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.

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.

Correction: Personalized Precision Medicine for Health Care Professionals: Development of a Competency Framework.

[This corrects the article DOI: 10.2196/43656.].

Personalized Precision Medicine for Health Care Professionals: Development of a Competency Framework.

BACKGROUND: Personalized precision medicine represents a paradigm shift and a new reality for the health care system in Spain, with training being fundamental for its full implementation and application in clinical practice. In this sense, health care professionals face educational challenges related to the acquisition of competencies to perform their professional practice optimally and efficiently in this new environment. The definition of competencies for health care professionals provides a clear guide on the level of knowledge, skills, and attitudes required to adequately carry out their professional practice. In this context, this acquisition of competencies by health care professionals can be defined as a dynamic and longitudinal process by which they use knowledge, skills, attitudes, and good judgment associated with their profession to develop it effectively in all situations corresponding to their field of practice. OBJECTIVE: This report aims to define a proposal of essential knowledge domains and common competencies for all health care professionals, which are necessary to optimally develop their professional practice within the field of personalized precision medicine as a fundamental part of the medicine of the future. METHODS: Based on a benchmark analysis and the input and expertise provided by a multidisciplinary group of experts through interviews and workshops, a new competency framework that would guarantee the optimal performance of health care professionals was defined. As a basis for the development of this report, the most relevant national and international competency frameworks and training programs were analyzed to identify aspects that are having an impact on the application of personalized precision medicine and will be considered when developing professional competencies in the future. RESULTS: This report defines a framework made up of 58 competencies structured into 5 essential domains: determinants of health, biomedical informatics, practical applications, participatory health, and bioethics, along with a cross-cutting domain that impacts the overall performance of the competencies linked to each of the above domains. Likewise, 6 professional profiles to which this proposal of a competency framework is addressed were identified according to the area where they carry out their professional activity: health care, laboratory, digital health, community health, research, and management and planning. In addition, a classification is proposed by progressive levels of training that would be advisable to acquire for each competency according to the professional profile. CONCLUSIONS: This competency framework characterizes the knowledge, skills, and attitudes required by health care professionals for the practice of personalized precision medicine. Additionally, a classification by progressive levels of training is proposed for the 6 professional profiles identified according to their professional roles.

Towards the European Health Data Space (EHDS) ecosystem: A survey research on future health data scenarios.

OBJECTIVE: The European Health Data Space (EHDS) aims to provide better exchange and expand access to health data across Europe. In this way, the EHDS will support healthcare delivery (known as the "primary use of data") and facilitate access to health data for research and policy-making purposes (known as the "secondary use of data"). To achieve this goal, we need to build the required ecosystem of the EHDS with all healthcare stakeholders. MATERIALS AND METHODS: We conducted a survey research study to explore the health informaticians' recommendations on future health data scenarios shaping the EHDS ecosystem. We created an anonymous- online questionnaire and disseminated it through wide international networks of health informaticians. In addition, we conducted a workshop during the Medical Informatics Europe Conference (MIE2022) and invited the attendees to complete the questionnaire during the workshop. RESULTS: We received 43 responses to our questionnaire from 15 European Union (EU) countries and 7 non-EU countries. Most respondents described the current health data scenario in their countries as a traditional healthcare system with moderate growth (25.6 %, n = 11). The second selected scenario was the reinventing healthcare scenario in a data-driven one-world framework (23.3 %, n = 10). DISCUSSION: The results of this work are matched with the findings of the recently published study on digital health implementation in the EU (conducted by the French government in April 2022). This also reflects the current ongoing efforts in the EU countries to deploy national infrastructure for health data management, exchange, and sharing. CONCLUSIONS: Upon the respondents' recommendations, there is a strong need to support the health democratization scenarios in Europe, as the main driver for building the EHDS ecosystem.

Recommendations of the International Medical Informatics Association (IMIA) on Education in Biomedical and Health Informatics: Second Revision.

BACKGROUND: The purpose of educational recommendations is to assist in establishing courses and programs in a discipline, to further develop existing educational activities in the various nations, and to support international initiatives for collaboration and sharing of courseware. The International Medical Informatics Association (IMIA) has published two versions of its international recommendations in biomedical and health informatics (BMHI) education, initially in 2000 and revised in 2010. Given the recent changes to the science, technology, the needs of the healthcare systems, and the workforce of BMHI, a revision of the recommendations is necessary. OBJECTIVE: The aim of these updated recommendations is to support educators in developing BMHI curricula at different education levels, to identify essential skills and competencies for certification of healthcare professionals and those working in the field of BMHI, to provide a tool for evaluators of academic BMHI programs to compare and accredit the quality of delivered programs, and to motivate universities, organizations, and health authorities to recognize the need for establishing and further developing BMHI educational programs. METHOD: An IMIA taskforce, established in 2017, updated the recommendations. The taskforce included representatives from all IMIA regions, with several having been involved in the development of the previous version. Workshops were held at different IMIA conferences, and an international Delphi study was performed to collect expert input on new and revised competencies. RESULTS: Recommendations are provided for courses/course tracks in BMHI as part of educational programs in biomedical and health sciences, health information management, and informatics/computer science, as well as for dedicated programs in BMHI (leading to bachelor's, master's, or doctoral degree). The educational needs are described for the roles of BMHI user, BMHI generalist, and BMHI specialist across six domain areas - BMHI core principles; health sciences and services; computer, data and information sciences; social and behavioral sciences; management science; and BMHI specialization. Furthermore, recommendations are provided for dedicated educational programs in BMHI at the level of bachelor's, master's, and doctoral degrees. These are the mainstream academic programs in BMHI. In addition, recommendations for continuing education, certification, and accreditation procedures are provided. CONCLUSION: The IMIA recommendations reflect societal changes related to globalization, digitalization, and digital transformation in general and in healthcare specifically, and center on educational needs for the healthcare workforce, computer scientists, and decision makers to acquire BMHI knowledge and skills at various levels. To support education in BMHI, IMIA offers accreditation of quality BMHI education programs. It supports information exchange on programs and courses in BMHI through its Working Group on Health and Medical Informatics Education.

Relationship between Prenatal or Postnatal Exposure to Pesticides and Obesity: A Systematic Review.

In recent years, the worldwide prevalence of overweight and obesity among adults and children has dramatically increased. The conventional model regarding the onset of obesity is based on an imbalance between energy intake and expenditure. However, other possible environmental factors involved, such as the exposure to chemicals like pesticides, cannot be discarded. These compounds could act as endocrine-disrupting chemicals (EDC) that may interfere with hormone activity related to several mechanisms involved in body weight control. The main objective of this study was to systematically review the data provided in the scientific literature for a possible association between prenatal and postnatal exposure to pesticides and obesity in offspring. A total of 25 human and 9 animal studies were analyzed. The prenatal, perinatal, and postnatal exposure to organophosphate, organochlorine, pyrethroid, neonicotinoid, and carbamate, as well as a combined pesticide exposure was reviewed. This systematic review reveals that the effects of pesticide exposure on body weight are mostly inconclusive, finding conflicting results in both humans and experimental animals. The outcomes reviewed are dependent on many factors, including dosage and route of administration, species, sex, and treatment duration. More research is needed to effectively evaluate the impact of the combined effects of different pesticides on human health.

Relationship between Autism Spectrum Disorder and Pesticides: A Systematic Review of Human and Preclinical Models.

Autism spectrum disorder (ASD) is a complex set of neurodevelopmental pathologies characterized by impoverished social and communicative abilities and stereotyped behaviors. Although its genetic basis is unquestionable, the involvement of environmental factors such as exposure to pesticides has also been proposed. Despite the systematic analyses of this relationship in humans, there are no specific reviews including both human and preclinical models. The present systematic review summarizes, analyzes, and discusses recent advances in preclinical and epidemiological studies. We included 45 human and 16 preclinical studies. These studies focused on Organophosphates (OP), Organochlorine (OC), Pyrethroid (PT), Neonicotinoid (NN), Carbamate (CM), and mixed exposures. Preclinical studies, where the OP Chlorpyrifos (CPF) compound is the one most studied, pointed to an association between gestational exposure and increased ASD-like behaviors, although the data are inconclusive with regard to other ages or pesticides. Studies in humans focused on prenatal exposure to OP and OC agents, and report cognitive and behavioral alterations related to ASD symptomatology. The results of both suggest that gestational exposure to certain OP agents could be linked to the clinical signs of ASD. Future experimental studies should focus on extending the analysis of ASD-like behaviors in preclinical models and include exposure patterns similar to those observed in human studies.

The International Academy of Health Sciences Informatics (IAHSI): 2020 Report.

OBJECTIVES: To summarize the major activities of the International Academy of Health Sciences Informatics (IAHSI) in the 2020 time period and to welcome its 2020 Class of Fellows. METHOD: Report from the members of the Academy's Board. RESULTS: Due to the SARS-CoV-2 pandemic, both Plenary meetings in 2020 had to be organized as virtual meetings. Scientific discussions, focusing on mobilizing computable biomedical knowledge and on data standards and interoperability formed major parts of these meetings. A statement on the use of informatics in pandemic situations was elaborated and sent to the World Health Organization. A panel on data standards and interoperability started its work. 34 Fellows were welcomed in the 2020 Class of Fellows so that the Academy now consists of 179 members. CONCLUSIONS: There was a shift from supporting to strategic activities in the Academy's work. After having achieved organizational stability, the Academy can now focus on its strategic work and so on its main objective.

International Academy of Health Sciences Informatics (IAHSI): Strategy and Focus Areas, 1st Version.

BACKGROUND: The International Academy of Health Sciences Informatics (IAHSI) is the Academy of the International Medical Informatics Association (IMIA). As an international forum for peers in biomedical and health informatics, the Academy shall play an important role in exchanging knowledge, providing education and training, and producing policy documents. OBJECTIVES: A major priority of the Academy's activities in its inaugural phase was to define its strategy and focus areas in accordance with its objectives and to prioritize the Academy's work, which can then be transferred to respective taskforces. METHOD: This document reflects the major outcomes of intensive discussions that occurred during 2019. It was presented at the Academy's 3rd Plenary on August 25th, 2019, in Lyon, France. RESULTS: Regardless of the 'living nature' of the strategy and focus areas document, it was concluded during the Plenary that the first version, which will be used as a base for decisions on the Academy's future activities, should be made available to a broad audience. Three out of eight 'Visions for IAHSI', presented in the IMIA Yearbook of Medical Informatics 2018, were identified as central for developing, implementing, and evaluating the Academy's strategic directions: (1) advise governments and organizations on developing health and health sciences through informatics, (2) stimulate progress in biomedical and health informatics research, education, and practice, and (3) share and exchange knowledge. Taskforces shall be implemented to work in the following areas, which were considered as priority themes: (1) artificial intelligence in health: future collaboration of entities with natural and with artificial intelligence in health care, and (2) current landscape of standards for digital health. CONCLUSIONS: Taskforces are now being established. Besides specific key performance indicators, suggested for monitoring the work of theses taskforces, the strategy to monitor the progress of the Academy itself has to be measured by relevant and acceptable metrics.

The International Academy of Health Sciences Informatics (IAHSI): IMIAs Academy is Now Established and on Track.

OBJECTIVES: To summarize the major activities of the International Academy of Health Sciences Informatics (IAHSI) from 2018 until 2019, and to provide an outline of actions planned for 2020. METHOD: Reporting about these activities and actions by the members of the Academy's first Board. RESULTS: Academy bylaws were accepted by the Academy Plenary and the IMIA General Assembly on August 25th, 2019 and August 26th, 2019, respectively. Academy's strategy and focus areas were developed. Based on the Academy's eligibility criteria, the 2018/2019 Class made of 26 new Academy Fellows was elected. Future activities will concentrate on building taskforces for developing and implementing major Academy focus areas. CONCLUSIONS: We are glad to report that the Academy is strong and thriving.

Progress in Characterizing the Human Exposome: a Key Step for Precision Medicine.

OBJECTIVE: Most diseases result from the complex interplay between genetic and environmental factors. The exposome can be defined as a systematic approach to acquire large data sets corresponding to environmental exposures of an individual along her/ his life. The objective of this contribution is to raise awareness within the health informatics community about the importance of dealing with data related to the contribution of environmental factors to individual health, particularly in the context of precision medicine informatics. METHODS: This article summarizes the main findings after a panel organized by the International Medical Informatics Association - Exposome Informatics Working Group held during the last MEDINFO, in Lyon (France) in August 2019. RESULTS: The members of our community presented four initiatives (PULSE, Digital exposome, Cloudy with a chance of pain, Wearable clinics), providing a detailed view of current challenges and accomplishments in processing environmental and social data from a health research perspective. Projects illustrate a wide range of research methods, digital data collection technologies, and analytics and visualization tools. This reinforces the idea that this area is now ready for health informaticians to step in and contribute their expertise, leading the application of informatics strategies to understand environmental health problems. CONCLUSIONS: The featured projects illustrate applications that use exposome data for the investigation of the causes of diseases, health care, patient empowerment, and public health. They offer a rich overview of the expanding range of applications that informatics is finding in the field of environmental health, with potential impact in precision medicine.

An Archetype Query Language interpreter into MongoDB: Managing NoSQL standardized Electronic Health Record extracts systems.

The fast development of today's healthcare and the need to extract new medical knowledge from exponentially-growing volumes of standardized Electronic Health Records data, as required by studies in Precision Medicine, brings up a challenge that may probably only be addressed using NoSQL DBMSs, due to the non-optimal performance of traditional relational DBMSs on standardized data; and these database systems operated by semantic archetype-based query languages, because of the expected generalized extension of standardized EHR systems. An AQL into MongoDB interpreter has been developed to its first version. It translates system-independent AQL queries posed on ISO/EN 13606 standardized EHR extracts into the NoSQL MongoDB query language. The new interpreter has the advantages of both the archetype-based system-independent AQL queries and the dual-model-based standardized EHR extracts stored on document-centric NoSQL DBMSs, such as MongoDB. AQL queries are independent of applications, programming languages and system environments due to the use of the dual model, but EHR extracts featuring this model are best persisted on document-based NoSQL databases. Consequently, the interpreter allows us to query standardized EHR extracts semantically, and also affording optimal performance.

TASoMe: Validating a Framework to Generate Evidence About Health Outcomes from Social Media Use.

Research surrounding social media's impact on patient-reported health outcomes continues to emerge. However, an ongoing challenge for researchers is generating valid and reliable evidence that draws upon rigorous frameworks. This manuscript details the development and refinement of a framework that defines criteria and methods for generating and evaluating evidence about social media use in chronic disease management; the Therapeutic Affordances of Social Media (TASoMe) framework. TASoMe was built through the considered combination of mixed research methods and data collection instruments. It represents a systematic methodology for conducting research that brings together the key concepts of: therapeutic affordances, patient-reported outcomes, and evidence-based practice to generate evidence about health outcomes from social media use. Its key building blocks include: the key research concepts, research methods, and stakeholders standing to benefit from outcomes. TASoMe contributes to the field of participatory health informatics by offering a stringent and reliable model for advancing research and practice. It has begun to be independently validated across a range of health conditions, and has the potential to be applied to a range of participatory health informatics technologies.

Development and Validation of a Taxonomy for Characterizing Measurements in Health Self-Quantification.

BACKGROUND: The use of wearable tools for health self-quantification (SQ) introduces new ways of thinking about one's body and about how to achieve desired health outcomes. Measurements from individuals, such as heart rate, respiratory volume, skin temperature, sleep, mood, blood pressure, food consumed, and quality of surrounding air can be acquired, quantified, and aggregated in a holistic way that has never been possible before. However, health SQ still lacks a formal common language or taxonomy for describing these kinds of measurements. Establishing such taxonomy is important because it would enable systematic investigations that are needed to advance in the use of wearable tools in health self-care. For a start, a taxonomy would help to improve the accuracy of database searching when doing systematic reviews and meta-analyses in this field. Overall, more systematic research would contribute to build evidence of sufficient quality to determine whether and how health SQ is a worthwhile health care paradigm. OBJECTIVE: The aim of this study was to investigate a sample of SQ tools and services to build and test a taxonomy of measurements in health SQ, titled: the classification of data and activity in self-quantification systems (CDA-SQS). METHODS: Eight health SQ tools and services were selected to be examined: Zeo Sleep Manager, Fitbit Ultra, Fitlinxx Actipressure, MoodPanda, iBGStar, Sensaris Senspod, 23andMe, and uBiome. An open coding analytical approach was used to find all the themes related to the research aim. RESULTS: This study distinguished three types of measurements in health SQ: body structures and functions, body actions and activities, and around the body. CONCLUSIONS: The CDA-SQS classification should be applicable to align health SQ measurement data from people with many different health objectives, health states, and health conditions. CDA-SQS is a critical contribution to a much more consistent way of studying health SQ.

Research Strategies for Biomedical and Health Informatics. Some Thought-provoking and Critical Proposals to Encourage Scientific Debate on the Nature of Good Research in Medical Informatics.

BACKGROUND: Medical informatics, or biomedical and health informatics (BMHI), has become an established scientific discipline. In all such disciplines there is a certain inertia to persist in focusing on well-established research areas and to hold on to well-known research methodologies rather than adopting new ones, which may be more appropriate. OBJECTIVES: To search for answers to the following questions: What are research fields in informatics, which are not being currently adequately addressed, and which methodological approaches might be insufficiently used? Do we know about reasons? What could be consequences of change for research and for education? METHODS: Outstanding informatics scientists were invited to three panel sessions on this topic in leading international conferences (MIE 2015, Medinfo 2015, HEC 2016) in order to get their answers to these questions. RESULTS: A variety of themes emerged in the set of answers provided by the panellists. Some panellists took the theoretical foundations of the field for granted, while several questioned whether the field was actually grounded in a strong theoretical foundation. Panellists proposed a range of suggestions for new or improved approaches, methodologies, and techniques to enhance the BMHI research agenda. CONCLUSIONS: The field of BMHI is on the one hand maturing as an academic community and intellectual endeavour. On the other hand vendor-supplied solutions may be too readily and uncritically accepted in health care practice. There is a high chance that BMHI will continue to flourish as an important discipline; its innovative interventions might then reach the original objectives of advancing science and improving health care outcomes.

Person-generated Data in Self-quantification. A Health Informatics Research Program.

OBJECTIVES: The availability of internet-connected mobile, wearable and ambient consumer technologies, direct-to-consumer e-services and peer-to-peer social media sites far outstrips evidence about the efficiency, effectiveness and efficacy of using them in healthcare applications. The aim of this paper is to describe one approach to build a program of health informatics research, so as to generate rich and robust evidence about health data and information processing in self-quantification and associated healthcare and health outcomes. METHODS: The paper summarises relevant health informatics research approaches in the literature and presents an example of developing a program of research in the Health and Biomedical Informatics Centre (HaBIC) at the University of Melbourne. The paper describes this program in terms of research infrastructure, conceptual models, research design, research reporting and knowledge sharing. RESULTS: The paper identifies key outcomes from integrative and multiple-angle approaches to investigating the management of information and data generated by use of this Centre's collection of wearable, mobiles and other devices in health self-monitoring experiments. These research results offer lessons for consumers, developers, clinical practitioners and biomedical and health informatics researchers. CONCLUSIONS: Health informatics is increasingly called upon to make sense of emerging self-quantification and other digital health phenomena that are well beyond the conventions of healthcare in which the field of informatics originated and consolidated. To make a substantial contribution to optimise the aims, processes and outcomes of health self-quantification needs further work at scale in multi-centre collaborations for this Centre and for health informatics researchers generally.

Refining the Concepts of Self-quantification Needed for Health Self-management. A Thematic Literature Review.

BACKGROUND: Questions like 'How is your health? How are you feeling? How have you been?' now can be answered in a different way due to innovative health self-quantification apps and devices. These apps and devices generate data that enable individuals to be informed and more responsible about their own health. OBJECTIVES: The aim of this paper is to review studies on health SQ, firstly, exploring the concepts that are associated with the users' interaction with and around data for managing health; and secondly, the potential benefits and challenges that are associated with the use of such data to maintain or promote health, as well as their impact on the users' certainty or confidence in taking effective actions upon such data. METHODS: To answer these questions, we conducted a comprehensive literature review to build our study sample. We searched a number of electronic bibliographic databases including Scopus, Web of Science, Medline, and Google Scholar. Thematic analysis was conducted for each study to find all the themes that are related to our research aims. RESULTS: In the reviewed literature, conceptualisation of health SQ is messy and inconsistent. Personal tracking, personal analytics, personal experimentation, and personal health activation are different concepts within the practice of health SQ; thus, a new definition and structure is proposed to set out boundaries between them. Using the data that are generated by SQS for managing health has many advantages but also poses many challenges. CONCLUSIONS: Inconsistency in conceptualisation of health SQ - as well as the challenges that users experience in health self-management - reveal the need for frameworks that can describe the users' health SQ practice in a holistic and consistent manner. Our ongoing work toward developing these frameworks will help researchers in this domain to gain better understanding of this practice, and will enable more systematic investigations which are needed to improve the use of SQS and their data in health self-management.