Horizon 2020: PharmaLedger Framework Architecture for Healthcare Industry

March 4, 2022

The structure of the PharmaLedger platform is detailed in the Framework Architecture document.

Our three-year PharmaLedger project started in January 2020 and is sponsored by the European Federation of Pharma Industries and Associations (EFPIA) and the Innovative Medicines Initiative (IMI). As part of the Horizon 2020 programme, PharmaLedger’s aim is to build a blockchain-based platform for a more trusted and interconnected healthcare ecosystem.

As our open blockchain-based platform is set to emerge within the healthcare industry, the infrastructure of PharmaLedger is paramount. To operate within the healthcare industry, such a platform must adhere to specific guidelines and regulations, such as the General Data Protection Regulation (GDPR). This is to ensure safety, security and privacy for all who engage with it.

Additionally, since blockchain technology implementation within the healthcare industry is relatively new, the structure of our project is expected to have many adjustments in the future. At PharmaLedger, we recognise this as well as the responsibility to protect the data of all individuals who use our platform.

The purpose of the Framework Architecture document, which you can read in full below, is to describe the initial structure of the PharmaLedger platform and establish the importance and purpose of its foundational components. The rest of the article provides some highlights of what you can find in the full report.

The PharmaLedger Project Organisation

The current framework of the PharmaLedger platform is based on the initial first year of the project and is informed by supplemental documents and work packages. You can read our Project Organisation visual for a better understanding of this. Work Packages 1, 3 and 4 significantly impacted the design of the platform’s architecture through various parallels—including definitions of functional and technical requirements, surveys of existing blockchain platforms and bi-directional feedback that pertain to possible governance options. While the governance model for the future state of PharmaLedger is still being worked on, this document includes emerging recommendations on the “Next Gen” (future governance) of the project.

At its core, the platform has been designed to adhere to the strictest privacy and confidentiality requirements. This is by and large due to its hierarchical blockchain structure along with the utilisation of Data Sharing Units (DSUs). The Framework Architecture report goes into further detail on how the platform’s design supports user safety and self-sovereignty, as well as the healthcare industry standards it builds upon.

Adapting to Changes

The final platform architecture specifications of the PharmaLedger project are expected to adjust and adapt in the future. One method that has been employed to account for these changes was to construct the platform to decouple blockchains from its applications. This allows a PharmaLedger application to switch to different blockchain infrastructure and protocols without the need to change the application code. The architecture has also been designed so that it may be integrated with existing or future health IT systems.

PharmaLedger’s Use Case Implementation

Implementation of use cases within PharmaLedger is covered in the final section of the Framework Architecture document. The functional and non-functional requirements of use cases are of the utmost importance and typically specific to each use case. While specific use case requirements and implementations are not part of the deliverable, the initial implementation of the electronic Product Information (ePI) use case is included as an example of using the platform in healthcare. DSU utilisation and the decentralised nature of the platform are both mentioned in this section as well.

The healthcare industry has many standards and regulations that require proper compliance. Nevertheless, such compliance can be difficult when working with emerging technologies, since revisions will undoubtedly be needed in the future. By choosing to approach the construction of the platform with safety, flexibility and versatility as top priorities, we hope PharmaLedger will provide the patients and stakeholders with innovative solutions for their healthcare-related needs.