Patient Access of Their Radiology Reports Before and After Implementation of 21st Century Cures Act Information-Blocking Provisions at a Large Multicampus Health System.

BACKGROUND. To implement provisions of the 21st Century Cures Act that address information blocking, federal regulations mandated that health systems provide patients with immediate access to elements of their electronic health information, including imaging results. OBJECTIVE. The purpose of this study was to compare patient access of radiology reports before and after implementation of the information-blocking provisions of the 21st Century Cures Act. METHODS. This retrospective study included patients who underwent outpatient imaging examinations from January 1, 2021, through December 31, 2022, at three campuses within a large health system. The system implemented policies to comply with the Cures Act information-blocking provisions on January 1, 2022. Imaging results were released in patient portals after a 36-hour embargo period before implementation versus being released immediately after report finalization after implementation. Data regarding patient report access in the portal and report acknowledgment by the ordering provider in the EMR were extracted and compared between periods. RESULTS. The study included reports for 1,188,692 examinations in 388,921 patients (mean age, 58.5 ± 16.6 [SD] years; 209,589 women, 179,290 men, eight nonbinary individuals, and 34 individuals for whom sex information was missing). A total of 77.5% of reports were accessed by the patient before implementation versus 80.4% after implementation. The median time from report finalization to report release in the patient portal was 36.0 hours before implementation versus 0.4 hours after implementation. The median time from report release to first patient access of the report in the portal was 8.7 hours before implementation versus 3.0 hours after implementation. The median time from report finalization to first patient access was 45.0 hours before implementation versus 5.5 hours after implementation. Before implementation, a total of 18.5% of reports were first accessed by the patient before being accessed by the ordering provider versus 44.0% after implementation. After implementation, the median time from report release to first patient access was 1.8 hours for patients with age younger than 60 years old versus 4.3 hours for patients 60 years old or older. CONCLUSION. After implementation of institutional policies to comply with 21st Century Cures Act information-blocking provisions, the length of time until patients accessed imaging results decreased, and the proportion of patients who accessed their reports before the ordering provider increased. CLINICAL IMPACT. Radiologists should consider mechanisms to ensure timely and appropriate communication of important findings to ordering providers.

Medicare Program; Revisions to Payment Policies Under the Physician Fee Schedule and Other Revisions to Part B for CY 2018; Medicare Shared Savings Program Requirements; and Medicare Diabetes Prevention Program. Final rule.

This major final rule addresses changes to the Medicare physician fee schedule (PFS) and other Medicare Part B payment policies such as changes to the Medicare Shared Savings Program, to ensure that our payment systems are updated to reflect changes in medical practice and the relative value of services, as well as changes in the statute. In addition, this final rule includes policies necessary to begin offering the expanded Medicare Diabetes Prevention Program model.

Guidelines Regarding §16 of the German Transplantation Act - Initial Experiences with Structured Reporting.

Purpose To transfer the report sheet from the guidelines regarding the German Transplantation Act to a standards-compliant report template and to evaluate it in the clinical routine. Materials and Methods The template was developed using the freely available software brackets.io. It was implemented in the clinical routine using a reporting platform developed in-house. Interfaces to the department RIS and PACS allowed for integration into the usual reporting workflow. The evaluation period was 70 days. Results Developing the template for implementation of the guidelines was possible without any difficulties. The content of the report sheet provided in the guidelines was transferred one to one. Additionally, a text field was included to allow for further remarks. In the period under review, 7 radiologists performed 44 evaluations in line with §â€Š16 of the German Transplantation Act. Users of the template, referring physicians and the employees of the transplantation office reported a high degree of satisfaction. Conclusion Implementing report sheets that are required by law (e. g. in the guidelines regarding §â€Š16 of the German Transplantation Act) in the clinical routine electronically is easy and achieves a high degree of acceptance. The standard supported by the German Radiological Society (IHE - "Management of radiology report templates") allows for a quick response to the growing demand for structured and standardized reporting. Key Points · Report sheets as required by law can easily be incorporated electronically into the clinical routine.. · Templates for structured reporting as supported by the German Radiological Society allow for a quick response to the growing demand for standardized reporting.. · Radiologists as well as referring physicians report a high degree of satisfaction with the electronic version of the report sheet.. Citation Format · Pinto dos Santos D, Arnhold G, Mildenberger P et al. Guidelines Regarding §16 of the German Transplantation Act - Initial Experiences with Structured Reporting. Fortschr Röntgenstr 2017; 189: 1145 - 1151.

[Required Framework for the Collection of Real-life Data: An Example from University Eye Hospital Munich]. / Rahmenbedingungen zur Sammlung von "Real-Life"-Daten am Beispiel der Augenklinik der Universität München.

Background The importance of evaluating real-life data is constantly increasing. Currently available computer systems better allow for analyses of data, as more and more data is available in a digital form. Before a project for real-life data analyses is started, technical considerations and staff, legal, and data protection procedures need to be addressed. In this manuscript, experiences made at the University Eye Hospital in Munich will be shared. Materials and Methods Legal requirements, as found in laws and guidelines governing documentation and data privacy, are highlighted. Technical requirements for information technology infrastructure and software are defined. A survey conducted by the German Ophthalmological Society, among German eye hospitals investigating the current state of digitalization, was conducted. Also, staff requirements are outlined. Results A database comprising results of 330,801 patients was set up. It includes all diagnoses, procedures, clinical findings and results from diagnostic devices. This database was approved by the local data protection officer. In less than half of German eye hospitals (n = 21) that participated in the survey (n = 54), a complete electronic documentation is done. Fourteen institutions are completely paper-based, and the remainder of the hospitals used a mixed system. Conclusion In this work, we examined the framework that is required to develop a comprehensive database containing real-life data from clinics. In future, these databases will become increasingly important as more and more innovation are made in decision support systems. The base for this is comprehensive and well-curated databases.

Partnering With Your Health System to Select and Implement Clinical Decision Support for Imaging.

Recent legislation mandates the documentation of appropriateness criteria consultation when ordering advanced imaging for Medicare patients to remain eligible for reimbursement. Implementation of imaging clinical decision support (CDS) is a solution adopted by many systems to automate compliance with the new requirements. This article is intended to help radiologists who are employed by, contracted with, or otherwise affiliated with systems planning to implement CDS in the near future and ensure that they are able to understand and contribute to the process wherever possible. It includes an in-depth discussion of the legislation, evidence for and against the efficacy of imaging CDS, considerations for selecting a CDS vendor, tips for configuring CDS in a fashion consistent with departmental goals, and pointers for implementation and change management.

Implications of Direct Patient Online Access to Radiology Reports Through Patient Web Portals.

In an era of increasing health information transparency and informed decision making, more patients are being provided with direct online access to their medical records, including radiology reports, via web-based portals. Although radiologists' narrative reports have previously been the purview of referring physicians, patients are now reading these on their own. Many potential benefits may result from patients reviewing their radiology reports, including improvements in patients' own understanding of their health, promotion of shared decision making and patient-physician communication, and, ultimately, improvements in patient outcomes. However, there may also be negative consequences, including confusion and anxiety among patients and longer patient-physician interactions. The rapid adoption of this new technology has led to major questions regarding ethics and professionalism for radiologists, including the following: Who is the intended audience of radiology reports? How should content be presented or worded? How will open access influence radiologists' relationships with patients and referring physicians? What legal ramifications may arise from increased patient access? The authors describe the current practices and research findings associated with patient online access to medical records, including radiology reports, and discuss several implications of this growing trend for the radiology profession.

Respuesta a la carta: «Ni científico ni moralista: solo radiólogo» / Response to the letter: "Neither a scientist nor a moralist: only a radiologist"

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Business Model for the Security of a Large-Scale PACS, Compliance with ISO/27002:2013 Standard.

Data security is a critical issue in an organization; a proper information security management (ISM) is an ongoing process that seeks to build and maintain programs, policies, and controls for protecting information. A hospital is one of the most complex organizations, where patient information has not only legal and economic implications but, more importantly, an impact on the patient's health. Imaging studies include medical images, patient identification data, and proprietary information of the study; these data are contained in the storage device of a PACS. This system must preserve the confidentiality, integrity, and availability of patient information. There are techniques such as firewalls, encryption, and data encapsulation that contribute to the protection of information. In addition, the Digital Imaging and Communications in Medicine (DICOM) standard and the requirements of the Health Insurance Portability and Accountability Act (HIPAA) regulations are also used to protect the patient clinical data. However, these techniques are not systematically applied to the picture and archiving and communication system (PACS) in most cases and are not sufficient to ensure the integrity of the images and associated data during transmission. The ISO/IEC 27001:2013 standard has been developed to improve the ISM. Currently, health institutions lack effective ISM processes that enable reliable interorganizational activities. In this paper, we present a business model that accomplishes the controls of ISO/IEC 27002:2013 standard and criteria of security and privacy from DICOM and HIPAA to improve the ISM of a large-scale PACS. The methodology associated with the model can monitor the flow of data in a PACS, facilitating the detection of unauthorized access to images and other abnormal activities.

Features and limitations of mobile tablet devices for viewing radiological images.

PURPOSE: Mobile radiological image display systems are becoming increasingly common, necessitating a comparison of the features of these systems, specifically the operating system employed, connection to stationary PACS, data security and rang of image display and image analysis functions. MATERIAL AND METHODS: In the fall of 2013, a total of 17 PACS suppliers were surveyed regarding the technical features of 18 mobile radiological image display systems using a standardized questionnaire. The study also examined to what extent the technical specifications of the mobile image display systems satisfy the provisions of the Germany Medical Devices Act as well as the provisions of the German X-ray ordinance (RöV). RESULTS: There are clear differences in terms of how the mobile systems connected to the stationary PACS. Web-based solutions allow the mobile image display systems to function independently of their operating systems. The examined systems differed very little in terms of image display and image analysis functions. CONCLUSION: Mobile image display systems complement stationary PACS and can be used to view images. The impacts of the new quality assurance guidelines (QS-RL) as well as the upcoming new standard DIN 6868 - 157 on the acceptance testing of mobile image display units for the purpose of image evaluation are discussed.

Who owns the image? Archiving and retention issues in the digital age.

Patients are often confused with respect to the ownership of radiologic images and the extent to which they may exert rights over their own imaging. In general, a facility that generates imaging maintains "ownership" rights. Patients have a right to inspect their images and obtain copies but they may not have the images or reports modified or stricken. Facilities may use images not only for treatment purposes but also have rights to use images with respect to educational training, quality control, and research, subject to HIPAA requirements. A facility has statutory obligations with respect to record retention and may face financial penalty and malpractice consequences for failure to retain images. Bankruptcy and state laws address issues of transfer of ownership of a patient's images in cases in which a facility goes out of business. Future questions remain as to whether the length of time a facility maintains images should increase as digital storage media improve and whether the use of inter-facility image sharing via "cloud" technology should alter obligations with respect to which facility must retain the images.

Financial impact of radiological reports on medical-legal evaluation of compensation for meniscal lesions.

To evaluate any discrepancy between radiological reports for clinical purposes and for medicolegal purposes and to quantify its economic impact on repayments made by private insurance companies for meniscal injuries of the knee. The medical records obtained pertaining to 108 knee injury patients (mean age 43.3 years) assessed over a period of 12 months were analysed. Clinical medical reports, aimed at assessing the lesion, and medicolegal reports, drawn up with a view to quantifying compensation, were compared. Unlike reports for clinical purposes in reports for medicolegal purposes, in the evaluation of meniscal lesions, in addition to morphological features of lesions, chronological, topographical, severity and exclusion criteria were applied. To estimate the economic impact resulting from the biological damage, we consulted an actuarial table based on the 9-point minor incapacity classification system. Meniscal lesions not compatible with a traumatic event and therefore not eligible for an insurance payout were found in 56 patients. Of these, 37 failed exclusion criteria, while 19 failed to meet chronological criteria. This difference resulted in a reduction in compensation made by private insurance companies with savings estimated with a saving between euro 203,715.41 and euro 622,315.39. The use of a clinical report for medicolegal purposes can be a source of valuation error, as chronological and/or dynamic information regarding the trauma mechanism may be lacking. Therefore, the use of a full radiological appraisal allows a better damage's assessment and an adequate compensation for injuries.

A review of medical image watermarking requirements for teleradiology.

Teleradiology allows medical images to be transmitted over electronic networks for clinical interpretation and for improved healthcare access, delivery, and standards. Although such remote transmission of the images is raising various new and complex legal and ethical issues, including image retention and fraud, privacy, malpractice liability, etc., considerations of the security measures used in teleradiology remain unchanged. Addressing this problem naturally warrants investigations on the security measures for their relative functional limitations and for the scope of considering them further. In this paper, starting with various security and privacy standards, the security requirements of medical images as well as expected threats in teleradiology are reviewed. This will make it possible to determine the limitations of the conventional measures used against the expected threats. Furthermore, we thoroughly study the utilization of digital watermarking for teleradiology. Following the key attributes and roles of various watermarking parameters, justification for watermarking over conventional security measures is made in terms of their various objectives, properties, and requirements. We also outline the main objectives of medical image watermarking for teleradiology and provide recommendations on suitable watermarking techniques and their characterization. Finally, concluding remarks and directions for future research are presented.

Collection and recording of radiological information for forensic purposes.

Forensic odontology is the application of dental expertise to legal issues. Commonly, it involves the comparison of dental records of a missing person with a deceased individual for the purposes of forensic personal identification, either in a single case, or as part of the response to an event involving multiple simultaneous fatalities (Disaster Victim Identification, or DVI). It may also involve studies to determine the age of an individual, which may be required as part of a forensic identification process, or for another legal purpose such as the determination of legal responsibility, or in connection with immigration. This report examines the types of radiological information currently used in such forensic studies, and discusses how this information may be accessed or recorded, as well as the techniques that are commonly applied to the radiological data to reach a satisfactory outcome for application in forensic casework.

Fraudulent retouching of digital radiographic images--a potential risk.

AIM: To determine whether radiologists can recognize images retouched to include sham lesions. MATERIALS AND METHODS: Ten representative key images were selected of aortic dissection, hepatocellular carcinoma, renal cell carcinoma, colon cancer, liver metastasis, hepatic cyst, gallbladder stones, splenic artery aneurysm, adrenal adenoma, and stomach cancer from abdominal computed tomography (CT) imaging performed in 2008. Five of the key images were replaced with retouched images using image-editing software. The time to complete retouching was recorded for each image. Radiologists were requested to make a diagnosis for the 10 images, and were then asked to identify possible retouched images. The time taken to reach a decision in each case was recorded. Thirty radiologists (13 residents and 17 attending radiologists) participated as reviewers. RESULTS: The time to complete retouching was 15.2±3.15 min. None of the reviewers recognized that some images were retouched during diagnosis. The rate of correct diagnosis was 90% (range 71.7-100%). After reviewers were informed of possible image retouching, the detection rate of retouched images was 50% (40-58.3%). This rate was statistically the same as random choice (p=0.876). There was no significant difference between residents and attending radiologists in the detection rate of retouched images (p=0.786). The time to diagnosis and the time to detection of the retouched images were 15 (14-17) and 6 (5-7) min, respectively. CONCLUSION: Digital images can be easily retouched, and radiologists have difficulty in identifying retouched images. Radiologists should be aware of the potential fraudulent use of retouched images.

Legal aspects of cross-border teleradiology.

The growth of cross-border teleradiology has created legal challenges that are insufficiently addressed by nation health laws. New legislation is currently under development at the European level. This article will look at the details of the existing and proposed legislation and the still unsettled issues and will discuss the implications for international teleradiology.

[Radiological digital imaging: a new tool for the patient medical file]. / L'image radiologique dans le dossier patient.

This paper will focus on the positive vs negative in-puts of new radiological imaging in the patient medical file.