Disruptive Innovation of Blockchain and Evolution of Pharmaceutical Ecosystem in Data Integrity and Transparency

“Changes call for innovation, and innovation leads to progress.” – Li Keqiang

The present-day goal recognized within the pharmaceutical ecosystem is of enabling a new era of an interconnected pharmaceutical ecosystem that empower patients, researchers, and manufacturers and supply chain organizations to work together towards improving patient safety and quality of life. Achieving this goal is entirely driven by responsible data sharing and transparency while adhering the highest regard for participant privacy and security.

As per the current pharmaceutical industry standards, regulations and goals rely heavily on encryption technology for secure data transmission between organizations. In an increasingly interconnected pharmaceutical ecosystem, security becomes a tricky task.

Software and hardware systems designed to detect intrusion, called parameter defenses, fail to secure vital pharma IT infrastructure. Centralized IT systems over cloud offer advantages regarding efficiency. However, data breaches, lack of transparency, and loss of data integrity may lead to the overall slowdown in adoption of these systems.

To leverage the value inherent in data sharing, the pharmaceutical ecosystem need better solutions to manage data and its security. As pointed by Sagar Anisingaraju in his blog, Analytics Trends 2018: Blockchain and AI to Accelerate Clinical Trials Transformation, advancements and extreme innovation in data management can be achieved via transformative changes brought by Blockchain in both the planning and conduct of pharmaceutical research. For an inherently safe pharmaceutical IT ecosystem, adoption of blockchain, which has distributed consensus mechanisms and a ledger that provides an immutable and auditable record of actions (and actors), can certainly be a more optimal solution for data integrity, data sharing and transparency.

What is Blockchain?

Blockchain is a form of distributed database (or decentralized ledger) made up of immutable, digitally recorded data, packaged as ‘blocks’. Each block of data is stored in a linear chain, and each chain is cryptographically hashed and timestamped. Any change in the data creates a new block, while the old block is preserved. Each new block of data is linked back to the previous block in the chain, to ensure that the overall blockchain is tamper-proof and that the data history of each record is completely traceable.1

In simple terms, blockchain is a database containing an ever-growing number of chained blocks of cryptographically secured information that is replicated and distributed across a network of independent, decentralized nodes.

Figure 1: An illustration depicting blockchain

Each block within blockchain displays the trust:

            – “I know.”

            – “I know that you know.”

            – “I know that you know that I know.”

Typical attributes of a blockchain are that it is Trusted, Shared, Tamper-Proof, Secure, Traceable, and a Single Source of Truth.2

Let us explore the disruptive innovation of blockchain and how it can lead the enablement of a new era of an interconnected pharmaceutical ecosystem that empower patients, researchers, and manufacturers and supply chain organizations to work together towards improving patient safety and quality of life.

Figure 2: Blockchain use cases assisting pharmaceutical ecosystem

All the blockchain use cases within pharmaceutical ecosystem foundationally rely on two aspects – ‘Data Integrity’ and ‘Secured and Trusted’ electronic creation, transfer, and storage of data.

“In Pharmaceutical Industry, Consistency between data security and its threat is a key factor in Reputation and Patient Trust.” – Anonymous

Creating Secured and Trusted Records

Trust is the foundation for the establishment of clinical services for patients. The required trust is bi-directional (i.e., patient to clinical research professional and vice versa). For example, trust between a clinical research professional and a patient involves the belief that the patient is sharing their experiences and conditions truthfully and honestly. Similarly, trust between patient and clinical research professional involves consent-driven sharing of patients personal health information for research purposes.

Substantial improvement in non-repudiation and auditability of each transaction (clinical research, development, manufacturing, supply chain, etc.) can be achieved by using the blockchain techniques such as cryptography, public and private key pairs and the distributed store. In case of clinical research use case, participating patients can manage their private keys and further managing their consent.

With the ability of systems to use cryptographic keys to authenticate a user, the risk related to sensitive patient health data leaks reduces drastically. Moreover, use of predefined governance rules would enable an adequate level of privacy. Another example of creating secured and trusted records is the ‘Shared Molecule Library Development’ in pharmaceutical research where multiple research institutes and organizations are involved. Here, use of predefined smart contracts would not only make sure that trust is maintained throughout the process, but will also ensure that the records on blockchain will act as a valid IT proof in case of any IP dispute.

Furthermore, authorized users can define and manage the governance rules of a blockchain solution around predefined access and control permissions to assure the appropriate levels of privacy versus transparency and ensure that only entitled parties (like CROs, central lab, statisticians, etc.) can see the necessary data. Besides this, to protect the privacy of each user, pharmaceutical organizations can also use a number of solutions such as tokenization, pseudonymization or masking technologies.3

Data Integrity

Blockchain allows for reaching a substantial level of historicity and inviolability of data for the whole document flow in a clinical trial. Blockchain ensures that events are tracked in their correct chronological order, which largely prevents a posteriori reconstruction analysis.

Within blockchain each transaction is cryptographically validated, thus asserting integrity. Further, each transaction with Blockchain is timestamped. This information is publicly transparent and any user can own a copy of the proof of the time-stamped data.

No one owns the data store; it is controlled by users and is not ruled by any trusted third party or central regulatory instance. Trust is coded within in the protocol and maintained by the community of users. Blockchain architecture allows for storing proofs of the existence of data. As the proof of data is the data of proof, we believe that this is a paradigm shift in clinical research methodology.4

Overall, the disruptive technology of immutability, transparency, auditability, distributed ledgers and powerful encryption methodology of cryptography within blockchain seems to have a huge potential in evolving the pharmaceutical ecosystem by ensuring trust, security, and privacy across the value chain.

In subsequent blogs, let us explore blockchain in detail and its applicable use cases in drug discovery and development, manufacturing and supply chain, and sales & marketing respectively.

References
Salaberry, J. d. (2017, August 9). IS BLOCKCHAIN THE DRIVER FOR TRANSFORMATION IN HEALTHCARE WE HAVE BEEN WAITING FOR?
Repec, C. A. (2017). Sharing Supply Chain Visibility Data with GS1 Standards, EPCIS and Blockchain. GS1.
Brodersen, C., Kalis, B., Leong, C., Mitchell, E., Pupo, E., & Truscott, A. (2016). Blockchain: Securing a New Health Interoperability Experience
Benchoufi, M., & Ravaud, P. (2017). Blockchain technology for improving clinical research quality. Trials.

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About Tushar Sinkar

mmTushar is a clinical solutions consultant with more than 8 years of experience in implementing cutting-edge solutions in the Life Science and Healthcare domain. His areas of expertise include enabling pharmaceutical companies and independent software vendors in conceptualizing, designing, and implementing clinical trial and real world evidence (RWE) solutions that are driven by semantics and are interoperable, secured, and GxP and HIPAA compliant.


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