Robotics and AI into healthcare from the perspective of European regulation: who is responsible for medical malpractice?

The integration of robotics and artificial intelligence into medical practice is radically revolutionising patient care. This fusion of advanced technologies with healthcare offers a number of significant benefits, including more precise diagnoses, personalised treatments and improved health data management. However, it is critical to address very carefully the medico-legal challenges associated with this progress. The responsibilities between the different players concerned in medical liability cases are not yet clearly defined, especially when artificial intelligence is involved in the decision-making process. Complexity increases when technology intervenes between a person's action and the result, making it difficult for the patient to prove harm or negligence. In addition, there is the risk of an unfair distribution of blame between physicians and healthcare institutions. The analysis of European legislation highlights the critical issues related to the attribution of legal personality to autonomous robots and the recognition of strict liability for medical doctors and healthcare institutions. Although European legislation has helped to standardise the rules on this issue, some questions remain unresolved. We argue that specific laws are needed to address the issue of medical liability in cases where robotics and artificial intelligence are used in healthcare.

A case of suicide of psychiatric patient in the Sicilian hospital: accidental or professional liability of "top management"?

Background: In the hospital environment, any liability for organizational inadequacy and/or inefficiency, or again for defects in the facilities, or inadequacy of health equipment may be found in the work of the apex professional figures: Medical Director, the General Manager, and/or others. The responsibility for the internal organization of the department falls on the figure of the Director of the Complex Structure where the deficiencies have not been promptly and adequately reported to the top figures. Case Report: A woman 61-year-old, was admitted on a voluntary basis to the Department of Psychiatry. On the third day, in the early morning hours, the patient was found on the ground floor, lying on the floor near the entrance door of the ward with a lacerated contusion wound to the head. The woman underwent total body CT examination with findings of fractured polytrauma as well as subarachnoid hemorrhage and complete fracture of the spleen, which was surgically removed. Three days later, despite the care given, death occurred. The injuries ascertained were consistent with voluntary precipitation from the second-floor stairwell window. The investigations conducted by the police and the checks carried out by the head of the Internal Prevention and Protection Service and the company's Risk Manager, highlighted multiple critical issues. Conclusion: The case allows for numerous considerations relating to liability profiles in the determinism of the patient's death, the hospital's company failure to implement measures to prevent the patient's suicide in the hospital was influential.

[Importance of documentation. Not documented is deemed to be not done]. / Bedeutung der Dokumentation. Nicht dokumentiert gilt als nicht gemacht.

Only a few physicians are willing to comprehensively concern themselves with how a legally watertight treatment documentation should be structured, in addition to their practical activities; however, the importance of the documentation cannot be emphasized enough, not only for a potential case of liability but also for the medical (further) treatment. This article therefore illustrates the legal foundations of the mandatory documentation and the most important questions associated with it for the practice, in particular on the content of the documentation, the timing of the documentation, the preservation of treatment documents and on the conduct in cases of an impending incident.

Analysis of the contentious relating to medical liability for healthcare-associated infections (HAI) in a Sicilian hospital.

Background: Since 2012, the Sicilian regional government, in view of the increase in malpractice claims, has adopted a "self-insurance system" The claims management activities have been delegated to the Claims Management Committees (CMCs), the importance of which was also emphasized by Law No. 24/2017. This study aims to describe the experience of Sicilian Hospital CMC and analyze the claims' features, especially for contentious HAIs. Healthcare-associated infections (HAIs) continue to be a major public health concern. The contraction of infection during hospitalization generally results in a significant worsening of the patient's quality of life and prolongation of his or her stay. Still, it is also responsible for an increase in costs that burden the hospital and the entire Health System. Material and Methods: The study investigates the analysis of claims received by a Messina Hospital Company between January 2015 and December 2023 even though for events that occurred in earlier years. From the database, cases in which the Company was sued for HAIs were extrapolated and analyzed, distinguishing them by year and by Department. The data collected were statistically processed with the Epi Info 7.1.5 program (CDC - Atlanta - USA). Conclusion: The CMC experience highlighted a statistically significant increase in complaints especially for those relating to HAI, without differences by Department. In most cases, the CMC admitted the hospital's liability, and an attempt at conciliation was promoted and moreover risk management initiatives were adopted. This is important when considering the recent ruling 6386/2023 of March 3, 2023.

Telemanagement and Radiology: current structure, opportunities and new horizons.

Background: Telemedicine is a method of providing remote services in compliance with data security, with a significant positive impact on healthcare, in which Teleradiology means the electronic transmission of radiographic images from one geographical area to another. In this context, the term "telemanagement" shows a real remote management of a diagnostic examination, concluded by the production of telereport and telediagnosis. Materials and Methods: On the basis of Italian position papers, National guidelines and current Laws, a careful analysis of multiple aspects was carried out, in order to understand the current obligations and application limits. Discussion and Conclusion.: Proper radiotelemanagement requires a shared operating protocol within the structure, which integrates verification and safety procedures, periodic checks and adequate resources. In addition, practical interface between the involved figures must be properly established. Then, guidelines highlight the "standard" radiological procedures that can be performed in the absence of the specialist: in ordinary hospitalization, it is allowed to perform Telemanagement procedures only within "standard" procedures; in emergency setting, the only limit is placed in case of administration of contrast agent. No provisions have been approved for teleradiological work in private settings. Finally, inter-company procedures are only provided for screening programs. In this context; potential negative implications are the risk of substitution of health professionals, as well as ethical issues related to data security, patient's consent and quality of the doctor-patient relationship. In an effort of optimism aimed at the future, we want to express our propensity towards a universe with lots of potential that, over time, will emerge in its concreteness.

Case of tracheal rupture after endotracheal intubation: clinical risk management and medico-legal considerations.

Background: Tracheal injury may be a rare complication of the endotracheal intubation procedure. Incidence and determinant factors are not well known, nevertheless a greater incidence have been recognized with a difficult maneuver or the use of nitrogen peroxide. The therapeutic approach can be conservative or surgical, depending on the characteristics of the lesion and of the patient and therefore the outcomes of medico-legal interest can be different. Case description: It is a case of alleged medical liability regarding a 70-year-old woman, that during the intubation procedure was pouncing on the right. Furthermore, nitrous oxide was used as an anaesthetic. A few hours after the operation the patient showed swelling on the right half of the face and on the right lateral region of the neck. The emergency chest CT scan highlighted subcutaneous emphysema and pneumomediastinum. In the operating room, fibrobronchoscopy was performed with a double-lumen bronchial tube which confirmed the hypotheses lesion; then, right posterolateral thoracotomy was perfor-med followed by suturing of the tracheal lesion. Subsequently, the patient was discharged in good clinical conditions but with a scar in the region of the right hemithorax. Conclusions: Iatrogenic tracheal injury is a rare and fearful complication of the orotracheal intubation procedure. Although risk factors that increase the probability of its onset have been recognized, in most cases it is not possible to identify the cause. From a medico-legal point of view, tracheal injury after intubation is unpredictable and inevitable, so in the case reported it was decided to proceed with a conciliatory solution.

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.

South Tyrol Healthcare Company: A Look at a Peculiar Model of Claims Management in Italy and Analysis of Its Last 11 Years.

BACKGROUND: Alternative Disputes Resolution (ADR) systems are becoming increasingly important tools in recent years for the management and resolution of health responsibility cases, but their dissemination and efficiency are still poorly described. The purpose of this paper is to present an ADR system in the autonomous province of Bolzano: the Conciliation Commission. METHODS: systematic collection of all claims of the South Tyrol Sanitary Service that were dealt with in the Conciliation Commission from 1 January 2012 to 31 December 2022. RESULTS: closing times of the applications received turn out to be less than a year in 63.8% of the cases, with a number of cases managed rather stably in the time, even if minimal if compared to the number of complaints received to the South Tirol Health Service. Only 5.3% of the application continued the legal process before a civil court. CONCLUSIONS: the Conciliation Commission of South Tirol appears to be an excellent instrument for the resolution of disputes in the healthcare field, with rapid resolution times and little to zero costs for the healthcare company, a public health institution. Despite its effectiveness, it seems to be a tool that is still little-known in South Tyrol.

A case of surgical site infection with severe spondylitis caused by Streptococcus gordonii in an adult healthy woman: how to apply medico-legal method to deny malpractice hypothesis in suspected healthcare-associated infection.

We describe a rare case of severe primary spondylitis caused by Streptococcus gordonii in a 45-year-old immunocompetent woman with no relevant comorbidities. The surgical site infection arose after a L4-L5 microdiscectomy and resulted in severe clinical disability. Allegations of possible negligence as the cause prompted a forensic review to clarify the original source and transmission of this uncommon pathogen, which dismissed its cause as due to malpractice during treatment.

Acute methotrexate toxicity in a patient with psoriasis: a case report.

Aside from rheumatoid arthritis, methotrexate is also used to treat cancer, psoriasis, and other diseases. Side effects with methotrexate are possible, as they are with any medication. This drug is extremely potent and has the potential to produce serious adverse effects. Those who use this medication need to be tracked often. We provide a case of a patient with psoriasis vulgaris who died due to methotrexate administration without proper dosage verification. A female patient in her forties had a history of psoriasis vulgaris of the lower limbs. Under treatment, she developed acute methotrexate toxicity. This drug was taken as an intramuscular injection per day in an infirmary without checking that the dose regimen prescribed was per week. She developed extensive bullous and pustular lesions associated with digestive signs related to generalized toxiderma. But at that point, she had septic shock, which led to her death a few weeks after the methotrexate injection. The medical responsibilities of the doctor, pharmacist, and nurse were discussed. To conclude, methotrexate is not a killer drug in most cases, but it can be extremely harmful if it's overused. Acute toxicity is a potentially fatal condition, and a deeper understanding of its potential toxicity is still necessary.

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.

Defining medical liability when artificial intelligence is applied on diagnostic algorithms: a systematic review.

Artificial intelligence (AI) in medicine is an increasingly studied and widespread phenomenon, applied in multiple clinical settings. Alongside its many potential advantages, such as easing clinicians' workload and improving diagnostic accuracy, the use of AI raises ethical and legal concerns, to which there is still no unanimous response. A systematic literature review on medical professional liability related to the use of AI-based diagnostic algorithms was conducted using the public electronic database PubMed selecting studies published from 2020 to 2023. The systematic review was performed according to 2020 PRISMA guidelines. The literature review highlights how the issue of liability in case of AI-related error and patient's damage has received growing attention in recent years. The application of AI and diagnostic algorithm moreover raises questions about the risks of using unrepresentative populations during the development and about the completeness of information given to the patient. Concerns about the impact on the fiduciary relationship between physician and patient and on the subject of empathy have also been raised. The use of AI in medical field and the application of diagnostic algorithms introduced a revolution in the doctor-patient relationship resulting in multiple possible medico-legal consequences. The regulatory framework on medical liability when AI is applied is therefore inadequate and requires urgent intervention, as there is no single and specific regulation governing the liability of various parties involved in the AI supply chain, nor on end-users. Greater attention should be paid to inherent risk in AI and the consequent need for regulations regarding product safety as well as the maintenance of minimum safety standards through appropriate updates.

Virtual reality evidence on the impact of physicians' open versus defensive communication on patients.

Using virtual reality (VR) in an experimental setting, we analyse how communicating more openly about a medical incident influences patients' feelings and behavioural intentions. Using VR headsets, participants were immersed in an actual hospital room where they were told by a physician that a medical incident had occurred. In a given scenario, half of the participants were confronted by a physician who communicated openly about the medical incident, while the other half were confronted with the exact same scenario except that the physician employed a very defensive communication strategy. The employed technology allowed us to keep everything else in the environment constant. Participants exposed to open disclosure were significantly more likely to take further steps (such as contacting a lawyer to discuss options and filing a complaint against the hospital) and express more feelings of blame against the physician. At the same time, these participants rated the physician's communication skills and general impression more highly than those who were confronted with a defensive physician. Nevertheless, communicating openly about the medical incident does not affect trust in the physician and his competence, perceived incident severity and likelihood of changing physician and filing suit.

Alleged Malpractice in Orthopedic Surgery in The Netherlands: Lessons Learned from Medical Disciplinary Jurisprudence.

BACKGROUND: Orthopedic surgery is a specialty at risk for medical malpractice claims. We aimed to assess the frequency of alleged malpractice cases related to orthopedic surgery in the Netherlands from the last 15 years. METHODS: We systematically searched the database of the Dutch Medical Disciplinary Court for verdicts related to orthopedic surgery between January 2009 and July 2023 and extracted case data and data on allegations and outcomes. RESULTS: We identified 158 verdicts (mean of 10.5 per year), of which 151 (96%) were filed against specialists and 7 (4%) against residents. Cases were most frequently classified as incorrect treatment/diagnosis (n = 107, 67.7%). Cases were related to the subspecialties of knee (n = 34, 21.5%), hip (n = 31, 19.6%), ankle (n = 25, 15.8%), spine (n = 22, 13.9%), and shoulder (n = 19, 12.0%). A total of 32 cases (20.3%) were judged as partially founded and 9 (6%) as founded. The Dutch Medical Disciplinary Court imposed 28 warnings, 10 reprimands, and 3 temporary suspensions. A total of 68 appeals were submitted, of which 95% were rejected for filing patients. In three instances, unfounded verdicts were changed to two warnings and a reprimand. In four appeals by an orthopedic surgeon, a warning and reprimand were dismissed, and two reprimands were changed to warnings. CONCLUSIONS: The amount of malpractice cases against orthopedic surgeons in the Netherlands is relatively low. The cases in our study may improve our understanding of allegations against physicians and improve the quality of patient care.

[Legal integration of artificial intelligence into internal medicine : Data protection, regulatory, reimbursement and liability questions]. / Rechtliche Einordnung von künstlicher Intelligenz in der Inneren Medizin : Von Datenschutz und Regulatorik, Erstattungs- und Haftungsfragen.

Artificial intelligence (AI) opens up new opportunities to improve medical care in internal medicine; however, legal uncertainties in the application of AI impede its integration into the daily practice of internal medicine. To clarify the situation this paper gives an overview of the legal aspects related to AI and shows which frameworks must be adhered to in order to exploit the benefits of AI without neglecting the rights and protection of patients. The paper first addresses data protection issues which arise when sensitive health data are processed by AI. This is followed by a discussion of the key regulatory requirements for the use of AI in internal medicine. As the establishment of AI in practice also depends on sufficient funding, legal issues of reimbursement are additionally examined. Finally, the specific features that need to be considered when using AI to avoid medical liability consequences are highlighted.

The regulatory environment for artificial intelligence-enabled devices in the United States.

The regulatory environment in the United States has not kept pace with the rapidly developing market for artificial intelligence (AI)-enabled devices. The number of AI-enabled devices has increased year after year. All of these devices are registered or cleared by the US Food and Drug Administration through exempt or 510(k) premarket notification pathways, and the majority are related to the radiology or cardiovascular spaces. US Food and Drug Administration guidance has not yet addressed the unique challenges of AI-enabled devices, including development, comprehensibility, and continuously learning models. The liability aspects of AI-enabled devices deployed into use by clinicians in practice have yet to be addressed. Future guidance from government regulatory sources will be necessary as the field moves forward.

Malpratice claims in cardiology and cardiac surgery: A medico-legal issue.

Medical liability has become a challenge in every physician's modern practice with the consequent loss of the physician's autonomy and an increase in "defensive medicine". From this perspective, the role of Legal Medicine in assessing medical liability has become increasingly specific and a homogenization of the methods of ascertainment is increasingly necessary, since such a process can contribute to strengthening the guarantees in professional liability procedures. Focusing on malpractice claims in the field of cardiology, the complexity of the management of cardiac pathologies and the frequency of severe adverse events implies the importance of a multi-disciplinary approach, together with the application of a shared ascertainment methodology. In particular, it is essential for the forensic pathologist to collaborate with experts in cardio-pathology, cardiology and/or cardiac surgery in cases of alleged medical liability in the cardiologic field and to follow the guidelines which have been produced to assist the expert dealing with deaths reflecting cardiac disease, in order to prevent criticism of case analysis in medico-legal environments and to promote the standardization of the structure of the juridical-legislative medical malpractice lawsuits.

Does patient behaviour drive physicians to practice defensive medicine? Evidence from a video experiment.

OBJECTIVE: By manipulating patients' critical attitude in a video experiment, we examined whether physicians are more intended to perform defensive acts because of a higher perceived liability risk in Belgium. METHODS: We assigned 85 practicing gynaecologists/obstetricians and orthopaedists randomly to four hypothetical video consultations, in which the patients show either a critical attitude (i.e., getting ahead of the facts, showing distrust) or a non-critical attitude (i.e., displaying more neutral questions and expressions). We asked the physicians about the care they would administer in the presented cases and the expected likelihood that the patient would sue the physician in case of a medical incident. RESULTS: By manipulating patients' verbal critical attitude (which indicates patients' intention to take further steps), while keeping constant physician's communication, patients' clinical situation, preferences, and non-verbal behaviour in the videos, we were able to discover differential treatment styles driven by physicians' perceived liability risk among patients with a different critical attitude. We found that physicians perform 17 percentage points more defensive acts (e.g., surgeries and diagnostic tests that are not medically necessary) when experiencing a high liability risk. CONCLUSIONS: Our results show that patients' critical attitude drives physicians' perceived liability risk and consequent defensive behaviour among obstetricians/gynaecologists and orthopaedists.

Serious complications related to regional anaesthesia: Study of Greek Courts' Decisions.

BACKGROUND: Regional anaesthesia and analgesia present many advantages. Related complications are few and have been fully described. Information on regional anaesthesia malpractice is lacking in Greece. The objectives of the analysis were to highlight areas of high litigation risk and report the financial impact of claims. METHODS: Published judicial decisions of criminal, civil, administrative and disciplinary content, from 1995 to 2020, were searched in the legal information banks. The court decisions were analysed by an expert in collaboration with the lawyers of the investigation. RESULTS: A total of 26 court decisions related to complications from regional anaesthesia were found involving 10 cases, which comprised: 8 convictions, 1 referral of the case for a new expert opinion and 1 acquittal. In 6 cases the medical negligence involved complications after epidural anaesthesia and in 2 after subarachnoid anaesthesia. In 1 case there was collective liability of the anaesthesiologist and the obstetrician for negligent homicide and in 7 cases liability of the anaesthesiologist for bodily injuries. The duration of the litigation was 5-16 years. CONCLUSIONS: Analysis of court cases made it possible to identify the causes that led to complications during regional anaesthesia. Informed consent, non-traumatic technique, careful patient selection, adherence to safety rules, and early diagnosis and treatment of complications are essential to avoid permanent injury.

A History of Medical Liability: From Ancient Times to Today.

Medical liability is a term associated with medical procedures and acts that has been a topic of controversy and research since ancient times all over the world. In ancient times, it was usually explained based on theocratic conceptions and was directly related to the social position of the patient to whom the physician applied medicine, while the capacity of the physician implied specific qualities. The present review of ancient history and geography provides a detailed description of the issues concerning medical responsibility through the years in ancient Greece, the birthplace of Asclepius and Hippocrates, the fathers of medical science, and the medical oath of conscientious performance of physician duties. Furthermore, it discusses the issue of medical liability globally from ancient times till more recently. Finally, medical liability and the interaction of its various aspects in Greece in recent years is presented according to Greek legislation to provide a good review for the reader to acknowledge the changes in medical liability through the centuries.