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Informed Consent Using the Blockchain

Written by Michael Pica, Associate Director, Portfolio and Capacity Management, AstraZeneca

We see recurring progressions of technological change in industries. We start with decentralized data in the physical form – digitize it to increase its portability and manipulation – then we outsource the management of data for increased functionality and security. This creates large, centralized institutions that allow for efficiency and growth.

In each stage, technology changes the cost/benefit calculation of what’s optimal.

 

For more than the last decade, the benefit of trading efficiency for counter-party risk was worth the cost. Now, we are seeing some phase transitions in finance and other industries. Like ice melting, we are transitioning state where the future state is clear, but we remain in both states at once. There needs to be a force that pulls us toward the state of decentralization, perpetual integration, and native security.

 

The Pistoia Alliance, in collaboration with AstraZeneca, Novartis, and Spherity has chosen a use-case that can begin a phase transition for the pharmaceutical and healthcare industry. The proof of concept for this use case started in 2019 and completes in May 2021. The next step is to create a Minimum Viable Product.

 

Informed Consent was the use case chosen by the Pistoia Alliance because of its complexity, requirement of multiple party interactions, and because it’s in the top ten of cited regulatory deficiencies. The change to informed consent puts the patient at the center of the model, where they have full control over what data gets shared and to whom. The patient will/can consent and revoke their consent at any point.

Informed consent has made the technological journey of starting off as a paper document, physically sent and signed between parties. Then graduated to eConsent for an improved user experience. Then centralized to allow for identification of parties getting access across multiple services. We now have the potential for decentralization and integration.
Blockchain is the technology that will allow this. Blockchain is a peer-to-peer immutable ledger where instead of a central authority it forms consensus via autonomous code. It is the back-end infrastructure that will have all the benefits of eConsent while decentralizing the data in a more secure and transparent way. One with interoperability between systems and with more functionality.

 

Pistoia Alliance’s implementation of blockchain is Blocksent. Blocksent uses a private blockchain technology known as Quorum by Consensys. Quorum is a soft fork of the Ethereum protocol which maintains the foundations of Ethereum (a distributed ledger and smart contracts) and all future updates to the protocol. Quorum adds on top of this, permissioning, privacy, and alternative consensus algorithms.

 

Click here for the Synaptic Health Alliance utilization of Quorum and further information on the technology.

 

Users will interact with Blocksent via wallets developed by Spherity. This user interface will look and feel like other portals we are used to. The difference is the decentralization of data with more functionality and privacy controls for the user. This is all enabled via the backend blockchain architecture.

 

The Pistoia Alliance is operating in the short-term with this use-case and thinking in the long term. They envision Blocksent becoming a platform to build additional functionality on. A marketplace where parties from different organizations can communicate and align to provide an optimal experience for the patient. And one where patients are incentivized and compensated for the sharing of their data.

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Posted on May 26, 2021 by Yasheaka Oakley
Categories: Informed Consent

Tags: AstraZeneca, blockchain, Informed Consent


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