Embleema has launched the first health records blockchain to give patients complete control over their health data – CEO and Founder, Robert Chu, tells us more…
What led you to establish Embleema?
As former SVP of Technology Solutions of IMS Quintiles, now IQVIA, world leader in health studies, I was able to see the limits of how the efficacy of drugs is monitored after they have been approved and launched. Currently, these “real world evidence studies,” as they are conducted, pool data without the patient’s consent, blurring information and making the identification of adverse effects less efficient.
We are meant to be in an era of “precision medicine,” but we should not be satisfied with the vicious circle of suspicion between patients, life sciences and regulators, which often end up delaying the release of life changing drugs.
A witness to this process from the inside, I thought to myself; ‘this is a great problem to solve.’ As an engineer, I like to solve problems through technology.
When blockchain emerged as a disrupting technology and has the scalability now to provide solutions for the healthcare industry, I knew that this could provide a fantastic opportunity to involve the patient again in the process of monitoring their own health and how they react to the drugs they pay a high price for, especially in the USA where we are launching first.
What is the mission of Embleema?
Embleema’s mission is to give back the ownership of data to patients, and securely connect the major stakeholders in the healthcare industry together; biopharma, hospitals, doctors and patients through blockchain technology.
We focus on enabling the sharing of real data from real patients in the real world, and our mission is to turn the bottle upside down and put patients first in the healthcare system. Patients suffer from a lack of information regarding their medical records and because of this, they struggle to play a central role within the system. This means less information on adverse effects post research, extra caution from regulators, and longer delays to access new drugs. We also aim to allow patients to take an active role in the how their data is used by other stakeholders and allow them to be rewarded for doing so.
Our big goal is to create a new standard for interoperability in the healthcare industry. The Embleema Healthcare Network leverages blockchain to restore trust in a dysfunctional system. The existing centralisation of patients’ EMRs makes that data vulnerable to leaks. 15.5mn Electronic Medical Records were breached in the US in 2016 according to the US Department of Health and Human Services, requiring the industry to spend an estimated $6.2bn that year to stanch the flow.
What led to the development of PatientTruth? How will it work to support researchers?
PatientTruth has set a new standard of quality, security and trust for patients’ stakeholders and researchers.
To allow patients’ to truly reclaim control over their data through blockchain, we required an app that would be functional and easy to use, regardless of whether it operates on blockchain or some other system.
So, we have first been focusing on creating a good user experience for a patient to collect all his information in one place, earn tokens to have proper incentives for uploading his data, and see audit trails of who has access to his information to have effective control.
The PatientTruth is a first step to accessing a blockchain based marketplace for patients to choose research to support and enrol in, using their data as a form of currency to be both in control, and to serve as a practical mean of exchange.
Other stakeholders will be rewarded for being part of the blockchain, for instance for mining the data or allowing the network to happen. Providers will be incentivised through tokens for enrolling patients and checking integrity of data.
The marketplace is taking shape as we speak, around a consortium we are forming with patients and their associations on one side, specifically for rare disease where the need for funnelling such data is highest, public research, regulators on both side of the Atlantic, and life science willing to embrace transparency and patient empowerment.
We strive to be at the center of a much wider ecosystem of blockchain based apps that help manage patient consent, enrolment in clinical studies data sharing, identity management, and smart contracts to reward patients. As such, we have an open-source policy and we welcome other blockchain startups to join us in a healthcare alliance.
Much in the way that Ethereum has created a platform for smart contracts, we hope to play a similar role for healthcare. As a co-chair of the Hyperledger Steering Committee on Healthcare, we are actively having these discussions.
What do you feel is driving digitisation within the healthcare industry?
The most striking effect of digitisation is how it is redistributing the cards between all stakeholders, first and foremost giving more power to patients. This is because they are actually adopting new technologies faster than healthcare professionals, leading to what thought leaders like Eric Topol have called the “consumerisation of healthcare.”
The smartphone revolution, among many by-products, made health sensors and connectivity available to the masses. Data once restricted to professionals is now accessible to everyone. Health monitoring has broadened its reach beyond athletes and very sick people. Beyond patient generated evidence, from IoT to DNA sequencing, blood sampling or drug administration, complex analytics previously thought to be a uniquely human ability are being done by AI now. This is accelerating the exceptional convergence between life sciences and informatics.
In a first phase, digitisation has automated repetitive tasks conducted by physicians conducted at the periphery of healthcare. With blockchain, we are entering a whole new territory, as distributed ledgers are now automating the very center of healthcare!
As a result, we are moving away from a model where medicine is always “too late” to a patient-centric world, fuelled by the promises of big data, in which each person could be warned before something undesirable happens.
What are the main advantages of blockchain for the healthcare industry?
By allowing certification without a certifying entity, blockchain creates trust without a trusted third party. The decentralised and immutable public ledger that blockchain infrastructure allows, provides three major benefits;
Certifying information exchange is really the essence of currency creation, and blockchain lets you do this more cheaply and securely, because distributed ledgers replace middle men. Profits are shared among the key stakeholders, and not taken away by middlemen offering very little to the process.
Beyond the mechanics, what is at stake here is that giving power to patients over their data means greater trust and greater willingness to engage with research which is essential to all our well-being. What technology wants, is for patients to become the true stewards of their data.
How will advanced data and analytics help drive positive patient outcomes?
If you look at how drugs are developed and tested today, this is done primarily in controlled research environments. The failure to capture the efficacy of treatments in a real-life setting. Yet, 32% of drugs approved by the FDA turn out to be affected by a post market safety event. This is inevitable because what you will see adverse effects on 10,000 patients that you could not have spotted on a few hundred. But current methods of gathering data on adverse effects and efficacy are slow, because they rely on the aggregation of data from third parties that compile electronic health records, like pharmacies or doctors.
Pooling data from such sources is convenient because you don’t need to secure patient consent. All you need to do is pay the providers or pharmacy chains that own other patients’ data. On the flip side, patients are left out of the sale of their own data, and they don’t know what their data serves to prove, since they have never given their consent.
Also, the aggregation of the data blurs the identification of adverse effects. This leads to lack of precise data and can cause delays in spotting public health crises. This generates a vicious circle of distrust between patients, life sciences, and regulators, who try to unbundle the data they are given by pharma to spot problems.
What are the main concerns of patients with regards to data sharing?
Today, healthcare entities tasked with providing healthcare services to patients share their data internally with little patient oversight or involvement. HIPAA, the US regulation for electronic health information, essentially lets these “covered entities” do this broadly. Providers can also share patient data for profit with little oversight.
Most data is shared by simply transferring the responsibility to third parties, without actually checking if these vendors will be true custodians of precious patient data. This has led to millions of health records being hacked every year which contains an incredible amount of personal health and personal information in general which can be exploited.
For research specifically, lack of patient consent for information sharing means not enough of this information is available at a grain fine enough to be useful. You cannot spot useful correlations, such as between a medication and an adverse effect, if you are only looking at aggregates.
How come we are only realising recently that over prescription of opioids has led to a major health crisis? With proper use of data, this crisis could probably have been minimised.
So, on the one hand, too much information is accessed by people who should not, while not enough is funnelled for public health or pharmacovigilance. To fix this, setting the right incentives and giving back ownership of data to patients needs to be a priority and that is our focus.
What are the key challenges organisations face, particularly with traditional EMRs?
EMRs were simply not designed with the goal of giving patients access to their own data but aimed at locking in doctors and providers into using a particular software, and never switching to another to avoid the associated cost. The result of this is that there is a major problem of interoperability between medical records across providers.
A patient will typically visit dozens of different providers throughout his treatment, and nobody has a complete picture of your health. Once you start to get really sick, this becomes a huge problem in getting speedy treatment.
The Department of Health and the Office of the National Coordinator, being aware of this problem, forced these vendors to introduce Continuity of Care Documents (CCD) as part of the Health Information Technology for Economic and Clinical Health (HITECH) Act enacted in 2009. These documents are essentially XML-based markup standard intended to specify the encoding, structure, and semantics of a patient summary clinical document for exchange. It’s great when providers speak to each other and experts are here to consolidate all this information.
In practice however, it’s extremely difficult to for most people to download these documents, and most patients have no idea they could consolidate their health information this way.
Apple, with its Healthkit app, has gone further than most IT companies in allowing the consolidation of some of these documents directly on the smartphone, easing the user experience to simply make it possible to consolidate your data. However, they have only capture a fraction of health systems and there is still a long way to go.
How will HL7 further support data sharing across a number of digital platforms?
To aggregate data, you need a standard, so that data from different sources can fall into similar buckets when you compile everything. Health Level-7 or HL7 refers to a set of international standards for the transfer of clinical and administrative data between software applications used by various healthcare providers.
While most organisations say they have adopted these standards, nobody applies the standard in the same way. That’s why Embleema has AI experts in its teams to align and clean-up the data in the same way that a human typically does it when all different records are brought together manually. It’s much better to do it with a machine for confidentiality purposes…
In practice, the patient that would do this himself would still need to download his CCD document, that follows the HL7 standard, and upload it onto the Embleema blockchain to recreate the complete picture of his health. But we are working to ease this process considerably.
How will Embleema seek to tackle complex regulation requirements on a global scale through the use of blockchain?
Today the process of regulatory submission and approval requires taking dynamic data and "freezing" it in summaries and reports that are no longer current by the time they are read, analysed and archived by the regulators.
Traditionally this process is rigid and consists of a series of steps to transform the source data to build different types of reports in a number of different formats that are then bundled (Common Technical Documents) and sent through an electronic gateway to the Agency who then deconstructs the entire process to use the source data in the original form. The information of this tightly packaged dossier sent to the agency is not as up-to-date as otherwise possible. The efficiency of the process and quality of decision making are therefore suboptimal.
We offer a radically different approach, by letting patients, regulators and life sciences share raw data in real-time with blockchain. This has the potential to radically transform and speed up the regulatory approval process.
In practice, we are getting support as we speak for this new type of information exchange. Embleema has gathered an exceptional team of healthcare stakeholders in the US and Europe that have the network and thought leadership necessary to formalise this new approach and convince all consortium members to adopt it.
Where do you see the industry sector heading long-term?
I see it going towards more patient empowerment, but also more continuity of care, moving away from a process where medicine is always too late to a place where prevention will be a service we will subscribe to.
This will happen faster than you think. What we know as modern medicine only gained public confidence during the 20th century, as improvements in drug and surgery made health benefits more apparent.
In addition, doctors built trust by formalising codes of conducts and validating treatments scientifically. Digital health must take a similar route - demonstrating impact, becoming custodians of personal data and eventually securing payer support. But the change will be faster because medicine has already paved the way. Still, in the world of Google and Facebook, people typically wonder how their personal health data can be secured if insurers pay for a preventative program. Failing to address these questions with new rules will hinder public trust.
Better technologies like blockchain rather than better regulations will give users the sense of empowerment they seek over their own data.