Challenges and Solutions for Designing and Managing pHealth Ecosystems

For improving quality and safety of healthcare as well as efficiency and efficacy of care processes, health systems turn toward personalized, preventive, predictive, participative precision medicine. The related pHealth ecosystem combines different domains represented by a huge variety of different human and non-human actors belonging to different policy domains, coming from different disciplines. Those actors deploy different methodologies, terminologies, and ontologies, offering different levels of knowledge, skills, and experiences, acting in different scenarios and accommodating different business cases to meet the intended business objectives. Core challenge is the formal representation and management of multiple domains' knowledge. For correctly modeling such systems and their behavior, a system-oriented, architecture-centric, ontology-based, policy-driven approach is inevitable, thereby following established Good Modeling Best Practices. The ISO Interoperability Reference Architecture model and framework offers such approach. The paper describes and classifies the ongoing paradigm changes. It presents requirements and solutions for designing and implementing advanced pHealth ecosystems, thereby correctly adopting and integrating existing pHealth interoperability standards, specifications and projects

Health Information Systems in the Digital Health Ecosystem—Problems and Solutions for Ethics, Trust and Privacy

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

Selected Papers from the pHealth 2021 Conference, Genoa, Italy, 8-10 November 2021

This Special Issue of the Journal of Personalized Medicine presents extended versions of selected contributions to pHealth 2021, the 18th International Conference on Wearable Micro and Nano Technologies for Personalized Health, held on 8-10 November 2021 in Genoa, Italy [...]

How Does GDPR Support Healthcare Transformation to 5P Medicine?

Health systems advance towards personalized, preventive, predictive, participative precision (5P) medicine, considering the individual's health status, contexts and conditions. This results in fully distributed, highly dynamic, highly complex business systems and processes with multiple, comprehensively cooperating actors from different specialty and policy domains, using their specific methodologies, terminologies, ontologies, knowledge and skills. Rules and regulations governing the business process as well as the organizational, legal and individual conditions, thereby controlling the behavior of the system, are called policies. Trust and confidence needed for running such system are strongly impacted by security and privacy concerns controlled by corresponding policies. The most comprehensive policy dealing with security and privacy requirements and principles in any business collecting, processing and sharing personal identifiable information (PII) is the recently implemented European General Data Protection Regulation (GDPR). This paper investigates how GDPR supports healthcare transformation and how this can be implemented based on international standards and specifications

Interoperable EHR Systems – Challenges, Standards and Solutions

Background: Electronic Health Record Systems (EHRS) and Personal Health Record Systems (PHRS) are core components of infrastructure needed to run any health system. Objectives: As health systems undergo paradigm changes, EHRS and PHRS have to advance as well to meet the related interoperability challenges. Methods: The paper discusses EHR types, implementations and standards, starting with different requirements specifications, systems and systems architectures, standards and solutions. Results: Existing standards and specifications are compared with changing requirements, presenting weaknesses and defining the advancement of EHRS, architectures and related services, embedded in advanced infrastructure systems. Conclusion: Future EHR systems are components in a layered architecture with open interfaces. The need of verifying data models at business domains level is specifically highlighted. Such approach is enabled by the ISO Interoperability Reference Architecture of a systemoriented, architecture-centric, ontology-based, policy- driven approach, meeting good modeling best practices

Challenges and Solutions for Designing and Managing pHealth Ecosystems

For improving quality and safety of healthcare as well as efficiency and efficacy of care processes, health systems turn toward personalized, preventive, predictive, participative precision medicine. The related pHealth ecosystem combines different domains represented by a huge variety of different human and non-human actors belonging to different policy domains, coming from different disciplines. Those actors deploy different methodologies, terminologies, and ontologies, offering different levels of knowledge, skills, and experiences, acting in different scenarios and accommodating different business cases to meet the intended business objectives. Core challenge is the formal representation and management of multiple domains' knowledge. For correctly modeling such systems and their behavior, a system-oriented, architecture-centric, ontology-based, policy-driven approach is inevitable, thereby following established Good Modeling Best Practices. The ISO Interoperability Reference Architecture model and framework offers such approach. The paper describes and classifies the ongoing paradigm changes. It presents requirements and solutions for designing and implementing advanced pHealth ecosystems, thereby correctly adopting and integrating existing pHealth interoperability standards, specifications and projects

Reference Architecture Model Enabling Standards Interoperability

Advanced health and social services paradigms are supported by a comprehensive set of domains managed by different scientific disciplines. Interoperability has to evolve beyond information and communication technology (ICT) concerns, including the real world business domains and their processes, but also the individual context of all actors involved. So, the system must properly reflect the environment in front and around the computer as essential and even defining part of the health system. This paper introduces an ICT-independent system-theoretical, ontology-driven reference architecture model allowing the representation and harmonization of all domains involved including the transformation into an appropriate ICT design and implementation. The entire process is completely formalized and can therefore be fully automated