Real Decreto 601/2019 sobre justificación y optimización: aspectos prácticos / Royal Decree 601/2019 on justification and optimization: Practical aspects

El Real Decreto 601/2019 de 18 de octubre es fruto de la transposición parcial al ordenamiento jurídico español de la Directiva EURATOM 59/2013. Este Real Decreto recoge los mandatos de la Directiva relacionados con la necesidad de justificar y optimizar la exposición médica, incluida la de personas asintomáticas, la propuesta de requisitos más estrictos en cuanto a la información que debe proporcionarse al paciente, el registro y la notificación de las dosis de los procedimientos médico-radiológicos, el uso de niveles de referencia para diagnóstico y la disponibilidad de dispositivos indicadores de dosis. El artículo revisa los aspectos más relevantes y novedades relacionadas con los principios de justificación, optimización, control de dosis y las obligaciones derivadas del derecho a la información y el consentimiento. El Real Decreto considera fundamental que exista un alto nivel de competencia, y una nueva enumeración de responsabilidades y funciones de los radiólogos, las cuales se detallan y analizan.(AU)

The Royal Decree 601/2019 of 18th october is the result of the partial transposition into the Spanish legal system of the EURATOM Directive 59/2013. This Royal Decree includes the mandates of the Directive related to the need to justify and optimize medical exposure, including that of asymptomatic people, proposal of stricter requirements regarding the information that must be provided to the patient, registration and notification of the doses of medical-radiological procedures, use of reference levels for diagnosis and the availability of dose-indicating devices. The article reviews the most relevant aspects and novelties related to the principles of justification, optimization, dose control and the obligations derived from the right to information and consent. This Royal Decree considers essential for radiologists to develop a high level of competence and a new list of responsibilities and functions, which are detailed and analysed in this article.(AU)

Regulatory Issues and Challenges to Artificial Intelligence Adoption.

Artificial intelligence technology promises to redefine the practice of radiology. However, it exists in a nascent phase and remains largely untested in the clinical space. This nature is both a cause and consequence of the uncertain legal-regulatory environment it enters. This discussion aims to shed light on these challenges, tracing the various pathways toward approval by the US Food and Drug Administration, the future of government oversight, privacy issues, ethical dilemmas, and practical considerations related to implementation in radiologist practice.

Federal Out-of-Network Balance Billing Legislation: Context and Implications for Radiology Practices.

Out-of-network (OON) balance billing, commonly known as surprise billing but better described as a surprise gap in health insurance coverage, occurs when an individual with private health insurance (vs a public insurer such as Medicare) is administered unanticipated care from a physician who is not in their health plan's network. Such unexpected OON care may result in substantial out-of-pocket costs for patients. Although ending surprise billing is patient centric, patient protective, and noncontroversial, passing federal legislation was challenging given its ability to disrupt insurer-physician good-faith negotiations and thus impact in-network rates. Like past proposals, the recently passed No Surprises Act takes patients out of the middle of insurer-physician OON reimbursement disputes, limiting patients' expense to standard in-network cost-sharing amounts. The new law, based on arbitration, attempts to protect good-faith negotiations between physicians and insurance companies and encourages network contracting. Radiology practices, even those that are fully in network or that never practiced surprise billing, could nonetheless be affected. Ongoing rulemaking processes will have meaningful roles in determining how the law is made operational. Physician and stakeholder advocacy has been and will continue to be crucial to the ongoing evolution of this process. © RSNA, 2021.

The Medical Malpractice Deposition: A Review for Radiologist-Defendants.

Depositions are critical components of any medical malpractice lawsuit and seek to help uncover the facts of the case to allow justice to be served. Depositions often create considerable anxiety for physician-defendants, including radiologists. Defendants unfamiliar with the rules of questioning or interviewing techniques used by plaintiffs' attorneys may fail to appreciate important and nuanced details of questions from the plaintiff's attorney, which in turn could impact the outcome of the case. Thorough and informed deposition preparation is thus essential. Highlighting issues relevant to radiologist-defendants, we discuss the role and structure of medical malpractice depositions as well as common scenarios, lines of questioning, and attorney strategies.

Artificial intelligence from A to Z: From neural network to legal framework.

Artificial intelligence (AI) will continue to cause substantial changes within the field of radiology, and it will become increasingly important for clinicians to be familiar with several concepts behind AI algorithms in order to effectively guide their clinical implementation. This review aims to give medical professionals the basic information needed to understand AI development and research. The general concepts behind several AI algorithms, including their data requirements, training, and evaluation methods are explained. The potential legal implications of using AI algorithms in clinical practice are also discussed.

Recent changes in UK medical law: implications for radiologists.

Since Lord Woolf declared in 2001 that the courts have been excessively deferential to the medical profession, there has been an incremental series of changes to the law concerning medical negligence. The most substantial changes concern consent, but significant change has also appeared regarding the concept of causation. This article reviews these changes, and points out areas of direct relevance to diagnostic and interventional radiology.

Medicolegal training in radiology; an overlooked component of the non-interpretive skills curriculum.

OBJECTIVE: Radiologists comprise approximately 3.6% of US physicians while ranked 6th-8th in medicolegal claims. Studies suggest that by the age of 60, about half of all radiologists will be sued at least once. Given this likelihood, it is surprising how little attention is paid to teaching of medicolegal issues. It is hypothesized that most trainees emerge from residency with only a vague notion of the medicolegal issues inherent in radiology. METHODS: All of the radiology attendings, trainees and alumni in our tertiary care teaching hospital were surveyed via an electronic questionnaire. Respondents were surveyed on overall knowledge of job-related medicolegal issues and willingness to receive additional education. The survey also included two real life medicolegal scenarios and the radiologists were asked to choose the most likely outcome. RESULTS: A questionnaire was sent to total of 359 trainees, attendings and alumni. There were 168 responses, constituting a 46.7% response rate, F:M 48:112. Only 41% of the respondents were aware that by the age of 60, half of them would be involved in at least one lawsuit. All knew the most common causes of malpractice claims; however, one-fourth were not aware of available medicolegal resources offered by radiological organizations; 85% of the respondents expressed willingness to attend medicolegal CME courses. All residents surveyed believed that medicolegal lectures should be included in their didactics. CONCLUSION: There is a dearth of knowledge among radiologists on job-related medicolegal topics. This survey suggests that incorporating additional medicolegal topics into the non-interpretive skills curriculum of residents and medicolegal CME for graduates would be well received.

The new radiation protection framework since 2019 - Implementation in Germany and comparison of some aspects in seven European countries. / Das neue Strahlenschutzrecht ab 2019 ­ Umsetzung in Deutschland und Vergleich einzelner Aspekte in 7 europäischen Ländern.

PURPOSE: The implementation of EU Directive 2013/59 EURATOM (EU-BSS) of 2014 led to a reorganization of radiation protection legislation in Germany in the form of a new radiation protection law Strahlenschutzgesetz (StrlSchG) of 2017 and a new radiation protection ordinance Strahlenschutzverordnung (StrlSchV) of 2018. For application of ionizing radiation in medicine these changes affect radiology, nuclear medicine and radiotherapy. A comparison between the old and the new legal system analyses changes that are relevant for diagnostic and interventional radiology. For the important new regulation of unintended exposures, a comparison is made with the implementation of Art. 63 EU-BSS in 7 European countries. MATERIAL AND METHODS: The provisions of the Röntgenverordnung (RöV) and the old Strahlenschutzverordnung (StrlSchV alt), which were valid until 2018, are compared with the new legislation of StrlSchG and StrlSchV for changes in radiation protection for patients, the population and occupational radiation protection of staff members. The occupational dose limit of the eye lens was reduced. The reduction by a factor of 7.5 results in new requirements for radiation protection equipment. New requirements in teleradiology are compared with the previous regulation, as well as the necessary involvement of medical physics experts (MPE) in high dose procedures, such as CT and fluoroscopic interventions. The regulation for unintended exposures of the German StrlSchV are analyzed in terms of their reporting criteria. RESULTS: The principles of medical radiation protection in Germany have not changed as a result of the new radiation protection legislation from 2019 onwards. However, there are a number of changes and new requirements that must be considered and implemented. Important points are e. g. new regulations on teleradiology, early detection of diseases in asymptomatic individuals and reporting of unintended exposure of patients. As all new regulations are no longer found in only one single regulation, both knowledge of the StrlSchG and the StrlSchV are necessary. KEY POINTS: · The EU Directive 2013/59 EURATOM (EU-BSS) was transposed into the new German radiation protection law 2018. · The basic regulations of the RöV and old StrlSchV remain unchanged. · Newly added regulations must be known and implemented in practice. · Many regulations of the EU-BSS are so vaguely formulated that they allow a wide scope for national implementation. CITATION FORMAT: · Loose R, Wucherer M, Walz M et al. The new radiation protection framework since 2019 - Implementation in Germany and comparison of some aspects in seven European countries. Fortschr Röntgenstr 2020; 192: 1036 - 1045.

Emergency Radiology: An Underappreciated Source of Liability Risk.

PURPOSE: While several studies analyze radiology malpractice lawsuits, none specifically examines the site of service. The purpose of this study is to estimate the relative likelihood of a lawsuit arising from a radiology study performed in emergency (ED), inpatient (IP) and outpatient (OP) settings. METHODS: Referrals from a malpractice review consulting company over a six year period were compared to the 2016 Medicare Part B file and stratified by site of service. The proportion of exams for each site of service was estimated, and using absolute differences in proportions and odds ratios (ORs), differences in the place of service were calculated. RESULTS: The Cleareview cohort contained 25 (17%) IP, 56 (38%) OP, and 68 (46%) ED exams. In 2016, Medicare assigned benefits for 27,009,053 (20%) IP, 84,075,848 (62%) OP and 23,964,794 (18%) ED exams. The ORs (Cleareview: Medicare) of the ED to IP, OP, and IP+OP were 3.07 (95% CI: 1.56-6.03), 4.26 (95% CI: 2.76-6.59), 3.89 (95% CI: 2.60-5.83), respectively. By contrast, the OR for IP:OP between Cleareview and Medicare was not significantly different than 1 (OR: 1.39, 95% CI: 0.68-2.83, P = .38). DISCUSSION: Radiological studies performed in the ED accounted for a disproportionate number of liability claims against radiologists. Further study is warranted to confirm this finding with a more robust data set.

The economics of quality and safety in radiology: Accreditation programs and landmark legislation.

Quality and patient safety are essential to the practice of radiology. "Quality is our image" is the slogan for the American College of Radiology (ACR), which has embraced the quality and safety movement as a central tenet. The impact of advances in radiology on diagnosis and management of complex medical disorders cannot be understated. Nevertheless, these revolutionary technologies do come at a cost. Increasing utilization of advanced imaging in emergency departments throughout the country poses challenges both in terms of appropriate use and management of radiation dose. The indispensable place advanced imaging plays in diagnosis has necessitated guidelines and accountability to protect patients and radiology staff. In this series, we have created a concise discourse on what we have determined to be the essentials of the economics of quality and safety as it pertains to radiology. In this first article, we summarize the accreditation programs in radiology, their legislative background, and the associated financial and market responses that have subsequently resulted. We discuss the progression from historical predecessors to the passage of the Mammography Quality and Safety Act (MQSA), which served as a model for subsequent laws governing the quality and safety of other imaging modalities. These laws have had real economic implications for radiology practices seeking to meet new increasingly stringent guidelines. We also break down the costs of participation in the ACR accreditation and center of excellence programs.

Coding and Legal Issues in Obstetric and Gynecologic Ultrasound.

This article addresses coding and liability related to obstetric and gynecologic ultrasound examinations. The coding section includes an overview of general concepts, highlighting the differences between coding in hospital-owned facilities and provider-owned clinics. It also addresses the importance of correct International Classification of Diseases, 10th edition, coding, emphasizing the use of the most specific applicable codes. This section discusses proper coding and applicable parameters for early pregnancy and gynecologic ultrasound examination. The liability section addresses common errors leading to litigation in obstetric and gynecologic ultrasound practice. Examples are given demonstrating how such errors lead to liability actions.