Blockchain technology is considered by many to be one of the most important technologies developed in recent years. It is often misunderstood and its potential has yet to be fully realised and harnessed. Blockchain has been the subject of a large amount of negative press due to volatile price fluctuations of its biggest user, the cryptocurrency, and this has generated a public mistrust.
However, blockchain could hold the answer to two of technology’s greatest challenges: data reliability and security. These two things are particularly important in the healthcare and life sciences sector where veracity of data is a life or death question and the safety of our most intimate data is paramount.
What is blockchain?
Blockchain is a digital ledger of time-stamped transactions forming a series of data records, which are incorruptible and undisputable. As a blockchain is not managed by any single entity it is a decentralised system, each block of data is secured and bound to each other using cryptographic principles.
A blockchain can be open or closed, the former meaning anyone can inspect and add to it and the latter meaning the blockchain is private and only open to members of its specific network with rules about access. However, its inherent transparency ensures that each contributor is accountable for their data whether the blockchain is open or closed.
Blockchain could also represent a cost-saving tool as there are no transaction costs (although there is an infrastructure cost). It is therefore a cost-efficient method of transferring data from one place to another in an automated and incorruptible manner. It is nearly impossible to falsify a record, which is what made it so useful for cryptocurrencies.
Why is it useful for the healthcare and life sciences sector?
Blockchain represents a secure, trusted source of information and removes the need for a centralised database run by an authority. For example, the recent UK test project between Methods and the HM Land Registry, where R3’s blockchain software has successfully been used to create a digital register for a small selection of properties.
Blockchain would remove the need to reconcile data between organisations as it provides access to a secure, reliable data with minimum cost. Additionally, due to the ‘distributed’ character of the data (no single entity controls the data) it means that each member of the network usually holds the same copy of the information and engenders trust and reliability in information sharing. It may also provide patients with greater control of their medical data.
In 2016, the Office of Science’s report named the NHS as a potential user of blockchain and that the software may improve the sharing of data. This is particularly relevant for the NHS as it comprises 7,494 GP practices, 234 NHS foundation trusts and NHS trusts and 207 commissioning groups and would aid in delivering a seamless service to patients. Several pharmaceutical companies have also embraced blockchain and have set up MediLedger to demonstrate compliance with supply chain regulations in relation to medicines.
Other examples of blockchain application within the life sciences and healthcare sector:
Storage and access to medical records: Access could be controlled and subject to levels of access. Blockchain would also prevent fragmented patient data by allowing all healthcare providers to access a patient’s data once consent has been given.
Patient management of their preferences: Patients could update their preferences eg organ transplant or the need for an interpreter. There is already a pilot investigating this aspect of blockchain between Medicalchain and the Groves Medical Group, announced in 2018.
Data for clinical trials: Blockchain would allow for time-stamped results, prevent alteration of data and ensure that accuracy of results.
Intellectual property evidence: Blockchain would allow research and development companies to prove the date and creation of their intellectual property and would give immutable evidence for patents and/or infringement claims.
Supply chain: Blockchain could also allow each batch of medicines to be time-stamped with a serial number and allow said batch to be easily tracked during each of its movements, so that each transaction is documented in the blockchain. This would help fight counterfeiting of drugs and the ease product recalls.
Medical negligence claims: If all treatment details and medical decisions are captured in a blockchain it could provide useful evidence in medical negligence claims.
Problems with blockchain
The distributed nature of blockchain raises the thorny issue of liability – who is responsible and can be held accountable when things go wrong? However, within a closed blockchain such liability issues would be greatly reduced, and it is most likely that a ledger used by medical or life sciences companies would be on a closed system.
Data privacy issues
The first issue is who would be considered to be data controller if no single party controls the data and who would be considered a processor? A French regulator, CNIL, recently found that all actors within a blockchain should be deemed controllers. However, this conclusion may unfairly demand obligations from parties with little responsibility for the information.
Secondly, despite the encryption or ‘hashing’ of data (ie the removal of personal identifiers and the substitution for a unique code) there remains the possibility of reverse engineering the code so that the data is not completely annoymised. Thereby risking breaches of sharing personal information.
Lastly, the unchangeable nature of data in a blockchain threatens the rights under data privacy as set out in the General Data Protection Regulation, such as the ‘right to be forgotten’ (deletion of data) and limitation of data storage (that data must not be kept for longer than is necessary).
However, solutions to these issues may be possible, if deletion is not possible then it may be possible to delete the data that allows for verification ie the ‘secret key’ as this would be an effective substitute for deletion and act as a tool to limit storage.
The lack of regulation allows for individuals to continue using blockchain in a damaging manner, this is particularly the case for cryptocurrencies, and leads to negative press and increases public mistrust. The public perception of blockchain as a tool for criminals and/or those wishing to abuse the system reduces the likelihood of blockchain’s widespread use. However, in April 2019, the International Association for Trusted Blockchain Applications was set up in order to encourage global governance and development of blockchain and some governments are discussing legislation.
Blockchain has many challenges but the opportunities connected with it far outstrip them. If blockchain can be properly harnessed its potential to disrupt the life sciences and healthcare industry could be incalculable. It could allow for greater control, and ensure the reliability and security of data and thereby change the sector’s landscape entirely.