Importance Although federal law has long promoted patients’ access to their protected health information, this access remains limited. Previous studies have demonstrated some issues in requesting release of medical records, but, to date, there has been no comprehensive review of the challenges that exist in all aspects of the request process. Objective To evaluate the current state of medical records request processes of US hospitals in terms of compliance with federal and state regulations and ease of patient access. Design, Setting, and Participants A cross-sectional study of medical records request processes was conducted between August 1 and December 7, 2017, in 83 top-ranked US hospitals with independent medical records request processes and medical records departments reachable by telephone. Hospitals were ranked as the top 20 hospitals for each of the 16 adult specialties in the 2016-2017 US News & World Report Best Hospitals National Rankings. Exposures Scripted interview with medical records departments in a single-blind, simulated patient experience. Main Outcomes and Measures Requestable information (entire medical record, laboratory test results, medical history and results of physical examination, discharge summaries, consultation reports, physician orders, and other), formats of release (pick up in person, mail, fax, email, CD, and online patient portal), costs, and request processing times, identified on medical records release authorization forms and through telephone calls with medical records departments. Results Among the 83 top-ranked US hospitals representing 29 states, there was discordance between information provided on authorization forms and that obtained from the simulated patient telephone calls in terms of requestable information, formats of release, and costs. On the forms, as few as 9 hospitals (11%) provided the option of selecting 1 of the categories of information and only 44 hospitals (53%) provided patients the option to acquire the entire medical record. On telephone calls, all 83 hospitals stated that they were able to release entire medical records to patients. There were discrepancies in information given in telephone calls vs on the forms between the formats hospitals stated that they could use to release information (69 [83%] vs 40 [48%] for pick up in person, 20 [24%] vs 14 [17%] for fax, 39 [47%] vs 27 [33%] for email, 55 [66%] vs 35 [42%] for CD, and 21 [25%] vs 33 [40%] for online patient portals), additionally demonstrating noncompliance with federal regulations in refusing to provide records in the format requested by the patient. There were 48 hospitals that had costs of release (as much as $541.50 for a 200-page record) above the federal recommendation of $6.50 for electronically maintained records. At least 6 of the hospitals (7%) were noncompliant with state requirements for pr...
While federal regulation provides patients the right to access their electronic health records and promotes increased use of health information technology, patient access to electronic health records remains limited. The 21st Century Cures Act, signed into law over a year ago, has important provisions that could significantly improve access and availability of health data. Specifically, the provisions call for partnerships among health information exchange networks, educational and research initiatives, and health information technology certification requirements that encourage interoperability. The article reviews the potential benefits and concerns regarding implementation of these provisions, particularly the difficulty of aligning incentives and requirements for data sharing and the question of whether currently proposed rules and guidance will support the goal of improved patient access and health information exchange. Researchers, clinicians, and patients have the power to advocate for improved patient access and interoperability as policy development and implementation of the 21st Century Cures Act continues.
On March 28, 2020, the US Food and Drug Administration (FDA) issued an emergency use authorization (EUA) for the use of hydroxychloroquine and chloroquine for certain hospitalized patients diagnosed with coronavirus disease 2019 (COVID-19). 1 Hydroxychloroquine and chloroquine have long been approved for the prophylaxis and treatment of malaria, with the former also used in the treatment of systemic lupus erythematosus and rheumatoid arthritis. Although these drugs appear to inhibit coronavirus replication in vitro, at the time of the EUA, there was no reliable clinical evidence to support the use of these drugs to treat COVID-19 in patients.An EUA is an authorization for the use of unapproved medical products or unapproved uses of approved medical products during a public health emergency. The FDA Commissioner has the authority to issue EUAs after the Secretary of Health and Human Services declares a public health emergency. The EUA can only be issued for "serious or life-threatening" 2 conditions for which there are no alternative treatments available. The criteria require that "it is reasonable to believe that the product may be effective" given "the totality of scientific evidence" and that the "known and potential benefits…outweigh the known and potential risks of the product." 2 As of April 30, 2020, the FDA had issued 174 EUAs, of which 143 (82.2%) have been for diagnostic tests for disease outbreaks that have affected the US. Only 4 EUAs (2.3%) had been issued for therapeutics: separate EUAs each for oseltamivir, zanamivir, and peramivir for the treatment of the 2009 influenza A(H1N1), and an EUA for hydroxychloroquine and chloroquine (issued in the same EUA) for COVID-19.During the influenza A(H1N1) pandemic, all patients who were diagnosed early and were tested for susceptibility to existing influenza treatments showed susceptibility to oseltamivir and zanamivir. These medicines were approved for the treatment of influenza A (of which H1N1 is a subtype). They had promising susceptibility testing and established safety profiles. Coupled with a need to treat seriously ill patients, oseltamivir (an oral formulation) and zanamivir (an inhaled formulation) were authorized under EUAs for more expansive use outside their approved indications.Investigations of new, unapproved therapies for the treatment of influenza A(H1N1) continued given the need for an intravenous treatment for severely ill patients and increasing antiviral resistance. Peramivir emerged as a potential therapeutic with encouraging results. A phase 1 study demonstrated few safety concerns with peramivir. The FDA also evaluated 3 phase 2 and phase 3 trials VIEWPOINT
Because of the establishment of the patients' right of access under the Health Insurance Portability and Accountability Act, patients have the right to access all information that is included in their designated record set, including imaging studies such as radiography and CT (1). Although federal regulations and policies have focused broadly on improving patient access to their medical information (2-4), there has been little emphasis on access to imaging studies, not merely radiology reports, despite studies that indicate patients prefer to view imaging studies in addition to receiving written radiology results (5-7).Previous studies (8,9) highlighted issues of noncompliance with federal regulation and barriers to access in the general medical records request process. We sought to assess the request process specifically for imaging studies to investigate whether similar barriers exist. Requests for imaging studies are subject to the same laws as requests for other portions of the medical record, in that requests must be fulfilled within 30 days of receipt, in the format requested by the patient if readily producible in that format, with health care providers permitted to impose a reasonable cost-based fee (1). To evaluate U.S. hospital compliance with federal regulations and patient ease of access to imaging studies, our study focused on assessing formats of release, costs of release, processing times, and, more generally, challenges to how patients request imaging studies in a subset of top-ranked U.S. hospitals through a simulated patient experience. Materials and MethodsThis cross-sectional study, conducted between June 6 and December 3, 2018, was approved by the institutional review board as a not human research protocol at Yale University. The requirement of written informed consent was waived for this study.
scite is a Brooklyn-based organization that helps researchers better discover and understand research articles through Smart Citations–citations that display the context of the citation and describe whether the article provides supporting or contrasting evidence. scite is used by students and researchers from around the world and is funded in part by the National Science Foundation and the National Institute on Drug Abuse of the National Institutes of Health.
hi@scite.ai
10624 S. Eastern Ave., Ste. A-614
Henderson, NV 89052, USA
Copyright © 2024 scite LLC. All rights reserved.
Made with 💙 for researchers
Part of the Research Solutions Family.