The evolution of Patient-Generated Health Data (PGHD) represents a major shift in healthcare, fueled by technological progress. The advent of PGHD, with technologies such as wearable devices and home monitoring systems, extends data collection beyond clinical environments, enabling continuous monitoring and patient engagement in their health management. Despite the growing prevalence of PGHD, there is a lack of clear understanding among stakeholders about its meaning, along with concerns about data security, privacy, and accuracy. This article aims to thoroughly review and clarify PGHD by examining its origins, types, technological foundations, and the challenges it faces, especially in terms of privacy and security regulations. The review emphasizes the role of PGHD in transforming healthcare through patient-centric approaches, their understanding, and personalized care, while also exploring emerging technologies and addressing data privacy and security issues, offering a comprehensive perspective on the current state and future directions of PGHD. The methodology employed for this review followed the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines and Rayyan, AI-Powered Tool for Systematic Literature Reviews. This approach ensures a systematic and comprehensive coverage of the available literature on PGHD, focusing on the various aspects outlined in the objective. The review encompassed 36 peer-reviewed articles from various esteemed publishers and databases, reflecting a diverse range of methodologies, including interviews, regular articles, review articles, and empirical studies to address three RQs exploratory, impact assessment, and solution-oriented questions related to PGHD. Additionally, to address the future-oriented fourth RQ for PGHD not covered in the above review, we have incorporated existing domain knowledge articles. This inclusion aims to provide answers encompassing both basic and advanced security measures for PGHD, thereby enhancing the depth and scope of our analysis.

Background: Recent studies demonstrate the potential of Artificial Intelligence to support diagnosis, mortality assessment, and clinical decisions in low-and-middle-income countries (LMICs). However, explicit evidence of strategies to overcome the particular challenges for transformed health systems in these countries does not exist.Objective: The present study undertakes a review of research on the current status of artificial intelligence (AI) to identify requirements, gaps, challenges, and possible strategies to strengthen the large, complex, and heterogeneous health systems in LMICs.Design: After introducing the general challenges developing countries face, the methodology of systematic reviews and the meta-analyses extension for scoping reviews (PRISMA-ScR) is introduced according to the preferred reporting items. Scopus and Web of Science databases were used to identify papers published between 2011–2022, from which we selected 151 eligible publications. Moreover, a narrative review was conducted to analyze the evidence in the literature about explicit evidence of strategies to overcome particular AI challenges in LMICs.Results: The analysis of results was divided into two groups: primary studies, which include experimental studies or case studies using or deploying a specific AI solution (n= 129), and secondary studies, including opinion papers, systematic reviews, and papers with strategies or guidelines (n= 22). For both study groups, a descriptive statistical analysis was performed describing their technological contribution, data used, health context, and type of health interventions. For the secondary studies group, an in-deep narrative review was performed, identifying a set of 40 challenges gathered in eight different categories: data quality, context awareness; regulation and legal frameworks; education and change resistance; financial resources; methodology; infrastructure and connectivity; and scalability. A total of 89 recommendations (at least one per challenge) were identified.Conclusion: Research on applying AI and ML to healthcare interventions in LMICs is growing; however, apart from very well-described ML methods and algorithms, there are several challenges to be addressed to scale and mainstream experimental and pilot studies. The main challenges include improving the quality of existing data sources, training and modeling AI solutions based on contextual data; and implementing privacy, security, informed consent, ethical, liability, confidentiality, trust, equity, and accountability policies. Also, robust eHealth environments with trained stakeholders, methodological standards for data creation, research reporting, product certification, sustained investment in data sharing, infrastructures, and connectivity are necessary.Systematic review registration: [https://rb.gy/frn2rz].

Digital health information systems (DHIS) are increasingly members of ecosystems, collecting, using and sharing a huge amount of personal health information (PHI), frequently without control and authorization through the data subject. From the data subject’s perspective, there is frequently no guarantee and therefore no trust that PHI is processed ethically in Digital Health Ecosystems. This results in new ethical, privacy and trust challenges to be solved. The authors’ objective is to find a combination of ethical principles, privacy and trust models, together enabling design, implementation of DHIS acting ethically, being trustworthy, and supporting the user’s privacy needs. Research published in journals, conference proceedings, and standards documents is analyzed from the viewpoint of ethics, privacy and trust. In that context, systems theory and systems engineering approaches together with heuristic analysis are deployed. The ethical model proposed is a combination of consequentialism, professional medical ethics and utilitarianism. Privacy enforcement can be facilitated by defining it as health information specific contextual intellectual property right, where a service user can express their own privacy needs using computer-understandable policies. Thereby, privacy as a dynamic, indeterminate concept, and computational trust, deploys linguistic values and fuzzy mathematics. The proposed solution, combining ethical principles, privacy as intellectual property and computational trust models, shows a new way to achieve ethically acceptable, trustworthy and privacy-enabling DHIS and Digital Health Ecosystems.

Machine learning has been proven to provide good performances on stress detection tasks using multi-modal sensor data from a smartwatch. Generally, machine learning techniques need a sufficient amount of data to train a robust model. Thus, we need to collect data from several users and send them to a central server to feed the algorithm. However, the uploaded data may contain sensitive information that can jeopardize the user’s privacy. Federated learning can tackle this challenge by enabling the model to be trained using data from all users without the user’s data leaving the user’s device. In this study, we implement federated learning-based stress detection and provide a comparative analysis between individual, centralized, and federated learning. The experiment was conducted on WESAD dataset by using Logistic Regression as the classifier. The experiment results show that in terms of accuracy, federated learning cannot reach the performance level of both individual and centralized learning. The individual learning strategy performs best with an average accuracy of 0.9998 and an average F₁-measure of 0.9996.

Summary Objectives: For improving safety and quality of care as well as efficiency of health delivery under the well-known burdens, health services become specialized, distributed, and therefore collaborative, thereby changing the health service paradigm from organization-centered over process-controlled to personal health (pHealth). Methods: Personalized eHealth services provided independent of time and location have to be based on advanced technical paradigms of mobile, pervasive and autonomous computing, enabling ubiquitous health services. Personalized eHealth systems require a multidiscipli-nary approach including medicine, informatics, biomedical engineering, bioinformatics and the omics disciplines but also legal and regulatory affairs, administration, security, privacy and ethics, etc. Interoperability between different components of the intended system must be provided through an architecture-centric, model-driven, formalized process. Results: In order to analyze, design, specify, implement and maintain such an interactive environment impacted by so many different domains, a formal and unified methodology for system analysis and design has been developed and deployed, based on an overall architectural framework. The paper introduces the underlying paradigms, requirements, architectural reference models, modeling and formalization principles as well as development processes for comprehensive service-oriented personalized eHealth inter-operability chains, thereby exploiting all inter-operability levels up to service interoperability. A special focus is put on ontologies and knowledge representation in the context of eHealth and pHealth solutions. Furthermore, EHR solutions, security requirements, existing and emerging standards, and educational challenges for realizing personalized pHealth are briefly discussed. Conclusion: For personal health, bridging between disciplines including ontology coordination is the crucial demand. All aspects of the design and development process have to be considered from an architectural viewpoint.

Objective: For realizing pervasive and ubiquitous health and social care services in a safe and high quality as well as efficient and effective way, health and social care systems have to meet new organizational, methodological, and technological paradigms. The resulting ecosystems are highly complex, highly distributed, and highly dynamic, following inter-organizational and even international approaches. Even though based on international, but domain-specific models and standards, achieving interoperability between such systems integrating multiple domains managed by multiple disciplines and their individually skilled actors is cumbersome. Methods: Using the abstract presentation of any system by the universal type theory as well as universal logics and combining the resulting Barendregt Cube with parameters and the engineering approach of cognitive theories, systems theory, and good modeling best practices, this study argues for a generic reference architecture model moderating between the different perspectives and disciplines involved provide on that system. To represent architectural elements consistently, an aligned system of ontologies is used. Results: The system-oriented, architecture-centric, and ontology-based generic reference model allows for re-engineering the existing and emerging knowledge representations, models, and standards, also considering the real-world business processes and the related development process of supporting IT systems for the sake of comprehensive systems integration and interoperability. The solution enables the analysis, design, and implementation of dynamic, interoperable multi-domain systems without requesting continuous revision of existing specifications.