Periodic Reporting for period 3 - Gravitate-Health (Gravitate–Health: Empowering and Equipping Europeans with health information for Active Personal Health Management and Adherence to Treatment)
Berichtszeitraum: 2022-11-01 bis 2023-10-31
Safe use of medicines is a major challenge and medication information is currently fragmented, unavailable or not used. Current information flow in health care is complex and often insufficient, largely due to lack of interoperability and limited information exchange between separate systems. This introduces risks user may be unaware of, adding potential for errors, adverse events, disability, and even death. WHO reports that more than 50% of all medicines are prescribed, dispensed, or sold inappropriately worldwide, and OECD estimates around 200,000 premature deaths annually in Europe relate to poor medication adherence. 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 information may not be up to date or well understood.
Gravitate-Health is an integrated digital health information project. We seek to equip and empower citizens with digital tools with relevant health information from trusted sources, starting with the electronic product information (ePI). The 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 access to actionable, understandable, relevant, reliable and evidence-based health information that meets their specific needs, health context, and literacy level. We will provide the Gravitate Lens (G-lens®), as a route for patients to access trustworthy, up-to-date health information, in ways that better meets their individual needs. The solution will offer a set of trusted Health Information sources, like the regulator-approved medicinal product information, use of IPS (International Patient Summary) definitions and two-way communication. We seek to demonstrate that improved availability, use and understanding of such health information from trusted sources translate to higher levels of adherence to treatment, safer use of medication (Pharmacovigilance), better health outcomes and quality of life.
Gravitate-Health can act 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 e personally relevant health information, at their discretion and convenience. Gravitate-Health is operating in an environment where the ongoing digital transformation increase 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 equip and empower citizens with digital tools with relevant health information from trusted sources, starting with the electronic product information (ePI). The 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 access to actionable, understandable, relevant, reliable and evidence-based health information that meets their specific needs, health context, and literacy level. We will provide the Gravitate Lens (G-lens®), as a route for patients to access trustworthy, up-to-date health information, in ways that better meets their individual needs. The solution will offer a set of trusted Health Information sources, like the regulator-approved medicinal product information, use of IPS (International Patient Summary) definitions and two-way communication. We seek to demonstrate that improved availability, use and understanding of such health information from trusted sources translate to higher levels of adherence to treatment, safer use of medication (Pharmacovigilance), better health outcomes and quality of life.
Gravitate-Health can act 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 e personally relevant health information, at their discretion and convenience. Gravitate-Health is operating in an environment where the ongoing digital transformation increase 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.
The key foundational work; stakeholder requirements, personas as a basis for 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 for self-care, active treatment and self-management relating to the testing scenarios. We have delivered MVP1 and MVP2 with early examples of future G-lens® services as improved access and basic focusing of ePI information in sample ePIs, and demonstrate that ePIs can be presented in different languages, retaining focused presentation.
The MVPs have been tested by the UAG and consortium members. Findings will guide the next iterations towards release of MVP3. We are planning assessment of G-lens® front-end services as “advanced tests” with synthetic data and realistic users and “controlled trials” recruiting patients using information related to medicines they are taking. The activity to select test sites for “testing – at – scale” progresses. With Grant Amendment#3 (accession of new EFPIA member and a new public partner), we have strengthened implementation of the action in terms of coordination of development and assessment activities, content preparation at scale 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.
The Gravitate-Health User Advisory Group (UAG) channel the 'voice of the customer' and drive 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 continues, and the “Gravitate-Health Triangle” converge and ensure synergies in our dissemination, communication, sustainability and stakeholder engagement activities and events as well as exploitation planning. The engagement with HIMSS regional communities and contracted, digital health ecosystems remain important outreach arenas, and we have formed the Gravitate-Health ePI Technology Community, open to participation by all stakeholders to prepare use of ePI.
The MVPs have been tested by the UAG and consortium members. Findings will guide the next iterations towards release of MVP3. We are planning assessment of G-lens® front-end services as “advanced tests” with synthetic data and realistic users and “controlled trials” recruiting patients using information related to medicines they are taking. The activity to select test sites for “testing – at – scale” progresses. With Grant Amendment#3 (accession of new EFPIA member and a new public partner), we have strengthened implementation of the action in terms of coordination of development and assessment activities, content preparation at scale 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.
The Gravitate-Health User Advisory Group (UAG) channel the 'voice of the customer' and drive 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 continues, and the “Gravitate-Health Triangle” converge and ensure synergies in our dissemination, communication, sustainability and stakeholder engagement activities and events as well as exploitation planning. The engagement with HIMSS regional communities and contracted, digital health ecosystems remain important outreach arenas, and we have formed the Gravitate-Health ePI Technology Community, open to participation by all stakeholders to prepare use of ePI.
The project takes place during a time of important, major initiatives for digital transformation in Europe and links with VULCAN HL7 FHIR Accelerator, Gravitate-Health ePI Technology Community, the EU Commission for European EHR exchange format and EHDS, and several Medicinal Product Information Compendia help progress beyond state of the art.
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 first FHIR ePI Implementation Guide for EU and global use, and regular briefings with regulators globally. We are meeting regularly with FDA in the Gravitate-Health ePI track at FHIR® Connectathons and regulators in Asia, Middle East and Latin America who are adopting FHIR for ePI. The Gravitate-Health ePI Technology Community is a new, open community where Content providers, SMEs, Medicinal Product information Compendia and industry meet up bi-monthly to prepare use of ePI.
We expect further impact by two recent initiative; a) collaboration with 4 Nordic Medicinal Product Information Compendia to prepare methodology to convert product information to FHIR ePI, 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 EHDS offering ePI to any eDispensation of ePrescription to 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 first FHIR ePI Implementation Guide for EU and global use, and regular briefings with regulators globally. We are meeting regularly with FDA in the Gravitate-Health ePI track at FHIR® Connectathons and regulators in Asia, Middle East and Latin America who are adopting FHIR for ePI. The Gravitate-Health ePI Technology Community is a new, open community where Content providers, SMEs, Medicinal Product information Compendia and industry meet up bi-monthly to prepare use of ePI.
We expect further impact by two recent initiative; a) collaboration with 4 Nordic Medicinal Product Information Compendia to prepare methodology to convert product information to FHIR ePI, 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 EHDS offering ePI to any eDispensation of ePrescription to strengthen citizens and health providers for personal and cross-border care purposes.