Road to a National Health Information Network: US Trusted Exchange Framework and Common Agreement (TEFCA).

The Trusted Exchange Framework and Common Agreement (TEFCA) is a U.S. government initiative aimed at promoting the secure and interoperable exchange of electronic health information (EHI) across the healthcare ecosystem. In the U.S., TEFCA was established as part of the 21st Century Cures Act, signed into law in December 2016. Methods: A literature search using the PRISMA guidelines will be conducted through PubMed, CINAHL, Google Scholar, and Web of Science, for dates 2013-2024 will be conducted. Results will be demonstrated with a timeline, graphics, and written text on the key points of technical and operational standards for HIE, rules and expectations for data sharing under the Common Agreement, governance framework for implementation and enforcement principles, stakeholders and collaborators, and interoperability challenges. TEFCA seeks to improve patient care, reduce healthcare costs, and enhance overall healthcare quality by facilitating the seamless exchange of data between different healthcare entities. Sharing this information can contribute to nursing informatics practice and knowledge as the U.S. and other countries strive towards better interoperability in the race to improve patient care and outcomes using health information technology.

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.

Provider Perspectives on Adolescent Confidentiality and the Electronic Health Record Postimplementation of the 21st Century Cures Act Final Rule.

PURPOSE: The 21st Century Cures Act Final Rule mandates increased transparency and accessibility of the Electronic Health Record (EHR). This mandate has exacerbated tensions in adolescent healthcare between transparency and confidentiality. This study evaluates clinicians' perspectives on how well the EHR maintains confidentiality for adolescents in the post-Cures Act era. METHODS: A web-based survey was distributed via the national listserv of the Society for Adolescent Health and Medicine in March-April 2022. English-speaking members practicing in the Unites States who used an EHR to document clinical visits with minors were eligible. The survey included questions about EHR training, features, and approach to information sharing with adolescent patients and proxies. RESULTS: Participants included 97 respondents from 32 states. Most participants were physicians (98%) and identified themselves as attending (89%). Several EHR vendors were represented, although the majority used Epic (76%). As has been seen in prior studies, there remains significant variability in approaches to patient portal access for adolescent patients and their adult proxies. Respondents report that training around adolescent-specific privacy issues remains infrequent and is perceived as inadequate. Adolescent providers, despite feeling confident in navigating the EHR generally, continue to report low rates of confidence in how well their EHR may protect adolescent privacy. DISCUSSION: Clinicians have persistent concerns about adolescent confidentiality postimplementation of the 21st Century Cures Act. Sharing sufficient information while protecting adolescent confidentiality might require standardization by EHR vendors to improve granularity of proxy information sharing. Healthcare institutions must also commit to training providers on management of adolescent confidentiality.

Artificial Intelligence to Improve Patient Understanding of Radiology Reports.

Diagnostic imaging reports are generally written with a target audience of other providers. As a result, the reports are written with medical jargon and technical detail to ensure accurate communication. With implementation of the 21st Century Cures Act, patients have greater and quicker access to their imaging reports, but these reports are still written above the comprehension level of the average patient. Consequently, many patients have requested reports to be conveyed in language accessible to them. Numerous studies have shown that improving patient understanding of their condition results in better outcomes, so driving comprehension of imaging reports is essential. Summary statements, second reports, and the inclusion of the radiologist's phone number have been proposed, but these solutions have implications for radiologist workflow. Artificial intelligence (AI) has the potential to simplify imaging reports without significant disruptions. Many AI technologies have been applied to radiology reports in the past for various clinical and research purposes, but patient focused solutions have largely been ignored. New natural language processing technologies and large language models (LLMs) have the potential to improve patient understanding of their imaging reports. However, LLMs are a nascent technology and significant research is required before LLM-driven report simplification is used in patient care.

Applying real-world data from expanded-access ("compassionate use") patients to drug development.

Our drug development process has produced many life-saving medications, but patients experiencing rare diseases and similar conditions often are left with limited options for treatment. For an approved treatment to be developed, research on a new candidate or existing drug must validate safety and efficacy based on contemporary research expectations. Randomized clinical trials are conducted for this purpose, but they are also costly, laborious, and time-consuming. For this reason, The 21st Century Cures Act mandates that the US Food and Drug Administration look for alternative methods for approving drugs, in particular exploring the uses of real-world data and evidence. Expanded access ("compassionate use") is a pathway for the clinical treatment of patients using drugs that are not yet approved for prescribing in the United States. Using real-world evidence generated from expanded-access patients presents an opportunity to provide critical data on patient outcomes that can serve regulatory approval in conjunction with other observational datasets or clinical trials, and in limited circumstances may be the best data available for regulatory review. In doing so, we may also support and encourage patient-centered care and a personalized medicine approach to drug development.

The 21st Century Cures Act: Inpatient Clinician Perceptions of Changes to Information Sharing at an Academic Medical Center.

Introduction To comply with the Information Blocking Rule in the 21st Century Cures Act, many hospitals began to release inpatient electronic health information such as clinical notes and results to patients immediately, starting in April 2021. We sought to understand the perceptions of hospital-based clinicians regarding the impact of these changes in information sharing on clinicians and patients. Materials and methods We developed and distributed an electronic survey to 122 inpatient attending physicians, resident physicians, and physician assistants within the internal medicine and family medicine departments at an academic medical center. The survey asked clinicians to rate their comfort with information-sharing protocols and describe their perceptions of the impact of immediate information sharing on their documentation habits and patient interactions following the implementation of the Cures Act. Results The survey response rate was 37.7% (46/122). Of the respondents, 56.5% felt comfortable with the note-sharing process, 84.8% reported omitting specific information from their notes to prevent patients from reading it, and 39.1% of clinicians agreed that patients have found clinical notes "more confusing than helpful." Conclusions Immediate sharing of electronic health information has the potential to be a powerful tool for communicating with hospitalized patients. However, our results show many hospital-based clinicians report limited comfort with the note-sharing process and perceive it to be confusing to patients. Efforts are needed to educate clinicians regarding information sharing, understand patient and family perspectives, and develop best practices to enhance communication through electronic notes.

Impact of notification policy on patient-before-clinician review of immediately released test results.

The 21st Century Cures Act mandates immediate availability of test results upon request. The Cures Act does not require that patients be informed of results, but many organizations send notifications when results become available. Our medical center implemented 2 sequential policies: immediate notifications for all results, and notifications only to patients who opt in. We used over 2 years of data from Vanderbilt University Medical Center to measure the effect of these policies on rates of patient-before-clinician result review and patient-initiated messaging using interrupted time series analysis. When releasing test results with immediate notification, the proportion of patient-before-clinician review increased 4-fold and the proportion of patients who sent messages rose 3%. After transition to opt-in notifications, patient-before-clinician review decreased 2.4% and patient-initiated messaging decreased 0.4%. Replacing automated notifications with an opt-in policy provides patients flexibility to indicate their preferences but may not substantially alleviate clinicians' messaging workload.

Decoding radiology reports: Potential application of OpenAI ChatGPT to enhance patient understanding of diagnostic reports.

PURPOSE: To evaluate the complexity of diagnostic radiology reports across major imaging modalities and the ability of ChatGPT (Early March 2023 Version, OpenAI, California, USA) to simplify these reports to the 8th grade reading level of the average U.S. adult. METHODS: We randomly sampled 100 radiographs (XR), 100 ultrasound (US), 100 CT, and 100 MRI radiology reports from our institution's database dated between 2022 and 2023 (N = 400). These were processed by ChatGPT using the prompt "Explain this radiology report to a patient in layman's terms in second person: ". Mean report length, Flesch reading ease score (FRES), and Flesch-Kincaid reading level (FKRL) were calculated for each report and ChatGPT output. T-tests were used to determine significance. RESULTS: Mean report length was 164 ± 117 words, FRES was 38.0 ± 11.8, and FKRL was 10.4 ± 1.9. FKRL was significantly higher for CT and MRI than for US and XR. Only 60/400 (15%) had a FKRL <8.5. The mean simplified ChatGPT output length was 103 ± 36 words, FRES was 83.5 ± 5.6, and FKRL was 5.8 ± 1.1. This reflects a mean decrease of 61 words (p < 0.01), increase in FRES of 45.5 (p < 0.01), and decrease in FKRL of 4.6 (p < 0.01). All simplified outputs had FKRL <8.5. DISCUSSION: Our study demonstrates the effective use of ChatGPT when tasked with simplifying radiology reports to below the 8th grade reading level. We report significant improvements in FRES, FKRL, and word count, the last of which requires modality-specific context.

"I don't think it should take you three days to tell me my baby is dead." A case of fetal demise: unintended consequences of immediate release of information.

The 21st Century Cures Act (Cures Act) information blocking regulations mandate timely patient access to their electronic health information. In most healthcare systems, this technically requires immediate electronic release of test results and clinical notes directly to patients. Patients could potentially be distressed by receiving upsetting results through an electronic portal rather than from a clinician. We present a case from 2018, several years prior to the implementation of the Cures Act. A patient was notified of fetal demise detected by ultrasound through her electronic health record (EHR) patient portal before her clinician received the result. We discuss the patient's ensuing complaint and healthcare system response. This unusual and dramatic case of fetal demise is relevant today because it underscores the importance of involving a patient and family advisory council in decision-making. It also highlights the value of "anticipatory guidance" as a routine clinical practice in this era of immediate access to test results.

Understanding the Cures Act Information Blocking Rule in cancer care: a mixed methods exploration of patient and clinician perspectives and recommendations for policy makers.

BACKGROUND: The 21st Century Cures Act Interoperability and Information Blocking Rule was created to increase patient access to health information. This federally mandated policy has been met with praise and concern. However, little is known about patient and clinician opinions of this policy within cancer care. METHODS: We conducted a convergent parallel mixed methods study to understand patient and clinician reactions to the Information Blocking Rule in cancer care and what they would like policy makers to consider. Twenty-nine patients and 29 clinicians completed interviews and surveys. Inductive thematic analysis was used to analyze the interviews. Interview and survey data were analyzed separately, then linked to generate a full interpretation of the results. RESULTS: Overall, patients felt more positive about the policy than clinicians. Patients wanted policy makers to understand that patients are unique, and they want to individualize their preferences for receiving health information with their clinicians. Clinicians highlighted the uniqueness of cancer care, due to the highly sensitive information that is shared. Both patients and clinicians were concerned about the impact on clinician workload and stress. Both expressed an urgent need for tailoring implementation of the policy to avoid unintended harm and distress for patients. CONCLUSIONS: Our findings provide suggestions for optimizing the implementation of this policy in cancer care. Dissemination strategies to better inform the public about the policy and improve clinician understanding and support are recommended. Patients who have serious illness or diagnoses such as cancer and their clinicians should be included when developing and enacting policies that could have a significant impact on their well-being. Patients with cancer and their cancer care teams want the ability to tailor information release based on individual preferences and goals. Understanding how to tailor implementation of the Information Blocking Rule is essential for retaining its benefits and minimizing unintended harm for patients with cancer.

Attitudes and Experiences of Clinicians After Mandated Implementation of Open Notes by the 21st Century Cures Act: Survey Study.

BACKGROUND: On December 13, 2016, the US Congress enacted the 21st Century Cures Act (hereafter the Cures Act), which contained the Final Rule mandate that took effect on April 5, 2021. Since then, health systems have been required to provide patients digital access to their eHealth information "without delay" and without charge. OBJECTIVE: This study aimed to assess clinicians' initial experiences with, and attitudes toward, sharing visit notes with patients after being mandated to do so by the Cures Act and to determine clinician preferences regarding instant record release. METHODS: This cross-sectional survey study was conducted between June 10, 2021, and August 15, 2021, at the University of Kansas Health System, a large academic medical center in Kansas City, Kansas, United States. Participants included clinicians currently employed by the health system, including resident and attending physicians, physician assistants, nurse practitioners, and critical care and emergency medicine registered nurses. RESULTS: A total of 1574 attending physicians, physician assistants, and nurse practitioners, as well as 506 critical care and emergency medicine nurses, were sent invitations; 538 (34.18%) and 72 (14.2%), respectively, responded. Of 609 resident physicians, 4 (response rate not applicable because it was unknown how many residents viewed the website while the link was available) responded. The majority of respondents were attending physicians (402/614, 65.5%) and within the department of internal medicine (160/614, 26.1%). Most agreed that sharing visit notes was a good idea (355/613, 57.9%) and that it is important to speak with the patients before they accessed their records (431/613, 70.3%). Those who agreed that sharing visit notes is a good idea tended to view the practice as a useful tool for engaging patients ("Agree": 139/355, 39.2%; "Somewhat agree": 161/355, 45.4%; P<.001) and experience no change in the clinical value of their notes for other clinicians (326/355, 91.8%; P<.001). Those who disagreed (or were neutral) tended not to encourage patients to read their notes (235/258, 91.1%; P<.001) and were more likely to experience a change in their charting practice (168/257, 65.4%; P<.001) and increased time charting (99/258, 38.4%; P<.001). CONCLUSIONS: The findings of this study may be generalizable to institutions similar to the University of Kansas Health System, and the clinician testimonies gathered in this study may provide valuable insight into the initial opinions and experiences of clinicians at these institutions. In addition, these clinician experiences collected early in the transition period may be used to guide future health policy implementation and to understand how best to prepare clinicians for these changes in practice.

The patient-friendly radiology report: history, evolution, challenges and opportunities.

The past several decades have witnessed dramatic developments and improvements in the field of radiology, including technologic innovations and new imaging modalities, picture archiving and communication systems, and the rise of artificial intelligence. At the same time, an evolution has been occurring in a fundamental component of radiology practice - the radiologist's report. Initially, the radiology report was a private written communication between the radiologist and the referring physician 1,2. Today, the report is an electronic document, displayed on web portals, and visible to both physicians and the patients themselves.3 A provision in the 21st Century Cures Act, signed into law on December 13, 2016, ensures that radiology reports in the electronic health record are visible to patients without delay 4. To meet modern patient expectations and legal requirements, the structure and purpose of the radiologist report is changing. This article will provide an overview of the history of radiology reporting and the law, discuss the role of the radiologist report within the context of patient and family centered care, review current strategies and investigations in patient-friendly reporting, and summarize radiology reporting challenges and opportunities for the future.

Establishing a Public Resource for Acceptable Surrogate Endpoints to Support FDA Marketing Applications.

Following a comprehensive and coordinated effort between CBER and CDER, FDA established a table of acceptable surrogate endpoints (SEs) to support drug marketing applications. The publicly accessible SE Table was first published in 2018 as a response to the 21st Century Cures Act legislation and is updated every 6 months to reflect current FDA thinking. The criteria for the table headings and content were chosen to foster succinctness and consistency, while reflecting the degree of scientific understanding for each listed SE. Prior to the publication of the SE table there was the misconception that FDA only approved drugs based on a limited number of SEs. Contrary to this viewpoint, the SE table demonstrates that FDA frequently uses SEs as they are used in over 100 disease/use and patient population combinations. This article describes the considerations and approach taken when establishing the SE table as well as a discussion of the benefits and limitations of the SE table when used by various stakeholders.

Patient-Friendly Radiology Reporting-Implementation and Outcomes.

OBJECTIVE: To evaluate patient use and experience with patient-centered radiology reports provided via a radiology-specific patient portal in an outpatient setting. METHODS: Patient-centered interactive radiology reports were made available to all patients who had imaging examinations performed at any of seven outpatient imaging centers via a radiology-specific patient portal, using commercially available software. We recorded portal usage statistics including report access rate, report view time, and use of interactive diagrams and plain language explanations. We assessed patients' subjective report comprehension and experience via survey questions. Results were stratified by age. RESULTS: The majority of patients accessed their online radiology report (59%). For patients who used the interactive plain language definitions and diagrams, the average report viewing time was 5.8 ± 6.6 min compared with 1.8 ± 1.9 min for patients viewing only the raw text report (P < .005). The majority (84.7%) of patients reported that the definitions and diagrams helped them understand their report, and 86.7% of patients endorsed an overall positive experience viewing their report online. CONCLUSIONS: Our results suggest that patient-centered radiology reporting is feasible in the outpatient private practice setting and that dedicated patient-centered content has the potential to increase engagement across all age groups. Our experience suggests that patient-centered radiology reports may improve subjective patient comprehension and positively impact the patient experience.

The 21st Century Cures Act and Multiuser Electronic Health Record Access: Potential Pitfalls of Information Release.

Although the Office of The National Coordinator for Health Information Technology's (ONC) Information Blocking Provision in the Cures Act Final Rule is an important step forward in providing patients free and unfettered access to their electronic health information (EHI), in the contexts of multiuser electronic health record (EHR) access and proxy access, concerns on the potential for harm in adolescent care contexts exist. We describe how the provision could erode patients' (both adolescent and older patients alike) trust and willingness to seek care. The rule's preventing harm exception does not apply to situations where the patient is a minor and the health care provider wishes to restrict a parent's or guardian's access to the minor's EHI to avoid violating the minor's confidentiality and potentially harming patient-clinician trust. This may violate previously developed government principles in the design and implementation of EHRs for pediatric care. Creating legally acceptable workarounds by means such as duplicate "shadow charting" will be burdensome (and prohibitive) for health care providers. Under the privacy exception, patients have the opportunity to request information to not be shared; however, depending on institutional practices, providers and patients may have limited awareness of this exception. Notably, the privacy exception states that providers cannot "improperly encourage or induce a patient's request to block information." Fearing being found in violation of the information blocking provisions, providers may feel that they are unable to guide patients navigating the release of their EHI in the multiuser or proxy access setting. ONC should provide more detailed guidance on their website and targeted outreach to providers and their specialty organizations that care for adolescents and other individuals affected by the Cures Act, and researchers should carefully monitor charting habits in these multiuser or proxy access situations.

The use of real-world data in drug repurposing.

Drug repurposing, or repositioning, is to identify new uses for existing drugs. Significantly reducing the costs and time-to-market of a medication, drug repurposing has been an alternative tool to accelerate drug development process. On the other hand, 'real world data (RWD)' has been also increasingly used to support drug development process owing to its better representing actual pattern of drug treatment and outcome in real world. In the healthcare domain, RWD refers to data collected from sources other than traditional clinical trials; for example, in electronic health records or claims and billing data. With the enactment of the 21st Century Cures Act, which encourages the use of RWD in drug development and repurposing as well, such increasing trend in RWD use will be expedited. In this context, this review provides an overview of recent progresses in the area of drug repurposing where RWD was used by firstly introducing the increasing trend and regulatory change in the use of RWD in drug development, secondly reviewing published works using RWD in drug repurposing, classifying them in the repurposing strategy, and lastly addressing limitations and advantages of RWDs.

Open notes sounds great, but will a provider's documentation change? An exploratory study of the effect of open notes on oncology documentation.

OBJECTIVE: The effects of shared clinical notes on patients, care partners, and clinicians ("open notes") were first studied as a demonstration project in 2010. Since then, multiple studies have shown clinicians agree shared progress notes are beneficial to patients, and patients and care partners report benefits from reading notes. To determine if implementing open notes at a hematology/oncology practice changed providers' documentation style, we assessed the length and readability of clinicians' notes before and after open notes implementation at an academic medical center in Boston, MA, USA. MATERIALS AND METHODS: We analyzed 143 888 notes from 60 hematology/oncology clinicians before and after the open notes debut at Beth Israel Deaconess Medical Center, from January 1, 2012 to September 1, 2016. We measured the providers' (medical doctor/nurse practitioner) documentation styles by analyzing character length, the number of addenda, note entry mode (dictated vs typed), and note readability. Measurements used 5 different readability formulas and were assessed on notes written before and after the introduction of open notes on November 25, 2013. RESULTS: After the introduction of open notes, the mean length of progress notes increased from 6174 characters to 6648 characters (P < .001), and the mean character length of the "assessment and plan" (A&P) increased from 1435 characters to 1597 characters (P < .001). The Average Grade Level Readability of progress notes decreased from 11.50 to 11.33, and overall readability improved by 0.17 (P = .01). There were no statistically significant changes in the length or readability of "Initial Notes" or Letters, inter-doctor communication, nor in the modality of the recording of any kind of note. CONCLUSIONS: After the implementation of open notes, progress notes and A&P sections became both longer and easier to read. This suggests clinician documenters may be responding to the perceived pressures of a transparent medical records environment.