Kenneth W. Goodman

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19ranked-venue papers
3as first author
5since 2021 · last 2022
0000-0002-0149-8432ORCID · corroborated

Domains — the database's venue-derived domains; a paper can count in several

Applied, interdisciplinary, general and emerging computing · 19 · 3 first-author · 5 since 2021
YearPublicationVenuePosition
2022 25 Years of ELSI in Biomedical and Health Informatics
Vignesh Subbian, Melissa D. Clarkson, Carolyn Petersen, Tony Solomonides, Kenneth W. Goodman
AMIA5
2022 Selecting venues for AMIA events and conferences: guiding ethical principles
abstract
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.
Christoph U. Lehmann, Kate Fultz Hollis, Carolyn Petersen, Paul DeMuro, Vignesh Subbian, Ross Koppel, Tony Solomonides, Eta S. Berner, Eric C. Pan, Julia Adler-Milstein, Kenneth W. Goodman
J. Am. Medical Informatics Assoc.11
2022 AMIA's code of professional and ethical conduct 2022
abstract
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.
Carolyn Petersen, Eta S. Berner, Anthony Cardillo, Kate Fultz Hollis, Kenneth W. Goodman, Ross Koppel, Diane M. Korngiebel, Christoph U. Lehmann, Tony Solomonides, Vignesh Subbian
J. Am. Medical Informatics Assoc.5
2021 Recommendations for the safe, effective use of adaptive CDS in the US healthcare system: an AMIA position paper
abstract
The development and implementation of clinical decision support (CDS) that trains itself and adapts its algorithms based on new data-here referred to as Adaptive CDS-present unique challenges and considerations. Although Adaptive CDS represents an expected progression from earlier work, the activities needed to appropriately manage and support the establishment and evolution of Adaptive CDS require new, coordinated initiatives and oversight that do not currently exist. In this AMIA position paper, the authors describe current and emerging challenges to the safe use of Adaptive CDS and lay out recommendations for the effective management and monitoring of Adaptive CDS.
Carolyn Petersen, Jeffery Smith, Robert R. Freimuth, Kenneth W. Goodman, Gretchen Purcell Jackson, Joseph L. Kannry, Subha Madhavan, Dean F. Sittig, Adam Wright
J. Am. Medical Informatics Assoc.4
2021 Ethics and informatics in the age of COVID-19: challenges and recommendations for public health organization and public policy
abstract
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.
Vignesh Subbian, Tony Solomonides, Melissa D. Clarkson, Vasiliki Nataly Rahimzadeh, Carolyn Petersen, Richard Schreiber, Paul DeMuro, Prerna Dua, Kenneth W. Goodman, Bonnie Kaplan, Ross Koppel, Christoph U. Lehmann, Eric C. Pan, Yalini Senathirajah
J. Am. Medical Informatics Assoc.9
2019 Effects of an Interactive Trust-enhanced Electronic Consent on Patient Experiences with Consenting to Share their Health Records for Research
Christopher A. Harle, Elizabeth H. Golembiewski, Kiarash P. Rahmanian, Babette A. Brumback, Janice L. Krieger, Kenneth W. Goodman, Arch G. Mainous III, Ray E. Moseley
AMIA6
2019 Does an interactive trust-enhanced electronic consent improve patient experiences when asked to share their health records for research? A randomized trial
abstract
OBJECTIVE: In the context of patient broad consent for future research uses of their identifiable health record data, we compare the effectiveness of interactive trust-enhanced e-consent, interactive-only e-consent, and standard e-consent (no interactivity, no trust enhancement). MATERIALS AND METHODS: A randomized trial was conducted involving adult participants making a scheduled primary care visit. Participants were randomized into 1 of the 3 e-consent conditions. Primary outcomes were patient-reported satisfaction with and subjective understanding of the e-consent. Secondary outcomes were objective knowledge, perceived voluntariness, trust in medical researchers, consent decision, and time spent using the application. Outcomes were assessed immediately after use of the e-consent and at 1-week follow-up. RESULTS: Across all conditions, participants (N = 734) reported moderate-to-high satisfaction with consent (mean 4.3 of 5) and subjective understanding (79.1 of 100). Over 94% agreed to share their health record data. No statistically significant differences in outcomes were observed between conditions. Irrespective of condition, black participants and those with lower education reported lower satisfaction, subjective understanding, knowledge, perceived voluntariness, and trust in medical researchers, as well as spent more time consenting. CONCLUSIONS: A large majority of patients were willing to share their identifiable health records for research, and they reported positive consent experiences. However, incorporating optional additional information and messages designed to enhance trust in the research process did not improve consent experiences. To improve poorer consent experiences of racial and ethnic minority participants and those with lower education, other novel consent technologies and processes may be valuable. (An Interactive Patient-Centered Consent for Research Using Medical Records; NCT03063268).
Christopher A. Harle, Elizabeth H. Golembiewski, Kiarash P. Rahmanian, Babette A. Brumback, Janice L. Krieger, Kenneth W. Goodman, Arch G. Mainous III, Ray E. Moseley
J. Am. Medical Informatics Assoc.6
2018 AMIA's code of professional and ethical conduct 2018
abstract
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.
Carolyn Petersen, Eta S. Berner, Peter J. Embí, Kate Fultz Hollis, Kenneth W. Goodman, Ross Koppel, Christoph U. Lehmann, Harold P. Lehmann, Sarah A. Maulden, Kyle A. McGregor, Tony Solomonides, Vignesh Subbian, Enrique Terrazas, Peter Winkelstein
J. Am. Medical Informatics Assoc.5
2017 Successes and Challenges in Developing and Implementing Electronic Informed Consent Tools for Research
Christopher A. Harle, David R. Nelson, Kenneth W. Goodman, Elizabeth Bell
AMIA3
2015 Challenges, Successes, and Future Directions of Consumer Health IT Evaluation
Uba Backonja, Rupa Valdez, William T. Riley, Katie A. Siek, Teresa Zayas-Cabán, Kenneth W. Goodman
AMIA6
2015 Comparative outcome studies of clinical decision support software: limitations to the practice of evidence-based system acquisition
abstract
Clinical decision support systems (CDSSs) assist clinicians with patient diagnosis and treatment. However, inadequate attention has been paid to the process of selecting and buying systems. The diversity of CDSSs, coupled with research obstacles, marketplace limitations, and legal impediments, has thwarted comparative outcome studies and reduced the availability of reliable information and advice for purchasers. We review these limitations and recommend several comparative studies, which were conducted in phases; studies conducted in phases and focused on limited outcomes of safety, efficacy, and implementation in varied clinical settings. Additionally, we recommend the increased availability of guidance tools to assist purchasers with evidence-based purchases. Transparency is necessary in purchasers' reporting of system defects and vendors' disclosure of marketing conflicts of interest to support methodologically sound studies. Taken together, these measures can foster the evolution of evidence-based tools that, in turn, will enable and empower system purchasers to make wise choices and improve the care of patients.
Gaurav Dhiman 0001, Kyle T. Amber, Kenneth W. Goodman
J. Am. Medical Informatics Assoc.3
2013 AMIA's Code of Professional and Ethical Conduct
abstract
AMIA, as other professional societies, has a long-standing interest in promoting a strong ethical framework for its membership. This white paper presents the latest AMIA Code of Professional and Ethical Conduct. It was approved in November of 2011 by the AMIA Board of Directors. This document constitutes a revision of, and update to, the first code, approved and published in J Am Med Inform Assoc1 in 2007. In an effort to keep pace with the field's vitality, the code presented here is intended to be a dynamic document, and will continue to evolve as AMIA and the field itself evolve. AMIA will publish on its web site this version of the code as part of a process that seeks ongoing response from, and involvement by, AMIA members. The code is meant to be practical and easily understood, so it is compact and uses general language. Unlike the ethics codes of some professional societies, the AMIA code is not intended to be prescriptive or legislative; it is aspirational, and as such, provides the broad strokes of a set of important ethical principles especially 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, students, and others—and with whom they interact. The AMIA Board and the AMIA Ethics Committee encourage members to offer suggestions for improvements and other changes. In this way, the code will continue to progress and best serve AMIA and the larger informatics community.
Kenneth W. Goodman, Samantha A. Adams, Eta S. Berner, Peter J. Embí, Robert C. Hsiung, John F. Hurdle, Dixie A. Jones, Christoph U. Lehmann, Sarah A. Maulden, Carolyn Petersen, Enrique Terrazas, Peter Winkelstein
J. Am. Medical Informatics Assoc.1
2013 Sorrell v. IMS Health: issues and opportunities for informaticians
abstract
In 2011, the US Supreme Court decided Sorrell v. IMS Health, Inc., a case that addressed the mining of large aggregated databases and the sale of prescriber data for marketing prescription drugs. The court struck down a Vermont law that required data mining companies to obtain permission from individual providers before selling prescription records that included identifiable physician prescription information to pharmaceutical companies for drug marketing. The decision was based on constitutional free speech protections rather than data sharing considerations. Sorrell illustrates challenges at the intersection of biomedical informatics, public health, constitutional liberties, and ethics. As states, courts, regulatory agencies, and federal bodies respond to Sorrell, informaticians' expertise can contribute to more informed, ethical, and appropriate policies.
Carolyn Petersen, Paul DeMuro, Kenneth W. Goodman, Bonnie Kaplan
J. Am. Medical Informatics Assoc.3
2013 Handbook of Analytic Philosophy of Medicine Series: Philosophy and Medicine, Vol 113. Kazem Sadegh-Zadeh (2012). XXXII, 1133 pp
Kenneth W. Goodman
J. Biomed. Informatics1
2012 An informatics agenda for public health: summarized recommendations from the 2011 AMIA PHI Conference
abstract
The AMIA Public Health Informatics 2011 Conference brought together members of the public health and health informatics communities to revisit the national agenda developed at the AMIA Spring Congress in 2001, assess the progress that has been made in the past decade, and develop recommendations to further guide the field. Participants met in five discussion tracks: technical framework; research and evaluation; ethics; education, professional training, and workforce development; and sustainability. Participants identified 62 recommendations, which clustered into three key themes related to the need to (1) enhance communication and information sharing within the public health informatics community, (2) improve the consistency of public health informatics through common public health terminologies, rigorous evaluation methodologies, and competency-based training, and (3) promote effective coordination and leadership that will champion and drive the field forward. The agenda and recommendations from the meeting will be disseminated and discussed throughout the public health and informatics communities. Both communities stand to gain much by working together to use these recommendations to further advance the application of information technology to improve health.
Barbara L. Massoudi, Kenneth W. Goodman, Ivan J. Gotham, John H. Holmes, Lisa Lang, Kathleen Miner, David D. Potenziani, Janise Richards, Anne M. Turner, Paul C. Fu Jr.
J. Am. Medical Informatics Assoc.2
2011 Challenges in ethics, safety, best practices, and oversight regarding HIT vendors, their customers, and patients: a report of an AMIA special task force
abstract
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.
Kenneth W. Goodman, Eta S. Berner, Mark A. Dente, Bonnie Kaplan, Ross Koppel, Donald W. Rucker, Daniel Z. Sands, Peter Winkelstein
J. Am. Medical Informatics Assoc.1
2010 Ethical, legal and social issues for personal health records and applications
Reid Cushman, A. Michael Froomkin, Anita Cava, Patricia S. Abril, Kenneth W. Goodman
J. Biomed. Informatics5
2003 Case Reports on the Web Redux: Confidentiality Still in Jeopardy
Barry P. Markovitz, Kenneth W. Goodman
AMIA2
1999 Case Reports on the Web: Is Confidentiality Being Maintained?
Barry P. Markovitz, Kenneth W. Goodman
AMIA2