Periodic Reporting for period 2 - PharmaLedger (PharmaLedger)
Berichtszeitraum: 2021-07-01 bis 2022-12-31
PharmaLedger is a 3 year Public Private Partnership (PPP) Project, that started in January 2020, and which ended in December 2022. The PharmaLedger project was funded through the Innovative Medicines Initiative (IMI) 2 Joint Undertaking (listed under grant agreement No.85399) which receives support from the European Union’s Horizon 2020 research and innovation programme and the European Federation of Pharmaceutical Industries and Associations (EFPIA).
PharmaLedger gathered a consortium of 30 public and private entities, including global pharmaceutical companies, technical partners, universities, research organizations, hospitals, and patients` organisations. These partners collaborated under one common goal, to create an agile and secure blockchain-enabled platform that supports, on the top of it, a set of decentralized and trustless healthcare solutions by nature. These applications were designed to: a) share data in a way that, data and processes are compliant not only with current standards of the healthcare sector, but also with the current legal and ethical framework (data and processes are privacy-enabled by design), and b) allow security, trust and provenance of data and information, by linking data and processes together through the PharmaLedger platform services, which provides the capabilities and infrastructure that allows secure, permissioned, auditable, and patient-mediated exchange of data environment, for exchanging data in the healthcare ecosystem and serving as a single source of truth for the pharma ecosystem.
PharmaLedger provides a 4 layer architecture (see fig. 1). The three layers at the bottom ensure the data self-sovereignty through the OpenDSU approach, while the top and fourth layer enables and integrates the solutions and applications being developed for the use cases.
Figure 1: PharmaLedger Architecture
OpenDSUs stands for Open Data Sharing Units that is a technology that works as a container for Data and the code being built in the blockchain. The DSU is one of the main innovations in the PharmaLedger project. It is cryptographically secured, anchored in the Blockchain, and in control of the user, defining a standard manner of how to store data and code outside the Blockchain (off-chain). The OpenDSUs are supported by digital wallets, which allow users to interact with the blockchain.
From the start of the PharmaLedger project, our goal has been to be technology agnostic, remaining as neutral as possible to the blockchain(s) technology selected by each use case solution. Meaning with this that the architecture and OpenDSUs technology can support any kind of programmable Blockchain technology and any kind of Self Sovereign Identities or any other certificate standards on the top of its architecture. With this approach, we combine the benefits of Blockchain such as integrity, traceability, and non-repudiation while preserving confidentiality and data privacy for the data owners. We, at PharmaLedger want to remain technology neutral; so in the future we can also integrate with any other new coming blockchain technologies.
PharmaLedger gathered a consortium of 30 public and private entities, including global pharmaceutical companies, technical partners, universities, research organizations, hospitals, and patients` organisations. These partners collaborated under one common goal, to create an agile and secure blockchain-enabled platform that supports, on the top of it, a set of decentralized and trustless healthcare solutions by nature. These applications were designed to: a) share data in a way that, data and processes are compliant not only with current standards of the healthcare sector, but also with the current legal and ethical framework (data and processes are privacy-enabled by design), and b) allow security, trust and provenance of data and information, by linking data and processes together through the PharmaLedger platform services, which provides the capabilities and infrastructure that allows secure, permissioned, auditable, and patient-mediated exchange of data environment, for exchanging data in the healthcare ecosystem and serving as a single source of truth for the pharma ecosystem.
PharmaLedger provides a 4 layer architecture (see fig. 1). The three layers at the bottom ensure the data self-sovereignty through the OpenDSU approach, while the top and fourth layer enables and integrates the solutions and applications being developed for the use cases.
Figure 1: PharmaLedger Architecture
OpenDSUs stands for Open Data Sharing Units that is a technology that works as a container for Data and the code being built in the blockchain. The DSU is one of the main innovations in the PharmaLedger project. It is cryptographically secured, anchored in the Blockchain, and in control of the user, defining a standard manner of how to store data and code outside the Blockchain (off-chain). The OpenDSUs are supported by digital wallets, which allow users to interact with the blockchain.
From the start of the PharmaLedger project, our goal has been to be technology agnostic, remaining as neutral as possible to the blockchain(s) technology selected by each use case solution. Meaning with this that the architecture and OpenDSUs technology can support any kind of programmable Blockchain technology and any kind of Self Sovereign Identities or any other certificate standards on the top of its architecture. With this approach, we combine the benefits of Blockchain such as integrity, traceability, and non-repudiation while preserving confidentiality and data privacy for the data owners. We, at PharmaLedger want to remain technology neutral; so in the future we can also integrate with any other new coming blockchain technologies.
The course of action within PharmaLedger project was organized in agile development cycles, staring with a foundational phase that provides the building blocks to generate the bases of a solid healthcare ecosystem using blockchain technology driven by the end users and stakeholders oriented requirements. The agile development is transversal to the seven (7) workpackages that rule the operative, technical, and managerial activities of the project.
PharmaLedger demonstrates its value through eight Use Cases through applications (SSAps): Clinical Supply, Finished Goods Traceability, Anti-Counterfeiting, Clinical Trial Recruitment, eConsent, IoT devices in Clinical Trial, and Personalized Medicine. When putting together the use cases in PharmaLedger, we can see that they are linked and can be shown as part of an upstream or downstream path of the healthcare value chain, depending on the stakeholder perspective.
Figure 2: PharmaLedger Use Cases in healthcare value chain.
The PharmaLedger Project has successfully achieved all its objectives by the end of the project. During the first half of the project, the consortium set the PharmaLedger pillars and common vision. The eight use cases deployed were selected from 88 proposed use cases. During this period the functional and technical requirements were elicited through deep dive visions, creating the use cases mock-ups as well as starting the development of the use cases as demonstrators. A legal and ethical assessment provided a comprehensive analysis of the ethical and legal requirements as well as recommendations. The dissemination and communication activities underpinned growing recognition and engagement of new stakeholders as collaborators of the project.
During the second half of the project PharmaLedger consolidated its vision towards the sustainability approach, completed the PharmaLedger architecture and deployed the eight use cases over the platform. All the use cases reached a prototype stage working in a pre-production environment. The electronic product information (ePI) use case was advanced moving to a pre-qualification of software stage, to be easily adopted by the industry. The PharmaLedger architecture and the DSUs were consolidated, having six (6) blockchain-based nodes deployed at the end of the project.
The eight use cases validated the developed technology and went through an evaluation approach, integrating collected insights from end-users, and very importantly from patients. The PharmaLedger brand was recognized in the industry; supported by strong digital communication & engagement in social media, conferences and through partnerships. Various Collaborations were signed (e.g. IMI Gravitate Health).
PharmaLedger demonstrates its value through eight Use Cases through applications (SSAps): Clinical Supply, Finished Goods Traceability, Anti-Counterfeiting, Clinical Trial Recruitment, eConsent, IoT devices in Clinical Trial, and Personalized Medicine. When putting together the use cases in PharmaLedger, we can see that they are linked and can be shown as part of an upstream or downstream path of the healthcare value chain, depending on the stakeholder perspective.
Figure 2: PharmaLedger Use Cases in healthcare value chain.
The PharmaLedger Project has successfully achieved all its objectives by the end of the project. During the first half of the project, the consortium set the PharmaLedger pillars and common vision. The eight use cases deployed were selected from 88 proposed use cases. During this period the functional and technical requirements were elicited through deep dive visions, creating the use cases mock-ups as well as starting the development of the use cases as demonstrators. A legal and ethical assessment provided a comprehensive analysis of the ethical and legal requirements as well as recommendations. The dissemination and communication activities underpinned growing recognition and engagement of new stakeholders as collaborators of the project.
During the second half of the project PharmaLedger consolidated its vision towards the sustainability approach, completed the PharmaLedger architecture and deployed the eight use cases over the platform. All the use cases reached a prototype stage working in a pre-production environment. The electronic product information (ePI) use case was advanced moving to a pre-qualification of software stage, to be easily adopted by the industry. The PharmaLedger architecture and the DSUs were consolidated, having six (6) blockchain-based nodes deployed at the end of the project.
The eight use cases validated the developed technology and went through an evaluation approach, integrating collected insights from end-users, and very importantly from patients. The PharmaLedger brand was recognized in the industry; supported by strong digital communication & engagement in social media, conferences and through partnerships. Various Collaborations were signed (e.g. IMI Gravitate Health).
The project ended laying down the foundations for the Digital Trust Ecosystem. The PharmaLedger Association was endorsed by all the PharmaLedger consortium members, created in mid-2022 as a non-for-profit organisation and included as a member of the consortium during the last quarter of the project. This approach allowed to smoothly transfer all the outcomes of the project to be sustainable and exploitable when the PharmaLedger project ended.
PharmaLedger created value through Responsible Research and Innovation (RRI) processes involving patients organisations, healthcare providers and other societal actors (researchers, policy makers, business and supply chain intermediaries, standardization organisations, etc.) through its whole research and innovation process, aligning the results and its outcomes with the values, needs and expectations of the healthcare sector and society.
PharmaLedger remains technology neutral; so in the future we can also create value by being able to quickly integrate with any other new coming blockchain technology.
PharmaLedger created value through Responsible Research and Innovation (RRI) processes involving patients organisations, healthcare providers and other societal actors (researchers, policy makers, business and supply chain intermediaries, standardization organisations, etc.) through its whole research and innovation process, aligning the results and its outcomes with the values, needs and expectations of the healthcare sector and society.
PharmaLedger remains technology neutral; so in the future we can also create value by being able to quickly integrate with any other new coming blockchain technology.