PharmaLedger was mentioned in the EU Blockchain Observatory and Forum Report, which explores blockchain applications in the healthcare industry.
The European Union Blockchain Observatory and Forum aims to evolve blockchain innovation and the blockchain ecosystem within the EU. In February 2022, they released a report titled “Blockchain Applications in the Healthcare Sector.” It covers the latest developments, use cases and applications of blockchain in the healthcare industry, as well as COVID-19 pandemic management including a number of interviews where PharmaLedger has been mentioned.
On pages 46-53, PharmaLedger’s Architecture & Reference Implementation Co-Lead Marco Cuomo (Novartis) is interviewed by PharmaLedger’s Clinical Supply MVP Lead Kristina Livitckaia (CERTH). The interview is titled, “From Innovation to Production in Big Pharma: Interview with Marco Cuomo, Blockchain Technology Expert.” You can read the full report by following the link below and a summary of the article is followed after.
Kristina asked Marco nine questions regarding the PharmaLedger project, which also covered OpenDSU & off-chain storage, identity management and transitioning from innovation to industry & pharma specificity. Highlights from the Q&A interview are summarised below.
The PharmaLedger Project
Marco explained how Novartis started being interested in blockchain technology implementation in 2016, which led to today’s PharmaLedger project, a consortium of 12 global pharmaceutical companies and 17 public and private partners across various sectors are working together since January 2020 to build a blockchain-enabled platform in the healthcare industry. You can read more about our project and eight use cases in our Official PharmaLedger Project presentation.
In order for the project to be blockchain technology/protocol-agnostic, meaning it can use any blockchain and retain integrity/traceability, an abstract architecture was necessary. This additional layer to blockchain technology was needed to implement the platform solution, which was first called off-chain storage, and is now known as OpenDSU (Data Sharing Unit). OpenDSU is covered more in-depth later in the interview.
PharmaLedger Use Cases
Marco talked about the eight use cases, with electronic Product Information (ePI) having the greatest potential. He stated that decentralised applications have gained recognition as a solution due to their ability to drive “patient engagement and healthcare data empowerment.”
The use cases related to clinical trials (eRecruitment/eConsent) aim to increase the exposure of the clinical trial recruitment process to patients and essentially enable them to become more empowered and responsible for their own data (personal/medical). Digitising today’s processes using new blockchain solutions is a lengthy process that will take years to onboard everyone participating in the healthcare ecosystem. PharmaLedger is helping to pioneer this new direction.
It is important to note that the project is working on implementing processes for the project’s sustainability, even after the end date of the project (end of 2022). The difference between other projects in the healthcare industry implementing blockchain solutions is that PharmaLedger is moving towards a “decentralised digitally trusted ecosystem that is blockchain technology-agnostic utilising OpenDSU.”
OpenDSU & Off-Chain
Marco noted that there are two important things to understand when it comes to OpenDSU. OpenDSU from a developer’s perspective allows them to build and program regardless of specific blockchain technologies. This is one big advantage for them. From a business perspective, OpenDSU strengthens security, confidentiality and privacy issues, which are often challenging to overcome when it comes to adopting blockchain technology. Patient or business data isn’t stored on the blockchain but instead, “blockchain is used as a layer to anchor the off-chain data.”
Blockchain will act as the backbone in PharmaLedger, by only representing 10-20% of the final solutions. The reason why OpenDSU is such a crucial aspect of the PharmaLedger project is that it “allows the building and collaboration of different use cases and applications to enable interoperability and cross-chain connectivity.”
Marco further emphasises that off-chain storage is necessary because blockchain is not a typical database for holding data. It should not be viewed as a technology that solves all problems. Blockchain can manage assets and values, but its goal is not to store data on-chain. If it were to store data on-chain, its solution would not be scalable. Storing data off-chain also allows for greater flexibility since data would have to be replicated on all participating nodes, which would take a long time with larger files.
Blockchain is especially useful for timestamping documents and tracking supply chain information, which is essential for notary services and data provenance. This helps to build trust in trustless environments. Blockchain can grant trusted data, “but the off-chain frameworks give the flexibility for the data we store.” This is a mere summary of what Marco talks about in the interview, which you can read through in the EU Blockchain Observatory and Forum – Blockchain full report.
PharmaLedger uses the Demiurge tool when it comes to identity management. This tool has been developed to manage the identities in PharmaLedger’s OpenDSU-based use cases. Users need to create an account for any simple tasks, such as opening a wallet. A decentralised identifier (DID) is an essential step for creating an identity for a user. The Demiurge tool simplifies DID creation and operates within OpenDSU but for those joining the ecosystem later in time, external DID’s are also supported. The tool simplifies the administrator’s tasks and is incorporated with the existing account management for a single sign-on.
The transition from Innovation to Industry & Pharma Specificity Challenges
Marco went on to state some of the main challenges of transitioning from innovation to operation. Funding is a challenge since the transformation needs investment in order to take place. A proof of concept is created to show the value of the technology on a large scale. Then, a business case is built out of the proof of concept, which would show the value of the investment.
For blockchain, this can be difficult since it’s an innovative technology with the future results of its implementation hard to showcase. Evaluating the impact is hard to do since there is a lack of reliable measurement for blockchain in the healthcare industry. It is a challenge to know how blockchain will progress and be shaped over time.
Other issues of blockchain such as stability, scalability, reliability and security have many businesses second-guessing implementing this technology. Small steps are needed to create a shift of perspective for communities. From a business perspective, blockchain has greater value when an ecosystem with various stakeholders adopt the technology rather than a single company.
And finally, the last challenge mentioned is that there is a lack of experience. Many of the processes within the PharmaLedger project are all-new, such as defining the governance, as there are no governance models to compare to and improve on.
Governance Models in the Healthcare Industry
Healthcare companies usually have a hierarchical structure, which is exactly what blockchain is overcoming when it comes to a decentralised model. Traditional organisation structures usually have a governance board that is in power, which might be PharmaLedger’s starting model. The goal is to grow into a decentralised structure and become a decentralised autonomous organisation (DAO).
Key Messages for Market Adoption
In closing remarks, Marco talked about the need for collaboration among the PharmaLedger consortium members in order to showcase the value of this technology to patients. “Building
networks, platforms, and applications take time, and refinement must be in incremental steps which is critical for use case success.” Willing to take risks is crucial for the success of blockchain implementation and progress. Make sure to read the full report to read the full Q&A interview, where you can also gain a deeper understanding of blockchain implementation in healthcare.
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