AMIA’s code of professional and ethical conduct 2018

SummaryContemporary bioethics was fledged and is sustained by challenges posed by new technologies. These technologies have affected many lives. Yet health informatics affects more lives than any of them. The challenges include the development and the appropriate uses and users of machine learning software, the balancing of privacy rights against the needs of public health and clinical practice in a time of Big Data analytics, whether and how to use this technology, and the role of ethics and standards in health policy. Historical antecedents in statistics and evidence-based practice foreshadow some of the difficulties now faced, but the scope and scale of these challenges requires that ethics, too, be brought to scale in parallel, especially given the size of contemporary data sets and the processing power of new computers. Fortunately, applied ethics affords a variety of tools to help identify and rank applicable values, support best practices, and contribute to standards. The bioethics community can in partnership with the informatics community arrive at policies that promote the health sciences while reaffirming the many and varied rights that patients expect will be honored.

Section: Duties To Use New Technologymentioning

confidence: 99%

Ethics in Health Informatics

Goodman

2020

“…Medical and health research conducted in Norway needs to be approved by an ethics committee if the aim is to trial new experimental treatments, acquire new knowledge about health and disease, or if human biological samples or identifiable personal information (either collected by researchers or obtained from one or several central health registers) is to be used. 3 Testing and evaluation of medical devices, defined as instruments or apparatus, produced to be used on people to diagnose, prevent, monitor, treat, or relieve disease, also require ethics approval. Research projects to evaluate how a new technology is being used (direct observations), to explore opinions (interviews) about new technologies, and quality assur- ance projects do not require ethics approval.…”

Section: Norway (E C Lehnbom R Pedersen)mentioning

confidence: 99%

“…As for medical informatics, the American Medical Informatics Association (AMIA) acknowledges that the Declaration of Helsinki "should guide all human subject research, including research that involves users of informatics tools and interventions as human subjects (e.g., workflow analysis studies, clinical decision support systems analysis, patient care innovations analysis, etc.)" [3]. Therefore, human and organizational factors (HOF)-related studies in the field of medical informatics must comply with the Declaration of Helsinki.…”

Section: Introductionmentioning

confidence: 99%

Challenges and Best Practices in Ethical Review of Human and Organizational Factors Studies in Health Technology: a Synthesis of Testimonies

Peute

Lichtner²,

Baysari

et al. 2020

Summary Objective: Human and Organizational Factors (HOF) studies in health technology involve human beings and thus require Institutional Review Board (IRB) approval. Yet HOF studies have specific constraints and methods that may not fit standard regulations and IRB practices. Gaining IRB approval may pose difficulties for HOF researchers. This paper aims to provide a first overview of HOF study challenges to get IRB review by exploring differences and best practices across different countries. Methods: HOF researchers were contacted by email to provide a testimony about their experience with IRB review and approval. Testimonies were thematically analyzed and synthesized to identify and discuss shared themes. Results: Researchers from seven European countries, Argentina, Canada, Australia, and the United States answered the call. Four themes emerged that indicate shared challenges in legislation, IRB inefficiencies and inconsistencies, general regulation and costs, and lack of HOF study knowledge by IRB members. We propose a model for IRB review of HOF studies based on best practices. Conclusion: International criteria are needed that define low and high-risk HOF studies, to allow identification of studies that can undergo an expedited (or exempted) process from those that need full IRB review. Enhancing IRB processes in such a way would be beneficial to the conduct of HOF studies. Greater knowledge and promotion of HOF methods and evidence-based HOF study designs may support the evolving discipline. Based on these insights, training and guidance to IRB members may be developed to support them in ensuring that appropriate ethical issues for HOF studies are considered.

“…On the other hand, codes of ethics from medical informatics address more specific guidance in informatics in addition to fundamental ethical principles. For example, both the International Medical Informatics Association (IMIA) code of ethics for health information professionals and the American Medical Informatics Association (AMIA) code of professional and ethical conduct provide ethical guidance regarding patient care, institutions and organizations, colleagues, and scientific research [7,8]. The principles of informatics and medical ethics, together, thus represent a core set of fundamental ideals relevant to any society, regardless of culture, and forming a system for moral reasoning and guidelines for professional ethics in medicine [9].…”

Section: Introductionmentioning

confidence: 99%

Ethics in Telehealth: Comparison between Guidelines and Practice-based Experience -the Case for Learning Health Systems

Hunter

Gogia²,

lyenger

et al. 2020

Self Cite

Objectives: To understand ethical issues within the telehealth domain, specifically how well established macro level telehealth guidelines map with micro level practitioner perspectives. Methods: We developed four overarching issues to use as a starting point for developing an ethical framework for telehealth. We then reviewed telemedicine ethics guidelines elaborated by the American Medical Association (AMA), the World Medical Association (WMA), and the telehealth component of the Health Professions council of South Africa (HPCSA). We then compared these guidelines with practitioner perspectives to identify the similarities and differences between them. Finally, we generated suggestions to bridge the gap between ethics guidelines and the micro level use of telehealth. Results: Clear differences emerged between the ethics guidelines and the practitioner perspectives. The main reason for the differences were the different contexts where telehealth was used, for example, variability in international practice and variations in the complexity of patient-provider interactions. Overall, published guidelines largely focus on macro level Keywords Ethics, telehealth, learning health system, informatics Yearb Med Inform 2020 http://dx.