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.

Acute aortic syndrome and radiology liability in Italy: Case reports and medico-legal considerations.

The trend for medical malpractice claims has increased in recent years, both in the USA and in Europe. Although diagnostic radiology is not considered a high-risk field, malpractice claims in this area follow this general trend. The most common legal action taken against radiologists includes failure to diagnose, poor communication between physicians, failure to supervise technologists properly and improper procedures. Recently, the Italian Civil Supreme Court delivered a judgment (Cass. Civ., N.10158-18) regarding the liability of radiologists, stating that in radiological practice, a correct and timely execution of the diagnostic investigation is required. By contrast, the same judgment states that requesting further clinical consultations and/or the execution of in-depth diagnostic examinations are not within their duties. Considering this judgment, we report two cases of radiologist malpractice and related responsibility for negligent conduct regarding the diagnosis of thoracic aortic dissection and the prevention and management of acute aortic syndrome.

Medical Malpractice Primer for Practicing Interventional Radiologists.

Medical professional liability (MPL), also commonly referred to as medical malpractice, is a costly issue in health care today, accounting for roughly 2.4% of total health care expenditure in the United States. Almost all physicians currently in clinical practice will either be subject to a lawsuit themselves or work with someone who has. Given a lack of formal structured education about MPL in medicine for trainees, this review aims to define and discuss the relevant concepts in MPL as a reference for early career interventionalists to understand the current medicolegal environment and learn best practices to avoid litigation.

Final Verdict? Case Tests Court's Ability to Overturn a Jury Verdict.

It was an overwhelming, 12-0 verdict - a jury's unanimous rejection of a negligence case against a Laredo physician. Then, a judge took that decision away and ordered a new trial - not because of jury misconduct, or any procedural stumble that usually negates a court decision. It was taken away, essentially, because the judge said so.

Hiding in the Hedges: Tips to Minimize Your Malpractice Risks as a Radiologist.

OBJECTIVE. Although few radiologists dwell on the notion of malpractice risk during their daily practice, the risk of malpractice within the specialty is real. CONCLUSION. This article provides an overview of the elements of a malpractice claim, discusses key ingredients for avoiding malpractice liability, touches on several topics interconnected with mitigating malpractice risks (hedging, apologies, and pace), and provides a series of tips a radiologist might consider in practice to decrease liability risk.

Shortage of paediatric radiologists acting as an expert witness: position statement from the British Society of Paediatric Radiology (BSPR) National Working Group on Imaging in Suspected Physical Abuse (SPA).

One of the most challenging areas of radiological imaging in children is the diagnosis of physical abuse. There is a dearth of paediatric radiologists willing to act as expert witnesses, particularly in the family courts. There are a number of reasons why radiologists may not be interested or willing to put themselves forward to work as expert witnesses in this field. A group of imaging experts recently formed the "British Society of Paediatric Radiology (BSPR) Working Group on Imaging in Suspected Physical Abuse (SPA)". The group comprises radiologists and neuroradiologists with current or previous experience of providing expert witness reports to the court in cases of SPA. The group met in January 2019 to explore pragmatic solutions to the chronic inefficiencies in both medical and legal practices and the challenges that arise from working in a legal arena with different structures, goals, and assessment criteria. Key issues concerned organisational inefficiencies, variable support from National Health Service Trusts and the Royal College of Radiologists to conduct this work, and the risk/benefit of involvement. This work is important for the patient, parents, and society in general, and highly rewarding for clinical practitioners who are involved, but there are several issues with current practices that discourage active participation. With several members of the group either retired or close to retirement, the shortage of experts is becoming a pressing issue within the UK, which requires an engaged multidisciplinary group to come up with creative solutions. Here, the group provide a consensus opinion highlighting the current barriers and potential facilitators to increasing the number of radiologists willing to provide opinions to the court.

Canadian Association of Radiologists White Paper on Ethical and Legal Issues Related to Artificial Intelligence in Radiology.

Artificial intelligence (AI) software that analyzes medical images is becoming increasingly prevalent. Unlike earlier generations of AI software, which relied on expert knowledge to identify imaging features, machine learning approaches automatically learn to recognize these features. However, the promise of accurate personalized medicine can only be fulfilled with access to large quantities of medical data from patients. This data could be used for purposes such as predicting disease, diagnosis, treatment optimization, and prognostication. Radiology is positioned to lead development and implementation of AI algorithms and to manage the associated ethical and legal challenges. This white paper from the Canadian Association of Radiologists provides a framework for study of the legal and ethical issues related to AI in medical imaging, related to patient data (privacy, confidentiality, ownership, and sharing); algorithms (levels of autonomy, liability, and jurisprudence); practice (best practices and current legal framework); and finally, opportunities in AI from the perspective of a universal health care system.

Medical Malpractice in Image-Guided Procedures: An Analysis of 184 Cases.

PURPOSE: To report types and outcomes of a small subset of malpractice lawsuits filed against physicians performing image-guided interventions in the United States. MATERIALS AND METHODS: In total, 1,312 cases involving common image-guided procedures were reviewed from the Westlaw and LexisNexis databases in the United States from 1963 to 2018. Social Security, disability, employment contract, product liability, criminal, and government employment claims were excluded. The final legal cohort comprised 184 (14.0%) cases. They were categorized into vascular (113/184; 61.4%), inferior vena cava filter (n = 22; 12.0%), neurointerventional (n = 13; 7.1%), gastrointestinal and genitourinary (n = 17; 9.2%), foreign body (n = 7; 3.8%), biopsy related (n = 9; 4.9%), and oncologic (n = 3; 1.6%) interventions. Claims were also organized by defendant type and by specialty, complication stage, verdict, and year. RESULTS: From 2001 to 2018, 58.7% of claims (n = 108) were reported. Procedural complications related to arteriography were most commonly litigated (63/113; 55.8%). Claims arising from intra-procedural and early post-procedural complications were common (84/184; 45.7%). Community hospitals were most often named as defendants (61/184; 33.2%). In reported outcomes, courts sided with defendants in 81.9% (104/127) of the cases, similar to national malpractice trends. Unreported outcomes comprised 31% (57/184) of the data. CONCLUSIONS: For the small subset of claims published within national legal databases, intra-procedural and early post-procedural complications after diagnostic arteriography were most commonly litigated. Most (81.9%) claims with reported outcomes sided with the defendant physician.

Outcomes and associated factors in malpractice litigation involving inferior vena cava filters.

OBJECTIVE: Placement of inferior vena cava (IVC) filters is a controversial focus of medical malpractice. Clinicians currently have little information to guide them regarding key issues and outcomes in litigation. In this retrospective legal case review, we analyzed the factors associated with malpractice actions involving IVC filters. METHODS: The legal databases LexisNexis and Westlaw were searched from 1967 to 2016 for all published legal cases in the United States involving placement of IVC filters. Keywords included "IVC," "inferior vena cava," "filter," and "malpractice." Social Security Disability claims, product liability actions, and hospital employment contract disputes were excluded. RESULTS: There were 310 search results eligible for initial review. After application of exclusion criteria, 29 cases involving medical malpractice were included in final analysis. The majority of excluded cases were insurance disputes and tax revenue cases. Overall, private practitioners were most often sued (11/29 [37.9%]), whereas 24.1% of defendants were academic hospitals (7/29), 20.7% were prisons (6/29), and 17.2% were community hospitals (5/29). The most common specialty named was vascular surgery (8/29), whereas interventional radiologists were named only twice. The most common indications for IVC filter placement were hypercoagulable state (8/29 [29.6%]), recurrent pulmonary embolism (PE; 6/29 [22.2%]), and trauma (5/29 [18.5%]). The most common underlying allegations involved failure to insert IVC filter when indicated (14/29 [48.3%]), intraprocedural negligence (5/29 [17.2%]), and failure to timely remove device (5/29 [17.2%]). Common complications included failure to prevent occurrence of PE (14/29 [48.3%]), device migration (4/29 [13.8%]), and perforation of organs or vasculature (3/29 [10.3%]). Death of the patient occurred in 41.4% of total cases (12/29). In cases in which the patient died, the most common indications for filter placement were trauma (4/12 [33.3%]) and deep venous thrombosis (3/12 [25.0%]), and the most common complication in those patients who died was the failure to prevent a subsequent PE (9/12 [75.0%]). Available verdicts favored defendants (13/14 [92.9%]). In cases with defense verdicts, the most common indications for filter placement similarly were trauma (4/13 [30.8%]) and deep venous thrombosis (3/13 [23.1%)], and the most common complication was failure to prevent PE (9/14 [64.3%]). CONCLUSIONS: Analysis of malpractice cases involving IVC filters revealed key factors associated with litigation. Overall, verdicts favored defendants. Private practitioners were most commonly sued, and the most common reasons for bringing suit were failure to insert filter, intraprocedural complications, and failure to remove filter. Deeper awareness of issues related to malpractice litigation can inform clinical practice and improve patient care and safety.

Malpractice litigation in the endovascular era.

OBJECTIVE: The standard of care in the treatment of vascular disease continues to evolve as endovascular therapies develop. Currently, it is unclear how medical malpractice litigation has adapted to the "endovascular era." This retrospective case review is the most comprehensive analysis to date of malpractice actions involving endovascular procedures performed by vascular surgeons (VSs), interventional radiologists (IRs), interventional cardiologists (ICs), and cardiothoracic surgeons (CTSs). METHODS: The legal databases LexisNexis and Westlaw were searched for all published legal cases in the United States involving endovascular procedures. The search was limited to state and federal cases up to and including the year 2016. Keywords included "malpractice," "vascular," "endovascular," "catheter," "catheterization," "stent," "angiogram," "angiography," and "surgery." Cases involving tax revenue, insurance disputes, Social Security Disability, and hospital employment contract disputes were excluded. Data were analyzed using χ2 test. RESULTS: There were 2115 initial search results identified, and 369 cases were included in final analysis. The rate of endovascular procedure-related lawsuits (per 1000 active physicians in the specialty) was highest for ICs (105.56), whereas rates for VSs and IRs were comparable (18.47 and 16.85, respectively); 93% of the IC cases were related to coronary interventions. Overall, 55% (148/271 classifiable cases) of actions were related to elective procedures. For VSs specifically, 46% (25/54) of cases arose from diagnostic angiography and inferior vena cava filter placement, two relatively minor procedure types. Overall, 83% (176/211 finalized cases) of verdicts favored defendants, with no significant differences across the specialties; 43% (157/368) of total cases involved death of the patient. Among the four specialties, there was a significant (P = .0004) difference in the primary allegation (informed consent, preprocedure negligence, intraprocedure complications, or postprocedure complications) underlying the litigation. For CTSs and VSs, there was a predominance of informed consent and preprocedure negligence allegations (70% [7/10] and 52% [28/54], respectively). Intraprocedure negligence was the most common allegation for IRs (59% [23/39]), whereas allegations were more evenly distributed among ICs. CONCLUSIONS: Key issues were identified regarding malpractice litigation involving the specialties that commonly perform endovascular procedures. Despite the increasing number of ICs doing peripheral interventions, a large majority of IC cases were related to coronary treatments. A surprisingly large percentage of VS cases were related to seemingly minor cases. There were significant interspecialty differences in the primary underlying allegations. As the scope of endovascular procedures broadens and deepens, it is important for clinicians to be aware of legal considerations relevant to their practice.

IR and the Sunshine Act: Two-Year Analysis of the Open Payments Database and Comparison with Related Specialties.

PURPOSE: To characterize medical industry-based payments made to US-based interventional radiology (IR) physicians, identify trends in compensation, and compare their payment profile with those of other related specialties, including vascular surgery (VS) and interventional cardiology (IC). Payments made to orthopedic surgery (OS) physicians are reported as a historical control. MATERIALS AND METHODS: For each group, the total payment number, amount, and mean and median numbers and amounts were calculated. The data were then reanalyzed after correcting for statistical outliers. For IR, VS, and IC, leading industry sponsors, payment amount, and differences in payments from 2013 to 2014 were highlighted. Payments to IR were grouped by category and geographic location. The Kruskal-Wallis test was used for statistical analysis. RESULTS: A total of $26,857,622 went to 1,831 IR physicians, representing 70.9% of active IR physicians, and the corrected mean payment was $597 ± 832.2 (standard deviation). The respective values were $18,861,041, 3,383, 80.6%, and $851.59 for VS; $32,008,213, 7,939, 78.6%, and $417.16 for IC; and $357,528,020, 21,829, 77.8%, and $598.48 for OS. OS had the largest number of payments (295,465 vs 24,246 for IR, 84,635 for VS, and 160,443 for IC) and greatest total payment amount. VS had a significantly higher corrected median payment amount ($463; P < .0001) than IR ($214) and IC ($99). Covidien and Sirtex Medical were the leading industry sponsors to IR, and 64.6% of IR payments were compensation for services other than consulting. There was no significant difference in median payment received per geographic region (P = .32). CONCLUSIONS: OS received the largest number and total payment amount, and VS received a significantly greater corrected median payment amount, versus IR and IC. As the Open Payments program continues to be implemented, it remains to be seen how this information will affect relationships among physicians, patients, and industry.

Radiologist Found Liable for Malpractice in Israel for Causing a Patient's Suicide by Sending a "Bad News" Report: Can This Happen in the United States?

OBJECTIVE: The purpose of this article is to present an example of a non-U.S. lawsuit in which a radiologist was found negligent in the case of a psychiatric patient who died by suicide after reading a radiology report sent directly to him. CONCLUSION: Although the lawsuit and its outcome do not influence laws in the United States or any country other than the one in which the case was tried, it should stimulate the radiologic community into giving serious thought to the format and manner in which reports of radiologic examinations are communicated to patients.