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.

[Medical overuse, defensive medicine and new reform of professional mistake].

Reflecting on the inappropriateness (medical overuse) and on defensive medicine, the Authors wonder whether the new Italian reform of professional guilt, desired at all institutional levels, will actually contain the high economic costs produced by these large and widespread phenomena. After having characterized the medical overuse and the defensive medicine indicating the common traits and main differences, the reflection is conducted by exploring the many scientific evidence that does not document any causal link between the decriminalization of professional conduct and the containment of the costs produced by the prescriptive inappropriateness. They conclude by stating that, for their containment, a third reform of professional liability will not be helpful. Instead, it must focus on other issues, mainly addressing the excessive reliance on judicial recourse. It should provide for mandatory out-of-court conciliatory mechanisms and clarifying the protective umbrella of the doctor's non-criminality.

Bleeding Control Protections Within US Good Samaritan Laws.

INTRODUCTION: In the United States, all 50 states and the District of Columbia have Good Samaritan Laws (GSLs). Designed to encourage bystanders to aid at the scene of an emergency, GSLs generally limit the risk of civil tort liability if the care is rendered in good faith. Nation-wide, a leading cause of preventable death is uncontrolled external hemorrhage. Public bleeding control initiatives aim to train the public to recognize life-threatening external bleeding, perform life-sustaining interventions (including direct pressure, tourniquet application, and wound packing), and to promote access to bleeding control equipment to ensure a rapid response from bystanders. METHODS: This study sought to identify the GSLs in each state and the District of Columbia to identify what type of responder is covered by the law (eg, all laypersons, only trained individuals, or only licensed health care providers) and if bleeding control is explicitly included or excluded in their Good Samaritan coverage. RESULTS: Good Samaritan Laws providing civil liability qualified immunity were identified in all 50 states and the District of Columbia. One state, Oklahoma, specifically includes bleeding control in its GSLs. Six states - Connecticut, Illinois, Kansas, Kentucky, Michigan, and Missouri - have laws that define those covered under Good Samaritan immunity, generally limiting protection to individuals trained in a standard first aid or resuscitation course or health care clinicians. No state explicitly excludes bleeding control from their GSLs, and one state expressly includes it. CONCLUSION: Nation-wide across the United States, most states have broad bystander coverage within GSLs for emergency medical conditions of all types, including bleeding emergencies, and no state explicitly excludes bleeding control interventions. Some states restrict coverage to those health care personnel or bystanders who have completed a specific training program. Opportunity exists for additional research into those states whose GSLs may not be inclusive of bleeding control interventions.

AI in radiology: Legal responsibilities and the car paradox.

The integration of AI in radiology raises significant legal questions about responsibility for errors. Radiologists fear AI may introduce new legal challenges, despite its potential to enhance diagnostic accuracy. AI tools, even those approved by regulatory bodies like the FDA or CE, are not perfect, posing a risk of failure. The key issue is how AI is implemented: as a stand-alone diagnostic tool or as an aid to radiologists. The latter approach could reduce undesired side effects. However, it's unclear who should be held liable for AI failures, with potential candidates ranging from engineers and radiologists involved in AI development to companies and department heads who integrate these tools into clinical practice. The EU's AI Act, recognizing AI's risks, categorizes applications by risk level, with many radiology-related AI tools considered high risk. Legal precedents in autonomous vehicles offer some guidance on assigning responsibility. Yet, the existing legal challenges in radiology, such as diagnostic errors, persist. AI's potential to improve diagnostics raises questions about the legal implications of not using available AI tools. For instance, an AI tool improving the detection of pediatric fractures could reduce legal risks. This situation parallels innovations like car turn signals, where ignoring available safety enhancements could lead to legal problems. The debate underscores the need for further research and regulation to clarify AI's role in radiology, balancing innovation with legal and ethical considerations.

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.

Including Pregnant and Lactating Women in Clinical Research: Moving Beyond Legal Liability.

This Viewpoint summarizes a new report from the National Academies of Sciences, Engineering, and Medicine that encourages the inclusion of pregnant and lactating individuals in clinical research.

[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.

[Is agression a valid reason to end the therapeutic relationship with a patient?] / Is agressie een reden om de behandelrelatie met een patiënt te beëindigen?

It regularly occurs that a physicians is abused by a patient. For physicians this may be a reason to consider to end the relationship with such patients, particularly if patients become violent. But is this permitted? The Dutch law and professional standards restrict physicians from doing so, unless there are 'serious reasons' to do so and only after having investigated all possibilities to restore the treatment relationship, including a discussion with the patient. We argue that these restrictions are too strict. Physicians should be able the end the relationship with patients that fail to respect the physical or mental integrity of physicians or their colleagues.

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.

Anesthesia Liability Related to Pre-existing Conditions.

In 1985, the American Society of Anesthesiologists initiated a quality improvement closed claims analysis project for anesthetic injury to elevate patient safety. To date, there have been a total of 8954 documented claims, describing injuries contracted under sedation, regional anesthesia, or failure to attend to a patient's post-operative needs. The Closed Claims database reveals that the most highly documented health care complications were a loss of life at 2%, nerve injuries at 2%, and damage to the brain at 9%. The highest documented cases of damage from anesthesia involved regional-block-related events at 20%, followed by respiratory-related adverse effects at 17%, cardiovascular-related events at 13%, together with apparatus-linked events at 10%. Injury may result from several causes. First, multiple techniques and interventions are used during surgery, and all have potential adverse effects. Additionally, many patients scheduled for surgery have extensive past medical histories and medical comorbidities, thereby increasing their baseline risk for injury. From the Closed Claims database, improved evaluation of clinical-related implications linked to injuries within the handling of airway, sedation, non-operational room locales, obstetric anesthesia, along with chronic pain management. In summary, anesthesia departments should review outcomes of their patients on a routine basis. Assessing factors when an adverse outcome occurs may allow for changes in techniques or other anesthesia considerations to help lessen or prevent future complications.

Whose Responsibility Is It to Define Exceptions in Abortion Bans?

This Viewpoint evaluates Texas' proposals to define the scope of the life exception for the state's abortion ban and argues that these approaches do not allow physicians to follow the national standards of care, avoid criminal liability, or have sufficient notice of what the law permits.

[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.

How different countries respond to adverse events whilst patients' rights are protected.

Patient safety is high on the policy agenda internationally. Learning from safety incidents is a core component in achieving the important goal of increasing patient safety. This study explores the legal frameworks in the countries to promote reporting, disclosure, and supporting healthcare professionals (HCPs) involved in safety incidents. A cross-sectional online survey was conducted to ascertain an overview of the legal frameworks at national level, as well as relevant policies. ERNST (The European Researchers' Network Working on Second Victims) group peer-reviewed data collected from countries was performed to validate information. Information from 27 countries was collected and analyzed, giving a response rate of 60%. A reporting system for patient safety incidents was in place in 85.2% (N = 23) of countries surveyed, though few (37%, N = 10) were focused on systems-learning. In about half of the countries (48.1%, N = 13) open disclosure depends on the initiative of HCPs. The tort liability system was common in most countries. No-fault compensation schemes and alternative forms of redress were less common. Support for HCPs involved in patient safety incidents was extremely limited, with just 11.1% (N = 3) of participating countries reporting that supports were available in all healthcare institutions. Despite progress in the patient safety movement worldwide, the findings suggest that there are considerable differences in the approach to the reporting and disclosure of patient safety incidents. Additionally, models of compensation vary limiting patients' access to redress. Finally, the results highlight the need for comprehensive support for HCPs involved in safety incidents.