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Digital assistants have become an indispensable tool in modern cardiology. The associated technological progress offers a significant potential to increase the efficiency of medical processes, enable more precise diagnoses in a shorter time, and thus improve patient care. However, the integration of digital assistants into clinical cardiology also raises new challenges and questions, particularly regarding the handling of legal issues. This review article aims to raise awareness of individual legal issues resulting from the use of digital technologies in cardiology. The focus is on how to deal with various legal challenges that cardiologists face, including issues related to treatment freedom, professional confidentiality and data protection. The integration of digital assistants in cardiology leads to a noticeable improvement in efficiency and quality of patient care, but at the same time, it involves a variety of legal challenges that need to be carefully addressed., (© 2024. The Author(s), under exclusive licence to Springer Medizin Verlag GmbH, ein Teil von Springer Nature.)

Legal proceedings for medical negligence usually origin from painful events and their management is often complex, also at an emotional level, both for the families involved and for the physicians assumed to carry responsibility. Many of these aspects are unfamiliar and unclear to the doctors themselves who then need to interact, together with their lawyers, with judges who must take serious decisions on technical facts not easy to be fully comprehended by non-medical persons.On the basis of our different and highly specific personal experience, we have tried to clarify some of the fundamental issues concerning medico-legal cases. Accordingly, we have discussed the different types of guilt, made the distinction between civil and penal cases, with special focus on one issue which is particularly critical, namely that of the importance of guidelines. We have presented some examples of clinical cases and highlighted some glaring differences existing in the management of medico-legal cases between Italy and the United States. Despite obvious complexities, these differences might suggest some approaches toward the simplification of these proceedings and the shortening of the time involved to reach a conclusion.

Nowhere is the influence of artificial intelligence (AI) likely to be more profoundly felt than in health care, from patient triage and diagnosis to surgery and follow-up. Over the medium-term, these effects will be more acute in the cardiovascular imaging context, in which AI models are already successfully performing at approximately human levels of accuracy and efficiency in certain applications. Yet, the adoption of unexplainable AI systems for cardiovascular imaging still raises significant legal and ethical challenges. We focus in particular on challenges posed by the unexplainable character of deep learning and other forms of sophisticated AI modelling used for cardiovascular imaging by briefly outlining the systems being developed in this space, describing how they work, and considering how they might generate outputs that are not reviewable by physicians or system programmers. We suggest that an unexplainable tendency presents 2 specific ethico-legal concerns: (1) difficulty for health regulators; and (2) confusion about the assignment of liability for error or fault in the use of AI systems. We suggest that addressing these concerns is critical for ensuring AI's successful implementation in cardiovascular imaging., (Copyright © 2021 Canadian Cardiovascular Society. Published by Elsevier Inc. All rights reserved.)

Competing Interests: Funding Support and Author Disclosures The authors have reported that they have no relationships relevant to the contents of this paper to disclose.

In order to evaluate physicians' willingness to seek legal action to mandate surgery when parents refuse surgery for various congenital heart lesions, we surveyed pediatric cardiologists and cardiovascular surgeons at 4 children's hospitals. We asked whether physicians would support parental refusal of surgery for specific heart defects and, if not, whether they would seek legal action to mandate surgery. We then analyzed associations between physicians' willingness to mandate surgery and national operative mortality rates for each lesion. We surveyed 126 cardiologists and 9 cardiac surgeons at four tertiary referral centers. Overall response rate was 77%. Greater than 70% of physicians would seek legal action and mandate surgery for the following lesions: ventricular septal defect, coarctation of the aorta, complete atrioventricular canal, transposition of the great arteries, tetralogy of Fallot, and unobstructed total anomalous pulmonary venous return. Surgery for all of these lesions has reported mortality rates of < 5%. Physicians were less likely to seek legal action when parents refused surgery for Shone complex, any single ventricle lesion, or any congenital heart disease accompanied by Trisomy 13 or Trisomy 18. Among experts in pediatric cardiology, there is widespread agreement about the appropriate response to parental refusal of surgery for most congenital heart lesions, and these lesions tended to be heart defects with lower surgical mortality rates. Lesions for which there was greater consensus among experts were those with the best outcomes. There was less consensus for lesions with higher mortality rates. Such surveys, revealing disagreement among expert professionals, can provide an operational definition of the current professional "gray zone" in which parental preferences should determine treatment.

In an effort to curb excessive health care spending and incentivize high-quality care, many payers have implemented value-based payment reforms designed to pay for the quality rather than the quantity of health care services. Medicare, the largest payer in the United States, has implemented numerous value-based payment policies over the past decade, many of which affect cardiovascular care. In this review, we discuss some of these major nationwide value-based payment reforms as they relate to cardiovascular care and what we may expect in the future from cardiovascular value-based policies., Competing Interests: Conflict of Interest Disclosure: The authors have completed and submitted the Methodist DeBakey Cardiovascular Journal Conflict of Interest Statement and none were reported., (© 2020 Houston Methodist Hospital Houston, Texas.)

Competing Interests: Disclosure The authors report no conflicts of interest in this work.

Background and Purpose- Industry payments to physicians raise concerns regarding conflicts of interest that could impact patient care. We explored nonresearch and nonownership payments from industry to vascular neurologists to identify trends in compensation. Methods- Using Centers for Medicare and Medicaid Services and American Board of Psychiatry and Neurology data, we explored financial relationships between industry and US vascular neurologists from 2013 to 2018. We analyzed payment characteristics, including payment categories, payment distribution among physicians, regional trends, and biomedical manufacturers. Furthermore, we analyzed the top 1% (by compensation) of vascular neurologists with detailed payment categories, their position, and their contribution to stroke guidelines. Results- The number of board certified vascular neurologist increased from 1169 in 2013 to 1746 in 2018. The total payments to vascular neurologist increased from $99 749 in 2013 to $1 032 302 in 2018. During the study period, 16% to 17% of vascular neurologists received industry payments. Total payments from industry and mean physician payments increased yearly over this period, with consulting fee (31.1%) and compensation for services other than consulting (30.7%) being the highest paid categories. The top 10 manufacturers made the majority of the payments, and the top 10 products changed from drug or biological products to devices. Physicians from south region of the United States received the highest total payment (38.72%), which steadily increased. Payments to top 1% vascular neurologists increased from 64% to 79% over the period as payments became less evenly distributed. Among the top 1%, 42% specialized in neuro intervention, 11% contributed to American Heart Association/American Stroke Association guidelines, and around 75% were key leaders in the field. Conclusions- A small proportion of US vascular neurologists consistently received the majority of industry payments, the value of which grew over the study period. Only 11% of the top 1% receiving industry payments have authored American Heart Association/American Stroke Association guidelines, but ≈75% seem to be key leaders in the field. Whether this influences clinical practice and behavior requires further investigation.

Pediatric cardiology and cardiovascular surgery have witnessed significant advancements over the last two decades. In spite of this progress, congenital heart disease (CHD) still remains as one of the major causes of death in infants and young children in the United States. Many patient-related and patient-independent factors influence the outcomes in patients with CHD, one of which is the geographical location. In the US-Mexico border, management and outcomes of patients with CHD are further complicated by additional problems stemming from complex interplay between two different health systems, and socioeconomic disparities. In this article, the authors evaluate the various interplaying factors and describe the difficulties facing the practicing pediatric cardiologists in a US-Mexico border city.

Competing Interests: Disclosure The authors report no conflicts of interest in this work.

With increasing healthcare costs and the high cost of spending driven by "defensive medicine," shedding light on recent litigation trends is critical for understanding current tort patterns, especially in the field of cardiology, a specialty with higher rates of malpractice suits than average. Understanding the characteristics of these liability claims and common types of patient injuries can aid cardiologists in mitigating malpractice risk and better patient care. Thus, the objective of this study was to characterize current malpractice trends in the field of cardiology and common sources of patient injury. An analysis of malpractice litigation claims from 2006 to 2015 in cardiology was performed on a database of nationwide professional liability insurers, health systems, and community hospitals. Both the total number of claims and annual indemnity payments in cardiology have seen an overall increase from 2006 to 2015. Of the 1,538 claims observed, the leading allegations were improper medical treatment and diagnostic error. However, despite the large number of claims, most cardiology claims during this decade were either decreased, denied, or dismissed (68%) and the plurality of the remainder was settled outside of court (30%). In conclusion, from 2006 to 2015, rates of cardiology malpractice claims and amount paid in compensation have increased substantially in the United States. Further understanding of the characteristics of these lawsuits can aid cardiologists in avoiding common sources of injury to improve patient care., (Copyright © 2018. Published by Elsevier Inc.)

Cardiologists performing preoperative cardiac evaluations for non-cardiac surgery have a unique opportunity to assess and optimize the patient's baseline and general health; determine the patient's inherent surgical risk based upon a comprehensive history, physical examination and pertinent laboratory data; ensure the patient has made an informed choice regarding surgery, and identify post-operative risks that must be considered to reduce the potential for major adverse cardiovascular events. There is always a small but inherent risk in surgical procedures. When an adverse outcome occurs there is potential for an allegation of negligence resulting in a detailed autopsy of the medical record. The best defense to an allegation of negligence is comprehensive documentation and a detailed rational for the cardiologist's management decisions., (Copyright © 2018 Elsevier B.V. All rights reserved.)

Objectives: To initiate a call to action for community pharmacists to maximize the opportunities to improve the management of hypertension (HTN) in light of the 2017 American College of Cardiology (ACC)/American Heart Association (AHA) HTN guideline., Summary: In November 2017, the ACC and the AHA, along with 9 other professional organizations, released a comprehensive guideline on the prevention, detection, evaluation, and management of high blood pressure (BP). Major changes included the reclassification of BP and redefinition of HTN to 130/80 mm Hg or above, significantly increasing the number of individuals with HTN. The 2017 ACC/AHA HTN guideline also emphasized out-of-office BP readings and recommended team-based care models that include pharmacists and other health professionals as one strategy to improve BP control rates and provide appropriate follow-up and monitoring. Community pharmacists are highly accessible health professionals that now have an even greater opportunity to improve the monitoring and management of patients with HTN. Monitoring of BP in pharmacies could be greatly improved if BP kiosks were replaced by automated BP monitors operated by appropriately trained personnel that would initiate a face-to-face consultation with a community pharmacist. Physicians and other prescribers should also refer patients directly to their community pharmacists to receive assistance in selecting a home BP monitor. Given recent expansion of collaborative practice legislation and prescriptive authority, health information exchanges, and reimbursement models, community pharmacists have a renewed opportunity to collaborate with medical practices and health systems to improve BP control. In addition, greater collaboration among pharmacists practicing in primary care and community pharmacy could improve care coordination., Conclusion: Community pharmacists have a significant opportunity to collaborate with patients, physicians, and the health care community at large to improve the monitoring and management of HTN and ensure that the 2017 ACC/AHA HTN guideline is successfully implemented., (Copyright © 2018 American Pharmacists Association®. Published by Elsevier Inc. All rights reserved.)

We are presently seeing exponential advances in medical knowledge and development of therapeutic and diagnostic tools. We have also begun to experience an historic restructuring of our health care system. But health care costs continue to rise, disparities persist, and the chaotic, disjointed, and often thoughtless discourse in Washington threatens to roll back the prior advances. Improvement in patient care will be severely stymied if the threats to academic medical centers are not countered. This paper will explore our present state through the lens of cardiovascular care. It will 1) examine clinical trends; 2) dissect the value and challenges to the Patient Protection and Affordable Care Act; 3) highlight limitations and alternatives to relying on the federal government; and 4) present the Academic Medical System construct, as a structure designed to retain and advance the academic mission., Competing Interests: Potential Conflicts of Interest: None disclosed.

Objective: To examine the epidemiologic data, identify the pattern of dispute, and determine clinical litigious errors by analyzing closed malpractice claims involving myocardial infarction (MI) in Taiwanese courts., Methods: A retrospective descriptive study was performed to analyze the verdicts pertaining to MI from the population-based database of the Taiwan judicial system between 2002 and 2013. The results of adjudication, involved specialists, primary dispute leading to lawsuits, and litigious errors were recorded., Results: A total of 36 closed malpractice claims involving MI were included. The mean interval between the incident and litigation closure was 65.5 ± 28.3 months. Nearly 20% of the cases were judged against clinicians and the mean payment was $100639 ± 49617, while the mean imprisonment sentence was 4.3 ± 1.8 months. Cardiologists and emergency physicians were involved in 56.3% of cases, but won 92.6% of lawsuits, while other specialists lost nearly 25% of lawsuits. The most common dispute was misdiagnosis (38.9%), but this dispute had the lowest percentage of loss (7.1%). Disputes regarding delayed diagnosis were judged against the defendants in 50% of claims. Clinicians lost the lawsuit in the following conditions: 1) misdiagnosis of MI in patients with typical chest pain and known coronary artery risk factors; 2) failure to perform thoughtful evaluation and series investigations in patients suspicious of ischemic heart disease; 3) failure to perform indicated treatment to avoid disease progression., Conclusions: Medical practitioners should keep a high index of MI suspicion, especially if the diagnosis and treatment of MI are beyond their daily practice. Prudent patient reevaluation, serial ECG and cardiac enzyme testing, and early consultation are suggested to reduce malpractice liability., (Copyright © 2017 Elsevier Ltd and Faculty of Forensic and Legal Medicine. All rights reserved.)

Telehealth offers an innovative approach to improve heart failure care that expands beyond traditional management strategies. Yet the use of telehealth in heart failure is infrequent because of several obstacles. Fundamentally, the evidence is inconsistent across studies of telehealth interventions in heart failure, which limits the ability of cardiologists to make general conclusions. Where encouraging evidence exists, there are logistical challenges to broad-scale implementation as a result of insufficient understanding of how to transform telemedicine strategies into clinical practice effectively. Ultimately, when implementation is reasonable, the application of these efforts remains hampered by regulatory, reimbursement, and other policy issues. The primary aim of this paper is to describe these challenges and to outline a path forward to apply telehealth approaches to heart failure in conjunction with payment reform and pragmatic research study design., (Copyright © 2017. Published by Elsevier Inc.)

Telemedicine has deeply innovated the field of emergency cardiology, particularly the treatment of acute myocardial infarction. The ability to record an ECG in the early prehospital phase, thus avoiding any delay in diagnosing myocardial infarction with direct transfer to the cath-lab for primary angioplasty, has proven to significantly reduce treatment times and mortality. This consensus document aims to analyze the available evidence and organizational models based on a support by telemedicine, focusing on technical requirements, education and legal aspects.

Over the past decade, personalized medicine has received considerable attention from researchers, drug developers, and regulatory agencies. Personalized medicine includes identifying patients most likely to benefit and those most likely to experience adverse reactions in response to a drug, and tailoring therapy based on pharmacokinetics or pharmacodynamic response, as well. Perhaps most exciting is finding ways to identify likely responders through genetic, proteomic, or other tests, so that only likely responders will be treated. However, less precise methods such as identifying historical, demographic, or other indicators of increased or reduced responsiveness are also important aspects of personalized medicine. The cardiovascular field has not used many genetic or proteomic markers, but has regularly used prognostic variables to identify likely responders. The development of biomarker-based approaches to personalized medicine in cardiovascular disease has been challenging, in part, because most cardiovascular therapies treat acquired syndromes, such as acute coronary syndrome and heart failure, which develop over many decades and represent the end result of several pathophysiological mechanisms. More precise disease classification and greater understanding of individual variations in disease pathology could drive the development of targeted therapeutics. Success in designing clinical trials for personalized medicine will require the selection of patient populations with attributes that can be targeted or that predict outcome, and the use of appropriate enrichment strategies once such attributes are identified. Here, we describe examples of personalized medicine in cardiovascular disease, discuss its impact on clinical trial design, and provide insight into the future of personalized cardiovascular medicine from a regulatory perspective., (© 2015 American Heart Association, Inc.)

Subjects with heart diseases at risk of sudden death may be free from symptoms and be able to perform high-level sports activities. Preparticipation screening helps to detect these diseases, reducing the risk of sudden death in athletes. Fortunately, sudden death in athletes is a rare event (1-2/100 000 in subjects aged <35 years). As a consequence, it is not clear whether extensive preparticipation screening is cost-effective. In Italy pre-participation screening is mandatory for both agonistic and nonagonistic sports, whereas in the United States it is not requested. In addition, many US authors suggest that compulsory medicine visits are in conflict with the freedom of any people to self-determine its own destiny. In the presence of heart disease, international guidelines exist that provide recommendations for sports eligibility. Although all of them are similar, US guidelines are more permissive. Guidelines are not laws. However, in case of legal disputes, they are taken into account and, hence, it is a good rule to know and follow them.

Background: Medical professional liability (MPL) remains a significant burden for physicians, in general, and cardiologists, in particular, as recent research has shown that average MPL defense costs are higher in cardiology than other specialties. Knowledge of the clinical characteristics and outcomes of lawsuits against cardiologists may improve quality of care and risk management., Methods: We analyzed closed MPL claims of 40,916 physicians and 781 cardiologists insured by a large nationwide insurer for ≥1 policy year between 1991 and 2005., Results: The annual percentage of cardiologists facing an MPL claim was 8.6%, compared with 7.4% among physicians overall (P < .01). Among 530 claims, 72 (13.6%) resulted in an indemnity payment, with a median size of $164,988. Mean defense costs for claims resulting in payment were $83,593 (standard deviation (s.d.) $72,901). The time required to close MPL claims was longer for claims with indemnity payment than claims without (29.6 versus 18.9 months; P < .001). More than half of all claims involved a patient's death (304; 57.4%), were based on inpatient care (379; 71.5%), or involved a primary cardiovascular condition (416; 78.4%). Acute coronary syndrome was the most frequent condition (234; 44.2%). Medical professional liability claims involving noncardiovascular conditions were common (66; 12.5%) and included falls or mechanical injuries had while under a cardiologist's care and a failure to diagnose cancer., Conclusions: Rates of malpractice lawsuits are higher among cardiologists than physicians overall. A substantial portion of claims are noncardiovascular in nature., (Copyright © 2014 Mosby, Inc. All rights reserved.)