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. Georg Thieme Verlag KG Stuttgart.

Introduction

Ethical, Legal, and Social Issues (ELSI) in medical informatics grow in tandem with advances in digital health and computing technologies. The year 2019 was marked by critical debates and scholarship on privacy and data sharing related to personal health. First, the pervasive technology-enabled collection of all forms of data (health records, social media posts, geolocation, online and credit card purchases) from consumers led to proliferation of health care data economies 1 and raised questions about intended use and perhaps misuse of data, particularly by large corporations. Second, the widespread development of artificial intelligence (AI)-based applications for healthcare resulted in a push for effective and responsible ways of validating, governing, and regulating such systems 2 . Third, implementation of new regulations such as the General Data Protection Regulation (GDPR) 3 4 and the California Consumer Privacy Act (CCPA) in mid-2018 led to a renewed focus on balancing privacy and sharing of personal data. In addition to these developments, there was continued interest in addressing ELSI in secondary use of data for biomedical research, especially in the context of large consortium-based studies.

Methods

The literature search was performed on PubMed/Medline in January 2020. Search queries were developed for three publication categories: ethics journals (e.g., Science and Engineering Ethics), informatics journals (e.g., Journal of the American Medical Informatics Association), and biomedical journals (e.g., BMJ). Both controlled vocabulary terms (e.g., MeSH) and key words were used in the search queries. A manual search was performed on relevant journals not indexed in PubMed (e.g., Applied Clinical Informatics Open). The inclusion criteria were (1) papers published in English language between January 1, 2019 and December 31, 2019, and (2) topic is of relevance to ELSI and medical informatics. One of the section editors performed the search, which yielded a total of 460 references. Of these, 19 articles were selected based on initial screening of title and abstract. Both section editors reviewed the full text of the 19 articles and categorized them into three groups (accept, discuss, and discard) based on their originality, innovativeness, scientific and/or practical impact, and scientific quality. Fifteen articles that both section editors agreed to accept were submitted as candidate best papers.

In accordance with the International Medical Informatics Association (IMIA) Yearbook selection process, the 15 candidate best papers were further evaluated by the two section editors, the chief editor of the section, and by additional external reviewers (at least four reviewers per paper). The section editors identified potential commercial interests in two of the 15 papers, and one of the section editors (Petersen) is a co-author of one of the candidate best papers (Lehmann et al 5 ). To avoid bias in the review of the best paper candidates, neither the section editors nor the chief editor of the section reviewed this paper. Three papers were finally selected as best papers for the special section based on reviewer ratings ( Table 1 ). A content summary of the selected best papers can be found in the appendix of this synopsis.

Table 1

Best paper selection of articles for the IMIA Yearbook of Medical Informatics 2020 in the special section ‘Ethics in Health Informatics’. The articles are listed in alphabetical order of the first author’s surname.

SectionEthics in Health Informatics
▪ Antonio MG, Petrovskaya O, Lau F. Is research on patient portals attuned to health equity? A scoping review. J Am Med Inform Assoc 2019 Aug 1;26(8-9)871-83.
▪ Lehmann CU, Petersen C, Bhatia H, Berner ES, Goodman KW. Advance directives and code status information exchange: a consensus proposal for a minimum set of attributes. Camb Q Healthc Ethics 2019 Jan;28(1):178-85.
▪ Pisani AR, Kanuri N, Filbin B, Gallo C, Gould M, Lehmann LS, Levine R, Marcotte JE, Pascal B, Rousseau D, Turner S, Yen S, Ranney ML. Protecting user privacy and rights in academic data-sharing partnerships: principles from a pilot program at crisis text line. J Med Internet Res 2019 Jan 17;21(1):e11507.

Conclusions and Outlook

Although the number of candidate papers was quite small compared to some other areas of informatics, it is common that few papers in this area meeting the selection criteria are published annually. As is often the case in ethics, the search for a balance between the rights of individuals to retain autonomy and self-determination and the need for society to benefit from initiatives experienced collectively ( e.g ., healthcare) figured prominently. The continued evolution of patient-centered healthcare and precision medicine, in an environment of rapidly evolving technologies, is creating more opportunities for patients, practitioners, researchers, informaticians, and population health specialists to collaborate and explore new areas. It is unsurprising that robust debate around the appropriate use of personal data and medical knowledge would take place at the forefront of discussion.

In recent years, the majority of papers addressing ethical issues have tended to concentrate on privacy and data sharing. This proved to be the case in 2019. Among the 19 shortlisted papers, seven focused on various forms of data sharing and/or data use, five addressed privacy concerns, and one paper addressed both topic areas. Articles in the data sharing area explored a broad range of issues including passive data collection 6 ; [patient] participatory methods in data-intensive biomedical research 7 and disease surveillance 8 ; data management, use/re-use, and sharing internationally 9 and under the GDPR 10 ; posthumous data donation 11 ; and human protection with regard to data sharing 12 . Papers focused on privacy looked at the use and understanding of anonymization and de-identification practices in the literature 13 ; health information disclosure 14 ; balancing privacy and data use under the GDPR 15 ; activities that work against citizen and patient trust with regard to personal information 16 ; and terms of use violations by researchers accessing online patient information 17 . The paper addressing both data sharing and privacy, which was selected as a best paper of 2019, proposed guidelines for protection of user privacy and rights in academic data sharing partnerships through the analysis of a crisis text line pilot program 18 .

Though data sharing and privacy dominated the results, the search for papers related to ELSI uncovered an emerging area of concern: the appropriate use and governance of artificial intelligence (AI) in informatics. Four papers addressed various aspects of ethics in AI, including the appropriate development, validation, and implementation of AI in patient care 19 ; a proposed governance model for AI 20 ; support for citizen trust when AI is in use 21 ; and ethical issues related to the use of AI in psychiatry 22 . The ongoing development of methods for reliably using large, multimodal data sources, and the need for answers to clinical questions more quickly ( e.g ., successful treatments for particular conditions) ensure that AI will grow as a focus area for ethics within informatics. Should health care organizations around the world work together to solve shared challenges, such as the effective management of COVID-19 infection, concerns about the appropriate use and management of AI may prove to be the next Grand Challenge for ethics in informatics.

The search for best papers yielded papers on two additional topics, the role of health equity in research on patient portals 23 and considerations related to managing advance directives through the electronic health record 5 , both of which were selected as best papers of 2019. The former found that the burden of addressing barriers to portal use often are placed on patients who are already experiencing health inequities. The latter developed a minimum set of data elements for advance directives and code status information exchange among health systems.