Recap PharmaLedger’s #4 Open Webinar “Building a Digital Trust Ecosystem: Blockchain & OpenDSU”

PharmaLedger’s 4th Open Webinar, “Building a Digital Trust Ecosystem: Blockchain & OpenDSU,” was held on two dates in June 2022. After initiating solutions in the healthcare industry from our blockchain-enabled use cases, PharmaLedger plans to enter the next phase of the project, which is to build a “Digital Trust Ecosystem (DTE).” The webinar covered this transition and went into more detail about the technology behind the framework of our project, termed OpenDSU (Open Data Sharing Unit).

The full webinar recording, which is available on our YouTube channel, also includes the Q&A sessions from both screenings. Audience members were encouraged to ask questions throughout the presentation and our speakers, PharmaLedger’s Architecture and Reference Implementation Co-Leads Sinica Alboaie (Romsoft) and Marco Cuomo (Novartis), answered them at the end of the webinar. PharmaLedger’s Culture and Adoption Team Member Martin Hunt (Onorach) was the moderator of this webinar.

You can watch the full recording, or read the summary below with timestamps included so you can easily navigate to specific presentations for more context. 

Recap of PharmaLedger’s 4th Open Webinar: Building a Digital Trust Ecosystem: Blockchain & OpenDSU 

Evolution From Blockchain Enabled Healthcare to a “Digital Trust Ecosystem” (3:20)

When the PharmaLedger project began in January 2020, “Blockchain Enabled Healthcare” was the main phrase associated with the project, with the aim being to build a blockchain infrastructure for the healthcare industry. As time passed, however, it became apparent that we needed to build an entire ecosystem, more specifically, a “Digital Trust Ecosystem.” 

Empowerment Through Digital Sovereignty (4:22)

One of PharmaLedger’s fundamental goals is “digital sovereignty,” meaning giving patients, organisations and countries better digital control over their data and identities. Power and control would shift toward individuals and away from big tech companies or other central authorities controlling the data. 

Digital sovereignty can be grouped into three areas:

1. Self-Sovereign Identities: these are the various identities, such as your digital identity
2. Data Self-Sovereignty: you have control over your data
3. Self-Sovereign Applications: having access to your personal data and your identities

What is a Digital Trust Ecosystem (DTE)? (7:45)

A digital ecosystem, defined by Gartner, has interdependent participants that collaborate amongst themselves toward a mutually beneficial goal. Standardised digital platforms help to bring these independent participants together, and the “digital trust” is established cryptographically through blockchain. 

There won’t be a single DTE in the healthcare sector, but PharmaLedger is helping to accelerate and establish this in the industry by being one of the first. There are other DTEs in other sectors, such as finance and government, which overlap to mutually benefit each other.

PharmaLedger’s Digital Trust Ecosystem (7:15)

PharmaLedger’s vision of the DTE structure in the healthcare industry has a layered architecture. As seen in the image below, the top layer features DTE applications: use cases that use reusable artefacts and standards so that the application can focus on the business use case solutions. These artefacts are using middleware, also referred to as OpenDSU, which interacts with the blockchain, or hierarchical ledgers and blockchain. 

This is PharmaLedger’s view of a DTE, but there will likely be many other DTEs in the healthcare industry with their own structures down the line. The difference is that PharmaLedger’s DTE is interoperable with other solutions, structures, and other DTEs. The vision is for the end-user to have a smooth user experience, which wouldn’t be hindered by technology or the need for various, individual applications.

PharmaLedger Platform Overview (10:52)

PharmaLedger is a decentralised platform, also termed a Digital Trust Ecosystem (DTE). There is a great focus on decentralising the ecosystem culture, which is embedded in the technical design of the PharmaLedger architecture. 

For such a large ecosystem, hundreds of use cases could appear, so the system needs to be broken down into smaller parts, where these smaller parts can still share data with each other and the use case applications should be interoperable. OpenDSU is like the Layer 2 blockchain technology that focuses on off-chain data storage, off-chain data integrity and cryptographic control of data sharing. Hyperledger fabric and quorum as layer 1 blockchain technology are also supported for anchoring.

PharmaLedger has built a decentralised architecture that serves the core interest of the health industry, healthcare professionals, pharma companies, hospitals, distributors and patients. The core values are embedded with an open-source approach, and OpenDSU helps with avoiding gateway problems and vendor lock-ins while supporting disintermediation and digital sovereignty.

PLA: Ecosystem Governance (15:20)

The PharmaLedger Association (PLA) (the PLA continues with all the progress that has been made when the PharmaLedger project ends at the end of 2022), plays the role of being the brand umbrella for multiple use cases, with the main goal being maintaining the stability and growth of the PharmaLedger DTE. The PLA would help facilitate new use cases and promote benefits to new members. These use cases would act independently with different stakeholders and constraints.

Blockchain can change society and how we collaborate, giving individuals better control over their data. OpenDSU is the central technology that enables the PharmaLedger DTE to become established in the Enterprise World. 

Why OpenDSU? (21:06)

OpenDSU is a generic approach to all use cases and is also referred to as the framework or middleware. For the given use cases, the business developer can focus on solving the business solution instead of worrying about technical details for each and every use case, which is why it’s referred to as a generic approach. 

PharmaLedger doesn’t store the data directly on the blockchain, but rather elsewhere, referred to as off-chain. It is connected to the blockchain by reference, so it can get to the data which is stored elsewhere. You can refer to the recording to find out more about why this is beneficial, especially in healthcare.

In order to access a blockchain, you need a digital wallet, which can be a mobile application, that handles the keys to access the data on the blockchain. Each blockchain solution needs its own digital wallet to handle the keys, which OpenDSU is helping to solve through the reusability of features, interoperability and data portability between the different use cases. This supports seamless integration between the different use cases while also preserving data confidentiality and data privacy.

The image above can be used to illustrate how OpenDSU works. On the left are companies or end-users using the data stored on the blockchain, known as the DSU storage. This is the execution environment, or the digital wallet, such as a mobile application, that has keys to read the right data on the ledger. It also brings data from the off-chain storage to the execution environment by decrypting it so that the right data can be seen and accessed. 

OpenDSU vs Private Transactions (28:51)

A common question asked is: what are the benefits of OpenDSU compared to private transactions or private managers? You can refer to the recording for a full explanation of the benefits of using OpenDSU vs private transactions or transaction managers. 

OpenDSU follows the principle of data mitigations by offering the concept of wallets and a stronger decentralised key management solution. Private transactions don’t address these concerns. They are designed for larger companies that can install nodes and additional Layer 2 transaction managers themselves. This typical approach doesn’t address the concerns of patients or small companies in the supply chain. OpenDSU has this digital wallet as a core concept for all blockchain solutions under PharmaLedger.

The Vision of the OpenDSU Smart Wallets (35:25)

Our DTE covers a variety of use cases, and there are other DTEs with different use cases that have their own separate applications. These separate applications would be hard to handle for end-users. It would be much easier to have something that brings everything together, such as an interoperable wallet, into one place. 

OpenDSU makes this possible by bringing together different use case functionalities into one smart wallet. The idea is that these different use cases are interoperable, meaning that they can exchange data or even features. 

An example could be that the eConsent wallet could be used with the Clinical Trials wallet and exchange necessary information seamlessly. This technology can even be integrated into bigger applications or other applications. The ideas are endless, and you can create a new platform through customisation. 

OpenDSU helps realise a seamless experience for healthcare applications, that can be combined with other applications or elements, and we’re excited to share our progress with you as time goes on. 

Live Q&A: Top 5 Questions & Answers (40:05)

Here are the top five questions and answers are taken from both streaming sessions of the webinar.

Q1. How far away are we from the mainstream adoption of blockchain in the pharmaceutical industry? What are the main showstoppers right now?

Answer: In terms of adoption, the electronic Product Information (ePI) use case is planned to go into a productive pilot, which is a qualified environment under the regulation of the regulatory requirements at the end of 2023. The productive pilot is in parallel to the existing processes and if it goes well, there will be an increased implementation of this new technology and adoption of the network.

There’s also a need for change in the regulatory requirements, such as going from paper to completely digital medicine leaflets. This adoption process could take 3-5 years. The law and regulatory factors need to change over time to complete this adoption process. Understanding the technology and changing the mindset of people to know why this complex adoption of blockchain technology is beneficial must also occur, which takes time.

Q2. How and when do you intend to onboard pharma companies, CDMOs and app developers who are currently not a member of the consortium?

Answer: After the PharmaLedger consortium ends at the end of 2022, it will be followed by the successor organisation, the PharmaLedger Association. This will be something like an umbrella with various use cases underneath. Each use case will receive a tailored approach for onboarding. 

The most advanced use case, the ePI use case, is a hybrid network. This means, anyone wanting to read can use it but those that want to write on it, mostly pharma companies, must be a member of the organisation and must be onboarded. The pharma companies in this case would have to be members of the PharmaLedger Association, but the users who want to read it don’t have to be members. The other use cases would have tailored approaches. 

Q3. I understand that this is a decentralised ledger. How is the infrastructure deployed and maintained? Is it peer-to-peer?

Answer: Yes, we tried from the beginning to be peer-to-peer. The ePI use case is hosting a node that has to follow the internal rules. We deployed the system in different clusters and clouds and connected these blockchain nodes in a single network. In terms of the other use cases, there is the flexibility of OpenDSU. All use cases will be adapted according to the needs and features of each use case. They could be more centralised or have a hosting provider, but what is important is that the architecture doesn’t impose centralisation.

Q4. Do you believe the cultural adoption will be more challenging than the technical implementation?

Answer: The technological implementation has a rational approach while cultural adoption has an emotional and mindset aspect that needs a paradigm shift in thinking. Cultural change and adoption is a harder and longer approach versus implementing new technology.

Q5. Will companies joining PharmaLedger have their own DSU? Or will one DSU be shared by different companies?

Answer: Every pharma company or every participant on the blockchain node will have their own data sharing unit where they store their own data, such as in the ePI use case. This is the decentralised approach. For ePI, pharma companies will store their eLeaflets in their own environment.