Embleema: The Blockchain That Lets You Own Your Health Data
Healthcare generates a lot of data, but most of it isn't available to those generating the data: patients. Learn how one team is using blockchain to address this issue.
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Robert Chu founded Embleema in November of 2017 to re-empower patients by applying blockchain to enable the patients to control and share the medical records.
Embleema utilizes blockchain to put patients at the center of clinical research. While disrupting the slow, manual, and opaque process used today to collect Real World Evidence, Embleema helps Americans monetize their health data.
Robert Chu spent sixteen years at IBM in roles in software and consulting. Later, he worked for INS Health, a global leader in healthcare data in consulting and technology. For 10 years, Robert Chu served as General Manager of France Afficialite and Head of the Asia Pacific and China at INS. Chu returned to the states to head the technology group, working directly with core clients in all the stakeholders in healthcare including pharmaceuticals, healthcare regulators, care centers, et al.
There's an audio version of this interview available too.
Why Is Embleema Needed?
The current fragmentation and lack of ownership of the patient of their health records is an issue in every country. This fragmentation could be disastrous in regards to emergencies. As it stands, the patient isn't aware of how their health data is used, even for useful purposes in terms of safety surveillance, measuring the efficiency of health products, and so on. Moreover, patient records is a billion-dollar industry. Pharma companies need to acquire patience records to prove to regulators that their drug is safe and efficient.
It is comparable to Facebook, where the users, in this case patients, generate the data but the value of it is captured entirely by third parties. Even though the patient is the source of the data, they don't receive a dime or a dollar from it. Embleema believes that patients should receive the value for their health records.
I see this being a great use case. For example, when you move countries, you have to start again healthwise. You have to prove that you know what you are talking about when you are moving to a different location. Why do you think that the health service is like this? Are there any countries that do it better than others?
Medical history doesn't travel well. To do this successfully, the state would have to fund it. Having medical history does augment the probability that the treatment is better informed. The best current example is Estonia. 1.2 million citizens have complete access to their history, images, procedures, and doctors notes. All other countries are struggling.
One of the reasons is because healthcare is comprised of a set of silos: the fragmentation healthcare professionals, primary care systems, hospital systems. Then patients generate their data with connected devices or patient portals — which creates another silo. Each silo claims that they have the best data and refuses to share it, which makes it difficult to achieve unity.
The commonality between all the silos is the patient. It all starts and ends with the patient. All the healthcare systems are geared to improve the health of the patient. We want the patient to be active in retrieving and aggregating their medical history. Only the patient knows which different hospitals they have been to in different locations. Only the patient has the right to their medical records in each country. The information is there — just separated. If the patient is engaged enough to do so — then we should compensate this patient.
It's labor and it takes time. The patient can have control over all different use cases.
For example, the painstaking process of filling in forms and forgetting half of the procedures, medications, allergies, pertinent information that could positively affect the treatment, and so on, could be alleviated by having a shared patient record data set with active input from the patient. This would be equally important for regulators and companies. Embleema is a grassroots venture, going to patients making sure that they are active, paying them for their activity and inviting them as a full participant in the data patient record business.
Why would anyone want to pay me for my information? Who wants to pay me, and what are they getting?
Excellent question. First, who is going to pay for it, and what's the value of it? Back in February of 2018, Rosch, one of the global pharma companies in Basel, acquired a company called Flat Iron. Flat Iron is a privately held market leader in oncology-specific electronic health record (EHR) software, as well as the curation and development of real-world evidence for cancer research.
Rosch acquired Flat Iron for $1.9 billion. With an estimated 200,000 good quality oncology patient records, this puts a price tag of roughly $10,000 on each patient record. In this case, Flat Iron is getting the full value of a patient's health record. The patient who has generated this data gets 0. Why is that so? Why shouldn't we pay the patient the money? Or give the patient the bulk of the share, at $9,000 and Flat Iron $1,000, for curating and cleaning the data? That's the first question that Embleema addresses.
The second point of view came from a conference in France where we held a debate around blockchain and patient empowerment. Whenever patients become sick, they lose their jobs, valuable resources, time, and revenue. Why doesn't the patient get compensated through the value of his data? Medical data could be a supplementary source of income.
Are you effectively looking to supplement or replace health insurance?
The better case is looking at Embleema as an addition to health insurance. This is money that Pharma companies are already paying; the issue is that the patient isn't receiving any value. It is not right, and we should change it.
The monetization of data is happening; it's a clear favorite use case for blockchain. Another aspect of Embleema is the free interchange of one's records between medical systems.
Yes, there are two use cases. The basic one is the sharing, interoperability, and moving from one medical system to another system while enjoying medical history continuity. It is incredibly important that each patient has the control to share when they move. Unfortunately, this use case is tough to sell. There are so many silos in health systems, that when you create a product that addresses all silos, no one wants to pay for it. The only entity with an interest ing paying for it would be the government.
Do you run into trust issues? One medical system could choose not to value the data from another medical system.
It is difficult for a country to trust the data from another country. Doctor certifications and standards vary from place to place. This issue is deeply rooted, affecting other professions including doctors and scientists. It won't change anytime soon. That is why we decided on the United States as the first market.
The international exchange could be a long time off. What's the interface, the GUI, the experience?
Embleema is a web application that is currently accessible for all the patients in the US at patienttruth.embleema.com. The patient opens the account and inputs their identifiers and personal information. Within the web application, the patient may upload their different medical records. The system recreates their medical history, and from there, the patient can grant access to doctors.
Once the patient has granted access to another doctor, in the form of a HIPAA consent form, the doctor may utilize the data in regards to the outlined scope. The patient also has another trail in terms of who access which data and what. The dynamic sharing is traced and tamper proof in the blockchain.
Is it a similar process for companies that want to consume public patient data and then compensate the patient? How do patients designate sections of their data as open for compensation?
We are working on this next version called the Marketplace, which is the sharing marketplace for regulatory purposes. The consent is still in the hands of the patient. Each consent is individual to the patient; consent isn't assumed, like on Facebook. Each patient can transparently decide what they want to expose, at what time, to whom, and for what purpose.
For example, if you are an oncology patient, and you want to expose your data for clinical research, you can decide which part of your medical records you wish to release.
A patient could say: "I want to share my medications, but I don't want to share my social history"; "I will only share my medical history for clinical research phase 3, not for marketing purposes"; "I want to share it with Pfizer and Merck, the FDA or not"; or "I'm going to share my entire history, for the next three months, only for analysis, not the raw data but if someone wants to run an analysis on it."
Then the patient decides the scope, all these options will be at the hands of each patient.
When companies like this try to anonymize data, implicit data connections can potentially expose sensitive information. For example, If you are happy to mention which drugs you take anonymously, but not to disclose a mental health condition for example. Any medical professional could surmise what those drugs are for. Is this something that Embleema has thought about?
Yes. This is a part of the broader and more critical requirement, which is ensuring that it is impossible to re-identify the patient. Generally, patients expose de-identified data, (although patients in the United States. have a right to exposed identified data). The Health Insurance Portability and Accountability Act (HIPAA) comes into play, which requires that de-identified information continues to be unidentifiable when merging your data set with other public sources like demographic data, and so on. This complex issue isn't addressed with blockchain, not even by the best, most sophisticated smart contract. This has to be addressed disease by disease, through hiring an epidemiologist that understands and maps out a patient pathway. This ensures that reasonable statistical inference of this data anonymized is not re-identifiable, as outlined in HIPAA.
The US is renowned for its slightly unfair health care system, but they are a bit more progressive with sharing health data.
One thing that helps a lot in the US is that the FDA is very progressive and aware of the value of data to improve the system. The 21st Century Cures Act (Cures Act), one of the last regulations from the Obama administration, requires the FDA to accelerate the availability of new treatments to patients.
The way you achieve this is through more data; clinical research results, CTs, evidence data, which will speed the development and review of novel medical products, including medical countermeasures. When you have this 360-degree view that incorporates a vast amount of data, the FDA can decide to make the drug available sooner. Embleema is working to align our system; the data sets that our system is going to store in blockchain to the FDA evidence repository so that we can accelerate available data to the FDA. In Europe, the authorities are less tech-savvy, a bit more traditional, and slow moving. The US is an excellent place to start.
What was the genesis story for you? What was the motivation to create Embleema?
In my tenure at IMS Health, I dealt with Big Pharma companies, regulators, payers, and so on. Selling big patient data sets is an entirely B2B contraction. The patients exist in another world, very far away. Even though the patients generated all the data, their worlds were utterly disconnected. The patient that generated the data received $0 from it. I thought there has to be a better way to break those silos.
Also, some people in my family had pretty severe health issues, and we're trying to get their medical records. It drove me crazy. Then, I took a look at blockchain, the ability of sharing, the ability to break data silos, taking out intermediaries that are frankly doing nothing more than collecting the data, and I recognized the new opportunity to put patients in the middle of the system and break some of those silos.
Has anything like this helped anyone yet? Is it too early to say?
Yes, we launched a pilot in July 2018 in a Cystic Fibrosis patient community. Cystic Fibrosis.com. I met with the President, Ms. Gene Barnett, a fantastic person. She was super knowledgeable of the disease and blockchain technology. Since it is a rare disease, with only 29,000 patients in the US, no one is interested in creating apps that address their needs.
Diabetes apps exist due to the sheer number of diabetes patients. It's a big market. Who's going to develop a patient app for Cystic Fibrosis? Nobody.
Since we are decentralized, we are an enabler to ensure that these patients get the attention they need by selling their data. They will be able to fund a patient app after they receive funds from pharma companies. The metrics of 10,000 per patient record apply to these patients.
You have to avoid putting patients with cystic fibrosis in the same room because they have the risk of cross-infecting each other. A very basic app with location services, with the patient's consent, of course, could outline colleagues with cystic fibrosis that are 30 feet away or 200 feet away. The app alerts the patient of other CF patients around and advises them not to move closer. This one straightforward functionality can save lives.
What's the tech underneath Embleema?
The current version we are running in production is based on Ethereum, as a private network. It is fully permissioned, as we are storing medical records. We are looking at other technologies including HyperLedger and EOS which is promising in terms of throughput and flexibility. Depending on the use case we're implementing, we'll utilize one or the other platforms. There will be several different platforms for healthcare. At a certain point, we will have to build interoperable layers like common token layers, common identity layer, common key layers.
What is on Embleema's roadmap for the next six months?
We will continue to work with more patient associations with different diseases, work with pharmas, and advance our work with the FDA to accelerate the evidence generation and sharing with the regulator. We have our work cut out for us!
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