By Deborah Borfitz

January 14, 2019 | A variety of new-to-market partnerships and platforms built around blockchain technology took center stage at the recent Distributed: Health conference in Nashville, Tennessee. Among them were a pair of European organizations endeavoring to reduce the current 12-year drug development timeline, an alliance between Hu-manity.co and IBM to pioneer management of “personal data property rights,” and a protocol-agnostic smart contract framework TIBCO Software is building in collaboration with Change Healthcare.

Aligning on Use Cases

Blockchain has emerged as one of the biggest topics among innovation leaders in the pharmaceutical industry and represents a major paradigm shift for drug R&D because no one company can effectively deploy the technology on its own, says Disa Lee Choun, head of innovation within Global Clinical Sciences and Operations at UCB. Because blockchain records transactions that get shared across a peer-to-peer network, implementation requires multi-organizational collaboration and a willingness to transparently exchange “lessons learned.” But up until now most of the experimentation has been happening within rather than among life science companies.

That is about to change, thanks in part to the Innovative Medicines Initiative (IMI) and the nonprofit Pharmaceutical Users Software Exchange (PhUSE) that are forging large-scale collaborations to explore potential uses of blockchain and speed development of better and safer medicines for patients, says Lee Choun.

IMI is the industry’s largest public-private partnership, funded by the European Commission and the European Federation of Pharmaceutical Industries and Associations. One of its most recent projects aims to establish a common blockchain ecosystem for pharmaceutical development, manufacturing, and distribution, says Lee Choun. The idea is to bring together patients, healthcare providers and health authorities to reach consensus on how to best apply the technology to industry challenges such as counterfeit medicines and lack of data access. More specifically, it aims to create a common set of functionalities (e.g., identity management, securities, and off-chain storage) linking underlying blockchain technologies with business applications in areas such as the supply chain, clinical development, and health data.

The IMI “blockchain-enabled healthcare” project involves UCB and eight other partnering companies, says Lee Choun, including Novartis (lead), Abbvie, AstraZeneca, Bayer, Johnson & Johnson, Novo Nordisk, Pfizer, and Sanofi. Proposals now under review from potential public partners (e.g., patient organizations, regulatory bodies, and companies in related fields such as diagnostics and IT) spell out how a use case might be launched—meaning the blockchain protocol and standards that will be used, governance model, and incentives for adopting a distributed ledger. The winner will join the consortium, with project launch slated for September 2019.

PhUSE Blockchain Workgroup, started by UCB in 2017, is a growing group of nearly 20 companies that collaborates with both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency. It facilitates the free sharing and exchange of information about blockchain and is protocol-agnostic, says Lee Choun. The first project was a white paper explaining the characteristics of blockchain and proposed three main use cases that would readily demonstrate the technology’s value to the industry:

• Smart contracts (self-executing code) to accelerate patient recruitment for clinical trials by accessing electronic health/medical records data for inclusion and exclusion criteria, and for benchmarking activities that trigger payments
• “Patient’s wallet” app to incentivize data sharing and access for clinical research
• Traceability across the drug supply chain

Lee Choun says the first use case, scheduled for completion in Q3 2019, is being piloted around accessing data for trials and will look at patient identity, eConsent, labs/genomics, and data sharing.

One of the biggest hurdles has been aligning on the use cases and best practices while the technology is still maturing, says Lee Choun. “Not everything is going to be a good fit. The only way [forward] is to go through a proof-of-concept exercise to learn what works and what blockchain can’t resolve.”

Blockchain has its roots in the financial arena, but may ultimately be more impactful in healthcare, Lee Choun says. “We see promise in a technology that lets patients access their own data and give their consent about how it gets used.” When coupled with other innovations such as artificial intelligence, blockchain has real potential to shorten lengthy drug development timelines, she adds.

Admittedly, it’ll take a while—possibly upwards of five years, says Lee Choun, but is definitely doable. In Estonia, where blockchain has been in widespread use since 2012, patients routinely use the technology to access their online health records with medical case notes, test results, digital prescriptions and X-rays, as well as a full log-file tracking access to the data. The FDA also used blockchain technology to enable real-time exchange of influenza patient data between a surveillance app for monitoring bad reactions to experimental drugs (RAPID) and a national group (USCIIT) focused on investigator-initiated hypothesis testing.

Fair Trade Data

Blockchain technology makes it possible to pool consensus about how regulations—including the Health Insurance Portability and Accountability Act (HIPAA)—are understood and complied with, says Richie Etwaru, founder and CEO of tech start-up Hu-manity.co. Most data in healthcare today are “improperly permissioned” and the power to interpret HIPAA lies with attorneys at software companies who take different spins on the regulations.

Hu-manity.co has teamed up with IBM to take sweeping corrective action by bringing everyday human beings into the data supply chain to exercise their “31st right” to own data as property, says Etwaru, building on the United Nation’s Universal Declaration of 30 Human Rights. IBM’s blockchain platform, based on the Hyperledger Fabric protocol, is the foundational technology for the global consent ledger that will enable individuals to claim property rights to their personal data.

Beta testing of a #My31 app with 2,500 consumers concludes at the end of 2018, with a full-on marketing push in January endeavoring to bring that number to 100,000 by the end of the first quarter. Ultimately, the permissioned blockchain-based data marketplace is expected to support millions of users.

On the B2B side of the house, Hu-manity.co will be working with data-buying companies that feel ethically obliged to check the permissions of users and also want to build a transparent relationship with those data owners, says Etwaru. To that end, IBM’s blockchain was an ideal fit—it came with a full-stack offering inclusive of cloud storage and computing horsepower, had a strong enough brand reputation to mitigate the newness of the Fabric technology, and possessed both the skill and capital to bring highly innovative ideas to fruition. The proposed use case also aligned with IBM’s call for code and ethics around data ownership.

Anyone will be able to lay claim to their data through the #My31 app and Hu-manity.co, as the title company, will issue the evidence of ownership and create an identifying hash of that title and the owner’s credentials, says Etwaru. The company will also securely store the private, referenced documents off-chain. “We’ll manufacture the necessary documents for users to renegotiate with companies on how they interpret HIPAA,” he adds, including language on the opt-in and out-out forms. Users will then be asked to declare their preferences about what medical data they do and don’t want to share and how it is to be treated when someone discovers they’re in its possession.

“Once we have a central pool of individuals using the app, we’ll pull them into a cohort and go out and negotiate with those who currently collect human data, like EHR and EMR companies,” says Etwaru, who 20 years ago made a living reselling driver records to transportation companies. That’s the starting point for how people will get paid a fair market price for commercial use of their data. “We have the historic Goldilocks conditions to reclassify human data in such a way that it can be a source of passive income.”

State governors and treasurers on both sides of the political aisle have taken notice of the taxable income potential of the #My31 movement, since laws could be passed formally classifying human data as property, says Etwaru. If that happens, individuals will start paying taxes on personal income generated by their data—and taking write-offs for any of it they donate.

The worst-case scenario, from the perspective of EHR and EMR companies, is that vast numbers of #My31 app users will explicitly state that their de-identified data is no longer up for grabs, says Etwaru. The reality is that most people are going to happily give their consent and authorize their de-identified data to be sold, as is already being done today. The only difference is that it will now be marked for fair trade with the addition of a title to the data via a Humanity.co key that grants them ownership, he adds. “The revenue of EHR and EMR companies is unaffected, but they now have authorization and consent to sell it that they didn’t have before.”

What’s of greatest interest to bulk data buyers, including pharmaceutical companies, is that the title points back to data owner preferences stored in the system, notes Etwaru. Companies can see on the Hu-manity.co blockchain which of the de-identified datasets they purchased have individuals behind them willing to be re-identified so their data can be cleansed of any errors. It also opens the door for them to use the data for whatever purpose and price the owner permits.

“Pharma is reaching out to us more than people are signing up for the app,” says Etwaru. “They have never before been offered properly consented data at scale.” The companies will pay individual users for their engagement and Humanity.co an annual fee for use of the blockchain enabling the relationship.

So far, the data-as-property vision has only been expressed in healthcare, but within a year Hu-manity.co plans to announce its foray into other types of human data—a vast digital universe that includes car and house titles, geolocation data, home energy consumption, and browser and spending habits. The ultimate goal is to add “liquidity” to the entire title ownership and consent management chain, says Etwaru. “Healthcare data is to us what books were to Amazon.com when it first got started.”

Smart Contracts for Healthcare

Representatives of Change Healthcare (Blockchain Product Director Emily Vaughn) and TIBCO Software (Principal Consultant Mike Myburgh) shared the stage at the Distributed: Health conference to announce a collaboration to build the first smart contract system for healthcare. The platform—using Change Healthcare’s Intelligent Healthcare Network blockchain technology and TIBCO's Project Dovetail smart contract developer project—will enable health plans and their financial partners to automate events composing the transaction processing lifecycle, according to Vaughn.

The collaboration will give developers a drag-and-drop type tool where they visually interact with data through streaming analytics to easily create smart apps that can be deployed “in any cloud, with any [blockchain] protocol,” Vaughn explained. This acknowledges the software engineer shortage in healthcare as well as the novelty of smart contracts, which are “very nuanced technology,” she says. “It’s hard to know how code will execute and the word itself is confusing.”

The smart contract framework should also make it easier for business leaders and technologists to “better talk to each other,” Vaughn added. They’ll be able to graphically model a smart contract without needing to know or discuss the underlying blockchain algorithm. Work on the protocol-agnostic platform will begin with Quorum and Hyperledger. And since the platform will be open source, developers can contribute to the architecture.

Change Healthcare’s own developers will be applying the new tool to develop solutions in the areas of health plan administration, records management, and patient engagement.  “Smart contracts are operating instructions for the blockchain, not a replacement for business agreements,” she noted, and provide a “consistent way for apps to communicate with the same system.”