Nurse workarounds in the electronic health record: An integrative review.

OBJECTIVE: The study sought to synthesize published literature on direct care nurses' use of workarounds related to the electronic health record. MATERIALS AND METHODS: We conducted an integrative review of qualitative and quantitative peer-reviewed research through a structured search of Academic Search Complete, EBSCO Cumulative Index of Nursing and Allied Health Literature (CINAHL), Embase, Engineering Village, Ovid Medline, Scopus, and Web of Science. We systematically applied exclusion rules at the title, abstract, and full article stages and extracted and synthesized their research methods, workaround classifications, and probable causes from articles meeting inclusion criteria. RESULTS: Our search yielded 5221 results. After removing duplicates and applying rules, 33 results met inclusion criteria. A total of 22 articles used qualitative approaches, 10 used mixed methods, and 1 used quantitative methods. While researchers may classify workarounds differently, they generally fit 1 of 3 broad categories: omission of process steps, steps performed out of sequence, and unauthorized process steps. Each study identified probable causes, which included technology, task, organizational, patient, environmental, and usability factors. CONCLUSIONS: Extensive study of nurse workarounds in acute settings highlights the gap in ambulatory care research. Despite decades of electronic health record development, poor usability remains a key concern for nurses and other members of care team. The widespread use of workarounds by the largest group of healthcare providers subverts quality health care at every level of the healthcare system. Research is needed to explore the gaps in our understanding of and identify strategies to reduce workaround behaviors.

Reconsidering hospital EHR adoption at the dawn of HITECH: implications of the reported 9% adoption of a "basic" EHR.

OBJECTIVE: In 2009, a prominent national report stated that 9% of US hospitals had adopted a "basic" electronic health record (EHR) system. This statistic was widely cited and became a memetic anchor point for EHR adoption at the dawn of HITECH. However, its calculation relies on specific treatment of the data; alternative approaches may have led to a different sense of US hospitals' EHR adoption and different subsequent public policy. MATERIALS AND METHODS: We reanalyzed the 2008 American Heart Association Information Technology supplement and complementary sources to produce a range of estimates of EHR adoption. Estimates included the mean and median number of EHR functionalities adopted, figures derived from an item response theory-based approach, and alternative estimates from the published literature. We then plotted an alternative definition of national progress toward hospital EHR adoption from 2008 to 2018. RESULTS: By 2008, 73% of hospitals had begun the transition to an EHR, and the majority of hospitals had adopted at least 6 of the 10 functionalities of a basic system. In the aggregate, national progress toward basic EHR adoption was 58% complete, and, when accounting for measurement error, we estimate that 30% of hospitals may have adopted a basic EHR. DISCUSSION: The approach used to develop the 9% figure resulted in an estimate at the extreme lower bound of what could be derived from the available data and likely did not reflect hospitals' overall progress in EHR adoption. CONCLUSION: The memetic 9% figure shaped nationwide thinking and policy making about EHR adoption; alternative representations of the data may have led to different policy.

Evaluating people's concern about their health information privacy based on power-responsibility equilibrium model: A case of Taiwan.

To address the issue of rising expenditure of healthcare service and to fulfill the skyrocketing demand for quality healthcare, the electronic medical records (EMR) exchange has become a vital and indispensable solution for healthcare facilities in terms of being able to share medical information among healthcare providers. Hence, EMR exchange was expected to improve the quality of healthcare and reduce the cost of repetitive medical check-ups and unnecessary treatments. However, recent reports affirming EMR data leaks and compromises have ignited major worldwide privacy concerns over the security of the EMR systems. How to effectively diminish patients' concern for EMR privacy has thus become an important issue that healthcare institution managers/stakeholders have to address urgently. This study leverages the power-responsibility equilibrium perspective to investigate the antecedents and consequences of concerns for the EMR exchange. A survey using 391 responses collected from medical centers, regional and district hospitals in Taiwan was used to conduct this study. The results show that government regulations have a positive effect on hospital privacy policies. Furthermore, both government regulations and hospital privacy policy are negatively associated with concern for EMR information privacy. Additional reports gathered from this study also showed that concern for EMR information privacy could result in patients' protective responses including refusal to provide personal health information (PHI), removal of PHI, negative word of mouth, complaining directly to the hospital, or complaining indirectly to third-party organizations. These findings demonstrate the need for healthcare facilities to formulate robust privacy policies in order to alleviate patients' concern for EMR information privacy based on governmental regulations. This regulation is top-priority as the incapability of reducing patients' concern for EMR information privacy may lead to the collapse of the campaign for the full-adoption of EMR or possibly jeopardize the promotion and application of EMR among healthcare facilities.

Electronic health records and protection of sensitive personal data in Brazil / Historiales médicos electrónicos y protección de datos personales sensibles en Brasil

On December 27, 2018, Law No. 13,787 was enacted in Brazil, regulating the electronic health record and establishing rules for its digitization and use. While already in force, the new Law refers to the General Data Protection Law - LGPD (Law No. 13,709 of August, 14, 2018, as amended by Law No. 13,853 of July 08, 2019), which will only come into effect in August 2020. In analyzing the documentary dimension of the right to health in the Brazilian regulation, this text proposes to analyze two issues: Could the electronic health record mean risk of leakage or misuse of patients' data in violation of their rights of personality? If the information is online, how could it be prevented from being accessed out of clinical objectives thus constituting a violation of the patient's personality rights?

El 27 de diciembre de 2018 se promulgó en Brasil la Ley Núm. 13.787, que regula la historia clínica electrónica y establece normas para su digitalización y uso. Si bien ya está vigente, la nueva Ley se refiere a la Ley General de Protección de Datos - LGPD (Ley Núm. 13.709 de 14 de agosto de 2018, modificada por la Ley Núm. 13.853 del 8 de julio de 2019), que sólo entrará en vigor en agosto de 2020. Al analizar la dimensión documental del derecho a la salud en la regulación brasileña, este trabajo propone analizar dos cuestiones: ¿Podría el historial médico electrónico significar un riesgo de uso indebido de los datos de los pacientes en violación de sus derechos de personalidad? Si la información está en línea, ¿cómo se puede evitar que se acceda a ella desde objetivos clínicos, lo que constituye una violación de los derechos de la personalidad del paciente?

California Takes the Lead on Data Privacy Law.

In the early 1970s, Congress considered enacting comprehensive privacy legislation, but it was unable to do so. In 1974, it passed the Privacy Act, applicable only to information in the possession of the federal government. In the intervening years, other information privacy laws enacted by Congress, such as the Health Insurance Portability and Accountability Act, have been weak and sector specific. With the explosion of information technology and the growing concerns about an absence of effective federal privacy laws, the legal focus has shifted to the states. Signaling a new direction in state data privacy and consumer protection law, the California Consumer Privacy Act establishes important rights and protections for California residents with regard to the collection, use, disclosure, and sale of their personal information. The CCPA is certain to spur similar legislation and to affect national and international businesses that collect data from California's residents. Understanding the new law is important for all data-driven industries, including health care.

Investigación, salud pública y asistencia sanitaria en el Reglamento General de Protección de Datos de la Unión Europea y en la Ley Orgánica de Protección de Datos Personales y Garantía de los Derechos Digitales / Research, public health and healthcare in the General Data Protection Regulation of the European Union and in the Fundamental Law of Personal Data Protection and Guarantee of Digital Rights

Este trabajo analiza las consecuencias que tiene el inicio de la aplicación del RGPD y la aprobación de la LOPDGDD en la investigación biomédica, la salud pública y la asistencia sanitaria. Aborda el objetivo y el ámbito de aplicación del RGPD, la disociación y la seudonimización y su relevancia en la investigación y la salud pública. También examina la incorporación de los datos biométricos y de los datos genéticos dentro de las categorías especiales de datos personales y la definición que hace el RGPD de los datos de salud. Asimismo, analiza los supuestos de legitimación del tratamiento de categorías especiales de datos personales para asistencia sanitaria, la salud pública y la investigación en salud. Finalmente estudia las previsiones de la disposición adicional decimoséptima de la LOPDGDD que facilita la investigación sanitaria

This paper analyzes the consequences of the beginning of the application of the GDPR and the approval of the LOPDGDD in biomedical research, public health and health care. It addresses the objective and scope of the GDPR, decoupling and pseudonymisation and their relevance to research and public health. It also examines the incorporation of biometric data and genetic data within the special categories of personal data and the GDPR definition of health data. It also analyses the legitimisation of the processing of special categories of personal data for health care, public health and health research. Finally, it studies the requirements of the seventeenth additional provision of the LOPDGDD that facilitates health research

[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.

Return of experience on the initial audit of Cofrac and projects for the release of results of emergency biological tests.

Legislation and ISO 15189 international standard provide that the clinical laboratories shall organize the communication of the biological assay results, especially with the establishment of a list of critical assays, whose results shall be reported during doctor's on call period but also through restricting result transmission to biologically validated results. Actually continuous validation and immediate procession of the medical records belonging to patients in emergency situation are not always possible, because of the biologist's workload and the other activities he is responsible for. Based on the modified version of SH REF 04, we intend to export on the servers the results of critical assays during both the day time and doctor's on call period, as they are validated by the authorized technician, under the responsibility of the biologist in charge of validation. With this project, it will be possible at the same time to respond to the clinical requirements, and, for the biologist, to perform all his functions that are important to ensure the smooth running and the development of the laboratory.

Are informed policies in place to promote safe and usable EHRs? A cross-industry comparison.

OBJECTIVE: Despite federal policies put in place by the Office of the National Coordinator (ONC) to promote safe and usable electronic health record (EHR) products, the usability of EHRs continues to frustrate providers and have patient safety implications. This study sought to compare government policies on usability and safety, and methods of examining compliance to those policies, across 3 federal agencies: the ONC and EHRs, the Federal Aviation Administration (FAA) and avionics, and the Food and Drug Administration (FDA) and medical devices. Our goal was to identify whether differences in policies exist and, if they do exist, how policies and enforcement mechanisms from other industries might be applied to optimize EHR usability. METHOD: We performed a qualitative study using publicly available governing documents to examine similarities and differences in usability and safety policies across agencies. RESULTS: The policy review and analysis revealed several consistencies within each agency's usability policies. Critical differences emerged in the usability standards and policy enforcement mechanisms utilized by the 3 agencies. The FAA and FDA look at evidence of usability processes and are more prescriptive when it comes to testing final products as compared to the ONC, which relies on attestation and is less prescriptive. DISCUSSION: A comparison of usability policies across industries illustrates key differences between the ONC and other federal agencies. These differences could be contributing to the usability challenges associated with EHRs. CONCLUSION: Our analysis highlights important areas of usability and safety policy from other industries that can better inform ONC policies on EHRs.