Digital Interventions and Their Unexpected Outcomes - Time for Digitalovigilance?

The application of digital interventions in healthcare beyond research has been translated in the development of software as a medical device. Along with corresponding regulations for medical devices, there is a need for assessing adverse events to conduct post-market surveillance and to appropriately label digital health interventions to ensure proper use and patient safety. To date unexpected consequences of digital health interventions are neglected or ignored, or at least remain undescribed in literature. This paper is intended to raise awareness across the research community about these upcoming challenges. We recommend that - together with developing a new research field of digitalovigilance - a systematic assessment and monitoring of adverse events and unexpected interactions be included in clinical trials, along with the reporting of such events and the conduct of meta-analyses on critical aspects.

Telehealth and Technology: New Directions in Cancer Care.

ABSTRACT: Telehealth is a broad concept that refers to any delivery of health care in real time using technologies to connect people or information that are not in the same physical location. Until fairly recently, telehealth was more aspiration than reality. This situation changed radically due in part to the COVID-19 pandemic, which led to a near-overnight inability for patients to be seen for routine management of chronic health conditions, including those with cancer. The purpose of this brief narrative review is to outline some areas where emerging and future technology may allow for innovations with specific implications for people with a current or past diagnosis of cancer, including underserved and/or historically excluded populations. Specific topics of telehealth are broadly covered in other areas of the special issue.

How Participatory Health Informatics Catalyzes One Digital Health.

OBJECTIVE: To identify links between Participatory Health Informatics (PHI) and the One Digital Health framework (ODH) and to show how PHI could be used as a catalyst or contributor to ODH. METHODS: We have analyzed the addressed topics within the ODH framework in previous IMIA Yearbook contributions from our working group during the last 10 years. We have matched main themes with the ODH's framework three perspectives (individual health and wellbeing, population and society, and ecosystem). RESULTS: PHI catalysts ODH individual health and wellbeing perspective by providing a more comprehensive view on human health, attitudes, and relations between human health and animal health. Integration of specific behavior change techniques or gamification strategies in digital solutions are effective to change behaviors which address the P5 paradigm. PHI supports the population and society perspective through the engagement of the various stakeholders in healthcare. At the same time, PHI might increase a risk for health inequities due to technologies inaccessible to all equally and challenges associated with this. PHI is a catalyst for the ecosystem perspective by contributing data into the digital health data ecosystem allowing for analysis of interrelations between the various data which in turn might provide links among all components of the healthcare ecosystem. CONCLUSION: Our results suggest that PHI can and will involve topics relating to ODH. As the ODH concept crystalizes and becomes increasingly influential, its themes will permeate and become embedded in PHI even more. We look forward to these developments and co-evolution of the two frameworks.

Shifting into Action: from Data Segmentation to Equitable Interoperability for Adolescents (and Everyone Else).

BACKGROUND: Technological improvements and, subsequently, the federal 21st Century Cures Act have resulted in increased access to and interoperability of electronic protected health information (ePHI). These not only have many benefits, but also have created unique challenges for privacy and confidentiality for adolescent patients. The inability to granularly protect sensitive data and a lack of standards have resulted in limited confidentiality protection and inequitable access to health information. OBJECTIVES: This study aimed to understand the challenges to safe, equitable access, and interoperability of ePHI for adolescents and to identify strategies that have been developed, ongoing needs, and work in progress. METHODS: Shift, a national task force formalized in 2020, is a group of more than 200 expert stakeholder members working to improve functionality to standardize efforts to granularly identify and protect sensitive ePHI to promote equitable interoperability. RESULTS: Shift has created high-priority clinical use cases and organized challenges into the areas of Standards and Terminology; Usability and Implementation; and Ethics, Legal, and Policy. CONCLUSION: Current technical standards and value sets of terminology for sensitive data have been immature and inconsistent. Shift, a national diverse working group of stakeholders, is addressing challenges inherent in the protection of privacy and confidentiality for adolescent patients. The diversity of expertise and perspectives has been essential to identify and address these challenges.

The lived experience of people with disabilities during the COVID-19 pandemic on Twitter: Content analysis.

Objective: People with disabilities (PWDs) are at greater risk of COVID-19 infection, complications, and death, and experience more difficulty accessing care. We analyzed Twitter tweets to identify important topics and investigate health policies' effects on PWDs. Methods: Twitter's application programming interface was used to access its public COVID-19 stream. English-language tweets from January 2020 to January 2022 containing a combination of keywords related to COVID-19, disability, discrimination, and inequity were collected and refined to exclude duplicates, replies, and retweets. The remaining tweets were analyzed for user demographics, content, and long-term availability. Results: The collection yielded 94,814 tweets from 43,296 accounts. During the observation period, 1068 (2.5%) accounts were suspended and 1088 (2.5%) accounts were deleted. Account suspension and deletion among verified users tweeting about COVID-19 and disability were 0.13% and 0.3%, respectively. Emotions were similar among active, suspended, and deleted users, with general negative and positive emotions most common followed by sadness, trust, anticipation, and anger. The overall average sentiment for the tweets was negative. Ten of the 12 topics identified (96.8%) related to pandemic effects on PWDs; "politics that rejects and leaves the disabled, elderly, and children behind" (48.3%) and "efforts to support PWDs in the COVID crisis" (31.8%) were most common. The sample of tweets by organizations (43.9%) was higher for this topic than for other COVID-19-related topics the authors have investigated. Conclusions: The primary discussion addressed how pandemic politics and policies disadvantage PWDs, older adults, and children, and secondarily expressed support for these populations. The increased level of Twitter use by organizations suggests a higher level of organization and advocacy within the disability community than in other groups. Twitter may facilitate recognition of increased harm to or discrimination against specific populations such as people living with disability during national health events.

Defining and Scoping Participatory Health Informatics: An eDelphi Study.

BACKGROUND: Health care has evolved to support the involvement of individuals in decision making by, for example, using mobile apps and wearables that may help empower people to actively participate in their treatment and health monitoring. While the term "participatory health informatics" (PHI) has emerged in literature to describe these activities, along with the use of social media for health purposes, the scope of the research field of PHI is not yet well defined. OBJECTIVE: This article proposes a preliminary definition of PHI and defines the scope of the field. METHODS: We used an adapted Delphi study design to gain consensus from participants on a definition developed from a previous review of literature. From the literature we derived a set of attributes describing PHI as comprising 18 characteristics, 14 aims, and 4 relations. We invited researchers, health professionals, and health informaticians to score these characteristics and aims of PHI and their relations to other fields over three survey rounds. In the first round participants were able to offer additional attributes for voting. RESULTS: The first round had 44 participants, with 28 participants participating in all three rounds. These 28 participants were gender-balanced and comprised participants from industry, academia, and health sectors from all continents. Consensus was reached on 16 characteristics, 9 aims, and 6 related fields. DISCUSSION: The consensus reached on attributes of PHI describe PHI as a multidisciplinary field that uses information technology and delivers tools with a focus on individual-centered care. It studies various effects of the use of such tools and technology. Its aims address the individuals in the role of patients, but also the health of a society as a whole. There are relationships to the fields of health informatics, digital health, medical informatics, and consumer health informatics. CONCLUSION: We have proposed a preliminary definition, aims, and relationships of PHI based on literature and expert consensus. These can begin to be used to support development of research priorities and outcomes measurements.

Social Media, Digital Health Literacy, and Digital Ethics in the Light of Health Equity.

OBJECTIVE: Social media is used in the context of healthcare, for example in interventions for promoting health. Since social media are easily accessible they have potential to promote health equity. This paper studies relevant factors impacting on health equity considered in social media interventions. METHODS: We searched for literature to identify potential relevant factors impacting on health equity considered in social media interventions. We included studies that reported examples of health interventions using social media, focused on health equity, and analyzed health equity factors of social media. We identified Information about health equity factors and targeted groups. RESULTS: We found 17 relevant articles. Factors impacting on health equity reported in the included papers were extracted and grouped into three categories: digital health literacy, digital ethics, and acceptability. CONCLUSIONS: Literature shows that it is likely that digital technologies will increase health inequities associated with increased age, lower level of educational attainment, and lower socio-economic status. To address this challenge development of social media interventions should consider participatory design principles, visualization, and theories of social sciences.

Interventions for Increasing Digital Equity and Access (IDEA) among rural patients who smoke: Study protocol for a pragmatic randomized pilot trial.

BACKGROUND: Cigarette smoking prevalence is higher among rural compared with urban adults, yet access to cessation programming is reduced. The Increasing Digital Equity and Access (IDEA) study aims to evaluate three digital access and literacy interventions for promoting engagement with an online evidence-based smoking cessation treatment (EBCT) program among rural adults. METHODS: The pilot trial will use a pragmatic, three-arm, randomized, parallel-group design with participants recruited from a Midwest community-based health system in Minnesota, Wisconsin, and Iowa. All participants will receive an online, 12-week, EBCT program, and written materials on digital access resources. Participants will be stratified based on state of residence and randomly assigned with 1:1:1 allocation to one of three study groups: (1) Control Condition-no additional study intervention (n = 30); (2) Loaner Digital Device-Bluetooth enabled iPad with data plan coverage loaned for the study duration (n = 30); (3) Loaner Digital Device + Coaching Support-loaner device plus up to six, 15-20 min motivational interviewing-based coaching calls to enhance participants' digital access and literacy (n = 30). All participants will complete study assessments at baseline and 4- and 12-weeks post-randomization. Outcomes are cessation program and trial engagement, biochemically confirmed smoking abstinence, and patient experience. RESULTS: A rural community advisory committee was formed that fostered co-design of the study protocol for relevance to rural populations, including the trial design and interventions. CONCLUSION: Study findings, processes, and resources may have relevance to other health systems aiming to foster digital inclusion in smoking cessation and chronic disease management programs and clinical trials in rural communities.

Selecting venues for AMIA events and conferences: guiding ethical principles.

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.

Defining AMIA's artificial intelligence principles.

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.

Digital health & low-value care.

Digital health advances offer a multitude of possibilities to improve public health and individual wellbeing. Little attention has been paid, however, to digital health's potential to create low-value care - the reduction of which is increasingly appreciated as a policy priority. This commentary provides a framework to illustrate the potential for consumer-facing digital health to generate three distinct categories of low-value care; 1) ineffective care because it is underdeveloped, 2) inefficient care because it supplements rather than substitutes, or 3) unwanted care because it is not aligned with clinician and patient preferences. We offer specific policy recommendations to reduce each type of low-value care.

Defining participatory health informatics - a scoping review.

Healthcare has been shifting toward individuals participating in decision-making and empowered to be active in their treatment, and health monitoring. The term "participatory health informatics" (PHI) started to appear in literature. A clear definition of PHI is missing, and facets of PHI still have to be shaped. The objective of this paper is to offer a definition of PHI considering themes and technologies that make healthcare participatory. We searched Pubmed, ACM Digital Library, IEEE Xplore, EMBASE, and conference proceedings for articles that reported about use of information technology or informatics in the context of PHI. We performed qualitative synthesis and reported summary statistics. 39 studies were eligible after screening 382 titles and abstracts and reviewing 82 full texts. The top 5 person-centered key themes related to PHI included empowerment, decision-making, informed patient, collaboration, and disease management. Finally, we propose to define PHI as multidisciplinary field that uses information technology as provided through the web, smartphones, or wearables to increase participation of individuals in their care process and to enable them in self-care and shared decision-making. Goals to be achieved through PHI include maintaining health and well-being; improving the healthcare system and health outcomes; sharing experiences; achieving life goals; and self-education.

Recommendations for the safe, effective use of adaptive CDS in the US healthcare system: an AMIA position paper.

The development and implementation of clinical decision support (CDS) that trains itself and adapts its algorithms based on new data-here referred to as Adaptive CDS-present unique challenges and considerations. Although Adaptive CDS represents an expected progression from earlier work, the activities needed to appropriately manage and support the establishment and evolution of Adaptive CDS require new, coordinated initiatives and oversight that do not currently exist. In this AMIA position paper, the authors describe current and emerging challenges to the safe use of Adaptive CDS and lay out recommendations for the effective management and monitoring of Adaptive CDS.