Gobernanza de datos en salud: ética, privacidad y seguridad: parte 2

La gobernanza de datos es un requisito en el actual entorno de los sistemas de salud, en el cual las demandas ciudadanas en cuanto al acceso a los servicios de salud son temas prioritarios en las agendas de salud de los países latinoamericanos. Ahora que las organizaciones relacionadas a la salud, tienen la oportunidad de captar cantidades inmensas de datos internos y externos, estructurados y no estructurados, necesitan una disciplina que les permita maximizar su valor, gestionar riesgos y reducir costes. En este webinar, discutimos uno de los dominios claves dentro de la gobernanza de datos en salud como es la privacidad, seguridad y uso ético de los mismos, como uno de los temas más sensibles de actualidad y que han puesto en jaque a muchos de los sistemas de salud durante la pandemia de COVID-19.

Gobernanza de datos en salud: ética, privacidad y seguridad: parte 1

La gobernanza de datos es un requisito en el actual entorno de los sistemas de salud, en el cual las demandas ciudadanas en cuanto al acceso a los servicios de salud son temas prioritarios en las agendas de salud de los países latinoamericanos. Ahora que las organizaciones relacionadas a la salud, tienen la oportunidad de captar cantidades inmensas de datos internos y externos, estructurados y no estructurados, necesitan una disciplina que les permita maximizar su valor, gestionar riesgos y reducir costes. En este webinar, discutimos uno de los dominios claves dentro de la gobernanza de datos en salud como es la privacidad, seguridad y uso ético de los mismos, como uno de los temas más sensibles de actualidad y que han puesto en jaque a muchos de los sistemas de salud durante la pandemia de COVID-19.

Ethics and informatics in the age of COVID-19: challenges and recommendations for public health organization and public policy.

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.

Trust and medical AI: the challenges we face and the expertise needed to overcome them.

Artificial intelligence (AI) is increasingly of tremendous interest in the medical field. How-ever, failures of medical AI could have serious consequences for both clinical outcomes and the patient experience. These consequences could erode public trust in AI, which could in turn undermine trust in our healthcare institutions. This article makes 2 contributions. First, it describes the major conceptual, technical, and humanistic challenges in medical AI. Second, it proposes a solution that hinges on the education and accreditation of new expert groups who specialize in the development, verification, and operation of medical AI technologies. These groups will be required to maintain trust in our healthcare institutions.

Combatting human trafficking in the United States: how can medical informatics help?

OBJECTIVE: Human trafficking is a global problem taking many forms, including sex and labor exploitation. Trafficking victims can be any age, although most trafficking begins when victims are adolescents. Many trafficking victims have contact with health-care providers across various health-care contexts, both for emergency and routine care. MATERIALS AND METHODS: We propose 4 specific areas where medical informatics can assist with combatting trafficking: screening, clinical decision support, community-facing tools, and analytics that are both descriptive and predictive. Efforts to implement health information technology interventions focused on trafficking must be carefully integrated into existing clinical work and connected to community resources to move beyond identification to provide assistance and to support trauma-informed care. RESULTS: We lay forth a research and implementation agenda to integrate human trafficking identification and intervention into routine clinical practice, supported by health information technology. CONCLUSIONS: A sociotechnical systems approach is recommended to ensure interventions address the complex issues involved in assisting victims of human trafficking.

[Is COVID-19 a hype?] / Is covid-19 een hype?

The answer to the question whether COVID-19 is a hype or not depends on how we define a hype. The article loosely builds on philosophical discussions about hypes in knowledge work and information sciences. The central idea is to make clear that hypes always imply a certain overload of information and that the paradoxical outcome of this that it is not just information that is piling up but also disinformation. It is argued that it is in this sense (and only in this sense) that COVID-19 is a hype. How we respond to this hype depends very strongly on subjective sensitivities towards both information and desinformation.

REVISITING HEALTH INFORMATION TECHNOLOGY ETHICAL, LEGAL, and SOCIAL ISSUES and EVALUATION: TELEHEALTH/TELEMEDICINE and COVID-19.

BACKGROUND: Information technologies have been vital during the COVID-19 pandemic. Telehealth and telemedicine services, especially, fulfilled their promise by allowing patients to receive advice and care at a distance, making it safer for all concerned. Over the preceding years, professional societies, governments, and scholars examined ethical, legal, and social issues (ELSI) related to telemedicine and telehealth. Primary concerns evident from reviewing this literature have been quality of care, access, consent, and privacy. OBJECTIVES: To identify and summarize ethical, legal, and social issues related to information technology in healthcare, as exemplified by telehealth and telemedicine. To expand on prior analyses and address gaps illuminated by the COVID-19 experience. To propose future research directions. METHODS: Literature was identified through searches, forward and backward citation chaining, and the author's knowledge of scholars and works in the area. EU and professional organizations' guidelines, and nineteen scholarly papers were examined and categories created to identify ethical, legal, and social issues they addressed. A synthesis matrix was developed to categorize issues addressed by each source. RESULTS: A synthesis matrix was developed and issues categorized as: quality of care, consent and autonomy, access to care and technology, legal and regulatory, clinician responsibilities, patient responsibilities, changed relationships, commercialization, policy, information needs, and evaluation, with subcategories that fleshed out each category. The literature primarily addressed quality of care, access, consent, and privacy. Other identified considerations were little discussed. These and newer concerns include: usability, tailoring services to each patient, curriculum and training, implementation, commercialization, and licensing and liability. The need for interoperability, data availability, cybersecurity, and informatics infrastructure also is more apparent. These issues are applicable to other information technologies in healthcare. CONCLUSIONS: Clinicians and organizations need updated guidelines for ethical use of telemedicine and telehealth care, and decision- and policy-makers need evidence to inform decisions. The variety of newly implemented telemedicine services is an on-going natural experiment presenting an unparalleled opportunity to develop an evidence-based way forward. The paper recommends evaluation using an applied ethics, context-sensitive approach that explores interactions among multiple factors and considerations. It suggests evaluation questions to investigate ethical, social, and legal issues through multi-method, sociotechnical, interpretive and ethnographic, and interactionist evaluation approaches. Such evaluation can help telehealth, and other information technologies, be integrated into healthcare ethically and effectively.

Transparency of Health Informatics Processes as the Condition of Healthcare Professionals' and Patients' Trust and Adoption: the Rise of Ethical Requirements.

OBJECTIVES: To provide an introduction to the 2020 International Medical Informatics Association (IMIA) Yearbook by the editors. METHODS: This editorial provides an introduction and overview to the 2020 IMIA Yearbook which special topic is: "Ethics in Health Informatics". The keynote paper, the survey paper of the Special Topic section, and the paper about Donald Lindberg's ethical scientific openness in the History of Medical Informatics chapter of the Yearbook are discussed. Changes in the Yearbook Editorial Committee are also described. RESULTS: Inspired by medical ethics, ethics in health informatics progresses with the advances in biomedical informatics. With the wide use of EHRs, the enlargement of the care team perimeter, the need for data sharing for care continuity, the reuse of data for the sake of research, and the implementation of AI-powered decision support tools, new ethics requirements are necessary to address issues such as threats on privacy, confidentiality breaches, poor security practices, lack of patient information, tension on data sharing and reuse policies, need for more transparency on apps effectiveness, biased algorithms with discriminatory outcomes, guarantee on trustworthy AI, concerns on the re-identification of de-identified data. CONCLUSIONS: Despite privacy rules rooted in the Health Insurance Portability and Accountability Act of 1996 (HIPAA) in the USA and even more restrictive new regulations such as the EU General Data Protection Regulation published in May 2018, some people do not believe their data will be kept confidential and may not share sensitive information with a provider, which may also induce unethical situations. Transparency on healthcare data processes is a condition of healthcare professionals' and patients' trust and their adoption of digital tools.

Special Section on Ethics in Health Informatics.

OBJECTIVE: To summarize significant research contributions on ethics in medical informatics published in 2019. METHODS: An extensive search using PubMed/Medline was conducted to identify the scientific contributions published in 2019 that address ethics issues in medical informatics. The selection process comprised three steps: 1) 15 candidate best papers were first selected by the two section editors; 2) external reviewers from internationally renowned research teams reviewed each candidate best paper; and 3) the final selection of three best papers was conducted by the editorial committee of the Yearbook. RESULTS: The three selected best papers explore timely issues of concern to the community and demonstrate how ethics considerations influence applied informatics. CONCLUSION: With regard to ethics in informatics, data sharing and privacy remain primary areas of concern. Ethics issues related to the development and implementation of artificial intelligence is an emerging topic of interest.

Human-Computer Interaction, Ethics, and Biomedical Informatics.

OBJECTIVES: To provide an overview of recent work at the intersection of Biomedical Informatics, Human-Computer Interaction, and Ethics. METHODS: Search terms for Human-Computer Interaction, Biomedical Informatics, and Ethics were used to identify relevant papers published between 2017 and 2019.Relevant papers were identified through multiple methods, including database searches, manual reviews of citations, recent publications, and special collections, as well as through peer recommendations. Identified articles were reviewed and organized into broad themes. RESULTS: We identified relevant papers at the intersection of Biomedical Informatics, Human-Computer Interactions, and Ethics in over a dozen journals. The content of these papers was organized into three broad themes: ethical issues associated with systems in use, systems design, and responsible conduct of research. CONCLUSIONS: The results of this overview demonstrate an active interest in exploring the ethical implications of Human-Computer Interaction concerns in Biomedical Informatics. Papers emphasizing ethical concerns associated with patient-facing tools, mobile devices, social media, privacy, inclusivity, and e-consent reflect the growing prominence of these topics in biomedical informatics research. New questions in these areas will likely continue to arise with the growth of precision medicine and citizen science.

Clinical Information Systems - Seen through the Ethics Lens.

OBJECTIVE: The more people there are who use clinical information systems (CIS) beyond their traditional intramural confines, the more promising the benefits are, and the more daunting the risks will be. This review thus explores the areas of ethical debates prompted by CIS conceptualized as smart systems reaching out to patients and citizens. Furthermore, it investigates the ethical competencies and education needed to use these systems appropriately. METHODS: A literature review covering ethics topics in combination with clinical and health information systems, clinical decision support, health information exchange, and various mobile devices and media was performed searching the MEDLINE database for articles from 2016 to 2019 with a focus on 2018 and 2019. A second search combined these keywords with education. RESULTS: By far, most of the discourses were dominated by privacy, confidentiality, and informed consent issues. Intertwined with confidentiality and clear boundaries, the provider-patient relationship has gained much attention. The opacity of algorithms and the lack of explicability of the results pose a further challenge. The necessity of sociotechnical ethics education was underpinned in many studies including advocating education for providers and patients alike. However, only a few publications expanded on ethical competencies. In the publications found, empirical research designs were employed to capture the stakeholders' attitudes, but not to evaluate specific implementations. CONCLUSION: Despite the broad discourses, ethical values have not yet found their firm place in empirically rigorous health technology evaluation studies. Similarly, sociotechnical ethics competencies obviously need detailed specifications. These two gaps set the stage for further research at the junction of clinical information systems and ethics.

Notable Papers and Trends from 2019 in Sensors, Signals, and Imaging Informatics.

OBJECTIVE: To highlight noteworthy papers that are representative of 2019 developments in the fields of sensors, signals, and imaging informatics. METHOD: A broad literature search was conducted in January 2020 using PubMed. Separate predefined queries were created for sensors/signals and imaging informatics using a combination of Medical Subject Heading (MeSH) terms and keywords. Section editors reviewed the titles and abstracts of both sets of results. Papers were assessed on a three-point Likert scale by two co-editors, rated from 3 (do not include) to 1 (should be included). Papers with an average score of 2 or less were then read by all three section editors, and the group nominated top papers based on consensus. These candidate best papers were then rated by at least six external reviewers. RESULTS: The query related to signals and sensors returned a set of 255 papers from 140 unique journals. The imaging informatics query returned a set of 3,262 papers from 870 unique journals. Based on titles and abstracts, the section co-editors jointly filtered the list down to 50 papers from which 15 candidate best papers were nominated after discussion. A composite rating after review determined four papers which were then approved by consensus of the International Medical Informatics Association (IMIA) Yearbook editorial board. These best papers represent different international groups and journals. CONCLUSIONS: The four best papers represent state-of-the-art approaches for processing, combining, and analyzing heterogeneous sensor and imaging data. These papers demonstrate the use of advanced machine learning techniques to improve comparisons between images acquired at different time points, fuse information from multiple sensors, and translate images from one modality to another.

Ethics in Health Informatics.

Contemporary 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.

Ethical Use of Electronic Health Record Data and Artificial Intelligence: Recommendations of the Primary Care Informatics Working Group of the International Medical Informatics Association.

OBJECTIVE: To create practical recommendations for the curation of routinely collected health data and artificial intelligence (AI) in primary care with a focus on ensuring their ethical use. METHODS: We defined data curation as the process of management of data throughout its lifecycle to ensure it can be used into the future. We used a literature review and Delphi exercises to capture insights from the Primary Care Informatics Working Group (PCIWG) of the International Medical Informatics Association (IMIA). RESULTS: We created six recommendations: (1) Ensure consent and formal process to govern access and sharing throughout the data life cycle; (2) Sustainable data creation/collection requires trust and permission; (3) Pay attention to Extract-Transform-Load (ETL) processes as they may have unrecognised risks; (4) Integrate data governance and data quality management to support clinical practice in integrated care systems; (5) Recognise the need for new processes to address the ethical issues arising from AI in primary care; (6) Apply an ethical framework mapped to the data life cycle, including an assessment of data quality to achieve effective data curation. CONCLUSIONS: The ethical use of data needs to be integrated within the curation process, hence running throughout the data lifecycle. Current information systems may not fully detect the risks associated with ETL and AI; they need careful scrutiny. With distributed integrated care systems where data are often used remote from documentation, harmonised data quality assessment, management, and governance is important. These recommendations should help maintain trust and connectedness in contemporary information systems and planned developments.

[The responsibilities arising from the use of information and communication technologies in health professional practice]. / Las responsabilidades derivadas del uso de las tecnologías de la información y comunicación en el ejercicio de las profesiones sanitarias.

The increasing use of Information and Communication Technologies (ICT) in the health setting has given rise to the current phenomenon of eHealth or eMedicine, terms equivalent to the cyberspace concept, but refer exclusively to health. Due to the appearance of Web 2.0 it can be stated that we are dealing with a phenomenon much greater than just using the technologies: we are facing a real social change, giving rise to that called Health 2.0. The legal regulation of this cyberspace requires two different types of rules. Some that regulate cyberspace itself, and others, the actions performed with its use and to those that appear applicable to conventional law. In this latter case, we are referring to the applying of already existing laws to actions performed using ICT, as is the case of medical actions. Within these latter situations, two clearly different ones have to be distinguished: the professional responsibilities arising from medical actions carried out within health organisation settings when the use of ICT is introduced, and those other actions carried out voluntarily, individually and privately, using personal media and devices. It is in these types of actions where the legality, as regards data protection and privacy of the patient, appears to be violated, and at the same time the professional may be held responsible.

From Return of Information to Return of Value: Ethical Considerations when Sharing Individual-Level Research Data.

The implementation of digital health technologies into research studies for Alzheimer's disease and other clinical populations is on the rise. Digital tools and strategies create opportunities to further expand the framework for conducting research beyond the traditional medical research model. The combination of participatory and community-based research methods, electronic health records, and the creation of multi-dimensional, large-scale research platforms to support precision medicine, along with the Internet of Things era, have led to more engaged and informed research participants. Research participants increasingly possess an expectation they will play a critical role as partners in the design and conduct of research. Moreover, there is growing interest among research participants to have access to individual-level research data in real-time and/or at study completion. The traditional medical research model is largely one-directional where participants contribute data that is analyzed by researchers to yield generalizable knowledge. In this Ethics Review, we discuss a framework for a more nuanced intermediate research model, which is largely bidirectional and individually customized. Based on the seven ethical guidelines adopted by the National Institutes of Health, we speak to the ethical challenges of this intermediate type research. We also introduce a concept we are calling "MyTerms," in which prospective participants tailor the terms and conditions of informed consent to their personalized preferences for receiving information, including research results. Digital health technologies offer a convenient and flexible approach for researchers to develop protocols that make it possible for participants to obtain access to their study data in a personalized and meaningful way.

Research Data Disclosure in the Digital Age.

New advances in digital technologies and data-collection methods support expansion of the traditional research model in the current Digital Age. As researchers continue to explore ways to collect, manage, and share individual-level research study data, investigators must also acknowledge new ethical considerations that arise. To ensure protection of research participants, participants must remain a priority across the research continuum by researchers, institutional review boards, funding agencies, and consumers. Big data and data sharing also require additional investments and oversight to ensure proper management and, and even more important, protection of human subjects.

Toward an accelerated adoption of data-driven findings in medicine : Research, skepticism, and the need to speed up public visibility of data-driven findings.

To accelerate the adoption of a new method with a high potential to replace or extend an existing, presumably less accurate, medical scoring system, evaluation should begin days after the new concept is presented publicly, not years or even decades later. Metaphorically speaking, as chameleons capable of quickly changing colors to help their bodies adjust to changes in temperature or light, health-care decision makers should be capable of more quickly evaluating new data-driven insights and tools and should integrate the highest performing ones into national and international care systems. Doing so is essential, because it will truly save the lives of many individuals.

The ethics of mHealth: Moving forward.

There is great power and promise for mobile health (mHealth) technology in the realms of clinical practice and research. By offering the opportunity to reshape the interaction between clinician and patient or researcher and subject, the introduction of this technology allows clinicians and researchers access to larger quantities of more timely and reliable data. The potential developments are significant, and they are ethically relevant. With all technological developments, however, come new sets of ethical risks. In this paper, I assess the ethics of mHealth. I argue that while we have an ethical obligation to advance this work in order to further the quality and scope of care, the use of mHealth technology also presents challenges that must be addressed before and during the use of this technology. After describing the ethical landscape, I offer a pragmatic approach to meeting some of these challenges and minimizing ethical risk by switching from a privacy-centered frame to a consent-centered frame.