DHU Radar

Electronic Product Information – Digital Trust Ecosystem – ePI by PharmaLedger

Keywords: Citizen/Patient Portal, Digital Application, Digital Health Infrastructure, Digital Health Innovation, Digital Health Services, Digital Health Tools
Digital solution and service (e.g. application/digital health portal/platform/AI based system/etc.)
Decentralized infrastructure – Product Trust related products
Short description
What is the solution about? PharmaLedger Association (PLA) is a nonprofit organization offering governance for digital solutions to healthcare problems that cannot be solved in isolation. When was it developed and by whom? PLA is a venue for collaborative innovation and the result of the funded IMI project PharmaLedger (2020-2022). ePI by PharmaLedger is the first digital product launched by PLA in a collaborative innovation model. The solution was developed by the collaboration between patient organizations, technology experts, research centers, pharmaceutical companies, and NGOs. What is the intended audience/target group? The front-end solution – our light-weight App is for Patients and healthcare providers The back-end solution – digital wallets and blockchain network is for Marketing Authorization Holders / Manufacturers of medical products How should the solution be used / how does it function? Standard industry barcodes are used as digital keys to a trusted product and to unlock user-centric cost-free services. Through a single mobile App for all brands and products, or as a service/feature of public health Apps patients and HCPs scan the unique product code to obtain the most updated, regulatory-approved, product information directly from the product manufacturer in a friendly format, the possibility of including barrier-free features and multi-language. Who might be interested in learning about or wish to use/apply it? Manufacturers of Pharma, Biopharma, Generics, medical devices, Animal Health, vitamins and supplements, herbal medicines, and any other health-related product that requires or offers a product information leaflet to end users or professional healthcare providers. What are the conditions for using/applying it (e.g., free, license agreement, etc.)? PLA develops Open Source solutions, however, to join the network, offer leaflets under ONE APP, and use it under the governance of the Digital Trust Ecosystem, manufacturers must become a member of the PharmaLedger Association and contribute to the maintenance and upscaling of the product. The product is free of charge and requires no data sharing or identification from users.
Contribution to citizen empowerment
The practice/case/tool is “on the market” and integrated in routine use. There is proven market impact in terms of job creation/spin-off creation or other company growth
ePI by PharmaLedger is live through the first GxP qualified blockchain network operated by independent pharma manufacturer nodes under PLAs governance and oversight.
Other (please specify in free text box below)
The product is currently live in Singapore. 2024 outlook includes expansion to all EU and other 15 markets.
Geographical scope
this solution will be deployed in Europe in 2024, likely to start with Spain.
English, French, German, Portuguese, Spanish, Arabic, Korean and other
Planned to reach double digit million product scans from 2024.
Submitted in other database or repository of digital health resources that is publicly available
IMI and Cordis both hold a record about PharmaLedger consortium for its activities between 2020 and 2022.

Additional information

to clinicians / care practitioners
Clinical decision support
Care pathway tracking and adherence
Clinical team care planning and collaboration tools (e.g. digital shared care plan)
Alerting systems for abnormal test results
Escalation systems tracking home monitoring data streams
eLearning for workforce development
ICT support for management of frailty and/or falls prevention
ePrescription solutions
Regional and national Electronic Health Record systems
Regional/national/local Integrated Care Record systems
to patients / citizens
Personalised prevention apps
Health promotion and wellness apps and wearables/virtual coaches
Digital tools to support health education (health literacy)/digital health literacy
Digital tools to support patient feedback and reporting of outcomes and experiences
Self-management/ICT supporting adherence to medication and care-plans
Home care
Primary target patient group (age)
Youth and young adults (15-24), Adults (25-64), Older adults (65+)
Addressed prevention area(s)
Nutrition and diet, Education, Other (please specify below)
Patient literacy and autonomy in managing outcomes, patient empowerment to verify product packaging prior to using it.
Use case and care pathway positioning
Disease monitoring, treatment compliance, self-management, Prevention and wellness, Integrated care pathways, Functional support and independent living (e.g., for frailty), Patient or citizen communities, self-help and mentoring
Capable but not yet fully connected. in 2024 a pilot integration with EMA is planned as well as with the FIHR format to enable use in multiple regions.
Ready to be transferred to
Ready for transfer, but the practice has not been transferred yet.
Plans for cross-border implementation
Implemented and deployed cross-border
Connectivity of the solution with regional and/or national services
Capable but not yet fully connected. in 2024 a pilot integration with EMA is planned as well as with the FIHR format to enable use in multiple regions.