims in negligence when they had acted in accordance with a standard of "competent professional practice". In recent years there has been controversy regarding whether that section required the practice to be one already established to satisfy the section. This section examines the decision, how it fits into the history of the Ipp reforms and what it means for other jurisdictions in Australia.

Legal Liability of Clinical Ethics Services in Australia: "Should I Be More Worried Than I Am?"

A key function of clinical ethics services (CESs) is to provide decision-making support to health care providers in ethically challenging cases. Cases referred for ethics consultation are likely to involve diverging views or conflict, or to confront the boundaries of appropriate medical practice. Such cases might also attract legal action due to their contentious nature. As CESs become more prevalent in Australia, this article considers the potential legal liability of a CES and its members. With no reported litigation against a CES in Australia, we look to international experience and first principles. We consider the prospects of a claim in negligence, the most likely legal action against a CES, through application of legal principles to a hypothetical case scenario. We conclude that, although unlikely to be successful at this time, a CES could face answerable claims in negligence brought by patients (and families) who are the subject of ethics case consultation.

Artificial Intelligence in Medicine: Issues When Determining Negligence.

The introduction of novel medical technology, such as artificial intelligence (AI), into traditional clinical practice presents legal liability challenges that need to be squarely addressed by litigants and courts when something goes wrong. Some of the most promising applications for the use of AI in medicine will lead to vexed liability questions. As AI in health care is in its relative infancy, there is a paucity of case law globally upon which to draw. This article analyses medical malpractice where AI is involved, what problems arise when applying the tort of negligence - such as establishing the essential elements of breach of duty of care and causation - and how can these can be addressed. Product liability under Australian Consumer Law is beyond the scope of this article. In order to address this question, the article: (1) identifies the general problems that black box AI causes in the health care sector; (2) identifies the problems that will arise in establishing breach and causation due to the "black box" nature of AI, with reference to the Civil Liability Act 2002 (NSW) and common law through two hypothetical examples; and (3) considers selected legal solutions to the problems caused by "black box" AI.