Globally, healthcare systems are in need of reform. From frequent data hacks to blatant inefficiencies in patient care, blockchain can provide an effective solution to the inefficiencies currently present in the healthcare sector. However, despite the incredible potential that such a technology can bring to healthcare, there lies a huge amount of development for the advantageous properties of blockchain to be realised.
So what are issues with current healthcare systems, and how can blockchain provide an answer to these inefficiencies? It is these questions that this article will seek to explore, and shed light on the application of blockchain within the healthcare sector.1 - Current inefficiencies in the healthcare sector?
An Electronic Health Record (EHR) is the systematised collection of patient and population health information electronically stored in a digital format. This eliminates that need for storage via ‘old-fashioned’ paper documentation. Although it is widely implemented in healthcare organisations, it is also often a source of great frustration.
This is primarily because currently EHRs are stored on centralised databases in which medical data remains largely non-portable. Health data contained in legacy systems is siloed and difficult to share with others because of varying formats and standards. To address this issue of interoperability, several international standards for transfer of clinical and administrative data between software applications used by various healthcare providers have been promoted. These attempts to standardise have not accomplished their goals, as this requires the collaboration between different EHR vendors who are not keen as data has become more of a commodity and competitive advantage than a basis for coordinated care.1.2 - Healthcare quality
The patient’s quality of care suffers as a result of this fragmented healthcare data landscape. As there are still different health records with assorted healthcare providers, institutions are not aware of a patient’s complete history and may rely on out-dated health information. Patients with complex chronic diseases can see up to 5 or 10 specialty departments. This could lead to incorrect decision-making, delays, and unnecessary costs for the patient. Medical errors are the third leading cause of death, and most of these represent systemic problems, including poorly coordinated care.1.3 - Inaccessibility
Presently, patients do not have control over the access privileges to their medical records. Patient engagement is an increasingly important component of strategies to reform health care. There is considerable evidence indicating the benefits of providing patients with access to their health information. Engaged patients have higher levels of satisfaction, and improved health and outcomes, have increased levels of trust of in their physicians and results in a reduction in overall expenditure. For this, it is essential that patients can access their own health information, enabling them to be the ‘source of control’ in making healthcare decisions.1.4 - Security and privacy issues
A substantial amount of data is retrieved from biomedical imaging, laboratory testing and omics data. Although increased data volume and complexity offers new exciting perspectives in healthcare industry development, it also introduces new challenges in privacy and security. Lack of adequate security measures has resulted in numerous data breaches. Recently, an attack caused by the WannaCry ransomware shut down work at 16 hospitals across the United Kingdom. Therefore it is not a surprise that patients are becoming increasingly anxious about the privacy of their medical records. As centralisation increases the security risk footprint, and requires trust in a single authority, the question is raised whether healthcare data should be trusted in the hands of third-parties.1.5 - Tampering with data
Although healthcare is very much based on evidence, there is a general lack of confidence in its sources. The bad science in clinical trials has been well documented and includes selective publication of positive results, performing unplanned analyses and changing the outcomes that were pre-specified at the beginning of the clinical trial. There is need for open science and open data, in which the trial protocol, pre-specified hypotheses, and raw data are made available. Today, companies that want to perform a clinical trial are required to register their trial on ClinicalTrials.gov. However, compliance is poor, with only 13% of clinical trials being registered within two years. Besides, only limited information needs to be published.
Altering or removing information in a patient record, e.g. to correct a mistake, is common practice for healthcare providers. Nevertheless, to pass off a rewritten record as contemporaneous is a criminal offence and any retrospective changes have to be clearly marked, dated and signed, and the reason for such changes clearly documented. However, today, it is very easy to alter information without it being noticed.1.6 - Counterfeit drugs
The size of the global counterfeit drug market ranges between $75 to $200 billion and comprises of 50% of all drugs sold in low-income nations. It may contain inappropriate quantities of active ingredients (or none at all), contain ingredients that are not on the label or be supplied with inaccurate packaging and labelling, putting the safety of the patient at risk.
The pharmaceutical supply chain is very complex as a consequence of decisions by the industry on how best to source and distribute their medicines in different markets. The supply chain complexity creates various factors that contribute to the problem of loss of system integrity. Integrity predictably fractures across international borders, and where production processes and supply involve a variety of intermediaries, or repackaging/relabelling and whereby the provenance is lost. Indeed, it is precisely this loss of information that creates the necessary holes in the system that are criminally exploited.2 - How blockchain can be applied to the healthcare sector
The inefficiencies in EHR accessibility and storage stems from a lack of standardisation. There lies no singular platform where EHR can be streamlined in a homogenous format that can be easily accessed by all clinicians regardless of institution or OS (“Operating System”). Such a platform must ensure interoperability is secure, and that data cannot be tampered with. This is where blockchain can provide an answer, and where the properties of blockchain can have a dramatic impact within the healthcare sector.2.1 - Improvements for patient care
An accessible, interoperable platform for storing patient data will necessarily benefit patient care.
Fundamentally, patients can be subject to more efficient and transparent healthcare. Firstly, patient history can be entered onto the blockchain (or data pointers and consent), whereby all clinicians can view a verified and homogenous version of patient data. Subsequent consultation minutes can be logged onto the blockchain, clinicians can enter and view an entire patient’s history on one single platform.
This prevents potential inconsistencies that arise from multiple copies of similar data-sets being recorded across various institutional databases. Since, all data (regardless of institution) is entered and stored on one universally accessible platform, this guarantees greater consistency with accuracy of patient data than with fragmented record systems currently used to store EHR.
Furthermore, creating an interoperable platform for clinicians to access EHR necessarily ensures more effective patient care. Since clinicians can see all previous consultations (e.g. which medication the patient is taking, which medication a patient has been prescribed and any additional notes taken by previous clinicians), a deeper understanding of a patient can be garnered compared to the ‘snapshot’ provided by current healthcare databases. With this platform, clinicians can ascertain more accurate diagnoses, prescribe more effective treatment methods, and ensure that such actions are performed quicker and more efficiently than relying on incumbent EHR platforms.
For example, say you are in an accident abroad and you need surgery. Utilising blockchain to create an interoperable system of data sharing, surgeons can access your healthcare records immediately, and see, for example, what blood type you are, if you’re allergic to any medication and any present ailments that may impact surgery. Under current EHR data storage systems, this information may only be retrieved from submitting a request to the relevant domestic health authority where you reside, and this bureaucratic delay can dramatically impair the quality of care patients can receive
This not only provides more effective medical treatment in situations where patient data is necessary in time-tight situations, but in general terms general such an overview is especially useful for patients who consult with multiple clinicians across various medical institutions (such as elderly or chronic disease patients).2.2 - Improvements in security
Not only can blockchain improve accessibility (which instrumentally improves patient care), but the decentralised nature of blockchain and DLTs reduces the chance of systemic breaches with traditionally centralised information seen in incumbent healthcare systems (in 2015 alone there were 112 million healthcare data breaches worldwide due to hacking).
Current EHR systems are centralised on specific and identifiable databases. These centralised data points (referred to as ‘honey pots’) provide a clear fault point for hackers to target. As we saw with the NHS ransomware attack, a breach of a centralised database breaches every server that is connected to that centralised database.
DLT ensures that there lies no single fault point for data breaches. If a node is hacked, only the data within that node will be breached, and not the entire system, and this proves an exponentially more secure system than incumbent systems for storing EHR. Regardless of the inevitable improvements in patient care that arise with DLT and blockchain, merely from a security perspective incumbent systems are in desperate need of reform, and utilising blockchain for storing healthcare records can provide a solution to this worldwide problem.
Finally, since data entries onto the blockchain are time-stamped and immutable, the risk of unscrupulous parties attempting to alter medical data is significantly reduced, and those interested in clinical research can have greater trust in the validity of the results. Both the timestamps and immutability of blockchain applies to tracking and regulating pharmaceutical drugs. By regulating the Chain of Custody (CoC) through blockchain, all records and evidence relating to the production of a drug until its delivery can be monitored more effectively, and relevant parties can be more sure of the provenance of the pharmaceutical, and that it has not been tampered with during transit.3 - Empirical implementation of blockchain in healthcare - case-study analysis
From a theoretical standpoint, blockchain appears to be a revolutionary force in the healthcare sector, and provides a platform that can significantly improve patient care and data security. But how is blockchain actually being implemented into the healthcare sector? What are the challenges that these firms face?
We have decided to analyse 3 very different empirical use-cases of blockchain within the healthcare sector that allows us to visualise the breadth of impact this technology can have within the healthcare sector. These are namely ‘Guardtime’ for storing EHR, Mediledger regarding chain of custody concerns for pharmaceuticals, and Robomed for utilising smart contracts to guarantee a standardised level of care for healthcare services.3.1 - Guardtime
One of the issues in the healthcare industry is regarding the exchange of medical data between different healthcare providers. As most hospitals and clinics use their own systems to store this data, it is more likely to be incompatible with the systems used by other providers. Guardtime, a company using KSI (Keyless Signature Infrastructure) blockchain technology, aims to solve this issue. However, it is not limited to only the medical sector as it provides services for the defence, advertising, financial and Government sectors.
The technology used by Guardtime in its application to healthcare is mainly in protecting the data of health patients whilst ensuring that access is still granted to the appropriate persons. The data is not stored in the blockchain itself but uses the existing databases of the participants in the network for storage. Each data, which in this case would be the patient health records, is given a hash value that is cryptographically generated. The hash value does not give away the contents of the data it is meant to represent, it only acts as an identifier within the blockchain. This makes it so that the security of the data comes not from preventing any malicious intent but in acting as a ‘speed-camera’ to see who gained access to which data and what changes are made. This is particularly useful as it helps keep sensitive or private documents away from those who are not meant to have access to them.
This technology has already been applied in several different countries, even if in sectors unrelated to healthcare. Altheia, the Chinese partner of Guardtime received a Government contract to develop a similar system for a national patent registration platform. Estonia, had also used Guardtime in order to secure their government services, which includes their national healthcare plans. Guardtime’s partnership with Estonia’s Ministry of Health started from 2016 and is now used by every Estonian with their e-identity card. The fact that Guardtime could be used on a national scale implies that it is possible to further scale up the infrastructure to become a global method of securing and granting access to data. The repercussions imply that even if a patient needs urgent medical attention outside of their residential country, they are still able to do so without having to gather all their health records before-hand.
The main limitations of blockchain includes the lack of trust in the integrity of the infrastructure due to the recent crypto-currency frauds, as most people still associate this technology to cryptocurrencies like bitcoin, as well as the slow transaction speed as the number of large data transactions increases. These are solved by how the technology is used as the fact that no actual data, but merely hash values are stored on the blockchain. Despite the resolving of these two major issues, there may be other forms of unforeseen difficulties such as adapting each infrastructure to the regulations of different countries, or other technical difficulties, as blockchain is still in its infancy.3.2 - Mediledger
The pharmaceutical industry, which has a long and (unnecessarily) complex supply chain has been extensively afflicted by the issue of counterfeit drugs. The size of the global counterfeit drug market ranges between $75 to $200 billion and comprises of 50% of all drugs sold in low-income nations. The supply chain, which includes several intermediaries has fostered a system facilitating a loss of information and its exploitation. The safety of these medicines is dependent on trust between intermediaries and trust in the system which has so far been ineffective in preventing the growth of the counterfeit marker.
A collaborative project between Chronicled and TheLinkLab, MediLedger aims to use blockchain to resolve this issue. Blockchain may redefine the need for trust in the industry and reduce regulatory and cross-border cost. Mediledger uses Ethereum to help improve traceability of the products in the supply chain by keeping record of all transactions made as the drugs go through intermediaries. The employment of an immutable permissioned ledger and zero-knowledge proofs (possible through zk-SNARKs, a novel form of non-interactive zero-knowledge proofs) allows transaction data to be secure and verifies transactions as drugs move through the supply chain thus improving traceability and patient safety.. Transactions are verified and posted to a Node of the blockchain and verifies that they are successfully accepted.
The pilot project conducted by MediLedger has been reported to be successful, The system prevents counterfeit drugs from entering the market as it ensures that “only the authorised manufacturer of a particular product can provision their own serialised units on the blockchain”. It subsequently transfers the product between trading partners using Electronic Product Code Information Services (EPCIS) messages augmented with hashes and mathematical proof. This message is then validated by the trading partner and posts it to the blockchain. Efficacy of the prototype has been confirmed and companies such as Genentech, Pfizer, McKesson, Abbvie and AmensourceBergen are involved in its implementation. The immediate benefit is the fulfilment of the Drug Supply Chain Security Act which aims to tackle the counterfeit drug market.
Although MediLedger has set up a prototype which records and verifies drugs onto the blockchain, the technology is in its infancy and we are yet to see whether the pharmaceutical industry will provide the financials to allow the formation of such a network. Additionally although long term benefits will include improved inventory, enhances patient safety and cost-reduction, short-term costs and competition with other companies using blockchain in the industry, such as BlockRx (based on tokenisation) may put into question whether companies will be willing to fund this project leading to unlikelihood of sufficient adoption for it to be effective. However, MediLedger has big names such as Pfizer and Genentech involved and with increased interest in blockchain and the extent of the pharmaceutical industry we might see blockchain solutions saving the pharmaceutical industry billions of dollars, and more importantly, saving people’s lives.3.3 - Robomed Network
A more unique application of blockchain in the healthcare sector is Robomed. Robomed utilises the Ethereum blockchain to connect patients and healthcare providers through smart contracts, ensuring greater accountability with patient care, and providing an accessible platform for patients and clinicians to value medical services. The service is especially useful for patients who pay privately for healthcare in developing countries with poor enforcement and regulation of healthcare standards.
A dedicated community of medical professionals sets clinical guidelines for how particular medical services must be performed. Patients utilise the Robomed network, and chose the service that they need from their relevant healthcare institution that operates on the Robomed Network. All transactions on the network are conducted through RBM tokens, with community guidelines implemented via smart contracts. When a patient agrees to a service at a particular institution through Robomed, RBM tokens are held in escrow until the treatment fulfils the specified guidelines that are attached to that form of treatment. To ensure dynamism and accountability with healthcare standards on the network, patients are rewarded with tokens for rating treatments, and likewise for healthcare professionals to provide insight and feedback on treatments as certain practices develop.
Robomed thus utilises smart contracts to ensure that industry monitored levels of healthcare are performed for various healthcare services. Robomed integrates the efficiency of interoperability (more so since incumbent EHR systems can be integrated with the dedicated Robomed Application Programming Interface) with an added layer of accountability to further develop and improve patient care, and there is clear interest in the project (Their ICO generated $14,140,000 in 2 months token sale). Robomed already have 20 clinics connected to their network in Russia and Dubai, have over 1.7 million clients using their network, and manage 2900 digitised clinical guidelines for treatments and procedures. With the lucrative market that is private healthcare, the Robomed network effectively validates participating clinics with a seal of approval on medical services, which generates greater revenue from increased demand for that clinic’s services, and a guaranteed level of care for the patient.
However, a key concern for adoption and scalability of the Robomed network lies with national healthcare standards. Although clinical guidelines are established via trustworthy healthcare professionals, different countries operate with varying levels healthcare standards. To force clinicians in e.g. Brazil to adhere to more developed western healthcare standards - where payment to those clinicians via smart contracts will only arise once those standards are met - prevents the adoption of the network amongst the key demographic of the Robomed network (namely healthcare institutions in developing countries). Realistically, Robomed must develop clinical guidelines based on the jurisdiction they intend to capitalise upon, and logistically this will require an enormous amount of cooperation with healthcare institutions and professionals within specific jurisdictions.
With the project in its infancy, although an appealing idea, the concept of developing greater medical care with blockchain is far from being realised. Despite these concerns, the development of Robomed in Dubai and Russia indicates the potential of the project, and one can speculate that as Robomed develops and expands its network over the coming years, more and more countries and jurisdictions can provide greater accountability and a greater level of care for patients in private healthcare.4 - What does the future hold for blockchain in healthcare?
Throughout this article we have discussed both the theoretical potential of blockchain, and how actual enterprises are utilising the technology. But what does the future hold for blockchain in the healthcare sector? Despite the huge amount of potential considerations, we have chosen a few that we believe highlight some interesting developments in the realm of healthcare and blockchain.4.1 - Privacy considerations?
We have seen that there are exciting use-cases of blockchain within this sector, yet there is still huge room for development from both implementation and regulatory standpoints. Despite the enormous investments in innovation, all too many efforts fail. One major reason is that regulation in healthcare is very complex and risk-averse. The health care sector has many stakeholders, each with their own agenda and substantial resources/power to influence policy and opinion. As possession of data has become very valuable for secondary research, it is unlikely that EHR providers are very willing to store their data. Therefore, enough stakeholders need to be incentivized to support the blockchain technology if it wants to succeed.
The fact that data cannot be modified or deleted once it has been put on the blockchain has troublesome consequences for how health care works today. First of all, patients have the right to be forgotten. This means that, on request of the patient, all personal data concerning him or her is erased (as seen in Article 7 of the GDPR). However, this is practically not possible when this data is stored on the blockchain, thereby violating regulation. There is evidence of firms being compliant with incoming GDPR regulations (through storing only pointers and audit information on the blockchain and that allows relevant to access the information off chain), however only time will tell when assessing future compliance with privacy regulation laws.
Moreover blockchain technology has become popular because it is more secure than traditional technology. However, it is not safe from fraud and has become attractive targets for cybercriminals. Smart contracts especially are the favourite target of hackers as they suffer through the code used to create them being prone to bugs. The problem is not yet off track as current efforts to validate smart contracts are inadequate. Therefore more research is needed on how to find exploits and bugs in smart contract codes in an efficient and inexpensive manner.4.2 Empowering patients and the Internet of things (IoT)
With decentralised data that is accessible by verified users, a key demographic of this dispersion of data is the patient themselves. With the potential of healthcare platforms allowing patients to view and monitor their own healthcare data, we can see instances where patients have managed to monitor their own health status, resulting in lifesaving findings for their health.
For example, Steven Keating (a doctoral student at M.I.T) monitored his own health after a brain scan showed an abnormality. It was only through his vigilance with monitoring his own data (which led to him pushing his doctors to conduct an MRI) that they found a cancerous tumour in his brain, and were able to remove this tumour before serious repercussions afflicted him. Steve’s case provides insight in how allowing patients access to their data can provide a strong preventative force for medical ailments.
As vested agents in our own well-being, it will be interesting to see how our ability to interact with our health-data will lead to improvements in lifestyle, and our ability to spot diseases/injuries before they manifest into something more serious. Although we can already request to have our medical records sent to us, blockchain provides a more dynamic platform for regulating our own healthcare, and this concept is especially relevant when we consider how blockchain can interact with wearables and the IoT, and how this data can be integrated with our healthcare data. By virtue of empowering individuals with their healthcare data, individuals are incentivised to monitor their health more frequently. If blockchain could also allow the data from wearables such as e.g. heart rate/blood pressure monitors to be integrated with our healthcare records, this allows individuals to garner a better understanding of their overall wellbeing as they can better monitor their own healthcare, and will both incentivise better lifestyle choices and aid in catching and preventing diseases.5 - Conclusion
The healthcare sector is truly an exciting area where blockchain can be implemented, and there is a real case of value that the technology can bring for the sector as a whole. There are far more applications of blockchain in healthcare, and many more considerations for the future that we could not include in this article. However, as we have mentioned, regulatory issues will always be a concern for future adoption and implementation of blockchain across all sectors (especially medical), and firms have a long way to go before sizeable change can manifest the purported benefit of this technology. Nevertheless, the potential benefits that can be seen from blockchain are extremely promising, and over the coming years we believe that developments in the healthcare sector will muster some truly incredible results that will arise from the adoption of blockchain.