Blockchain and Clinical Trial Securing Patient Data

Author: Hamid Jahankhani, Stefan Kendzierskyj, Arshad Jamal, Gregory Epiphaniou, Haider Al-Khateeb

Published in: Springer

ISBN: 978-3-030-11289-9

File Type: pdf

File Size:  9 MB

Language: English


Blockchain technology to regulate and control the data flows of personal data of participants in clinical trials while privacy and anonymity are preserved (Alevtina Dubovitskaya 2018; Gordon and Catalini 2018; Alhadhrami et al. 2017). In all cases, there is a difficulty to move and share medical data promptly securely that seems to have a detrimental effect on patient’s care. Also, specific legal and regulatory compliance requirements restrict patients and the proxies from accessing data about their health posing Blockchain-based medical record storage, and data exchange systems is a suitable solution to these problems (Rifi et al. 2017).
The blockchain through its decentralised structure promises to be resilient against the data outages and provide a certain degree of data contingency within the communication network. The reliability of data often depends on the controls imposed for the creation of the transactions by specified authorities. It is therefore essential to identify the exact means by which these medical records are created before their input onto the Blockchain network. Some aspects around the authenticity of data are often outside the scope of the Blockchain operation, and it must always be assured utilising defensive measures outside the Blockchain network (Mayo 2016).

Each block in the Blockchain consists of the block header and its body where the block version, the Merkle tree root has, timestamp, nonce, nbits and the parent block hash (except for the first block) are included. Consent of the next block in the chain is found by solving, i.e. mining a hashed-based proof of work (hash puzzle) with high computational overhead. Changes in the blocks cannot be granted without re-calculating the hash puzzle. The main idea is that after several blocks, it should be computationally infeasible to change a block containing transactions (Scheuermann 2016). The complexity of the proof of work scales dynamically with the combined computation in the network. The maximum number of transactions that a block can contain depends on the block size of each transaction.

Concepts of  asymmetric cryptography are used to validate the authentication of these transactions using a pair of private and public keys. The digitally signed transactions use Elliptic curve digital signature algorithm (ECDSA) and variations of it (Yi 2018; Liu et al. 2018). The transactions made can be validated quickly, and invalid transactions would not be admitted to the Blockchain network. The discovery of invalid transactions in the Blockchain is almost immediate. However, immutability aspects might be considered as the number of participants in private Blockchain can affect the possibility of tampering these transactions. It is also available to control nodes/ participants who can join the consensus process of the private Blockchain (Ana Reyna 2018).
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