Periodic Reporting for period 4 - Gravitate-Health (Gravitate–Health: Empowering and Equipping Europeans with health information for Active Personal Health Management and Adherence to Treatment)
Berichtszeitraum: 2023-11-01 bis 2024-10-31
Safe use of medicines is a major challenge and medication information is currently insufficient, unavailable or not used while information flow in health care is complex and often fragmented, largely due to lack of interoperability and limited information exchange between separate systems. This 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 an integrated digital health information project. We seek to mitigate reported 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. To do so, we offer the Gravitate Lens (G-lens®) as a route for patients to access actionable, understandable, relevant, reliable and evidence-based health information that meets their specific needs, health context, and literacy level. The solution will offer access to a set of trusted Health Information sources, including regulator-approved medicinal product information, and use of IPS (International Patient Summary) definitions. We seek to demonstrate that improved availability, use and understanding of such health information from trusted sources 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 very 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 how to exchange and use health data for multiple purposes. We will offer digital tools that support access to and understanding of personally relevant ePI content, as an essential case for trust in digital health, meaningful engagement with digitally provided information and demand for interoperable digital health ecosystem.
Gravitate-Health is an integrated digital health information project. We seek to mitigate reported 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. To do so, we offer the Gravitate Lens (G-lens®) as a route for patients to access actionable, understandable, relevant, reliable and evidence-based health information that meets their specific needs, health context, and literacy level. The solution will offer access to a set of trusted Health Information sources, including regulator-approved medicinal product information, and use of IPS (International Patient Summary) definitions. We seek to demonstrate that improved availability, use and understanding of such health information from trusted sources 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 very 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 how to exchange and use health data for multiple purposes. We will offer digital tools that support access to and understanding of personally relevant ePI content, as an essential case for trust in digital health, meaningful engagement with digitally provided information and demand for 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 to support self-care, active treatment and self-management as in focus in the testing scenarios. We have delivered minimal viable products (MVPs) with examples of G-lens® services that improve access and focusing of ePI information in sample ePIs, and demonstrate ePIs in different languages, retaining focused presentation. The MVPs have been tested by the Gravitate-Health User Advisory Group UAG, external stakeholders and consortium members. We are planning assessment of G-lens® front-end services as “advanced tests” with synthetic data/realistic users and “controlled trials” recruiting patients using information related to medicines they are taking. In the last year we have strengthened implementation of the action in terms of coordination of development and assessment activities, content preparation at scale with preparation of ePIs in FHIR format, and include ISO IDMP global standards for reliable access to ePI in language of choice, as an important, additional functionality in the next releases of MVPs 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 sound strategic direction and ethical/legal compliance of all work in the project. Dissemination, Communication and Stakeholder Engagement activities continue, with the “Gravitate-Health Triangle” ensuring synergies in these areas, also supporting exploitation planning. We hosted Hackathon#1 as well as the first Interoperability showcase to illustrate core features of our solutions. 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 Technology Communities, 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. We have suggested “ePrescription – eDispensation - ePI” or [eP-eD]+ePI - as an augmented service giving access to information about medicines 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 as an international 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 are meeting regularly with FDA and regulators in Asia, Middle East and Latin America who are adopting FHIR for ePI. The FHIR ePI IG is in active use for ePI in industry preparation for ePI implementation, and alignment on further “ePI enrichment levels” is ongoing, to drive efficiency in structured ePI creation and more productive interactions between industry/regulators upstream.
The Gravitate-Health Technology Community is an open community where content providers, SMEs, Medicinal Product information Compendia and industry meet up bi-monthly to prepare use of ePI. There has been participation by more than 106 organizations to date and this ‘collaborative community’ approach is being further leveraged to accelerate progress in the later stages of the project and address clinical, ethical, legal, and technical challenges, and issues related to trust and business models for uptake and growth. We can report further impact by accession of the 4 Nordic Medicinal Product Information Compendia to prepare methodology to convert product information to FHIR ePI, contributing to our growing repository of ePI (currently 2500), and b) interactions with relevant projects (e.g. XpanDH and UNICOM), 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 as an international 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 are meeting regularly with FDA and regulators in Asia, Middle East and Latin America who are adopting FHIR for ePI. The FHIR ePI IG is in active use for ePI in industry preparation for ePI implementation, and alignment on further “ePI enrichment levels” is ongoing, to drive efficiency in structured ePI creation and more productive interactions between industry/regulators upstream.
The Gravitate-Health Technology Community is an open community where content providers, SMEs, Medicinal Product information Compendia and industry meet up bi-monthly to prepare use of ePI. There has been participation by more than 106 organizations to date and this ‘collaborative community’ approach is being further leveraged to accelerate progress in the later stages of the project and address clinical, ethical, legal, and technical challenges, and issues related to trust and business models for uptake and growth. We can report further impact by accession of the 4 Nordic Medicinal Product Information Compendia to prepare methodology to convert product information to FHIR ePI, contributing to our growing repository of ePI (currently 2500), and b) interactions with relevant projects (e.g. XpanDH and UNICOM), 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.