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Gravitate–Health: Empowering and Equipping Europeans with health information for Active Personal Health Management and Adherence to Treatment

Periodic Reporting for period 1 - Gravitate-Health (Gravitate–Health: Empowering and Equipping Europeans with health information for Active Personal Health Management and Adherence to Treatment)

Reporting period: 2020-11-01 to 2021-10-31

Safe use of medicines is a major challenge and medication information is fragmented, unavailable or not used. The current information flow in health care is complex and insufficient, largely due to lack of interoperability, and lack of citizen active involvement, introducing risks of which the user may be unaware, adding risk of 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 medicinal product information intended for patients is the paper leaflet provided with the medicinal product. The production of and dissemination of new/revised information is both time-consuming and costly, and information may not be up to date. Furthermore, information may not be understandable or relevant to the needs of many patients, and the problem is only aggravated by aging, multimorbidity, and chronic diseases. Moreover, advances in personalized healthcare require complex medication regimes, increasing the challenges a patient may experience when referring to multiple paper leaflets of general content presented in fine print / small font or language that is difficult to comprehend.
Gravitate-Health is an integrated digital health information project. We seek to equip and empower citizens with digital tools that make them confident, active, and responsive in their health journey, specifically encouraging safe use of medicines for better health outcomes and quality of life. It is our vision that engagement in personal health can only be achieved with 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 from trusted sources, in ways that better meets their individual needs. To do so, Gravitate-Health we will demonstrate how use of an integrated, digital, user-centric health information solution could enable tangible improvements in availability and understanding of health information. The solution is based on 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. Se seek to demonstrate that the improved availability and understanding of 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. Finally, Gravitate – Health would also help develop new and deeper insights into how use of available health information can be optimized to act as effective risk minimization measures.
Gravitate-Health is operating in an environment with increasing focus on how to exchange and use health data for multiple purposes. Currently, telehealth transforms interactions in health care, especially collaboration between patients and health providers as well as in access to and reach of health interventions. Digital tools for citizens empowerment, person-centered care and EU-mobility can enhance access to and understanding of trusted health information, for adherence, disease prevention and personalized health care. Gravitate-Health can act as a catalyst for bringing very different ongoing digital development perspectives together to provide usable digital services needed to equip the most important, but least supported actors in health care - the person as patient, informal care giver or family member - with novel opportunities to use personally relevant health information, at their discretion and convenience. Hence, our ambition to offer digital tools that support access to and understanding of personally relevant ePI content are essential to build up necessary trust in digital health, foster “health data activism” as a demand-side push for a more interoperable digital health ecosystem, and contribute to citizens’ meaningful engagement with digitally provided information.
The first year contributed key foundational work; analysis of stakeholder requirements, development of personas as a basis for user-centred design, first mapping of information/knowledge sources, and further definition and selection of appropriate KPIs. This contributed to conceptualize G-lens® services, for self-care, active treatment and self-management relating to the testing scenarios. These shared representations point to future users of G-lens® as the first step for the Federated Open Source Platform and Services.
The Gravitate-Health User Advisory Group (UAG) har 20 members, representing patients, healthcare professionals and citizens. The UAG has been established with a remit to channel the 'voice of the customer' and drive our vision for “Patient Voice – Human Touch” across several WPs. They represent a diverse range of health literacy and digital literacy, disease groups, ages, genders and geographical origins and are an important resource within the project to enable us to work towards development of tools that best meet the needs of the end user. We established two formal advisory board, the Ethics and Legal Advisory Board (ELAB) and the International Advisory Board (IAB) to enable consultation on and review of the strategic approach in the work performed and ethical / legal compliance of the work within the project.
Dissemination, Communication and Stakeholder Engagement activities have been a strong area of focus with significant progress as the activities are critical to longer term sustainability. We have contracted with 11 digital ecosystems and they represent important outreach opportunities to reach patient and healthcare professional communities globally. Two scientific papers are published and more papers, evaluating health literacy of medication applications, drug safety and key performance indicators for digital health interventions are currently under review. At this early stage in the project is encouraging to engage widely with external stakeholders via national and international conferences, with 6 presentations at various DIA and EFMI conferences amongst others.
The project has begun to forge strategically-important links with other organisations and initiatives. These have included the connection with the VULCAN HL7 FHIR® Accelerator, leading to establishing the Gravitate-Health ePI / e-labeling track at FHIR® Connectathons. This ePI track will progress development of FHIR® based interoperability standards for ePI, as the emerging ePI standard in Europe is based on the HL7 FHIR® interoperability standard. The first FHIR® connectathon on ePI, held in September 21, was successful, in terms of technical accomplishments and in attracting considerable interest from stakeholders and developers. EMA engaged with Gravitate-Health for this Connectathon, and provided important support in terms of access to servers and expertise. Overall, this Gravitate-Health ePI track under the HL7 VULCAN Accelerator offers an important opportunity for convergence of ePI/technical stakeholders to progress the development of internationally-relevant standards for medicinal product information and gain interest across relevant stakeholders beyond our consortium.
Gravitate-Health Kick-off participants
example - Gravitate-Health Personas
Gravitate-Health introduction - poster