The Representational Challenge for Designing and Managing 5P Medicine Ecosystems.

Health and social care systems around the globe currently undergo a transformation towards personalized, preventive, predictive, participative precision medicine (5PM), considering the individual health status, conditions, genetic and genomic dispositions, etc., in personal, social, occupational, environmental and behavioral context. This transformation is strongly supported by technologies such as micro- and nanotechnologies, advanced computing, artificial intelligence, edge computing, etc. For enabling communication and cooperation between actors from different domains using different methodologies, languages and ontologies based on different education, experiences, etc., we have to understand the transformed health ecosystems and all its components in structure, function and relationships in the necessary detail ranging from elementary particles up to the universe. That way, we advance design and management of the complex and highly dynamic ecosystem from data to knowledge level. The challenge is the consistent, correct and formalized representation of the transformed health ecosystem from the perspectives of all domains involved, representing and managing them based on related ontologies. The resulting business view of the real-world ecosystem must be interrelated using the ISO/IEC 21838 Top Level Ontologies standard. Thereafter, the outcome can be transformed into implementable solutions using the ISO/IEC 10746 Open Distributed Processing Reference Model. Model and framework for this system-oriented, architecture-centric, ontology-based, policy-driven approach have been developed by the first author and meanwhile standardized as ISO 23903 Interoperability and Integration Reference Architecture.

Principles and Standards for Designing and Managing Integrable and Interoperable Transformed Health Ecosystems.

The advancement of sciences and technologies, economic challenges, increasing expectations, and consumerism result in a radical transformation of health and social care around the globe, characterized by foundational organizational, methodological, and technological paradigm changes. The transformation of the health and social care ecosystems aims at ubiquitously providing personalized, preventive, predictive, participative precision (5P) medicine, considering and understanding the individual's health status in a comprehensive context from the elementary particle up to society. For designing and implementing such advanced ecosystems, an understanding and correct representation of the structure, function, and relations of their components is inevitable, thereby including the perspectives, principles, and methodologies of all included disciplines. To guarantee consistent and conformant processes and outcomes, the specifications and principles must be based on international standards. A core standard for representing transformed health ecosystems and managing the integration and interoperability of systems, components, specifications, and artifacts is ISO 23903:2021, therefore playing a central role in this publication. Consequently, ISO/TC 215 and CEN/TC 251, both representing the international standardization on health informatics, declared the deployment of ISO 23903:2021 mandatory for all their projects and standards addressing more than one domain. The paper summarizes and concludes the first author's leading engagement in the evolution of pHealth in Europe and beyond over the last 15 years, discussing the concepts, principles, and standards for designing, implementing, and managing 5P medicine ecosystems. It not only introduces the theoretical foundations of the approach but also exemplifies its deployment in practical projects and solutions regarding interoperability and integration in multi-domain ecosystems. The presented approach enables comprehensive and consistent integration of and interoperability between domains, systems, related actors, specifications, standards, and solutions. That way, it should help overcome the problems and limitations of data-centric approaches, which still dominate projects and products nowadays, and replace them with knowledge-centric, comprehensive, and consistent ones.

Designing and Managing Advanced, Intelligent and Ethical Health and Social Care Ecosystems.

The ongoing transformation of health systems around the world aims at personalized, preventive, predictive, participative precision medicine, supported by technology. It considers individual health status, conditions, and genetic and genomic dispositions in personal, social, occupational, environmental and behavioral contexts. In this way, it transforms health and social care from art to science by fully understanding the pathology of diseases and turning health and social care from reactive to proactive. The challenge is the understanding and the formal as well as consistent representation of the world of sciences and practices, i.e., of multidisciplinary and dynamic systems in variable context. This enables mapping between the different disciplines, methodologies, perspectives, intentions, languages, etc., as philosophy or cognitive sciences do. The approach requires the deployment of advanced technologies including autonomous systems and artificial intelligence. This poses important ethical and governance challenges. This paper describes the aforementioned transformation of health and social care ecosystems as well as the related challenges and solutions, resulting in a sophisticated, formal reference architecture. This reference architecture provides a system-theoretical, architecture-centric, ontology-based, policy-driven model and framework for designing and managing intelligent and ethical ecosystems in general and health ecosystems in particular.

Future pHealth Ecosystem-Holistic View on Privacy and Trust.

Modern pHealth is an emerging approach to collecting and using personal health information (PHI) for personalized healthcare and personalized health management. For its products and services, it deploys advanced technologies such as sensors, actuators, computers, mobile phones, etc. Researchers have shown that today's networked information systems, such as pHealth ecosystems, miss appropriate privacy solutions, and trust is only an illusion. In the future, the situation will be even more challenging because pHealth ecosystems will be highly distributed, dynamic, increasingly autonomous, and multi-stakeholder, with the ability to monitor the person's regular life, movements, emotions, and health-related behavior in real time. In this paper, the authors demonstrate that privacy and trust in ecosystems are system-level problems that need a holistic, system-focused solution. To make future pHealth ethically acceptable, privacy-enabled, and trustworthy, the authors have developed a conceptual five-level privacy and trust model as well as a formula that describes the impact of privacy and trust factors on the level of privacy and trust. Furthermore, the authors have analyzed privacy and trust challenges and possible solutions at each level of the model. Based on the analysis performed, a proposal for future ethically acceptable, trustworthy, and privacy-enabled pHealth is developed. The solution combines privacy as personal property and trust as legally binding fiducial duty approaches and uses a blockchain-based smart contract agreement to store people's privacy and trust requirements and service providers' promises.

Standards and Principles to Enable Interoperability and Integration of 5P Medicine Ecosystems.

Health and social care ecosystems are currently a matter of foundational organizational, methodological and technological paradigm changes towards personalized, preventive, predictive, participative precision (5P) medicine. For designing and implementing such advanced ecosystems, an understanding and correct representation of structure, function and relations of their components is inevitable. To guarantee consistent and conformant processes and outcomes, the specifications and principles must be internationally standardized. Summarizing the first author's Keynotes over the last 15 years of pHealth conferences, the paper discusses concepts, standards and principles of 5P medicine ecosystems including their design and implementation. Furthermore, a guidance to find and to deploy corresponding international standards in practical projects is provided.

Privacy and Trust in pHealth - Past, Present and Future.

From beginning to today, pHealth has been a data driven service that collects and uses personal health information (PHI) for personal health services and personalized healthcare. As a result, pHealth services use intensively ICT technology, sensors, computers and mathematical algorithms. In past, pHealth applications were focused to certain health or sickness related problem, but in today they use mobile devices, wireless networks, Web-technology and Cloud platforms. In future, pHealth uses information systems that are highly distributed, dynamic, increasingly autonomous, multi-stakeholder data driven eco-system having ability to monitor anywhere person's regular life, movements and health related behaviours. Because privacy and trust are pre-requirements for successful pHealth, this development raises huge privacy and trust challenges to be solved. Researchers have shown that current privacy approaches and solutions used in pHealth do not offer acceptable level of privacy, and trust is only an illusion. This indicates, that today's privacy models and technology shall not be moved to the future pHealth. The authors have analysed interesting new privacy and trust ideas published in journals, and found that they seem to be effective but offer only a partial solution. To solve this weakness, the authors used a holistic system view to aspects impacting privacy and trust in pHealth, and created a template that can be used in planning and development future pHealth services. The authors also propose a tentative solution for future trustworthy pHealth. It combines privacy as personal property and trust as legal binding fiducial duty approaches, and uses a Blockchain-based smart contract solution to store person's privacy and trust requirements and service providers' promises.

Privacy and Trust in eHealth: A Fuzzy Linguistic Solution for Calculating the Merit of Service.

The use of eHealth and healthcare services are becoming increasingly common across networks and ecosystems. Identifying the quality and health impact of these services is a big problem that in many cases it is difficult determine. Health ecosystems are seldom designed with privacy and trust in mind, and the service user has almost no way of knowing how much trust to place in the service provider and other stakeholders using his or her personal health information (PHI). In addition, the service user cannot rely on privacy laws, and the ecosystem is not a trustworthy system. This demonstrates that, in real life, the user does not have significant privacy. Therefore, before starting to use eHealth services and subsequently disclosing personal health information (PHI), the user would benefit from tools to measure the level of privacy and trust the ecosystem can offer. For this purpose, the authors developed a solution that enables the service user to calculate a Merit of Service (Fuzzy attractiveness rating (FAR)) for the service provider and for the network where PHI is processed. A conceptual model for an eHealth ecosystem was developed. With the help of heuristic methods and system and literature analysis, a novel proposal to identify trust and privacy attributes focused on eHealth was developed. The FAR value is a combination of the service network's privacy and trust features, and the expected health impact of the service. The computational Fuzzy linguistic method was used to calculate the FAR. For user friendliness, the Fuzzy value of Merit was transformed into a linguistic Fuzzy label. Finally, an illustrative example of FAR calculation is presented.

Transformation of Health and Social Care Systems-An Interdisciplinary Approach Toward a Foundational Architecture.

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.

Transformed Health Ecosystems-Challenges for Security, Privacy, and Trust.

A transformed health ecosystem is a multi-stakeholder coalition that collects, stores, and shares personal health information (PHI) for different purposes, such as for personalized care, prevention, health prediction, precise medicine, personal health management, and public health purposes. Those services are data driven, and a lot of PHI is needed not only from received care and treatments, but also from a person's normal life. Collecting, processing, storing, and sharing of the huge amount of sensitive PHI in the ecosystem cause many security, privacy, and trust challenges to be solved. The authors have studied those challenges from different perspectives using existing literature and found that current security and privacy solutions are insufficient, and for the user it is difficult to know whom to trust, and how much. Furthermore, in today's widely used privacy approaches, such as privacy as choice or control and belief or perception based trust does not work in digital health ecosystems. The authors state that it is necessary to redefine the way privacy and trust are understood in health, to develop new legislation to support new privacy and approaches, and to force the stakeholders of the health ecosystem to make their privacy and trust practices and features of their information systems available. The authors have also studied some candidate solutions for security, privacy, and trust to be used in future health ecosystems.

Autonomous Systems and Artificial Intelligence - Hype or Prerequisite for P5 Medicine?

For meeting the challenge of aging, multi-diseased societies, cost containment, workforce development and consumerism by improved care quality and patient safety as well as more effective and efficient care processes, health and social care systems around the globe undergo an organizational, methodological and technological transformation towards personalized, preventive, predictive, participative precision medicine (P5 medicine). This paper addresses chances, challenges and risks of specific disruptive methodologies and technologies for the transformation of health and social care systems, especially focusing on the deployment of intelligent and autonomous systems.

How a Service User Knows the Level of Privacy and to Whom Trust in pHealth Systems?

pHealth is a data (personal health information) driven approach that use communication networks and platforms as technical base. Often it' services take place in distributed multi-stakeholder environment. Typical pHealth services for the user are personalized information and recommendations how to manage specific health problems and how to behave healthy (prevention). The rapid development of micro- and nano-sensor technology and signal processing makes it possible for pHealth service provider to collect wide spectrum of personal health related information from vital signs to emotions and health behaviors. This development raises big privacy and trust challenges especially because in pHealth similarly to eCommerce and Internet shopping it is commonly expected that the user automatically trust in service provider and used information systems. Unfortunately, this is a wrong assumption because in pHealth's digital environment it almost impossible for the service user to know to whom to trust, and what the actual level of information privacy is. Therefore, the service user needs tools to evaluate privacy and trust of the service provider and information system used. In this paper, the authors propose a solution for privacy and trust as results of their antecedents, and for the use of computational privacy and trust. To answer the question, which antecedents to use, two literature reviews are performed and 27 privacy and 58 trust attributes suitable for pHealth are found. A proposal how to select a subset of antecedents for real life use is also provided.

Why Interoperability at Data Level Is Not Sufficient for Enabling pHealth?

Multidisciplinary and highly dynamic pHealth ecosystems according to the 5P Medicine paradigm require careful consideration of systems integration and interoperability within the domains knowledge space. The paper addresses the different aspects or levels of knowledge representation (KR) and management (KM) from cognitive theories (theories of knowledge) and modeling processes through notation up to processing, tooling and implementation. Thereby, it discusses language and grammar challenges and constraints, but also development process aspects and solutions, so demonstrating the limitation of data level considerations. Finally, it presents the ISO 23903 Interoperability and Integration Reference Architecture to solve the addressed problems and to correctly deploy existing standards and work products at any representational level including data models as well as data model integration and interoperability.

Privacy Is Dead - Solutions for Privacy-Enabled Collections and Use of Personal Health Information in Digital Era.

Today's digital information systems and applications collect every day a huge amount of personal health information (PHI) from sensor and surveillance systems, and every time we use personal computers or mobile phones. Collected data is processed in clouds, platforms and ecosystems by digital algorithms and machine learning. Pervasive technology, insufficient and ineffective privacy legislation, strong ICT industry and low political will to protect data subject's privacy have together made it almost impossible for a user to know what PHI is collected, how it is used and to whom it is disclosed. Service providers' and organizations' privacy policy documents are cumbersome and they do not guarantee that PHI is not misused. Instead, service users are expected to blindly trust in privacy promises made. In spite of that, majority of individuals are concerned of their privacy, and governments' assurance that they meet the responsibility to protect citizens in real life privacy is actually dead. Because PHI is probably the most sensitive data we have, and the authors claim it cannot be a commodity or public good, they have studied novel privacy approaches to find a way out from the current unsatisfactory situation. Based on findings got, the authors have developed a promising solution for privacy-enabled use of PHI. It is a combination of the concept of information fiduciary duty, Privacy as Trust approach, and privacy by smart contract. This approach shifts the onus of privacy protection onto data collectors and service providers. A specific information fiduciary duty law is needed to harmonize privacy requirements and force the acceptance of proposed solutions. Furthermore, the authors have studied strengths and weaknesses of existing or emerging solutions.

Autonomous Systems and Artificial Intelligence in Healthcare Transformation to 5P Medicine - Ethical Challenges.

The paper introduces a structured approach to transforming healthcare towards personalized, preventive, predictive, participative precision (P5) medicine and the related organizational, methodological and technological requirements. Thereby, the deployment of autonomous systems and artificial intelligence is inevitably. The paper discusses opportunities and challenges of those technologies from a humanistic and ethical perspective. It shortly introduces the essential concepts and principles, and critically discusses some relevant projects. Finally, it offers ways for correctly representing, specifying, implementing and deploying autonomous and intelligent systems under an ethical perspective.

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.

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.

Healthcare Transformation Towards Personalized Medicine - Chances and Challenges.

The paper introduces a structured approach to transforming healthcare towards personalized, preventive, predictive, participative precision (P5) medicine. It highlights the promising methodological paradigm changes, accompanied by related organizational and technological ones. In the latter context, the deployment of artificial intelligence and autonomous systems is crucial beside miniaturization and mobility. Beside their opportunities, those advanced technologies also bear risks to be managed. Beside the relationships between technology and human actors, the behavior of intelligent and autonomous systems from a humanistic and ethical perspective is in the center of considerations. The different existing approaches for guaranteeing the intended properties are presented and compared for deriving a common set of necessary principles to be met for P5 medicine.

Digital pHealth - Problems and Solutions for Ethics, Trust and Privacy.

The penetration of digital platforms and ecosystem based business-model together with the use algorithm and machine leaning are changing the environment where pHealth takes place. Traditional pHealth is changing to Digital pHealth. This development brings new ethical, privacy and trust problems which have to solve to make Digital pHealth successful. In this paper ethical, privacy and trust problems in Digital pHealth are studied at conceptual level. Concerns caused by the use novel ICT-technology and regulatory environment are also discussed. The starting point is that the Digital pHealth as a system and its applications and algorithms should be ethically acceptable, trustworthy and enable the service user to set own context-aware privacy policies. Mutual trust is needed between application and all stakeholders. Solution proposed for trustworthy Digital pHealth include ethical design, policy based privacy management and on-line calculation of privacy and trust levels using proven mathematical methods. In the future, novel solutions such as algorithm based access control and data sharing, and algorithm based privacy prediction together with cryptography based blockchain seems to have potential to change the way privacy is managed in Digital pHealth. Technology alone cannot solve current privacy and trust problems. New regulations which not only give users of the Digital pHealth right to set personal privacy polies but also force pHealth service providers and platform owners to prove regulatory compliance of their services are needed.

Modeling the Personal Health Ecosystem.

Complex ecosystems like the pHealth one combine different domains represented by a huge variety of different actors (human beings, organizations, devices, applications, components) belonging to different policy domains, coming from different disciplines, deploying 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. For correctly modeling such systems, a system-oriented, architecture-centric, ontology-based, policy-driven approach is inevitable, thereby following established Good Modeling Best Practices. However, most of the existing standards, specifications and tools for describing, representing, implementing and managing health (information) systems reflect the advancement of information and communication technology (ICT) represented by different evolutionary levels of data modeling. The paper presents a methodology for integrating, adopting and advancing models, standards, specifications as well as implemented systems and components on the way towards the aforementioned ultimate approach, so meeting the challenge we face when transforming health systems towards ubiquitous, personalized, predictive, preventive, participative, and cognitive health and social care.

A Model for Calculated Privacy and Trust in pHealth Ecosystems.

A pHealth ecosystem is a community of service users and providers. It is also a dynamic socio-technical system. One of its main goals is to help users to maintain their personal health status. Another goal is to give economic benefit to stakeholders which use personal health information existing in the ecosystem. In pHealth ecosystems, a huge amount of health related data is collected and used by service providers such as data extracted from the regulated health record and information related to personal characteristics, genetics, lifestyle and environment. In pHealth ecosystems, there are different kinds of service providers such as regulated health care service providers, unregulated health service providers, ICT service providers, researchers and industrial organizations. This fact together with the multidimensional personal health data used raises serious privacy concerns. Privacy is a necessary enabler for successful pHealth, but it is also an elastic concept without any universally agreed definition. Regardless of what kind of privacy model is used in dynamic socio-technical systems, it is difficult for a service user to know the privacy level of services in real life situations. As privacy and trust are interrelated concepts, the authors have developed a hybrid solution where knowledge got from regulatory privacy requirements and publicly available privacy related documents is used for calculation of service providers' specific initial privacy value. This value is then used as an estimate for the initial trust score. In this solution, total trust score is a combination of recommended trust, proposed trust and initial trust. Initial privacy level is a weighted arithmetic mean of knowledge and user selected weights. The total trust score for any service provider in the ecosystem can be calculated deploying either a beta trust model or the Fuzzy trust calculation method. The prosed solution is easy to use and to understand, and it can be also automated. It is possible to develop a computer application that calculates a situation-specific trust score, and to make it freely available on the Internet.