Biopharma companies depend on a high level of trust with all the participants in the healthcare system. Everyone needs to be able to rely on the accuracy of data generated by clinical trials, or ensure transparency when it comes to compliance. Medicines pass through long and complex distribution chains where they must be validated in the face of increased counterfeiting. Patients and payers are insisting on increased levels of transparency as well to bolster trust in the healthcare system overall.
The sheer volume of shared data in healthcare today, driven by technology, represents a major challenge to maintaining trust and transparency. The answer may lie in an emerging technology developed for an entirely different purpose: Blockchain.
Blockchain technology is the foundation for digital currencies like Bitcoin and others, allowing anonymous parties to engage in secure, private transactions over an open or even public network. The basic concept, however, has an array of potential uses where mutual trust and verification are essential, including healthcare.
In fact, blockchain already is being used in pilots for health data analytics, medical device security and electronic patient records. Beyond that is the potential to apply the technology to everything from more efficient clinical trials and speedier approvals of new therapies to reducing counterfeiting and increasing transparency about cost – a potential to change the entire industry.
How It Works
Blockchain technology stores information in discrete units called blocks. Almost any kind of data can be stored in a block, from a medicine’s pricing and safety data to an individual’s personal health information. The key to the technology is that it has security, privacy and identity built into each block; information can be shared and trusted, yet allow the individual linked to the data to remain anonymous.
These blocks are connected to each other, becoming links in a “chain” of data; it’s almost impossible to change the information in a block without changing all the other links in the chain. There are many copies of the chain stored on servers across the network as well, always kept up to date, so any attempt at hacking the data would be spotted and rejected.
“It’s global truth at global scale,” Etwaru said.
This ability to guarantee the accuracy of the data in a block while protecting it from prying eyes allows for storing and sharing of highly sensitive and valuable information. That makes it ideal for managing personal health-care information that requires a high degree of trust by multiple parties.
The technology has also been advancing rapidly, Etwaru noted, since it was first deployed a few years ago. Today, there are non-profit foundations and consortia building standardized blockchain networks for many uses; some have their own programming languages that offer far more flexibility than the earlier platforms built for digital currency.
From Transactions to Treatments
As blockchain technology becomes more prevalent in healthcare, some of the first uses will be in creating a greater environment of trust with partners as well as government agencies and patients, said Remi Chossinand, Head of the Digital Clinical Solution Center for Sanofi.
For example, blockchain can play a major role in the growth of “value-based” payment contracts in healthcare, where participants are paid based on factors like patient outcomes. These are often complex contracts that require the secure exchange of sensitive information that also protects privacy – an ideal role for blockchain. Using the technology can enable all the parties to share – and trust – the information they require in order to fulfill the terms of the contract.
Late last year, Sanofi Ventures made an equity investment in Curisium, a Manhattan Beach, Calif, technology company that makes a blockchain-based platform for that purpose. In combination with secure computation technologies, the platform provides the basis for payers, providers, and life science companies to automate patient-centered, value-based contracts.
Another way the technology’s trust could deliver much needed benefits is in the fight against counterfeit drugs.
The traffic in fake or adulterated medicines has reached near epidemic proportions: The World Health Organization reported in November that one in 10 medical products in developing nations is either counterfeit or substandard. The problem has only gotten worse over the past decade, and while it is more pronounced in developing nations, it has serious global consequences – including the risk of deaths caused when there is too little or no active ingredient in the counterfeit product.
Using blockchain technology, however, it would be possible to create a system that would track and trace a medicine from production to patient. If that information were available to government health care systems, pharmacies and patients, it would become significantly more difficult for fake medicines to make their way to patients undetected. It also would help all the participants in the supply chain meet stronger government requirements, such as the Drug Supply Chain Security Act in the U.S.
“We’re seeing consortiums forming already to deal with this issue,” said Kamkolkar.
Improving Clinical Trials
Clinical trials are another vital aspect of healthcare where the element of trust is crucial. Trials not only generate a large volume of data, but also can involve many vendors with complex performance requirements and a large volume of sensitive patient and proprietary data. Blockchain technology could be used to ensure the necessary data is collected and shared where it’s needed while maintaining patient privacy or proprietary information. The result could be reduced costs and increased efficiency, Chossinand said.
It could also be useful in clinical trials for rare diseases, where there are very few patients qualified to participate. Could a consortium of pharmaceutical companies jointly enroll patients in a cohort of clinical trials, sharing the same placebo cohort? Blockchain could be used to exchange data, while preserving the confidentiality required in a double-blind, randomized, controlled clinical study. This new approach would reduce the time required for drug development, getting treatments to patients faster.
Changing the Patient Data Relationship
Blockchain could also eventually be used as the foundation for universal electronic health records, but with one important difference from the proprietary technologies now in use: Who controls the data in the record.
By giving patients more control and ownership of their health information, blockchain technology could shift the relationship between patients and payers or pharmaceutical researchers. Because the data in those records can be valuable when it comes to predicting costs, understanding outcomes or identifying potential clinical trial candidates, we could envisage companies paying individuals for access to that information.
“You can set it up so the patient owns the block ID, and so it becomes their data,” Kamkolkar said. “It creates a new kind of commerce where patients charge payers for their information.”
On the Horizon
In addition to its investment in Curisium, Sanofi is looking at the possibility of incorporating blockchain technology in various areas of its business, Kamkolkar said. It would become another part of the company’s larger digital strategy that seeks to merge IT innovation more closely with pharmaceutical R&D as well as operations.
One of the first tests could be a pilot program involving a late-stage clinical trial in oncology, possibly sometime in 2018, although there are no specific plans as yet.
“It’s still very early in the development of the technology and the use case in health care,” Chossinand said. “But I would be very happy to put it to the test.”