2017 has seen an increased focus on the use of blockchain technology in the healthcare industry.
The latest IBM Institute for Business Value blockchain study found that, of the 200 healthcare executives surveyed, around 16% are intending to implement a commercial blockchain solution later this year.
Earlier this year, the US Food and Drug Administration (FDA) and IBM (through IBM Watson Health) announced a new research initiative aimed at “defining a secure, efficient and scalable exchange of health information using blockchain technology”.
The two-year collaboration, which will initially focus on oncology-related data, will test how data from disparate sources, can be securely stored and shared. This information might come from clinical trials, patient data or health data generated from mobile devices or wearables. This data can then be securely stored and shared amongst researchers and healthcare providers using blockchain technology. The FDA and IBM plan to publicise their initial findings later this year.
The collaboration is one of several government and industry blockchain partnerships occurring in the healthcare space. Another notable example is the Estonian government’s partnership with cyber-security company, Guardtime, to deploy a blockchain-based system to secure over one million online patient records.
Blockchain, or ‘distributed ledger technology’, is technology which allows a database or ledger to be shared amongst a distributed network of computers rather than sitting with a single provider. You might know blockchain as the technology which sits behind the virtual currency, bitcoin.
Data captured on a blockchain can be shared in real-time across a wide group of individuals and institutions. Each addition or change to the data becomes part of a permanent ‘chain’ and, as a result, it is almost impossible to tamper with data after it is captured and added to the chain.
Complex encryption protocols can be employed across the blockchain ensuring that certain data is restricted to particular groups or individuals. In Australia, the financial services industry is leading the way in blockchain research, with the ASX investing $50 million in a potential blockchain solution to replace its current equities settlement and clearing system.
For the clinical trials industry, the use of blockchain technology means that, instead of medical or clinical trial data sitting with a single entity (such as a contract research organisation conducting a clinical trial) and that entity being responsible for sharing the data with interested parties (such as the sponsor and the regulator), the same data set can be accessed and verified in real-time by all relevant parties.
In this way, blockchain technology can be used to increase the transparency and trustworthiness of clinical trial data. Using blockchain technology to capture and report on clinical trial data makes it nearly impossible for data to be selectively reported, altered or falsified. Using the blockchain also means that exactly the same live data set is visible to contract research organisations, sponsors, ethics committees and regulators alike. Versions of trial protocols can also be stored on the blockchain, so that all changes to that protocol can be time-stamped, tracked and verified.
For the broader medical industry, the blockchain may be a secure, reliable way to share patient information between providers. Currently, healthcare data is recorded in individual databases held by organisations or networks which means that large amounts of patient data is captured, but not shared. Implementing a universal, interoperable database for viewing patient data captured by multiple sources creates obvious opportunities for patient care (avoiding the need for patients to act as conduits between heathcare professionals and the medical industry). The blockchain can also be used for tracking the use of prescription medication by patients (as it could allow doctors to see (in real time) the medications that have been prescribed to a patient by other medical practitioners).
In general, patients and healthcare providers in Australia recognise the benefits that could be gained from the sharing of heath data, provided there is anonymity. A survey conducted by Research Australia in 2016 revealed over 90% of Australians were willing to share their de-identified health-related information to help advance medical research and improve patient care. Blockchain is one technology solution that could be used to allow such data to be securely shared.
The Productivity Commission’s draft report into Data Availability and Use identified the health sector as a key industry in which opportunities to develop new products and services, enhance patient experiences and better inform decision-making were being foregone due to impediments around the sharing of health data. The use of blockchain technology may be one way in which these impediments can be overcome.
Use of blockchain technology in the heathcare industry raises obvious issues of privacy, security and patient consent. As identified by the Productivity Commission, near real-time data that identifies individual persons carries with it the highest risks to privacy and security.
Personally identifiable health data stored on the blockchain needs to be handled in accordance with the Privacy Act and applicable Health Records legislation. Blockchain systems will need to be designed in a manner which addresses these issues and ensures that data is appropriately encrypted and restricted, while maintaining the integrity of the system.
The storage and accessing of information on multiple computer systems also increases the possibility that patient data will be disclosed outside of Australia, meaning that users of a blockchain will need to ensure that patients are appropriately notified of (and, if required, patient consent is obtained to) the cross-border disclosure of data.
As noted, one of the attractions of a blockchain-based system is that once data is incorporated in the chain, a permanent record of that data is formed. However, what happens if there is then a legal requirement imposed that requires deletion of that data? For example, under the Victorian Health Records Act, Health Privacy Principle 4.5 requires certain organisations to take reasonable steps to destroy or permanently de-identify health information which is no longer needed for the purpose for which it was collected. If that data was held in a blockchain system, this would be technically difficult, but could also undermine one of the features of blockchain that makes it so attractive. Again, encryption and security protocols in any blockchain system will need to be designed to address this issue.
In its draft report into Data Availability and Use, the Productivity Commission described the risks associated with the increased sharing of data to be “real but manageable”. The Productivity Commission is of the view that the difficulties associated with protecting the privacy and security of individuals can be managed through appropriate security frameworks and protocols (and should not be permitted to stand in the way of the enormous benefits that can be gained through the increased sharing of data). In its final report (which was presented to Parliament at the end of March, but which is yet to be publically released) the Productivity Commission is expected to recommend a new legislative framework to balance the privacy and other risks associated with increased access to data against the national interests associated with data sharing. If this framework is accepted by Parliament, this may pave the way for the increased use of blockchain technology in the Australian healthcare sector in the near future.
The content of this publication is for reference purposes only. It is current at the date of publication. This content does not constitute legal advice and should not be relied upon as such. Legal advice about your specific circumstances should always be obtained before taking any action based on this publication.