627 research outputs found

    eHealth implementation in Europe: a scoping review on legal, ethical, financial, and technological aspects

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    Background: The evolution of eHealth development has shifted from standalone tools to comprehensive digital health environments, fostering data exchange among diverse stakeholders and systems. Nevertheless, existing research and implementation frameworks have primarily emphasized technological and organizational aspects of eHealth implementation, overlooking the intricate legal, ethical, and financial considerations. It is essential to discover what legal, ethical, financial, and technological challenges should be considered to ensure successful and sustainable implementation of eHealth.Objective: This review aims to provide insights into barriers and facilitators of legal, ethical, financial, and technological aspects for successful implementation of complex eHealth technologies, which impacts multiple levels and multiple stakeholders.Methods: A scoping review was conducted by querying PubMed, Scopus, Web of Science, and ACM Digital Library (2018–2023) for studies describing the implementation process of eHealth technologies that facilitate data exchange. Studies solely reporting clinical outcomes or conducted outside Europe were excluded. Two independent reviewers selected the studies. A conceptual framework was constructed through axial and inductive coding, extracting data from literature on legal, ethical, financial, and technological aspects of eHealth implementation. This framework guided systematic extraction and interpretation.Results: The search resulted in 7.308 studies that were screened for eligibility, of which 35 (0.48%) were included. Legal barriers revolve around data confidentiality and security, necessitating clear regulatory guidelines. Ethical barriers span consent, responsibility, liability, and validation complexities, necessitating robust frameworks. Financial barriers stem from inadequate funding, requiring (commercial) partnerships and business models. Technological issues include interoperability, integration, and malfunctioning, necessitating strategies for enhancing data reliability, improving accessibility, and aligning eHealth technology with existing systems for smoother integration.Conclusions: This research highlights the multifaceted nature of eHealth implementation, encompassing legal, ethical, financial, and technological considerations. Collaborative stakeholder engagement is paramount for effective decision-making and aligns with the transition from standalone eHealth tools to integrated digital health environments. Identifying suitable stakeholders and recognizing their stakes and values enriches implementation strategies with expertise and guidance across all aspects. Future research should explore the timing of these considerations and practical solutions for regulatory compliance, funding, navigation of responsibility and liability, and business models for reimbursement strategies

    The Telehealth Chain: a protocol for secure and transparent telemedicine transactions on the blockchain

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    Blockchain technology provides a secure and decentralized platform for storing and transferring sensitive medical data, which can be utilized to enable remote medical consultations. This paper proposes a theoretical framework for creating a blockchain-based digital entity to facilitate telemedicine services. The proposed framework utilizes blockchain technology to provide a secure and reliable platform for medical practitioners to remotely interact with patient transactions. The blockchain will serve as a one-stop digital service to secure patient data, ensure privacy, and facilitate payments. The proposed framework leverages the existing Hyperledger Fabric platform to build a secure blockchain-assisted telemedicine platform

    Dia-Continua: An Information System for Type 1 Diabetes Consultation. (Interoperability, Privacy, and Information Quality on a FHIR-Based Information System for Type 1 Diabetes Consultations based on Patient-Generated Health Data)

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    Patient-generated health data (PGHD) is required to monitor chronic conditions like Type 1 Diabetes (T1D). This data includes information from medical devices like insulin pumps and continuous glucose monitors and lifestyle insights from commercial wearables devices such as smartwatches. To improve the quality of medical consultations, we need a unified information system that can integrate PGHD. Designing such a system will pose several challenges. The system should be able to navigate through fragmented information and the complexities of various data formats, proprietary interfaces, and storage methods while ensuring robust security, privacy, and adherence to data ownership principles. It should also enable controlled data sharing with healthcare providers (HCPs) and external entities such as national registries and informal caregivers. This dissertation details designing, developing, and testing an information system for individuals with T1D. The project involved integrative research in health informatics, collaboration with international projects, and collaboration with experienced users and HCPs to address three research questions. These questions focused on interoperability, the security and privacy of the information collected, and the quality of the information presented during consultations. The result is Dia-Continua, a Fast Healthcare Interoperability Resources (FHIR)-based information system with a microservices architecture orchestrated through Kubernetes on an Infrastructure as a Service (IaaS) platform. The system integrates data from various diabetes management devices, questionnaires, and PGHD. Furthermore, using SMART on FHIR for authorization and authentication enables data sharing and reuse with national registries and informal caregivers. Eleven interviews with HCPs evaluated Dia-Continua's new functionalities and information quality. Despite the limitations due to proprietary device systems, the system was assessed positively by HCPs, highlighting the need for a system like Dia-Continua that includes physical activity, sleep, and stress in medical consultations. Dia-Continua is a significant step for a patient-centred model for consultations in T1D. Future work should expand the system's model to other chronic diseases.Utviklingen av medisinske konsultasjoner for kroniske tilstander, spesifikt Type 1 Diabetes (T1D), avhenger i stor grad av pasientgenererte helsedata (PGHD). Disse dataene inkluderer informasjon fra medisinsk utstyr slik som insulinpumper, CGM, samt livsstils data fra kommersielt utstyr som sensorer på smartklokker og smarte ringer. Et helhetlig informasjonssystem som kan integrere PGHD er nødvendig for å forbedre informasjonskvalitet under medisinske konsultasjoner. Imidlertid bør et slikt system være i stand til å la brukeren navigere gjennom fragmentert informasjon og komplekse heterogene dataformater, proprietære grensesnitt og lagringsmetoder, samtidig som systemet sikrer robust sikkerhet, personvern og ivaretakelse av prinsipper for eierskap til data. Systemet bør også muliggjøre kontrollert deling av data med helsepersonell og eksterne aktører slik som nasjonale registre (Noklus) og pasientens omsorgspersoner. Denne avhandlingen beskriver design, utvikling, testing og evaluering av et nytt informasjonssystem for T1D basert på pasientens egne data. Prosjektet har involvert ulike samarbeidspartnere og profesjoner, samt samarbeid med internasjonale prosjekter, erfarne brukere og HP for å adressere de tre forskningsspørsmålene i prosjektet. Ett av resultatene er systemet Dia-Continua, et Fast Healthcare Interoperability Resources (FHIR)-basert informasjonssystem med en Microservice arkitektur orkestrert gjennom Kubernetes på en infrastruktur som en tjenesteplattform (Azure). Systemet integrerer data fra ulike diabetesenheter, spørreskjemaer og andre sensorer. Videre, ved å bruke «SMART on FHIR» for autorisasjon og autentisering, muliggjøres deling og gjenbruk av data med nasjonale registre og uformelle omsorgspersoner. Elleve intervjuer med helsepersonell ble gjort for å evaluere Dia-Continua sine nye funksjonaliteter, samt dets informasjonskvalitet. Til tross for begrensningene på grunn av proprietære standarder, ble systemet positivt mottatt av HP. Informantene understreket behovet for et system som Dia-Continua som inkluderer fysisk aktivitet, søvn og stress i medisinske konsultasjoner. Dia-Continua er et betydelig skritt fram mot en pasientsentrert modell for konsultasjoner i T1D. Fremtidig arbeid bør utvide systemets modell til andre kroniske sykdommer

    Distributed Ledger Technologies (DLTs) and right to health: the impact of blockchain in the healthcare sector

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    The aim of this contribution is to understand whether and how the blockchain technology can be used in the health sector, analyzing the ways in which its incorporation into the management of health data infrastructure might have the potential to create a more efficient national healthcare system. L’obiettivo del presente contributo è quello di analizzare se e come la tecnologia blockchain possa essere utilizzata nel settore sanitario, verificando le modalità in cui la sua incorporazione nella gestione dell’infrastruttura dei dati sanitari potrebbe avere il potenziale per creare un sistema sanitario nazionale più efficiente

    Security in remote monitoring devices in critical areas

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    Dissertação de mestrado integrado em Engineering and Management of Information SystemsThe use of Information Technologies has grown exponentially over the past years affecting many critical sectors from the industrial to the financial, energy, and health sectors. The ability to track and remotely monitor people and objects in real-time is one of the changes made possible by Information Technologies. Although those Information Technologies innovations sprang several significant advantages for people and organizations, there are also some security and privacy concerns regarding the monitoring of people, objects, and processes in critical areas. Every day new and more effective cyberattacks are discovered which steal sensitive information from their holders and affect people and organizations. Computational power is increasing and organizations are emerging whose main objective is to profit from the sale of the stolen information assets. These attacks can impact critical areas, such as health and energy; they may even jeopardize the physical integrity of individuals. In Healthcare, a Critical Area, the number of Remote Patient Monitoring Devices Systems is increasing, and the number of patients using them increases as well. At the same time, there have been identified new security vulnerabilities on high technological medical devices. People privacy is also being called into question. Several privacy gaps have forced governments to take action with the main objective of safeguarding the privacy of their citizens, as was the case with the much-discussed General Data Protection Regulation of the European Union. Standards and Frameworks play an important role in the improvement o security. In this scientific work, it was developed and validated a proposal of a sector-specific Security Framework that can be applied to Remote Patient Monitoring Devices Systems to improve their overall security. That framework is based on the best widely spread Security Standards and Frameworks. The Framework define 30 requirements divided into 5 assets. Each requirement has one or more functions, in a total of 4 available. It was also defined 8 implementation groups. To validate the Framework it was developed a Remote Patient Monitoring Device System Simulator composed by a Micro-controller NodeMCU with an ESP8266 Wi-Fi chip connected to a Heart Rate Analog Sensor, and an Interface. When applied to the Framework, the developed simulator obtained a score of 9 in 29 available requirements for that implementation group device. The selected research method used to guide this scientific research was the Design Science Research.A utilização das Tecnologias de Informação tem crescido exponencialmente ao longo dos últimos anos afetando vários setores críticos que vão desde a indústria, passando pelo setor financeiro, energético e até mesmo pela saúde. A capacidade de acompanhamento e monitorização remota de pessoas e objetos em tempo real é uma das mudanças potenciadas pelas Tecnologias de Informação. Embora destas inovações ao nível das Tecnologias de Informação advenham um conjunto de vantagens significativas para pessoas e organizações, surgem também algumas preocupações ao nível da segurança e privacidade no que concerne à monitorização de pessoas, objetos e processos em áreas críticas. Diariamente são identificados e descritos novos e mais eficazes ataques cibernéticos, a pessoas e organizações com o intuito de roubar informação sensível para os seus detentores. O poder computacional é crescente e insurgem-se organizações cujo principal objetivo é lucrar com a venda de ativos informacionais roubados. Estes ataques podem atingir áreas tão críticas, como o setor da saúde e energético, podendo mesmo colocar em causa a integridade física de pessoas. Nos cuidados de saúde, uma área crítica, o número de Sistemas de Dispositivos de Monitorização Remota esta a crescer, bem como o número de pacientes que os usam. Ao mesmo tempo, têm sido identificadas novas vulnerabilidades de segurança em dispositivos médicos altamente tecnológicos. A privacidade das pessoas está também a ser comprometida. É possível assistir-se a várias falhas ao nível da privacidade que obrigou os governos a tomar medidas com o principal objetivo de salvaguardar a privacidade dos seus cidadãos como foi o caso do tão falado Regulamento Geral de Proteção de Dados da União Europeia. Standards e Frameworks desempenham um papel importante na melhoria da segurança. Neste trabalho de investigação foi desenvolvida e validada uma proposta de Framework de Segurança específica para o setor da Saúde e que pode ser aplicada em Sistemas de Dispositivos de Monitorização Remota com o objetivo de aumentar a sua segurança. Esta Framework é baseada nas melhores e mais usadas Frameworks e Standards. A Framework define 30 requisitos divididos em 5 ativos. Cada requisito tem uma ou mais funções, de um total de 4. Foi também definido 8 grupos de implementação. Para validar a Framework foi desenvolvido um Simulador composto por um micro controlador NodeMCU com um chip Wi-FI ESP8266 conectado a um Sensor Analógico de Frequência Cardíaca. Quando aplicado à Framework, o simulador obteve um score de 9 em 29 requisitos disponíveis para aquele grupo de implementação. A metodologia de investigação selecionada para guiar este projeto foi a Design Science Research

    Assessment of the EU Member States' rules on health data in the light of GDPR

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    In the context of the Single Framework Contract Chafea/2018/Health/03 between the EUHealthSupport Consortium and the Consumers, Health and Food Executive Agency (Chafea), a study was conducted with the objective to examine and present the EU Member States’ rules governing the processing of health data in light of the GDPR, with the objective of highlighting possible differences and identifying elements that might affect the cross-border exchange of health data in the EU, and examining the potential for EU level action to support health data use and re-use. We distinguish between using health data for primary purposes (for treatment of the patient) and secondary purposes (for research, registries and management of the healthcare system). The study provides an evidence-based comparison of the state of play regarding health data governance within the EU. This will help to assess in what areas EU intervention might be needed and if so, through which types of measures, be it measures such as a Code of Conduct for data processing in the health area, which could be supported by an EU level implementing act or more direct legislative action, taking into account the particularities of the health systems in the Member States. The study uses a mixed-methods approach, consisting of the following elements: - Literature review to provide an overview of best practices, bottlenecks, policy options and possible solutions already identified in the literature. - Mapping legal and technical aspects of health data usage at national level to provide an overview of the differences among countries in legislation, regulation and governance models regarding processing health data. - In-depth case studies of national governance models for health data sharing. - Workshops held with MoH representatives, experts, stakeholder representatives and experts from national data protection offices. - Stakeholder Survey to cross validate and supplement the topics addressed and identified in the Member State legal and technical aspects mapping. The results of this study allow for a detailed assessment of possible elements at Member States/EU level that might affect the movement of health data across borders. It also identifies practices that could facilitate this exchange of data, as well as possible policy options for strategies in this area. Finally, we explored possibilities for sustainable governance structures for health data collection, processing and transfer, as well as measures empowering citizens to have more control of their own health data and to ensure portability and interoperability of these data
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