Gabriele Napoletano

Background: Artificial intelligence (AI) is entering gynecologic and obstetric imaging, risk prediction, decision support, robotic surgery, remote monitoring, and patient communication. An estimated 260,000 maternal deaths occurred worldwide in 2023, and in England obstetric claims account for 11% of clinical negligence claims but 55% of their value. AI errors, bias, or opacity in this specialty therefore carry major clinical and legal consequences. Objective: To synthesize the principal medico-legal and bioethical challenges associated with AI in gynecology and obstetrics and to propose a lifecycle governance framework for responsible clinical adoption. Methods: A narrative review with thematic synthesis was conducted. PubMed, Scopus, and Google Scholar were searched for records published from January 2020 to August 2026, supplemented by citation chaining and official legal databases. Two reviewers screened 131 records against predefined eligibility criteria; 41 sources (36 publications and 5 legal instruments) were included and analyzed thematically. Selection is reported in a PRISMA-style flow diagram. Results: Six connected risk domains were derived from five prespecified themes, namely validation and generalizability; professional competence and automation bias; distributed liability and evidentiary opacity; informed consent and patient autonomy; privacy and cybersecurity of reproductive data; and discrimination, access, and reproductive justice. Generative AI adds risks of hallucination, non-reproducibility, persuasive framing, and undocumented use. Existing law does not eliminate clinician responsibility: accountability is shared across developers, institutions, and professionals, but clinical judgment and documented oversight remain central. In the European Union, Medical Device Regulation and GDPR obligations already apply, whereas AI Act requirements for AI-enabled medical devices apply from August 2028 and the revised Product Liability Directive covers products placed on the market after 9 December 2026; causation and professional fault remain governed by national law. Conclusions: Safe adoption requires more than technical accuracy. We translate the findings into seven actionable institutional requirements, namely accountable ownership, minimum local validation, role-specific training, auditable documentation, equity monitoring, post-deployment surveillance, and incident reporting. AI should augment—not displace—clinically accountable and relational care.

Background/Objectives: The pituitary gland is highly susceptible to hypoxic–ischemic injury because of its distinctive vascular architecture, yet its forensic significance in non-traumatic deaths remains poorly defined. This study aimed to compare pituitary histopathology across deaths caused by different mechanisms of systemic hypoxia. Methods: This retrospective observational study investigated pituitary histopathology in 30 forensic autopsies performed between 2019 and 2025, including suicidal hanging (n = 10), fatal heroin intoxication with respiratory failure (n = 10), and sudden cardiac death controls (n = 10). Hematoxylin–eosin-stained sections were systematically evaluated for hemorrhagic, ischemic, and necrotic changes and their anatomical distribution. Results: Neurohypophyseal hemorrhage was detected in 6/10 hanging cases and 8/10 heroin-related deaths, but in no controls. Adenohypophyseal ischemic–necrotic lesions occurred in 2/10 hanging cases and 6/10 heroin cases and were absent in controls. Lesions were generally more extensive in heroin intoxication, where hemorrhage often coexisted with vascular congestion and coagulative necrosis. The preferential involvement of the posterior lobe by hemorrhage and the anterior lobe by ischemic–necrotic injury is consistent with their different vascular supplies. Conclusions: These exploratory findings require validation. Hypoxia duration and residual perfusion were not measured. Pituitary sampling may be a complementary tool worth investigating in selected forensic cases; its routine utility was not assessed. Because all sections were stained with hematoxylin–eosin only, these findings are preliminary and require confirmation.

Background: Pain is among the most frequent reasons for seeking medical care and presenting to the Emergency Department (ED). In Italy, Law No. 38/2010 establishes the right to pain therapy and requires pain intensity and its evolution during treatment to be assessed and documented. This process may be challenging in patients with language barriers because conventional verbal or numerical instruments require a degree of linguistic or numerical comprehension. Emoji-based visual tools may provide an additional means of communicating pain intensity in linguistically diverse clinical settings. Methods: We conducted a single-center, prospective, observational pilot study involving adult patients presenting to the ED with acute pain and a clinically relevant language barrier. Pain was assessed before and after analgesic treatment using a six-category Emoji-Based Pain Scale, scored 0, 2, 4, 6, 8, and 10, and the 11-point Numeric Rating Scale (NRS). Feasibility, independent completion, monotonic association, and agreement between the instruments were evaluated. Spearman’s rank correlation, exploratory Bland–Altman analysis, and quadratic-weighted Cohen’s kappa were calculated separately before and after treatment. A post hoc ancillary rank-ordering exercise was subsequently conducted in 50 adult volunteers using the same unlabelled and randomly shuffled emoji cards. Results: Eighty-seven ED patients were enrolled. The Emoji-Based Pain Scale was completed independently by 78 patients (89.7%), compared with 61 patients (70.1%) for the NRS. Mean pre-treatment scores were 4.90 ± 1.77 for the Emoji-Based Pain Scale and 5.15 ± 1.65 for the NRS; post-treatment scores were 2.16 ± 1.62 and 2.46 ± 1.73, respectively. Strong positive associations were observed before treatment (Spearman’s ρ = 0.860, p < 0.001) and after treatment (ρ = 0.805, p < 0.001). Mean paired differences were −0.25 points before treatment and −0.30 points after treatment. Quadratic-weighted kappa was 0.747 before treatment (95% bootstrap confidence interval [CI], 0.661–0.818) and 0.720 after treatment (95% bootstrap CI, 0.609–0.806). Exact categorical agreement was observed in 62.1% and 58.6% of assessments, respectively. In the ancillary exercise, all 50 volunteers reproduced the prespecified emoji sequence, with no inversion of the two upper anchors. Conclusions: The Emoji-Based Pain Scale was feasible and more frequently completed without assistance than the NRS in this selected population of adult ED patients with language barriers. Strong monotonic association, good ordinal agreement, and limited mean differences were observed between the instruments. These findings support further evaluation of the scale but do not establish formal validity, reliability, or interchangeability. Direct psychometric comparison with established visual pain scales remains necessary before routine clinical integration.

Arrhythmogenic cardiomyopathy (ACM/ARVC) is an inherited myocardial disease characterized by progressive fibro-fatty replacement, ventricular arrhythmias, and an increased risk of sudden cardiac death. In addition to mutations in desmosomal genes, growing evidence suggests that microRNAs (miRNAs) actively contribute to disease pathogenesis by regulating key processes such as fibrosis, cell adhesion, and cardiac remodeling. This systematic review analyzed the main miRNAs identified in studies of human cardiac tissue and animal models of ARVC. Materials and Methods: Studies based on human myocardial tissue analysis (including autopsy and biopsy samples) and animal models of arrhythmogenic cardiomyopathy were included, using RNA sequencing, small RNA sequencing, miRNA arrays, and RT-qPCR. Studies on circulating miRNAs and narrative reviews were excluded. miRNAs were analyzed in relation to their functional pathways and their role in disease pathogenesis. Results: The synthesis of studies on human and animal cardiac tissue reveals a consistent miRNA signature associated with arrhythmogenic cardiomyopathy. MiR-21-5p and miR-29b-3p are associated with fibrosis and extracellular matrix remodeling, whereas miR-133a-b and miR-130a are linked to cardiomyocyte integrity loss and desmosomal dysfunction. A second group of miRNAs, including miR-217-5p, miR-708-5p, and miR-135b, regulates key pathways such as Wnt/β-catenin and Hippo signaling, contributing to structural remodeling and loss of cellular identity. Furthermore, downregulation of miR-499-5p is associated with mitochondrial dysfunction and cellular vulnerability, while the miR-142-3p, miR-182-5p, and miR-183-5p clusters contribute to differential molecular signatures compared with other cardiomyopathies. Overall, miRNAs converge on three main pathogenic axes: myocardial fibrosis, desmosomal impairment, and remodeling of cellular signaling pathways. Conclusions: The available evidence indicates that arrhythmogenic cardiomyopathy is regulated by a coordinated network of miRNAs that actively drives myocardial damage progression. These miRNAs represent not only biomarkers but also functional mediators of disease, suggesting potential diagnostic and therapeutic applications based on tissue-specific molecular signatures, including in post-mortem settings.

Background/Objectives: Viper envenomation in Italy is uncommon but carries significant clinical and forensic implications: an average of 257 bites per year are estimated, with only one fatality. This epidemiological context necessitates careful consideration of the standard of care and professional liability The article aims to outline the clinical and medico-legal dimensions of viper bites within both national and international contexts. Methods: We report the case of a 40-year-old woman bitten by a viper in an urban environment. At the initial emergency department visit the presentation was classified as Grade 0 (“dry bite”) according to Boels and, after 21 h, was discharged in good condition. Three days later, she returned with worsening symptoms and CT imaging revealed intrafascial and subcutaneous edema. The subsequent onset of complications prompted a criminal malpractice investigation. Therefore, we performed a PubMed search which yielded 125 records; after applying eligibility criteria, 33 articles were included, supplemented by manual reference checking for a total of 60 sources reviewed. Results: Comparison with the Australian model suggests the need for more standardized care pathways in Italy, while accounting for local toxicological and epidemiological specificities. Conclusions: This case and the accompanying literature analysis highlight that, even in low-incidence settings, structured patient communication, multidisciplinary management, collaboration with Poison Control Centers, and adherence to good clinical practice are crucial for patient safety and for mitigating medico-legal risk.

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A textiloma or gossypiboma is a rare but serious iatrogenic complication, caused by the retention of surgical sponges or gauze within the body after surgery. Often underreported, it may remain undetected for years, leading to diagnostic challenges with significant clinical and medicolegal implications. Our study reviewed the clinical and legal aspects of textilomas. We conducted a review by searching the terms "textiloma" and "post-surgery" in a single database (PubMed) from 2014 to 2024. After excluding non-iatrogenic cases and article with no forensic or surgical interest, 25 relevant articles were found and analyzed. Clinical presentation of textilomas is variable, depending on the surgical site. Seventy percent of cases occurred after abdominal surgery, with all patients requiring further surgeries. In some cases, the foreign body migrated to other organs, and diagnosis was often delayed due to the ability of textilomas to mimic tumors, complicating differential diagnoses. Medicolegal consequences are significant: healthcare professionals may face criminal charges for negligence, even years after the index surgery. In cases of multiple surgeries, identification of the origin of the retained foreign body can be challenging, though modern tissue tracing methods may assist in identifying hospital sources. Professionally, physicians can be held liable for personal injury or patient death, leading to career damage and malpractice claims. Given that textilomas occurrence is a preventable event, they pose not only a professional and legal concern but also a public health issue, emphasizing the importance of effective prevention and risk management strategies.