OBJECTIVE: To support ambulatory care innovation, we created Observer, a multimodal dataset comprising videotaped outpatient visits, electronic health record (EHR) data, and structured surveys. This paper describes the data collection procedures and summarizes the clinical and contextual features of the dataset. MATERIALS AND METHODS: A multistakeholder steering group shaped recruitment strategies, survey design, and privacy-preserving design. Consented patients and primary care providers (PCPs) were recorded using room-view and egocentric cameras. EHR data, metadata, and audit logs were also captured. A custom de-identification pipeline, combining transcript redaction, voice masking, and facial blurring, ensured video and EHR HIPAA compliance. RESULTS: We report on the first 100 visits in this continually growing dataset. Thirteen PCPs from 4 clinics participated. Recording the first 100 visits required approaching 210 patients, from which 129 consented (61%), with 29 patients missing their scheduled encounter after consenting. Visit lengths ranged from 5 to 100 minutes, covering preventive care to chronic disease management. Survey responses revealed high satisfaction: 4.24/5 (patients) and 3.94/5 (PCPs). Visit experience was unaffected by the presence of video recording technology. DISCUSSION: We demonstrate the feasibility of capturing rich, real-world primary care interactions using scalable, privacy-sensitive methods. Room layout and camera placement were key influences on recorded communication and are now added to the dataset. The Observer dataset enables future clinical AI research/development, communication studies, and informatics education among public and private user groups. CONCLUSION: Observer is a new, shareable, real-world clinic encounter research and teaching resource with a representative sample of adult primary care data.

OBJECTIVES: We report on findings from a meeting convened by the American College of Medical Informatics (ACMI) to characterize aspects of the patient experience that could be improved using informatics. MATERIALS AND METHODS: The American College of Medical Informatics fellows were invited to share their experiences as patients and suggest informatics approaches that may improve the patient experience. RESULTS: We identified 4 themes: (1) getting the right care, (2) data sharing and data interoperability, (3) guiding low-cost evaluations, and (4) predictive analytics. DISCUSSION: Despite widespread adoption of health IT, patient experiences remain far from optimal. CONCLUSION: The American College of Medical Informatics fellows identified informatics approaches, applications, and research areas that have the potential to improve patient experiences with health care systems.

I very much appreciated the article by Bapna, Miller, and Ratwani, “Electronic health record ‘gag clauses’ and the prevalence of screenshots in peer-reviewed literature.”1 It was insightful and useful to look at the use of screenshots before and after the Office of the National Coordinator of Healthcare IT (ONC) sought to restrict the non-disclosure clauses in Electronic Healthcare Records (EHR) vendor contracts—vendor contract clauses that prevented medical informaticists from including EHR screenshots that showed poor usability and even harm to patients. However, the article misses 2 critical points: First, although Bapna et al are of course right that the ONC ruled against including the non-disclosure clauses in 2020, they should have noted that 2 IOM reports and our own AMIA task force called for the elimination of those clauses within years of the our exposing those clauses in 2009.2 Thus, the push to remove those clauses started in 2009, long before 2022.

A discussion and debate on the American Medical Informatics Association's (AMIA) Ethical, Legal, and Social Issues (ELSI) Working Group listserv in 2021 raised important issues related to a forthcoming conference in Texas. Texas had recently enacted a restrictive abortion law and restricted voting rights. Several AMIA members advocated for a boycott of the state and the scheduled conference. The discussion led the AMIA Board of Directors to request that the organization's Ethics Committee provide general guidance for principle-based venue selection. This document recommends overarching principles for the venue selection for future AMIA events and conferences. Discussions by the AMIA Board, the Ethics Committee, and the ELSI Working Group informed these recommendations, and this document on guiding principles was approved by the AMIA Board of Directors in April 2022.

AMIA has a longstanding interest and a professional obligation to promote a strong ethical framework for its members and the field of biomedical and health informatics. This white paper presents the latest AMIA Code of Professional and Ethical Conduct. The original code was approved in 20071 by the AMIA Board of Directors and revised in 2013.2 Recognizing the need to regularly update the Code to ensure that it remains current and relevant, we present this document that constitutes a revision of and update to the third version, approved and published in the Journal of the American Medical Informatics Association in 2018.3 The code presented here remains an evolving document, with modifications expected as information technology, informatics, policy, and health care environments change over time. AMIA publishes on its web site the most recent version of the Code of Ethics as part of a process that seeks ongoing response from and involvement by AMIA members. Because the Code of Professional and Ethical Conduct (from now on “Code of Ethics”) is meant to be practical, applicable in real life, and easily understood, it is compact and uses general language. The AMIA Code of Ethics is not intended to be prescriptive or legislative; it is aspirational and extends beyond regulatory and legal obligations to provide the broad strokes of a set of important ethical principles pertinent to the field of biomedical and health informatics. The Code is organized around the common roles of AMIA members and the constituents they serve including patients, caregivers, colleagues and collaborators, clinicians, researchers, students, agencies, hospitals and practices, medical organizations, vendors, insurance companies, and others with whom they interact. The AMIA Board of Directors and the AMIA Ethics Committee encourage members to offer suggestions for improvements and changes. In this way, the Code will continue to evolve to best serve AMIA and the larger informatics community. AMIA members are professionally diverse,4,5 and include those who are, or are in training to be nurses, physicians, pharmacists, dentists, informaticians, computer scientists, analysts, implementation scientists, and other professionals. In many cases, these professions have their own codes of ethics.6–13 The International Medical Informatics Association, an international federation for which AMIA serves as the US membership organization, also has a revised “Code of Ethics for Health Information Professionals”.14 The AMIA Code of Ethics incorporates issues covered by other documents bearing on ethics and professional conduct: AMIA’s support for and efforts to incorporate and execute upon diversity, equity, inclusion, and accessibility goals and objectives throughout the organization.15 AMIA’s revised “Conflict of Interest Policy”, which governs the organization’s employees and leaders with regard to some of their financial and other interactions with outside entities.16 AMIA’s principles for selecting venues for conferences and other events, which affirm AMIA’s commitment to applying ethical principles and ensuring basic human rights when planning association events.17 AMIA’s “Meeting Anti-Harassment Policy”, which describes AMIA’s commitment to providing an atmosphere that is safe and welcoming to all members and supports learning and professional growth.18 AMIA’s principles for artificial intelligence (AI)19 and position on the appropriate development, use, and maintenance of adaptive clinical decision support.20 Members of the Ethics Committee are unanimous in their view that those who work in informatics, much as in other health professions, are duty-bound to embrace a patient-centered approach to their work, even if that work does not involve direct patient care or research involving human participants. As elsewhere in the health professions, vulnerable populations, historically and intentionally excluded/disinvested groups, and people with disabilities may reasonably expect additional considerations and support. The importance of professionalism and ethics has been recognized for millennia by health professionals and organizations,21 now including informaticians and information technology professionals. This code of ethics emphasizes AMIA’s commitment to adhere to and promote the highest standard of ethical and professional behavior. AMIA members acknowledge as their professional duty to uphold the following principles of and guidelines for ethical conduct. AMIA members are expected to know how to seek the advice of institutional ethics committees, AMIA’s Ethics Committee, or appropriate institutional review boards, as necessary. The following details address patient care, interactions with colleagues, responsibilities to employers, and roles regarding society and research. I. Key ethical guidelines regarding patients, guardians, and their authorized representatives (called here collectively “patients”) AMIA members involved in patient care should: Recognize that patients and their loved ones and caregivers have the right to know about the existence and use of electronic records containing their personal health and healthcare information, to access these records as written, and have the right to create and maintain their own personal health records and manage personal health information using a variety of platforms including mobile devices. In this context AMIA members should: Not mislead patients about the collection, use, or communication of their health information. Educate—when requested and within reason and the scope of their position—patients on the type, amount, and use of health information collected. Enable and—as appropriate, within reason and the scope of their position and in accord with independent ethical and legal standards—facilitate patients’ rights and ability to access, review, and correct their electronic health information, including clinicians’ notes. Recognize that patient-provided/generated health data, such as those collected on mobile devices and wearable devices, deserve the same diligence and protection as biomedical and health data gathered in the process of providing health care. Ensure that patients and their care team members are made aware of the role and use of AI and other complex automated tools that are not clearly apparent when such systems are involved in medical decision-making or care planning.19,20 Advocate and work as appropriate to ensure that protected health information (PHI),22 personally identifiable information (PII), and other biomedical data are acquired, recorded, stored, maintained, analyzed, transmitted, and communicated in an appropriately safe, reliable, secure, and confidential manner, and that such data management is consistent with applicable laws, local privacy and security policies, and accepted informatics standards. Never knowingly disclose PHI, PII, or biomedical or health data in violation of legal requirements or accepted local confidentiality practices, or in ways that are inconsistent with the explanation of data disclosure and use to the patient.23 AMIA members should understand that inappropriate disclosure of biomedical information can cause harm, and so should work to prevent such disclosures. AMIA members should avoid acquiring data through means that run the risk of, or fail to prevent, inappropriate disclosure. AMIA members should not accept, use, disseminate, or store data that they are aware were obtained in violation of applicable laws. Likewise, even if an action does not involve disclosure, one should not use or reuse—or through negligence permit the use of—patient information and data in ways inconsistent with the stated purposes, goals, or intentions of the patient or organization responsible for these data, except as appropriate for public health, previously approved and communicated research uses, quality improvement, or reporting as required under the law. Engage with patients, guardians, and their authorized representatives so as to support inclusion, promote equity, advance accessibility, and avoid bias and discrimination. II. Key ethical guidelines regarding colleagues AMIA members should: Endeavor, as appropriate, to support and foster colleagues’ and/or team members and their work, in a timely, respectful, and conscientious way to support their roles in healthcare and/or research and education. Support and foster the efforts of patients to be actively involved in the collection, management, and curation of their health data. Advise colleagues and others, as appropriate, about actual or potential information or systems issues (including system flaws, defects, usability or performance issues, etc.) that negatively affect patient safety, privacy, data security, or health outcomes or could hinder colleagues’ abilities to delegate responsibilities to patients, other colleagues, involved institutions, or other stakeholders. Actively support the inclusion of all professional colleagues and promote a diverse and inclusive environment in which all individuals have equitable access to resources, educational opportunities, and opportunities for professional advancement.15 An AMIA member in any leadership position should: Be familiar with these guidelines and their applicability to their practice, unit, or organization. Communicate as appropriate about these ethical guidelines to those they lead. Strive to promote familiarity with, and use of, these ethical guidelines. Use AMIA position statements to guide organizational decision-making with regard to diversity, equity, inclusion, and accessibility initiatives,15 including selection of event locations.17 Promote transparent and equitable decision-making among AMIA professional staff, volunteer member leaders, and others with whom they engage. Never allow personal political views or ideological stances to interfere with or impede their ability to represent AMIA and advocate for it. AMIA leaders who may pose a reputational liability to the organization due to criminal convictions should declare this information and be prepared to stand down from leadership positions. Members who may pose a reputational liability should recuse themselves from leadership positions. III. Key ethical guidelines regarding institutions, employers, business partners, and clients (called here collectively “employers”) AMIA members should: Understand their duties and obligations to current and former employers and fulfill them to the best of their abilities within the bounds of ethical and legal norms. Understand and appreciate that employers have legal and ethical rights and obligations, including those related to intellectual property. Understand and respect the obligations of their employers and comply with local policies and procedures to the extent that they do not violate ethical and legal norms. Consider the tradeoffs that occur with the configuration and use of technologies (eg, decision support systems) before implementation, and monitor, measure, and manage results when the optimal approach is unclear. Inform the employer and act in accordance with ethical-legal mandates and patient rights when employer actions, policies, or procedures would violate actual or understood ethical or legal obligations, contracts, or other agreements made with patients. Maintain a safe and high-quality environment even while implementing innovation, recognizing that all changes in a complex adaptive environment generate unanticipated consequences and potential harm. IV. Key ethical guidelines regarding society and regarding research AMIA members involved in research should: Be aware of the Declaration of Helsinki (Ethical Principles for Medical Research Involving Human Subjects), the Nuremberg Report, and the Belmont Report, which should guide all human subjects research, including research that involves users of informatics tools and interventions as participants (eg, workflow analysis studies, evaluation of clinical decision support systems, patient care innovations, analysis, etc.).24–27 Recognize that duty and care to individuals such as patients and colleagues exist regardless of whether such responsibilities are acknowledged by institutional review boards, vendors, and others involved in informatics activities. Be mindful and respectful of the social or public health implications of their work, ensuring that the greatest good for society is balanced by ethical obligations to individual patients. Uphold standards for publication and authorship, including the International Committee of Medical Journal Editors’ “Recommendations for the Conduct, Reporting, Editing, and Publication of Scholarly Work in Medical Journals.”28 These recommendations are paralleled by the editorial policies for the past29 and current30 publishers of the Journal of the American Medical Informatics Association, as well as the publisher of Applied Clinical Informatics31 and their open access companion journals. Such efforts include, but are not limited to, avoiding any plagiarism or self-plagiarism or other misrepresentations of the truth in the publication of research and other work. Disseminate new knowledge—both positive and negative findings—expeditiously, to allow the field to advance and to permit others to take advantage of novel discoveries and understanding to improve patient care. Strive, as appropriate, in the context of one’s position to foster the generation of knowledge and biomedical advances through appropriate support for ethical and institutionally approved research efforts facilitated through informed consent and robust data governance, including disclosure processes and procedures, particularly when third-party entities not meeting the definition of business associates are involved. Know and abide by the applicable governmental regulations and institutional policies that define ethical research in their professional environment. V. General professional and ethical guidelines AMIA members should: Maintain competence as informatics professionals: Obtain applicable continuing education and be dedicated to a culture of lifelong learning and self-improvement. Recognize technical and ethical limitations and seek consultation when needed, particularly in ethically conflicting situations. Contribute to the education and mentoring of students, early-career members, and others, as appropriate. Promote a culture of diversity, equity, inclusion, and accessibility in their work and professional conduct. Strive to encourage the adoption of informatics approaches supported by adequate evidence to improve health and healthcare; and to encourage and support efforts to improve the amount and quality of such evidence. Treat all individuals with respect and not discriminate against anyone based on age, race, ethnicity, gender identity, disability (visible or invisible), national origin, sexual orientation, religion, or residency status. Be mindful that their work and actions reflect on the profession and on AMIA. The Code’s authors are aware that all professionals will, from time to time, find themselves in situations shaped by what has been called “dual agency” or “multiple agency”. In these circumstances, a professional encounters conflicting commitments, duties, or loyalties. An informatics professional may have conflicting duties to patients, to colleagues, to society, and to an employer. No code of ethics can resolve contradictions, but a well-crafted code may enable priorities to be set down explicitly and so provide a guide to action. In addition to this Code of Ethics, the AMIA’s Ethics Committee and its Conflict of Interest Panel are primary resources for members who find themselves in ethically unclear or challenging situations. For scholarship and education related to ethical issues in the broader field of medical information, the AMIA Ethical, Legal, and Social Issues (ELSI) Working Group serves as a community forum for members. As a matter of personal and professional integrity, adherence to the principles laid out here is expected of all who have the privilege of serving in the field of biomedical and health informatics. Those whose skills allow them to contribute in one way or another to the health of individuals and populations carry important responsibilities. This code of ethics provides guidance about how informaticians may best do so. All authors participated in the revision, review, and approval of this manuscript. Because this work is a revision of AMIA’s Code of Professional and Ethical Conduct 2018, no author can be considered to be responsible for the conception or design of the work. The authors and the AMIA Ethics Committee would like to thank the AMIA Board of Directors for its continuing interest in refining and publishing these guidelines. Phyllis Burchman, AMIA’s former Director of Office Operations and Human Resources, long provided invaluable support to the Ethics Committee in its work. Members of the AMIA Ethics Committee who contributed to the third version of the code in 2018 and are not otherwise listed here include Peter Embi, Harold Lehmann, Sarah A. Maulden, Kyle A. McGregor, and Enrique Terrazas. This version of the code also owes much to the members of AMIA’s Ethical, Legal, and Social Issues (ELSI) Working Group. None declared.

Clinicians often attribute much of their burnout experience to use of the electronic health record, the adoption of which was greatly accelerated by the Health Information Technology for Economic and Clinical Health Act of 2009. That same year, AMIA's Policy Meeting focused on possible unintended consequences associated with rapid implementation of electronic health records, generating 17 potential consequences and 15 recommendations to address them. At the 2020 annual meeting of the American College of Medical Informatics (ACMI), ACMI fellows participated in a modified Delphi process to assess the accuracy of the 2009 predictions and the response to the recommendations. Among the findings, the fellows concluded that the degree of clinician burnout and its contributing factors, such as increased documentation requirements, were significantly underestimated. Conversely, problems related to identify theft and fraud were overestimated. Only 3 of the 15 recommendations were adjudged more than half-addressed.

The COVID-19 pandemic response in the United States has exposed significant gaps in information systems and processes that prevent timely clinical and public health decision-making. Specifically, the use of informatics to mitigate the spread of SARS-CoV-2, support COVID-19 care delivery, and accelerate knowledge discovery bring to the forefront issues of privacy, surveillance, limits of state powers, and interoperability between public health and clinical information systems. Using a consensus-building process, we critically analyze informatics-related ethical issues in light of the pandemic across 3 themes: (1) public health reporting and data sharing, (2) contact tracing and tracking, and (3) clinical scoring tools for critical care. We provide context and rationale for ethical considerations and recommendations that are actionable during the pandemic and conclude with recommendations calling for longer-term, broader change (beyond the pandemic) for public health organization and policy reform.

Individual and organizational computer security rests on how people interpret and use the security information they are presented. One challenge is determining whether a given URL is safe or not. This paper explores the visual behaviors that users employ to gauge URL safety. We conducted a user study on 20 participants wherein participants classified URLs as safe or unsafe while wearing an eye tracker that recorded eye gaze (where they look) and pupil dilation (a proxy for cognitive effort). Among other things, our findings suggest that: users have a cap on the amount of cognitive resources they are willing to expend on vetting a URL; they tend to believe that the presence of www in the domain name indicates that the URL is safe; and they do not carefully parse the URL beyond what they perceive as the domain name.

OBJECTIVE: Physician burnout associated with EHRs is a major concern in health care. A comprehensive assessment of differences among physicians in the areas of EHR performance, efficiency, and satisfaction has not been conducted. The study sought to study relationships among physicians' performance, efficiency, perceived workload, satisfaction, and usability in using the electronic health record (EHR) with comparisons by age, gender, professional role, and years of experience with the EHR. MATERIALS AND METHODS: Mixed-methods assessments of the medical intensivists' EHR use and perceptions. Using simulated cases, we employed standardized scales, performance measures, and extensive interviews. NASA Task Load Index (TLX), System Usability Scale (SUS), and Questionnaire on User Interface Satisfaction surveys were deployed. RESULTS: The study enrolled 25 intensive care unit (ICU) physicians (11 residents, 9 fellows, 5 attendings); 12 (48%) were men, with a mean age of 33 (range, 28-55) years and a mean of 4 (interquartile range, 2.0-5.5) years of Epic experience. Overall task performance scores were similar for men (90% ± 9.3%) and women (92% ± 4.4%), with no statistically significant differences (P = .374). However, female physicians demonstrated higher efficiency in completion time (difference = 7.1 minutes; P = .207) and mouse clicks (difference = 54; P = .13). Overall, men reported significantly higher perceived EHR workload stress compared with women (difference = 17.5; P < .001). Men reported significantly higher levels of frustration with the EHR compared with women (difference = 33.15; P < .001). Women reported significantly higher satisfaction with the ease of use of the EHR interface than men (difference = 0.66; P =.03). The women's perceived overall usability of the EHR is marginally higher than that of the men (difference = 10.31; P =.06). CONCLUSIONS: Among ICU physicians, we measured significant gender-based differences in perceived EHR workload stress, satisfaction, and usability-corresponding to objective patterns in EHR efficiency. Understanding the reasons for these differences may help reduce burnout and guide improvements to physician performance, efficiency, and satisfaction with EHR use. DESIGN: Mixed-methods assessments of the medical intensivists' EHR use and perceptions. Using simulated cases, we employed standardized scales, performance measures, and extensive interviews.

AMIA has a longstanding interest in and a professional obligation to promote a strong ethical framework for the field of biomedical and health informatics. This white paper presents the latest AMIA Code of Professional and Ethical Conduct. The original Code was approved in 20071 by the AMIA Board of Directors. Recognizing the need to update the Code to ensure that it remains current and relevant, this document constitutes a revision of and update to the second code, approved in 2012 and published in the Journal of the American Medical Informatics Association in 2013.2 The code presented here remains an evolving document, with modifications expected as the information technology, informatics, and healthcare environments change over time. AMIA will publish on its web site the most recent version of the Code of Ethics as part of a process that seeks ongoing response from and involvement by AMIA members. Because the Code is meant to be practical, applicable in real life, and easily understood, it is compact and uses general language. The AMIA Code of Ethics is not intended to be prescriptive or legislative; it is aspirational and extends beyond regulatory and legal obligations to provide the broad strokes of a set of important ethical principles pertinent to the field of biomedical and health informatics. The Code is organized around the common roles of AMIA members and the constituents they serve, including patients, caregivers, clinicians, researchers, students, agencies, hospitals and practices, medical organizations, vendors, insurance companies, and others with whom they interact. The AMIA Board and the AMIA Ethics Committee encourage members to offer suggestions for improvements and changes. In this way, the Code will continue to evolve to best serve AMIA and the larger informatics community. The Code’s authors are aware that all professionals will, from time to time, find themselves in situations shaped by what has been called “dual agency” or “multiple agency.” In these circumstances, a professional encounters conflicting commitments, duties, or loyalties. An informatics professional may have conflicting duties to patients, to colleagues, to society, and to an employer. Few, if any, codes of ethics are nimble enough to provide guidance in such situations. Further, AMIA’s Ethics Committee is a resource to members who find themselves in ethically unclear or challenging situations. AMIA members may contact the AMIA Ethics Committee, which can provide guidance in some circumstances. AMIA members are professionally diverse,3,4 and include those who are, or are in training to be, nurses, physicians, pharmacists, dentists, informaticians, computer scientists, and others. In many cases, these professions have their own codes of ethics.5–12 The International Medical Informatics Association, an international federation for which AMIA serves as the U.S. membership organization, also has a revised “Code of Ethics for Health Information Professionals.”13 This document incorporates issues covered by other documents and laws bearing on ethics and professional conduct: AMIA’s “Conflict of Interest Policy,” which governs the organization’s employees and leaders in regard to some of their financial and other interactions with outside entities.14 AMIA’s “Meeting Anti-Harassment Policy,” which describes AMIA’s commitment to providing an atmosphere that is welcoming to all members and supports learning and professional growth.15 The International Committee of Medical Journal Editors’ “Recommendations for the Conduct, Reporting, Editing, and Publication of Scholarly Work in Medical Journals.”16 This document is widely accepted as identifying standards for publication and authorship, and is paralleled by the editorial policies for the past17 and current18 publishers of the Journal of the American Medical Informatics Association, as well as the publisher of Applied Clinical Informatics.19 Privacy laws. Several sections herein address patient privacy or the rights of patients to view and control access to their health information. These sections are intended to parallel and make explicit duties under the law. In the United States, for instance, the Privacy Rule under the Health Insurance Portability and Accountability Act20 lays out many duties for those who are entrusted with health information. Many other countries have similar laws to protect patient data. Informatics professionals are expected to be familiar with and follow the laws governing their practice. Members of the Ethics Committee are unanimous in their view that those who work in informatics, much as in other health professions, are duty-bound to embrace a patient-centered approach to their work, even if that work does not involve direct patient care or human subjects research. As elsewhere in the health professions, vulnerable populations or those with special needs may be entitled to additional considerations. The importance of professionalism and ethics has been recognized for millennia by health professionals and organizations,21 now including information technology professionals. This code of ethics emphasizes AMIA’s commitment to adhere to and promote the highest standard of ethical and professional behavior. AMIA members acknowledge as their professional duty to uphold the following principles of and guidelines for ethical conduct. AMIA members are expected to know to seek the advice of institutional ethics committees, AMIA’s Ethics Committee, or appropriate institutional review boards, as necessary. The following code details address patient care, interactions with colleagues, responsibilities to employers, and roles regarding society and research. I. Key ethical guidelines regarding patients, guardians, and their authorized representatives (called here collectively “patients”) AMIA members involved in patient care should: A. Recognize that patients and their loved ones and caregivers have the right to know about the existence and use of electronic records containing their personal healthcare information, and have the right to create and maintain their own personal health records and manage personal health information using a variety of platforms including mobile devices. In this context AMIA members should: Not mislead patients about the collection, use, or communication of their healthcare information. Enable and — as appropriate, within reason and the scope of their position and in accord with independent ethical and legal standards — facilitate patients’ rights and ability to access, review, and correct their electronic health information. Recognize that patient-provided/generated health data, such as those collected on mobile devices, deserve the same diligence and protection as biomedical and health data gathered in the process of providing health care. B. Advocate and work as appropriate to ensure that protected health information (PHI),20 personally identifiable information (PII), and other biomedical data are transmitted, acquired, recorded, stored, maintained, analyzed, and communicated in an appropriately safe, reliable, secure, and confidential manner, and that such data management is consistent with applicable laws, local privacy and security policies, and accepted informatics standards. C. Never knowingly disclose PHI, PII, or biomedical or health data in violation of legal requirements or accepted local confidentiality practices, or in ways that are inconsistent with the explanation of data disclosure and use to the patient. AMIA members should understand that inappropriate disclosure of biomedical information can cause harm, and so should work to prevent such disclosures. AMIA members should avoid acquiring data through means that run the risk of, or fail to prevent, inappropriate disclosure. Likewise, even if an action does not involve disclosure, one should not use — or through negligence permit the use of — patient information and data in ways inconsistent with the stated purposes, goals, or intentions of the patient or organization responsible for these data, except as appropriate for public health, previously approved and communicated research uses, or reporting as required under the law. II. Key ethical guidelines regarding colleagues AMIA members should: A. Endeavor, as appropriate, to support and foster colleagues’ and/or team members’ work, in a timely, respectful, and conscientious way to support their roles in healthcare and/or research and education. B. Support and foster the efforts of patients to be actively involved in the collection, management, and curation of their health data. C. Advise colleagues and others, as appropriate, about actual or potential information or systems issues (including system flaws, bugs, usability issues, etc.) that negatively affect patient safety, privacy, data security, or outcomes or could hinder colleagues’ ability to delegate responsibilities to patients, other colleagues, involved institutions, or other stakeholders. D. If a leader, an AMIA member should: Be familiar with these guidelines and their applicability to their practice, unit, or organization. Communicate as appropriate about these ethical guidelines to those they lead. Strive to promote familiarity with, and use of, these ethical guidelines. III. Key ethical guidelines regarding institutions, employers, business partners, and clients (called here collectively “employers”) AMIA members should: A. Understand their duties and obligations to current and former employers and fulfill them to the best of their abilities within the bounds of ethical and legal norms. B. Understand and appreciate that employers have legal and ethical rights and obligations, including those related to intellectual property. Understand and respect the obligations of their employers, and comply with local policies and procedures to the extent that they do not violate ethical and legal norms. Consider the tradeoffs that occur with the configuration and use of technologies (eg, decision support systems) before implementation, and monitor and manage results when the optimal approach is unclear. C. Inform the employer and act in accordance with ethico-legal mandates and patient rights when employer actions, policies, or procedures would violate ethical or legal obligations, contracts, or other agreements made with patients. Maintain a safe and high-quality environment even while implementing innovation, recognizing that all changes in a complex adaptive environment generate unanticipated consequences and potential harm. IV. Key ethical guidelines regarding society and regarding research AMIA members involved in research should: A. Be aware of the Declaration of Helsinki (Ethical Principles for Medical Research Involving Human Subjects), which should guide all human subject research, including research that involves users of informatics tools and interventions as human subjects (eg, workflow analysis studies, clinical decision support systems analysis, patient care innovations, analysis, etc.).22,23 Recognize that duty and care to colleagues exist regardless of whether such responsibilities are acknowledged by institutional review boards, vendors, and others involved in informatics activities. B. Be mindful and respectful of the social or public health implications of their work, ensuring that the greatest good for society is balanced by ethical obligations to individual patients. C. Avoid any plagiarism or self-plagiarism or other misrepresentations of the truth in the publication of research and other work. D. Disseminate new knowledge — both positive and negative — expeditiously, to allow the field to advance and to permit others to take advantage of novel discoveries to improve patient care. E. Strive as appropriate in the context of one’s position to foster the generation of knowledge and biomedical advances through appropriate support for ethical and institutionally approved research efforts facilitated through informed consent and disclosure processes and procedures, particularly when third-party entities not meeting the definition of business associates are involved. F. Know and abide by the applicable governmental regulations and local policies that define ethical research in their professional environment. V. General professional and ethical guidelines AMIA members should: A. Maintain competence as informatics professionals: Obtain applicable continuing education and be dedicated to a culture of lifelong learning and improvement; Recognize technical and ethical limitations and seek consultation when needed, particularly in ethically conflicting situations; Contribute to the education and mentoring of students, junior members, and others, as appropriate; Promote a culture of inclusivity in their work and professional conduct. B. Strive to encourage the adoption of informatics approaches supported by adequate evidence to improve health and healthcare; and to encourage and support efforts to improve the amount and quality of such evidence. C. Be mindful that their work and actions reflect on the profession and on AMIA. As a matter of personal and professional integrity, adherence to the principles laid out here is expected of all who have the privilege of serving in the field of biomedical and health informatics. Those whose skills allow them to contribute in one way or another to the health of individuals and populations carry important responsibilities, and this Code of Ethics delineates how informaticians may best do so. None. Not commissioned; not peer reviewed. Conflict of interest statement. None. The authors and the AMIA Ethics Committee would like to thank the AMIA Board of Directors for its continuing interest in refining and publishing these guidelines. Phyllis Burchman, AMIA’s Director of Office Operations and Human Resources, provided invaluable support to the Ethics Committee in its work. Members of the AMIA Ethics Committee who contributed to the second version of the code in 2012 and are not otherwise listed here include Samantha Adams, Robert Hsiung, John Hurdle, and Dixie A. Jones. This version of the code also owes much to the members of AMIA’s Ethical, Legal, and Social Issues (ELSI) Working Group.

To reduce the risk of wrong-patient errors, safety experts recommend limiting the number of patient records providers can open at once in electronic health records (EHRs). However, it is unknown whether health care organizations follow this recommendation or what rationales drive their decisions. To address this gap, we conducted an electronic survey via 2 national listservs. Among 167 inpatient and outpatient study facilities using EHR systems designed to open multiple records at once, 44.3% were configured to allow ≥3 records open at once (unrestricted), 38.3% allowed only 1 record open (restricted), and 17.4% allowed 2 records open (hedged). Decision-making centered on efforts to balance safety and efficiency, but there was disagreement among organizations about how to achieve that balance. Results demonstrate no consensus on the number of records to be allowed open at once in EHRs. Rigorous studies are needed to determine the optimal number of records that balances safety and efficiency.

Objective: To examine medication errors potentially related to computerized prescriber order entry (CPOE) and refine a previously published taxonomy to classify them. Materials and Methods: We reviewed all patient safety medication reports that occurred in the medication ordering phase from 6 sites participating in a United States Food and Drug Administration-sponsored project examining CPOE safety. Two pharmacists independently reviewed each report to confirm whether the error occurred in the ordering/prescribing phase and was related to CPOE. For those related to CPOE, we assessed whether CPOE facilitated (actively contributed to) the error or failed to prevent the error (did not directly cause it, but optimal systems could have potentially prevented it). A previously developed taxonomy was iteratively refined to classify the reports. Results: Of 2522 medication error reports, 1308 (51.9%) were related to CPOE. Of these, CPOE facilitated the error in 171 (13.1%) and potentially could have prevented the error in 1137 (86.9%). The most frequent categories of "what happened to the patient" were delays in medication reaching the patient, potentially receiving duplicate drugs, or receiving a higher dose than indicated. The most frequent categories for "what happened in CPOE" included orders not routed to or received at the intended location, wrong dose ordered, and duplicate orders. Variations were seen in the format, categorization, and quality of reports, resulting in error causation being assignable in only 403 instances (31%). Discussion and Conclusion: Errors related to CPOE commonly involved transmission errors, erroneous dosing, and duplicate orders. More standardized safety reporting using a common taxonomy could help health care systems and vendors learn and implement prevention strategies.

In many hospitals and health systems, a 'new' electronic health record means a shift to one vendor: Epic, a vendor that dominates in large and medium hospital markets and continues its success with smaller institutions and ambulatory practices. Our paper examines the implications of this emerging monoculture: its advantages and disadvantages for physicians and hospitals and its role in innovation, professional autonomy, implementation difficulties, workflow, flexibility, cost, data standards, interoperability, and interactions with other information technology (IT) systems.

Despite substantial investments in health information technology (HIT), the nation's goals of reducing cost and improving outcomes through HIT remain elusive. This period of transition, with new Office of National Coordinator for HIT leadership, upcoming Meaningful Use Stage III definitions, and increasing congressional oversight, is opportune to consider needed course corrections in HIT strategy. This article describes current problems and recommended changes in HIT policy, including approaches to usability, interoperability, and quality measurement. Recommendations refrain from interim measures, such as electronic health record adoption rates, and instead focus on measurable national value to benefit the economy, to reduce healthcare costs, and to improve clinical efficiency and care quality.

OBJECTIVE: To model inconsistencies or distortions among three realities: patients' physical reality; clinicians' mental models of patients' conditions, laboratories, etc; representation of that reality in electronic health records (EHR). To serve as a potential tool for quality improvement of EHRs. METHODS: Using observations, literature, information technology (IT) logs, vendor and US Food and Drug Administration reports, we constructed scenarios/models of how patients' realities, clinicians' mental models, and EHRs can misalign to produce distortions in comprehension and treatment. We then categorized them according to an emergent typology derived from the cases themselves and refined the categories based on insights gained from the literature of interactive sociotechnical systems analysis, decision support science, and human computer interaction. Typical of grounded theory methods, the categories underwent repeated modifications. RESULTS: We constructed 45 scenarios of misalignment between patients' physical realities, clinicians' mental models, and EHRs. We then identified five general types of misrepresentation in these cases: IT data too narrowly focused; IT data too broadly focused; EHRs miss critical reality; data multiplicities-perhaps contradictory or confusing; distortions from data reflected back and forth across users, sensors, and others. The 45 scenarios are presented, organized by the five types. CONCLUSIONS: With humans, there is a physical reality and actors' mental models of that reality. In healthcare, there is another player: the EHR/healthcare IT, which implicitly and explicitly reflects many mental models, facets of reality, and measures thereof that vary in reliability and consistency. EHRs are both microcosms and shapers of medical care. Our typology and scenarios are intended to be useful to healthcare IT designers and implementers in improving EHR systems and reducing the unintended negative consequences of their use.

The current commercial health information technology (HIT) arena encompasses a number of competing firms that provide electronic health applications to hospitals, clinical practices, and other healthcare-related entities. Such applications collect, store, and analyze patient information. Some vendors incorporate contract language whereby purchasers of HIT systems, such as hospitals and clinics, must indemnify vendors for malpractice or personal injury claims, even if those events are not caused or fostered by the purchasers. Some vendors require contract clauses that force HIT system purchasers to adopt vendor-defined policies that prevent the disclosure of errors, bugs, design flaws, and other HIT-software-related hazards. To address this issue, the AMIA Board of Directors appointed a Task Force to provide an analysis and insights. Task Force findings and recommendations include: patient safety should trump all other values; corporate concerns about liability and intellectual property ownership may be valid but should not over-ride all other considerations; transparency and a commitment to patient safety should govern vendor contracts; institutions are duty-bound to provide ethics education to purchasers and users, and should commit publicly to standards of corporate conduct; and vendors, system purchasers, and users should encourage and assist in each others' efforts to adopt best practices. Finally, the HIT community should re-examine whether and how regulation of electronic health applications could foster improved care, public health, and patient safety.

All methods of identifying medication prescribing errors are fraught with inaccuracies and systematic bias. A systematic, efficient, and inexpensive way of measuring and quantifying prescribing errors would be a useful step for reducing them. We ask if rapid discontinuations of prescription-orders--where physicians stop their orders within 2 hours--would be an expedient proxy for prescribing errors? To study this we analyzed CPOE-system medication orders entered and then discontinued within 2 hours. We investigated these phenomena in real time via interviews with corresponding ordering physicians. Each order was also independently reviewed by a clinical pharmacist or physicians. We found that of 114 rapidly discontinued orders by 75 physicians, two-thirds (35 of 53, PPV = 66; 95% CI = 53-77) of medication orders discontinued within 45 minutes were deemed inappropriate (overdose, underdose, etc.). Overall, 55% (63 of 114; 95% CI = 46-64%) of medication orders discontinued within 2 hours were deemed inappropriate. This measure offers a rapid, constant, inexpensive, and objective method to identify medication orders with a high probability of error. It may also serve as a screening and teaching mechanism for physicians-in-training.

The authors develop a typology of clinicians' workarounds when using barcoded medication administration (BCMA) systems. Authors then identify the causes and possible consequences of each workaround. The BCMAs usually consist of handheld devices for scanning machine-readable barcodes on patients and medications. They also interface with electronic medication administration records. Ideally, BCMAs help confirm the five "rights" of medication administration: right patient, drug, dose, route, and time. While BCMAs are reported to reduce medication administration errors--the least likely medication error to be intercepted--these claims have not been clearly demonstrated. The authors studied BCMA use at five hospitals by: (1) observing and shadowing nurses using BCMAs at two hospitals, (2) interviewing staff and hospital leaders at five hospitals, (3) participating in BCMA staff meetings, (4) participating in one hospital's failure-mode-and-effects analyses, (5) analyzing BCMA override log data. The authors identified 15 types of workarounds, including, for example, affixing patient identification barcodes to computer carts, scanners, doorjambs, or nurses' belt rings; carrying several patients' prescanned medications on carts. The authors identified 31 types of causes of workarounds, such as unreadable medication barcodes (crinkled, smudged, torn, missing, covered by another label); malfunctioning scanners; unreadable or missing patient identification wristbands (chewed, soaked, missing); nonbarcoded medications; failing batteries; uncertain wireless connectivity; emergencies. The authors found nurses overrode BCMA alerts for 4.2% of patients charted and for 10.3% of medications charted. Possible consequences of the workarounds include wrong administration of medications, wrong doses, wrong times, and wrong formulations. Shortcomings in BCMAs' design, implementation, and workflow integration encourage workarounds. Integrating BCMAs within real-world clinical workflows requires attention to in situ use to ensure safety features' correct use.

Many unintended and undesired consequences of Healthcare Information Technologies (HIT) flow from interactions between the HIT and the healthcare organization's sociotechnical system-its workflows, culture, social interactions, and technologies. This paper develops and illustrates a conceptual model of these processes that we call Interactive Sociotechnical Analysis (ISTA). ISTA captures common types of interaction with special emphasis on recursive processes, i.e., feedback loops that alter the newly introduced HIT and promote second-level changes in the social system. ISTA draws on prior studies of unintended consequences, along with research in sociotechnical systems, ergonomics, social informatics, technology-in-practice, and social construction of technology. We present five types of sociotechnical interaction and illustrate each with cases from published research. The ISTA model should further research on emergent and recursive processes in HIT implementation and their unintended consequences. Familiarity with the model can also foster practitioners' awareness of unanticipated consequences that only become evident during HIT implementation.