Since it entered the wider public consciousness, blockchain has been virtually synonymous with cryptocurrencies such as Bitcoin. However, this association has tended to overshadow some of the more practical benefits it can offer in the healthcare domain. The IMI-backed Pharmaledger project is exploring how blockchain can add value and improve patient-driven healthcare delivery, enabling the seamless and secure sharing of information between people and technologies, across multiple sites and organisations.
The digital revolution is in the process of changing – and improving - almost every aspect of our lives, and healthcare is no exception. Despite the fact that the improvements digital technologies bring can be difficult to detect, they are real and their impact is significant and growing. At the same time, implementing digital technologies pose its own challenges; it is vital that the security of patient data is protected and its confidentiality ensured.
A potential solution to this implementation challenge in healthcare is blockchain, a method of recording information that is impossible to change – a so-called ‘digital ledger’. Any change to the information is timestamped and indelibly recorded as a ‘block’ in the blockchain. As the data in the chain is decentralised, any attempts to interfere are quickly apparent.
The possibilities offered by blockchain are currently being explored by the Innovative Medicines Initiative (IMI) project, PharmaLedger. It is currently examining a number of use cases that it hopes will build the case for the wider adoption of blockchain within the pharma industry. These include the security of the supply chain, the protection of health data and empowering patients taking part in clinical trials.
For the supply chain, using blockchain would bring tangible benefits by reducing the risk for patients. By using an app on their smartphones they could rapidly check the veracity of their medicines, confirming it was not counterfeit and is within its shelf life. It would also ensure that the electronic information leaflet for the product is the most up-to-date version available. There are also other potential opportunities; the blockchain app could be used to provide the latest information on medicine recalls, the safest methods of disposal, with many others to follow.
In the area of clinical trials and health data, the introduction of blockchain could provide a number of significant advances. Given that most newer medicines are increasingly designed for small patient populations, recruiting for clinical trials can be a challenge – often creating bottlenecks in completing clinical studies. The PharmaLedger project is looking at a use case for using health data to match patients to relevant clinical trials, while at the same time preserving the patient’s privacy and data security.
In addition, the technology can assist in gathering so-called ‘real world’ evidence. Clinical evidence derived from real-world data, such as clinical histories and devices, can be gathered. Now, data from wearable medical devices that can be captured remotely, meaning that patients taking part in the trial can reduce the number of clinic visits. This could represent a significant saving of time for them and their carers and potentially increase the efficiency of the trial. Indeed, as health data becomes an increasingly important resource in medical research, it is important to empower patients to decide who can use their information, when they can use it, and for which purpose.
However, as Daniel Fritz - PharmaLedger’s industry project leader – explains, there’s much more to the project than the use cases. As he puts it: 'The project is greater than the sum of its parts. It’s a new way of sharing information, one that allows us to solve problems that we wouldn’t be able to do individually.'
While the principle goal of the PharmaLedger project is to examine the use cases capable of making blockchain part of the future of healthcare, the recognition of the need for trust has been central from day one. The multi-stakeholder approach adopted within the project saw patients – through two high-profile patient organisations - involved from the outset, thus allowing their input and consultation at every step in the development of the project. It ensured, as PharmaLedger Coordinator-Xenia Beltrán explains: 'It respects the privacy of individual data and it ensures that everyone has a voice.' This approach has delivered a governance structure that was up to the task and future proofed. So much so, in fact, the governance structure will continue – at the behest of the members - after the finalisation of the project at the end of this year. It will be set up as a not-for-profit organisation.
Trust, accessibility, transferability and privacy compliance of data are key to maximising the benefits of digital transformation. Blockchain will undoubtedly have a role to play in the future of healthcare; the main question is simply what will be the extent of its reach.
PharmaLedger is supported by the Innovative Medicines Initiative, a partnership between the European Union and the European pharmaceutical industry.