Behind the mask: a critical perspective on the ethical, moral, and legal implications of AI in ophthalmology.

PURPOSE: This narrative review aims to provide an overview of the dangers, controversial aspects, and implications of artificial intelligence (AI) use in ophthalmology and other medical-related fields. METHODS: We conducted a decade-long comprehensive search (January 2013-May 2023) of both academic and grey literature, focusing on the application of AI in ophthalmology and healthcare. This search included key web-based academic databases, non-traditional sources, and targeted searches of specific organizations and institutions. We reviewed and selected documents for relevance to AI, healthcare, ethics, and guidelines, aiming for a critical analysis of ethical, moral, and legal implications of AI in healthcare. RESULTS: Six main issues were identified, analyzed, and discussed. These include bias and clinical safety, cybersecurity, health data and AI algorithm ownership, the "black-box" problem, medical liability, and the risk of widening inequality in healthcare. CONCLUSION: Solutions to address these issues include collecting high-quality data of the target population, incorporating stronger security measures, using explainable AI algorithms and ensemble methods, and making AI-based solutions accessible to everyone. With careful oversight and regulation, AI-based systems can be used to supplement physician decision-making and improve patient care and outcomes.

Analysis of the characteristics, efficiency, and influencing factors of third-party mediation mechanisms for resolving medical disputes in public hospitals in China.

BACKGROUND: Medical disputes, which are prevalent in China, are a growing global public health problem. The Chinese government has proposed third-party mediation (TPM) to resolve this issue. However, the characteristics, efficiency, and influencing factors of TPM in resolving medical disputes in public hospitals in China have yet to be determined. METHODS: We conducted a systematic study using TPM records from medical disputes in Gansu Province in China from 2014 to 2019. A χ2 test was used to compare differences between groups, and binary logistic analysis was performed to determine the factors influencing the choice of TPM for resolving medical disputes. RESULTS: We analyzed 5,948 TPM records of medical disputes in Gansu Province in China. The number of medical disputes and the amount of compensation awarded in public hospitals in the Gansu Province increased annually from 2014 to 2019, with most of the disputes occurring in secondary and tertiary hospitals. Approximately 89.01% of the medical disputes were handled by TPM; the average compensation amount with TPM was Chinese Yuan (CNY) 48,688.73, significantly less than that awarded via court judgment and judicial mediation. TPM was more likely to succeed in settling medical disputes in the < CNY10,000 compensation group than in the no-compensation group (odds ratio [OR] = 3.14, 95% confidence interval [CI] 1.53-6.45). However, as the compensation amount increased, the likelihood of choosing TPM decreased significantly. Moreover, TPM was less likely to be chosen when medical disputes did not involve death (OR = 0.49, 95% CI 0.36-0.45) or when no-fault liability was determined (vs. medical accidents; OR = 0.37, 95% CI 0.20-0.67). CONCLUSION: Our findings demonstrate that TPM mechanisms play a positive role in efficiently reducing compensation amounts and increasing medical dispute resolution rates which was the main settlement method in resolving medical disputes in public hospitals of Gansu Province in China. TPM could help greatly reduce conflicts between doctors and patients, avoid litigation, and save time and costs for both parties. Moreover, compensation amounts, non-fatal outcomes, and no-fault liability determinations influence the choice of TPM for settling medical disputes.

Management of Behaviours in Dementia: Treatment or Restraint?

The use of antipsychotic medication in the management of behaviours of concern in dementia is complex. Antipsychotics may be part of medical treatment or be a restrictive practice. The uncertainty around consent for restrictive practices exposes patients to the risk of antipsychotic use without consent and doctors to the risk of liability. This situation is even less clear in Victoria following the ruling in HYY [2022] VCAT 97. This article examines the process of consent, the potential liabilities and possible defences. It concludes that changes are needed to the process for obtaining consent to use antipsychotic medications for restrictive practices, especially in Victoria.

Necrotizing Fasciitis of the Thigh as Unusual Colonoscopic Polypectomy Complication: Review of the Literature with Case Presentation.

Necrotizing fasciitis (NF) is an infection characterized by necrosis of the superficial muscle fascia and surrounding soft tissues. It usually occurs following skin breaches from penetrating traumas or high-degree burns. Less frequently, it could be related to major abdominal surgery. However, no cases of thigh NF after minor abdominal procedures have ever been reported. A previously healthy 59-year-old male patient underwent a colonoscopic polypectomy. After the procedure, the patient developed an increasing right groin pain. The CT scan showed a gas collection in the right retroperitoneum space and in the right thigh soft tissues. Thus, a right colon perforation was hypothesized, and the patient was moved to the nearest surgery department and underwent a right hemicolectomy procedure. During surgery, the right thigh was also incised and drained, with gas and pus leakage. Nevertheless, the right lower limb continued to swell, and signs of systemic infection appeared. Afterward, clinical conditions continued to worsen despite the drainage of the thigh and antibiotic therapy, and the patient died of septic shock after just two days. This case shows that, although rare, lower limb NF should be considered among the causes of early post-operative local painful symptoms.

Professional medical liability, clinical practice guidelines and Lex Artis. The importance of following clinical practice guidelines recommendations.

Professional medical liability is the result of medical malpractice, which may be due to negligence, incompetence or carelessness. Lex Artis is the set of skills and knowledge that have been universally accepted by peers, which must be diligently applied in the specific situation of a given patient. Thus, Lex Artis is essentially everything contained in clinical practice guidelines. Judicially speaking, the practice of medicine in Mexico is an obligation of means, but not of results. Therefore, adherence to clinical practice guidelines recommendations is the most effective way to defend oneself against a malpractice lawsuit.

La responsabilidad médica profesional es el resultado de mala praxis médica, la cual puede deberse a negligencia, impericia o imprudencia. Se conoce como lex artis al conjunto de conocimientos y habilidades que han sido universalmente aceptados por los pares, los cuales deben ser diligentemente aplicados en la situación específica de un paciente determinado. Entonces, lex artis es fundamentalmente todo lo contenido en las guías para la práctica clínica. Judicialmente hablando, en México el ejercicio de la medicina es una obligación de medios, mas no de resultados. Por consiguiente, apegarse a las recomendaciones de las guías para la práctica clínica es más efectivo para defenderse de una demanda legal por mala praxis.

A Five-Year Survey for Plastic Surgery Malpractice Claims in Rome, Italy.

(1) Introduction: Medical malpractice claims against both health institutions and physicians are a crucial topic in Italy, as well as in other countries, particularly regarding civil proceedings. Our study reports an analysis of all of the malpractice judgments concerning plastic surgery decided in the Civil Court of Rome between 2012 and 2016. (2) Methods: the database of the Observatory Project on Medical Responsibility (ORMe) was analyzed, which collects all of the judgments of the Civil Court of Rome, that is, the first instance district court. Therefore, neither the jurisprudence of the second level court nor that of the Supreme Court was taken into account. (3) Results: 144 judgments concerning plastic surgery were delivered in the five-year period of 2012-2016 (corresponding to 10.6% of total professional liability verdicts of the Civil Court of Rome in the same period). In 101/144 cases (70.14%), the claim was accepted. A total of €4,727,579.00 was paid in compensation for plastic surgery malpractice claims, with a range from a minimum amount of €1555.96 to a maximum amount of €1,425,155.00 and an average compensation of €46,807.71 per claim that was significantly lower compared to other surgical disciplines. (4) Conclusions: Our data confirm that the analyzed branch has a high litigation rate, with a prevalence of convictions for cosmetic procedures over reconstructive ones, both for malpractice and for violation of the informed consent. Plastic surgery is also confirmed among those branches in which the professionals are more frequently sued compared to health institutions.

Patient blood management: The best approach to transfusion medicine risk management.

In advanced health systems it is increasingly important to offer effective medical services that have high quality and safety standards. We present an overview of the direct hazards and the indirect hazards associated with blood transfusions. Our aim is to focus on the potential medico-legal impacts of these hazards in the context of clinical risk management, incorporating the accumulating evidence from Patient Blood Management programs. The direct or deterministic hazards of transfusion refer to scenarios where the mechanisms for post transfusion damage are clearly traceable to the blood transfused in a 1:1 cause and effect manner. The indirect hazards can be defined as probabilistic and are associated with transfusion through epidemiological studies. The implementation of Patient Blood Management programs demonstrates that the use of a blood transfusion is not always necessary or unavoidable but can be considered modifiable. Review of the literature confirms that transfusion should not be the default option to manage anemia or blood loss. Instead, accumulating evidence demonstrates that a patient-centred, proactive approach to managing a patient's own blood is the new standard of care. It thus follows, an adverse transfusion event, where the transfusion was avoidable through the application of patient blood management, may constitute a profile for medical professional medical negligence. In an effort to maximise patient safety, transfusion medicine practice culture needs to shift towards a patient blood management approach, with hospitals implementing it as an important tool to minimize the risks of allogeneic blood transfusion.

Patient blood management implementation in light of new Italian laws on patient's safety.

The present work aims to analyze the impact - from legal and medical perspective - of the recent Italian legislative provisions on the subject of healthcare safety, and how these affect current transfusion practices, also in light of the accumulation of evidence deriving from the implementation of the Patient Blood Management (PBM) program. The scientific evidence shows that PBM is a bundle of care that improves patient outcomes including mortality and morbidity, improves the quality of life of patients and the population, reduces healthcare costs and decreases consumption of blood components. These aspects should be largely sufficient to carry out an urgent implementation of PBM in Italian hospitals. However, it is now also possible to indicate a further incentive for implementation which is made up of medico-legal aspects and is characterized by the need to decrease the intrinsic risks of the use of blood products so as to protect doctors and hospitals from possible future medico-legal disputes regarding adverse transfusion events that could be effectively avoided.

[The doctor as user is always to blame? : How to be covered in event of claims]. / Der Arzt als Anwender ist immer schuld? : Wie absichern bei Schadensfällen?

This liability-related article on patient safety in the context of orthopedic implant surgery clarifies the question of whether the physician meets the strict manufacturer's liability under the Medizinproduktegesetz (Medical Devices Act) or the provisions of civil law for contract liability and tort liability apply to the installation of the implant. Basically, the doctor is only liable for a culpable default violation. He is not responsible for the burden of proof that a design, fabrication or instruction error caused the damage. The physician benefits from therapeutic freedom also in the choice and application of the implant. In individual cases, however, even the wrong choice of implant may lead to a "gross" error in treatment. Incidentally, the doctor may confine himself to a visual and mechanical examination of the functional capability of a prosthesis. The doctor may benefit from the principle of trust, according to which each partner may rely on the diligence of the contractor. The article concludes with a number of practical hints.

[Immediate consent directly after patient enlightening talk-valid or void? : Consider time for thought!] / Die sofortige Einwilligung unmittelbar nach dem Aufklärungsgespräch ­ wirksam oder unwirksam? : Bedenkzeit bedenken!

Patients must be informed of the chances of success and risks well in advance of the intended treatment measure so that they can adequately maintain a freedom of choice and thus the right to self-determination by carefully considering the reasons for and against the recommended measure. Fixed deadlines for the time between information and consent cannot be set as a blanket measure. There can be many different aspects that must be considered, which can lead to different deadlines in individual cases, which should lie between information, consent and the start of the measure. If a treatment measure does not have to be carried out immediately, a reflection period adapted to the circumstances should be allowed until shortly before the intervention. If this period of deliberation is not granted and consent is requested immediately, the doctor must convince himself before the treatment measure is carried out that the consent given still corresponds to the patient's will. This request is not necessary if the patient has expressly waived a period of reflection after receiving appropriate clarification.

Natural Products in Neurodegenerative Diseases: A Great Promise but an Ethical Challenge.

Neurodegenerative diseases (NDs) represent one of the most important public health problems and concerns, as they are a growing cause of mortality and morbidity worldwide, particularly in the elderly. Despite remarkable breakthroughs in our understanding of NDs, there has been little success in developing effective therapies. The use of natural products may offer great potential opportunities in the prevention and therapy of NDs; however, many clinical concerns have arisen regarding their use, mainly focusing on the lack of scientific support or evidence for their efficacy and patient safety. These clinical uncertainties raise critical questions from a bioethical and legal point of view, as considerations relating to patient decisional autonomy, patient safety, and beneficial or non-beneficial care may need to be addressed. This paper does not intend to advocate for or against the use of natural products, but to analyze the ethical framework of their use, with particular attention paid to the principles of biomedical ethics. In conclusion, the notable message that emerges is that natural products may represent a great promise for the treatment of many NDs, even if many unknown issues regarding the efficacy and safety of many natural products still remain.

Doctor's Criminal Liability and Medically Assisted Death - The Portuguese Case.

Recently, the Portuguese Parliament discussed four proposals aimed at allowing some forms of medically assisted death. However, all of them were rejected by the majority. Therefore, doctors who in some way accelerate a patient's death risk being convicted of the crime of homicide. Portuguese law provides some legal mechanisms that can exempt a doctor from criminal liability, such as causes excluding the conduct's wrongfulness, and causes excluding the doctor's culpability. Other elements to take into consideration are a proper interpretation of homicide crimes, thereby excluding conducts without the intent to kill; the relevance of patient consent; and the rejection of medical futility. This article explains how a doctor may not be held criminally accountable for medically assisted death, even in restrictive jurisdictions such as the Portuguese one.

[Medical liability for secondary surgery]. / Responsabilité médicale en chirurgie secondaire.

Taking care of a patient for secondary surgery is an important moral, ethical and legal responsibility. The patient is expecting a lot of this recovery. A new failure is hardly not acceptable to him. Before agreeing to operate, the new surgeon must well evaluate the possibilities of success and the operational risks, as well as the psychological aspects of this recovery. He must also inform the patient extensively. In front of the technical difficulty of these secondary surgeries, a new failure is always possible. It can lead to a judicial questioning of the last surgeon. The latter is responsible only for his own actions, however the reality of the prior state at the origin of this secondary surgery will have to be investigated and demonstrated, as it will not be borne by the last surgeon in terms of compensation.

Perceptions of patients and providers on myocardial perfusion imaging for asymptomatic patients, choosing wisely, and professional liability.

BACKGROUND: Despite efforts by professional societies to reduce low value care, many reports indicate that unnecessary tests, such as nuclear myocardial perfusion imaging (MPI), are commonly used in contemporary practice. The degree to which lack of awareness and professional liability concerns drive these behaviors warrants further study. We sought to investigate patient and provider perceptions about MPI in asymptomatic patients, the Choosing Wisely (CW) campaign, and professional liability concerns. METHODS: We administered an anonymous, paper-based survey with both discrete and open-response queries to subjects in multiple outpatient settings at our facilities. The survey was completed by 456 respondents including 342 patients and 114 physicians and advanced practice providers between May and August 2014. Our outcome was to compare patient and provider perceptions about MPI in asymptomatic patients and related factors. RESULTS: Patients were more likely than providers to report that MPI was justified for asymptomatic patients (e.g. asymptomatic with family history of heart disease 75% versus 9.2%, p < 0.0001). In free responses to the question "What would be an inappropriate reason for MPI?" many responses echoed the goals of CW (for example, "If you don't have symptoms", "If the test is too risky", "For screening or in asymptomatic patients"). A minority of providers were aware of CW while even fewer patients were aware (37.2% versus 2.7%, p < 0.0001). Over one third of providers (38.9%) admitted to ordering MPI out of concern for professional liability including 48.3% of VA affiliated providers. CONCLUSIONS: While some patients and providers are aware of the low value of MPI in patients without symptoms, others are enthusiastic to use it for a variety of scenarios. Concerns about professional liability likely contribute, even in the VA setting. Awareness of the Choosing Wisely campaign is low in both groups.

Forensic clinical anatomy: A new field of study with application to medicolegal issues.

Forensic clinical anatomy is a new practical application of the discipline of Clinical Anatomy for ascertaining and evaluating medicolegal questions. In particular, individual anatomy (normal anatomy, anatomical variations, age-, disease-, or surgery-related modifications) can acquire significant relevance in various fields of legal medicine such as child abuse, sudden death, medical responsibility and/or liability, personal injury and damage. Anatomical data of forensic interest frequently arise from the correct application of methods of ascertainment; anatomical methods may then be required for further comprehensive analysis. The rigorous interpretation of anatomical data, derived from the ascertainment phase and analyzed on the basis of pertinent literature, can be pivotal for the correct application of evaluation criteria in various forensic contexts. Clin. Anat. 30:2-5, 2017. © 2016 Wiley Periodicals, Inc.

Impact of the Food and Drug Administration Safety Communication on the Use of Power Morcellator in Daily Clinical Practice: An Italian Survey.

STUDY OBJECTIVE: To assess the impact of the Food and Drug Administration (FDA) warning about power morcellation use on the daily clinical practice of Italian gynecologists. DESIGN: Electronic survey mailed to the main gynecologic centers (Canadian Task Force Classification type III). SETTING: Unit of Obstetrics and Gynecology, IRCCS - Arcispedale S. Maria Nuova di Reggio Emilia (Italy). PATIENTS: The study did not include patient data. INTERVENTION: There was no intervention. MEASUREMENTS AND MAIN RESULTS: From 490 surveys sent out, 426 replies were included in the final analysis (return rate = 86.9%). Four hundred of the 426 (93.9%) gynecologists were aware of the FDA warning. One hundred fifty of 302 (49.7%) of experienced gynecologists and 176 of 349 (50.4%) of oncology gynecologists considered laparoscopy the best approach for myomectomy. The FDA communication was considered overly restrictive by experienced and oncology gynecologists who declared that they had no intention of changing their surgical approach. Two hundred fifty of the 426 (58.7%) gynecologists declared that they would change their surgical approach only to prevent legal litigation. CONCLUSION: The FDA warning also affected Italian gynecologists. Particularly, less experienced gynecologists and those without oncologic practice seem to be more interested in avoiding legal litigation rather than a real clinical risk of upstaging an unexpected leiomyosarcoma. Fear of undiagnosed sarcoma could increase the number of laparotomies.

Health Law 2015: Individuals and Populations.

In this article, we assess two particular trends in judicial doctrine that are likely to emerge in the post-ACA era. The first trend is the inevitable emergence of enterprise medical liability (EML) that will supplant tort law's unstable attempt to apportion liability between physicians and institutions. Arguments favoring EML in health law date back to the early 1980s. But health care's ongoing consolidation suggests that the time has arrived for courts or state legislatures to develop legal doctrine that more closely resembles the ways in which health care is now delivered. This would result in a more appropriate allocation of liability to the institutional level. The second judicial trend will be the convergence of health law and public health law concepts. Because the ACA arguably stimulates closer engagement between health systems and public health departments, health systems will have greater responsibility for keeping their communities healthy along with obligations for individual patient care (i.e., individuals and populations). If so, courts will need to incorporate elements from health law and public health law in resolving disputes.

Does Experience Rating Improve Obstetric Practices? Evidence from Italy.

Using inpatient discharge records from the Italian region of Piedmont, we estimate the impact of an increase in malpractice pressure brought about by experience-rated liability insurance on obstetric practices. Our identification strategy exploits the exogenous location of public hospitals in court districts with and without schedules for noneconomic damages. We perform difference-in-differences analysis on the entire sample and on a subsample which only considers the nearest hospitals in the neighborhood of court district boundaries. We find that the increase in medical malpractice pressure is associated with a decrease in the probability of performing a C-section from 2.3 to 3.7 percentage points (7-11.6%) with no consequences for medical complications or neonatal outcomes. The impact can be explained by a reduction in the discretion of obstetric decision-making rather than by patient cream skimming.

A comprehensive obstetric patient safety program reduces liability claims and payments.

Begun in 2003, the Yale-New Haven Hospital comprehensive obstetric safety program consisted of measures to standardize care, improve teamwork and communication, and optimize oversight and quality review. Prior publications have demonstrated improvements in adverse outcomes and safety culture associated with this program. In this analysis, we aimed to assess the impact of this program on liability claims and payments at a single institution. We reviewed liability claims at a single, tertiary-care, teaching hospital for two 5-year periods (1998-2002 and 2003-2007), before and after implementing the safety program. Connecticut statute of limitations for professional malpractice is 36 months from injury. Claims/events were classified by event-year and payments were adjusted for inflation. We analyzed data for trends as well as differences between periods before and after implementation. Forty-four claims were filed during the 10-year study period. Annual cases per 1000 deliveries decreased significantly over the study period (P < .01). Claims (30 vs 14) and payments ($50.7 million vs $2.9 million) decreased in the 5-years after program inception. Compared with before program inception, median annual claims dropped from 1.31 to 0.64 (P = .02), and median annual payments per 1000 deliveries decreased from $1,141,638 to $63,470 (P < .01). Even estimating the monetary awards for the 2 remaining open cases using the median payments for the surrounding 5 years, a reduction in the median monetary amount per case resulting in payment to the claimant was also statistically significant ($632,262 vs $216,815, P = .046). In contrast, the Connecticut insurance market experienced a stable number of claims and markedly increased cost per claim during the same period. We conclude that an obstetric safety initiative can improve liability claims exposure and reduce liability payments.

Forensic evaluation of medical liability cases in general surgery.

Although medical liability (disciplinary, civil and criminal) is increasingly becoming an issue, few studies exist, particularly from the perspective of forensic science, which demonstrate the extent to which medical malpractice occurs, or when it does, the reasons for it. Our aims were to evaluate the current situation concerning medical liability in general surgery (GS) in Portugal, the reasons for claims, and the forensic evaluations and conclusions, as well as the association between these issues and the judicial outcomes. We analysed the Medico-Legal Council (CML) reports of the National Institute of Legal Medicine and Forensic Sciences of Portugal related to GS during 2001-2010. The judicial outcomes of each case were requested from the Public Prosecutor Office (PPO) and the court. Alleged cases of medical liability in GS represented 11.2% of the total cases analysed by the CML. We estimated that in Portugal, 4:100,000 surgeries are subject to litigation. The majority of complaints were due to the patient's death (75.4%), with laparoscopic cholecystectomy surgeries representing 55.2% of cases. In 76.1% of the cases, the CML believed that there was no violation of legesartis and in 55.2% of cases, no causal nexus was found between the medical practice and the alleged harm. The PPO prosecuted physicians in 6.4% of the cases and resulted in one conviction. Finally, the importance of the CML reports as a relevant technical-scientific tool for judicial decision was evident because these reports significantly (p < 0.05) influenced the prosecutor's decision, whether to prosecute or not.