Periodic Reporting for period 5 - Gravitate-Health (Gravitate–Health: Empowering and Equipping Europeans with health information for Active Personal Health Management and Adherence to Treatment)
Okres sprawozdawczy: 2024-11-01 do 2025-10-31
Safe use of medicines is a major challenge. Information flow in health care is complex and often fragmented, largely due to lack of interoperability and limited information exchange between separate systems. Medication information is part of the picture and we observe that insufficient, unavailable or not used which introduces risks users may be unaware of, leading to potential for errors, adverse events, disability, and even death. The primary source of information about medicines intended for patients is the paper leaflet provided with any dispensed medicinal product. The production and dissemination of new/revised information is laborious, time-consuming and costly, and content may not be up to date or well understood.
Gravitate-Health is a public-private partnership. As an integrated digital health information we seek to mitigate challenges to safe use of medicines as we equip and empower citizens with digital tools holding relevant health information from trusted sources, starting with the electronic product information (ePI). Our overall aim is that all users are confident, active, and responsive in their health journey, encouraging safe use of medicines for better health outcomes and quality of life. W develop the Gravitate Lens (G-lens®) as a route to access actionable, understandable, relevant, reliable and evidence-based health information that meets user’s needs, health context, and literacy level. The solution use of IPS (International Patient Summary) definitions to offer access to trusted Health Information, including regulator-approved medicinal product information. We seek to demonstrate that improved availability, use and understanding of health information translates to higher levels of adherence to treatment, safer use of medication (Pharmacovigilance), better health outcomes and quality of life.
Gravitate-Health acts as a catalyst bringing different, ongoing digital development initiatives together to provide usable, digital services needed by the most important, but least supported actors in health care - the person as patient, informal care giver or family member – with personally relevant health information, at their discretion and convenience. The ongoing digital transformation in the wider environment increases focus on exchange and use health data for multiple purposes. We demonstrate digital tools that support access to and understanding of personally relevant ePI content, essential for trust in digital health, and meaningful engagement with digitally provided information in an interoperable digital health ecosystem.
Gravitate-Health is a public-private partnership. As an integrated digital health information we seek to mitigate challenges to safe use of medicines as we equip and empower citizens with digital tools holding relevant health information from trusted sources, starting with the electronic product information (ePI). Our overall aim is that all users are confident, active, and responsive in their health journey, encouraging safe use of medicines for better health outcomes and quality of life. W develop the Gravitate Lens (G-lens®) as a route to access actionable, understandable, relevant, reliable and evidence-based health information that meets user’s needs, health context, and literacy level. The solution use of IPS (International Patient Summary) definitions to offer access to trusted Health Information, including regulator-approved medicinal product information. We seek to demonstrate that improved availability, use and understanding of health information translates to higher levels of adherence to treatment, safer use of medication (Pharmacovigilance), better health outcomes and quality of life.
Gravitate-Health acts as a catalyst bringing different, ongoing digital development initiatives together to provide usable, digital services needed by the most important, but least supported actors in health care - the person as patient, informal care giver or family member – with personally relevant health information, at their discretion and convenience. The ongoing digital transformation in the wider environment increases focus on exchange and use health data for multiple purposes. We demonstrate digital tools that support access to and understanding of personally relevant ePI content, essential for trust in digital health, and meaningful engagement with digitally provided information in an interoperable digital health ecosystem.
Foundational work; stakeholder requirements, personas is a basis for the user-centred design, mapping information/knowledge sources, and selection of appropriate KPIs are incorporated in the Federated Open Source Platform (FOSPS) and G-lens® services are developed to support self-care, active treatment and self-management. We have delivered minimal viable products (MVPs) with examples of G-lens® services that improve access and personalize information in the ePI and demonstrate ePIs in different languages retaining focused presentation. The MVPs have been tested by the Gravitate-Health User Advisory Group (UAG), consortium members, testing scenarios and external stakeholders. We have assessed G-lens® front-end services with synthetic data by realistic users and with patients using information related to medicines they are taking. We are strengthened implementation of the action in terms of coordination of development and assessment activities, content preparation at scale with preparation of ePIs in HL7 FHIR format, and ISO IDMP global standards for reliable access to ePI in language of choice. This is important functionality for the release of the final MVP G-lens® front-end services. UAG drives our vision for “Patient Voice – Human Touch”. We consult our advisory boards; Ethics and Legal Advisory Board (ELAB) and International Advisory Board (IAB) to secure ethical/legal compliance and sound strategic direction of work in the project. Dissemination, Communication and Stakeholder Engagement activities continue, interacting with the Gravitate-Health ePI Technology Community and the Gravitate-Health Open E2E ePI Community and furthering the “Gravitate-Health Triangle” for synergies that support longer term sustainability and exploitation. The Interoperability showcase#2 illustrate features of our solutions and will be further progress in Hackathon#2. Engagement with HIMSS regional communities and contracted, digital health ecosystems (ECHA) remain important outreach arenas, and we have formed the Gravitate-Health Technology Communities, open to participation by all interested stakeholders.
The project takes place during a time of important, major digital transformation initiatives in Europe and links with VULCAN HL7 FHIR Accelerator, Gravitate-Health Collaborative Communities (ePI Technology Community and Open E2E community), the EU Commission for European EHR exchange format and European Health Data Space (EHDS), and several Medicinal Product Information Compendia help progress beyond state of the art. Our suggested “ePrescription – eDispensation - ePI” or [eP-eD]+ePI gain traction as augmented service for access to medicinal product information in preferred language in cross-border situations under EHDS primary use priorities.
The Gravitate-Health ePI / e-labeling track at FHIR® Connectathons has accelerated development of interoperability standards with a balloted FHIR ePI Implementation Guide, FHIR ePI IG v.1 approved by HL7 international as Standard for Trial Use (STU) for global use fully and aligned with EU ePI common standard. EMA engage with Gravitate-Health for the ePI work; illustrated by the joint statement by Gravitate-Health and EMA-HMA-EU on full alignment of efforts, the FHIR ePI Implementation Guide for EU and global use, and regular briefings with regulators globally. We meet with FDA and regulators in Asia, Middle East and Latin America who are adopting FHIR for ePI. The FHIR ePI IG is important for industry preparation of ePI implementation. Elaboration of “ePI enrichment levels” is ongoing to drive efficiency in structured ePI creation and productive interactions between industry/regulators.
The Gravitate-Health Collaborative Community (ePI Technology Community and the Open E2E ePI community) is an open community where content providers, SMEs, Medicinal Product information Compendia and industry meet up to prepare use of ePI. There has been participation by more than 125 organizations to date, and this ‘collaborative community’ approach are leveraged to accelerate progress in ePI and personalization that consider clinical, ethical, legal, and technical challenges, and issues related to trust and business models for uptake and growth. We can report further impact by a) contributions of our Medicinal Product Information Compendia exploiting methodology to convert product information to FHIR ePI, and contributing to grow repository of ePI for test use, and b) interactions with relevant projects (e.g. XpanDH, UNICOM, xShare, XiA), EMA and the EU Commission for pan-European effort to develop the European EHR exchange format (EEHRxF) and the future implementing acts under the EHDS to offer ePI to any eDispensation of ePrescription, which strengthen citizens and health providers for personal and cross-border care purposes.
The Gravitate-Health ePI / e-labeling track at FHIR® Connectathons has accelerated development of interoperability standards with a balloted FHIR ePI Implementation Guide, FHIR ePI IG v.1 approved by HL7 international as Standard for Trial Use (STU) for global use fully and aligned with EU ePI common standard. EMA engage with Gravitate-Health for the ePI work; illustrated by the joint statement by Gravitate-Health and EMA-HMA-EU on full alignment of efforts, the FHIR ePI Implementation Guide for EU and global use, and regular briefings with regulators globally. We meet with FDA and regulators in Asia, Middle East and Latin America who are adopting FHIR for ePI. The FHIR ePI IG is important for industry preparation of ePI implementation. Elaboration of “ePI enrichment levels” is ongoing to drive efficiency in structured ePI creation and productive interactions between industry/regulators.
The Gravitate-Health Collaborative Community (ePI Technology Community and the Open E2E ePI community) is an open community where content providers, SMEs, Medicinal Product information Compendia and industry meet up to prepare use of ePI. There has been participation by more than 125 organizations to date, and this ‘collaborative community’ approach are leveraged to accelerate progress in ePI and personalization that consider clinical, ethical, legal, and technical challenges, and issues related to trust and business models for uptake and growth. We can report further impact by a) contributions of our Medicinal Product Information Compendia exploiting methodology to convert product information to FHIR ePI, and contributing to grow repository of ePI for test use, and b) interactions with relevant projects (e.g. XpanDH, UNICOM, xShare, XiA), EMA and the EU Commission for pan-European effort to develop the European EHR exchange format (EEHRxF) and the future implementing acts under the EHDS to offer ePI to any eDispensation of ePrescription, which strengthen citizens and health providers for personal and cross-border care purposes.