OBJECTIVES: To assess the potential to adapt an existing technology regulatory model, namely the Clinical Laboratory Improvement Amendments (CLIA), for clinical artificial intelligence (AI). MATERIALS AND METHODS: We identify overlap in the quality management requirements for laboratory testing and clinical AI. RESULTS: We propose modifications to the CLIA model that could make it suitable for oversight of clinical AI. DISCUSSION: In national discussions of clinical AI, there has been surprisingly little consideration of this longstanding model for local technology oversight. While CLIA was specifically designed for laboratory testing, most of its principles are applicable to other technologies in patient care. CONCLUSION: A CLIA-like approach to regulating clinical AI would be complementary to the more centralized schemes currently under consideration, and it would ensure institutional and professional accountability for the longitudinal quality management of clinical AI.

BACKGROUND: The use of real-world data (RWD) in artificial intelligence (AI) applications for healthcare offers unique opportunities but also poses complex challenges related to interpretability, transparency, safety, efficacy, bias, equity, privacy, ethics, accountability, and stakeholder engagement. METHODS: A multi-stakeholder expert panel comprising healthcare professionals, AI developers, policymakers, and other stakeholders was assembled. Their task was to identify critical issues and formulate consensus recommendations, focusing on the responsible use of RWD in healthcare AI. The panel's work involved an in-person conference and workshop and extensive deliberations over several months. RESULTS: The panel's findings revealed several critical challenges, including the necessity for data literacy and documentation, the identification and mitigation of bias, privacy and ethics considerations, and the absence of an accountability structure for stakeholder management. To address these, the panel proposed a series of recommendations, such as the adoption of metadata standards for RWD sources, the development of transparency frameworks and instructional labels likened to "nutrition labels" for AI applications, the provision of cross-disciplinary training materials, the implementation of bias detection and mitigation strategies, and the establishment of ongoing monitoring and update processes. CONCLUSION: Guidelines and resources focused on the responsible use of RWD in healthcare AI are essential for developing safe, effective, equitable, and trustworthy applications. The proposed recommendations provide a foundation for a comprehensive framework addressing the entire lifecycle of healthcare AI, emphasizing the importance of documentation, training, transparency, accountability, and multi-stakeholder engagement.

OBJECTIVES: In 2023, AMIA's Inclusive Language and Context Style Guidelines (the "Guidelines") were approved by the Board of Directors and made a publicly available resource. This work began in 2021 through AMIA's DEI Task Force and subsequent DEI Committee; many members provided input, feedback, and time to create the Guidelines. In this paper, the authors provide a transparent account of the origin, development, contents, and dissemination of the Guidelines and share plans for their future development and use. MATERIALS AND METHODS: Our approach to drafting, refining, and distributing the Guidelines included consulting existing language guides, AMIA member reviews, external expert reviews, webinars, and workshops. Through an iterative approach to drafting and refining the Guidelines, the authors consulted relevant language guidelines and many experts throughout and beyond the AMIA community. RESULTS: The Inclusive Language Context Guidelines were formally approved by the AMIA Board of Directors on February 15, 2023. The Guidelines included four principles to be considered in scientific communications: Plurality, Precision, Transparency, and Destigmatization. DISCUSSION: A moment of vulnerability where an AMIA member raised concerns about the use of harmful language during a presentation resulted in the creation of a principled approach to support inclusive language within biomedical and health informatics communications. We envision that the Guidelines will support health equity by challenging dominant public narratives around health, fostering stronger interdisciplinary collaboration and critical thinking about the impact of language, and creating a more welcoming environment for the broader AMIA community. This work could not have been completed without the support of many AMIA members and other researchers in biomedical and health informatics. The Guidelines are a living document that will continue to be updated with input and feedback from the AMIA community into the future.

BACKGROUND: Integrating artificial intelligence (AI) in healthcare settings has the potential to benefit clinical decision-making. Addressing challenges such as ensuring trustworthiness, mitigating bias, and maintaining safety is paramount. The lack of established methodologies for pre- and post-deployment evaluation of AI tools regarding crucial attributes such as transparency, performance monitoring, and adverse event reporting makes this situation challenging. OBJECTIVES: This paper aims to make practical suggestions for creating methods, rules, and guidelines to ensure that the development, testing, supervision, and use of AI in clinical decision support (CDS) systems are done well and safely for patients. MATERIALS AND METHODS: In May 2023, the Division of Clinical Informatics at Beth Israel Deaconess Medical Center and the American Medical Informatics Association co-sponsored a working group on AI in healthcare. In August 2023, there were 4 webinars on AI topics and a 2-day workshop in September 2023 for consensus-building. The event included over 200 industry stakeholders, including clinicians, software developers, academics, ethicists, attorneys, government policy experts, scientists, and patients. The goal was to identify challenges associated with the trusted use of AI-enabled CDS in medical practice. Key issues were identified, and solutions were proposed through qualitative analysis and a 4-month iterative consensus process. RESULTS: Our work culminated in several key recommendations: (1) building safe and trustworthy systems; (2) developing validation, verification, and certification processes for AI-CDS systems; (3) providing a means of safety monitoring and reporting at the national level; and (4) ensuring that appropriate documentation and end-user training are provided. DISCUSSION: AI-enabled Clinical Decision Support (AI-CDS) systems promise to revolutionize healthcare decision-making, necessitating a comprehensive framework for their development, implementation, and regulation that emphasizes trustworthiness, transparency, and safety. This framework encompasses various aspects including model training, explainability, validation, certification, monitoring, and continuous evaluation, while also addressing challenges such as data privacy, fairness, and the need for regulatory oversight to ensure responsible integration of AI into clinical workflow. CONCLUSIONS: Achieving responsible AI-CDS systems requires a collective effort from many healthcare stakeholders. This involves implementing robust safety, monitoring, and transparency measures while fostering innovation. Future steps include testing and piloting proposed trust mechanisms, such as safety reporting protocols, and establishing best practice guidelines.

Scientific discovery depends on access to data and the knowledge this data makes possible.Research data sharing is increasingly recognized as a priority for organizations to support the successful conduct of research.The National Institutes of Health states, "data sharing enables researchers to rigorously test the validity of research findings, strengthen analyses through combined datasets, reuse hard-to-generate data, and explore new frontiers of discovery" [1].Conversely, in the absence of data sharing, there are increased risks related to the robustness, rigor, and replicability of results, and the potential of valuable data is diminished.For these reasons and more, institutional data sharing capacity is a critical topic for organizations to scrutinize, discuss, and advance.Advocacy and support for data sharing are often discussed with an emphasis on understanding and supporting the practices of individual investigators or scientific communities [2,3].However, a researcher's ability to successfully engage in and benefit from sound data sharing depends on their organizational setting and, specifically, the organization's data sharing capacity.For example, sharing data is easier and more equitable when organizational processes and procedures are established and documented, and research workforce members can access centralized training and infrastructure resources.The effect of how an organization approaches and supports data sharing extends beyond the success of its investigators.Institutions that share data can participate in innovative largescale initiatives and pursue new funding opportunities.Universities that contribute to creating

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.

Natural hazards (NHs) associated with climate change have been increasing in frequency and intensity. These acute events impact humans both directly and through their effects on social and environmental determinants of health. Rather than relying on a fully reactive incident response disposition, it is crucial to ramp up preparedness initiatives for worsening case scenarios. In this perspective, we review the landscape of NH effects for human health and explore the potential of health informatics to address associated challenges, specifically from a preparedness angle. We outline important components in a health informatics agenda for hazard preparedness involving hazard-disease associations, social determinants of health, and hazard forecasting models, and call for novel methods to integrate them toward projecting healthcare needs in the wake of a hazard. We describe potential gaps and barriers in implementing these components and propose some high-level ideas to address them.

Recent advances in the science and technology of artificial intelligence (AI) and growing numbers of deployed AI systems in healthcare and other services have called attention to the need for ethical principles and governance. We define and provide a rationale for principles that should guide the commission, creation, implementation, maintenance, and retirement of AI systems as a foundation for governance throughout the lifecycle. Some principles are derived from the familiar requirements of practice and research in medicine and healthcare: beneficence, nonmaleficence, autonomy, and justice come first. A set of principles follow from the creation and engineering of AI systems: explainability of the technology in plain terms; interpretability, that is, plausible reasoning for decisions; fairness and absence of bias; dependability, including "safe failure"; provision of an audit trail for decisions; and active management of the knowledge base to remain up to date and sensitive to any changes in the environment. In organizational terms, the principles require benevolence-aiming to do good through the use of AI; transparency, ensuring that all assumptions and potential conflicts of interest are declared; and accountability, including active oversight of AI systems and management of any risks that may arise. Particular attention is drawn to the case of vulnerable populations, where extreme care must be exercised. Finally, the principles emphasize the need for user education at all levels of engagement with AI and for continuing research into AI and its biomedical and healthcare applications.

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.

We would like to ask the question, how much can we understand of a physician's diagnostic reasoning process from what is in the electronic record? However, it is well known that a good deal of important information about the diagnostic process is not recorded; it would be impractical to record every detail unless it somehow has a bearing on a treatment decision. What remains is the formal record of "chief complaint", vitals and physical examination, medications prescribed, referrals made, orders written—for tests, imaging, etc.—and any procedures performed. The sequencing of these events (which we have defined as the diagnostic path) and decisions made on that basis, vary considerably from patient to patient and from physician to physician. Equally, it is likely that some diagnostic paths are more efficacious than others. We therefore (a) seek to identify paths; (b) group them by "similarity"; (c) consider which archetypal paths, in different circumstances, prove more effective, or more cost-effective. We report on the extensive methodological effort undertaken at this stage of the project.

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.

The problems of poor or biased information and of misleading health and wellbeing advice on the Internet is well known. The recent decision by Internet Corporation for Assigned Names and Numbers (ICANN) to authorize a large number of new generic top-level domains, including some with a clear connection to health or healthcare, presents an opportunity to bring some order to this chaotic situation. In the case of the most general of these domains, ".health", experts advance a compelling argument in favor of some degree of content control. On the opposing side, advocates for Internet freedom counter that this is too valuable to be compromised, and once lost it may never be recovered. The author supports a proposal to bridge the credibility gap in online health information by providing provenance information for websites in the .health domain.

The management of privacy and personal information within multi-cultural domain such as clouds and other universal collaborative systems requires intrinsic compliance-checking and assurance modules in order to increase social trust and acceptance. Focusing mainly on medical domains, this issue is particularly important due to the sensitivity of health related data in international data protection law. The use of ontologies and semantic technologies can provide relatively easy interpretation of legislation at run time, and can allow the logging of data access events to serve for future audits. However, the enforcement of semantic web rules (SWRL rules) on complex and heterogeneous architectures is expensive and might present runtime overheads. We believe a mapping of our semantic web privacy policies to a standard access control language such as XACML would be a useful alternative. A translation to XACML, would allow the integration of these policies with existing security and privacy policies being adopted on clouds environments. This paper describes a mathematical formalism for mapping SWRL (Semantic Web Rule Language) privacy rules to XACML policies and also explains the underline implementation requirements of this formalism.

The Chicago Area Patient-Centered Outcomes Research Network (CAPriCORN) represents an unprecedented collaboration across diverse healthcare institutions including private, county, and state hospitals and health systems, a consortium of Federally Qualified Health Centers, and two Department of Veterans Affairs hospitals. CAPriCORN builds on the strengths of our institutions to develop a cross-cutting infrastructure for sustainable and patient-centered comparative effectiveness research in Chicago. Unique aspects include collaboration with the University HealthSystem Consortium to aggregate data across sites, a centralized communication center to integrate patient recruitment with the data infrastructure, and a centralized institutional review board to ensure a strong and efficient human subject protection program. With coordination by the Chicago Community Trust and the Illinois Medical District Commission, CAPriCORN will model how healthcare institutions can overcome barriers of data integration, marketplace competition, and care fragmentation to develop, test, and implement strategies to improve care for diverse populations and reduce health disparities.

Pre-implantation genetic diagnosis and screening (PGD and PGS) are treatments for patients that have (or are carriers of) an inherited genetic disorder, or who have had a history of miscarriage, problems with embryo implantation, etc. Often conducted alongside assisted reproductive technologies (ART), a number of embryos are produced, and the DNA and chromosomes of each are tested for various disorders by removing one or two cells for analysis. A retrospective cross-sectional study looking at the health and development of children born following PGD and PGS is now underway, aided by an online system developed by the EuroPGDcode project. Data has been collected from a number of ART/PGD centres worldwide, and has been entered into this system. A number of complex queries have been constructed to interrogate the data; although retrospective and not case controlled, indications are that the birth abnormality rate is low at 1.42%. However the special care requirements of PGD infants was 22.9% and the incidence of health problems after birth was 22.3%. In addition to statistical analysis of the data, a number of cases of particular interest have been identified. The online system provides the facility for the full details of these cases to be exported in a specially designed XML format for further analysis.

The 24th International Symposium on Computer-Based Medical Systems, CBMS 2011, took place at the University of the West of England, Bristol, UK, on 27th to 30th June 2011. As a special feature, instead of the traditional (since 2005) special track on “healthgrids”, i.e. grid computing for biomedicine and healthcare, latterly encompassing cloud computing also, the conference HealthGrid 2011 colocated with CBMS to the benefit of both. This was the culmination of a hope that those of us working at UWE had entertained since 2008. The invitation to CBMS was first made in Jyväskylä in 2008, became a formal proposal in Albuquerque in 2009 and was confirmed in Perth in 2010. As for HealthGrid, it seemed an opportunity not to be missed to colocate with CBMS in Bristol, only the second time the conference has been awarded to a British city (after Oxford in 2005).

Integrated care pathways (ICPs), a fine-grained form of medical guideline including the explicit recording of any deviation, or `variance', could serve as a rich source of data for research. Not only do they incorporate a wealth of operational knowledge, but feeding the results of the analysis of variance into the development of a pathway could be an effective way of capturing evidence from practice. In our principal case study we propose a system for extracting data from care pathways with the aid of ontologies, and a method for inferring ICPs from other patient records, combining these with data collected for retrospective and prospective studies in preimplantation genetic diagnosis (PGD) for assisted reproduction.

The integration of different European medical systems by means of grid technologies will continue to be challenging if technology does not intervene to enhance interoperability between national regulatory frameworks on data protection. Achieving compliance in European healthgrid domains is crucial but challenging because of the diversity and complexity of Member State legislation across Europe. Lack of automation and inconsistency of processes across healthcare organizations increase the complexity of the compliance task. In the absence of automation, the compliance task entails human intervention. In this paper we present an approach to automate privacy requirements for the sharing of patient data between Member States across Europe in a healthgrid domain and ensure its enforcement internally and within external domains where the data might travel. This approach is based on the semantic modelling of privacy obligations that are of legal, ethical or cultural nature. Our model reflects both similarities and conflicts, if any, between the different Member States. This will allow us to reason on the safeguards a data controller should demand from an organization belonging to another Member State before disclosing medical data to them. The system will also generate the relevant set of policies to be enforced at the process level of the grid to ensure privacy compliance before allowing access to the data.

This presentation reviews the variety of contributions and attempts an historical perspective on the evolution of work in healthgrids. In particular, it attempts to compare and contrast work carried out on the two sides of the Atlantic. The project SHARE has completed its work in devising a road map for research and deployment of healthgrids as the infrastructure of choice for biomedical research informatics in the first place and healthcare informatics in the future. A brief report of the road map and a comparison with actual developments completes the presentation.

Clinical practice and research rely increasingly on analytic approaches to patient data. Visualization enables the comparative exploration of similar patients, a key requirement in certain clinical decision support systems. Patient data is complex and heterogeneous, may have different formats, reside in various structures and carry different semantics. This makes the comparison and analysis of clinical data a challenging task. Most medical applications visualize patient data without integrating additional semantic information to structure the analysis. Our objective is to map patient data onto relevant fragments of ontologies and inferred ontological structures as a basis for improved patient data visualization, comparison, and analysis. Two visualization scenarios that we have implemented using the patient data acquired in the Health-e-Child project will be presented and their clinical evaluation will be provided.

The Business Process Models and grid-enabled Service Oriented Architecture (BPMSOA) framework facilitates the enactment of a business process using application domain specific grid services. In this paper, we use a role-based instance of BPMSOA to enact the Search process of the digital libraries domain. Furthermore, in order to find the extent to which the BPMSOA contributes in bridging the gap between business process models and grid systems, an evaluation framework has been defined. Using this evaluation framework the structural, flow and informational translations are verified at different levels of the BPMSOA for correctness and consistency. In addition, the evaluation framework is used to validate the behavioural correctness of the process being enacted. The BPMSOA evaluation using the Search process reveals that the step by step model translations enable the Search process model to be enacted using Pi-Architectural Description Language (π-ADL) and to be executed using application domain specific grid services as a step towards bridging the gap between business process models and grid-enabled SOA (GSOA).

This paper presents an overview of the MammoGrid project and some of its achievements. In terms of the global grid project, and European research in particular, the project has successfully demonstrated the capacity of a grid-based system to support effective collaboration between physicians, including handling and querying image databases, as well as using grid services, such as image standardization and computer-aided detection (CADe) of suspect or indicative features. In terms of scientific results, in radiology, there have been significant epidemiological findings in the assessment of breast density as a risk factor, but the results for CADe are less clear-cut. Finally, the foundations of a technology transfer process to establish a working "MammoGrid plus" system in Spain through the company Maat GKnowledge and the collaboration of CIEMAT and hospitals in Extremadura

This work presents a perspective on the Healthgrid initiative which involves European projects deploying pioneering applications of Grid technology in the health sector. In the last couple of years, several Grid projects have been funded on health related issues at national and European levels. A crucial issue is to maximize their cross fertilization in the context of an environment where data of medical interest can be stored and made easily available to the different actors in health care, physicians, health care centres and administrations, and of course the citizens. The Healthgrid initiative, represented by the Healthgrid association, was initiated to bring the necessary long term continuity, to reinforce and promote awareness of the possibilities and advantages linked to the deployment of Grid technologies in health. Technologies to address the specific requirements for medical applications are under development. Results from the DataGrid and other projects are given as examples of early applications.