The Food and Drug Administration and IBM Watson Health are forming a partnership to investigate potential ways that blockchain technology can be used in healthcare.

The agency and IBM subsidiary have signed a two-year agreement that will enable them to jointly explore ways to use the emerging technology. Initial efforts will focus on oncology-related data.

Proponents of blockchain technology believe it could have wide applicability in healthcare. It enables the collection of data from a variety of sources, and keeps an audit trail of transactions, thus establishing accountability and transparency in the data exchange process.

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The FDA and IBM Watson Health will look at ways blockchain technology can enable healthcare entities to work together with more trust. They believe the technology can support the exchange of “owner-mediated data from several sources,” such as electronic health records, clinical trials, genomic data and information gathered from currently untapped information sources, such as mobile devices, wearable’s and Internet of Thing devices.

Initial efforts of the partners will focus on how a blockchain framework can assist public health efforts.

“One aspect of the FDA’s role as a regulatory science agency is to conduct research that informs the development of new tools, standards, and approaches to assess the safety, efficacy, quality, and performance of all FDA-regulated products,” said Sean Khozin, MD, senior medical officer, Office of hematology and oncology products, Center for Drug Evaluation and Research at the FDA. “By studying blockchain technology, the FDA is contributing to the advancement of clinical research by testing novel frameworks for secure exchange of valuable patient-level health data at scale.”

It’s this wider view of patient information that will assist researchers in improving research initiatives, says Shahram Ebadollahi, vice president for innovations and chief science officer for IBM Watson Health.

“One of the issues in research is the availability of a longitudinal record of patient information that offers a 360 degree view of the patient,” Ebadollahi says. “There’s been no central place to put the data. Blockchain offers the opportunity to produce value and outcomes on the distributed ledger, interoperability, privacy and security, while putting the patient in the center.

Shahram Ebadollahi

The initiative will be built on IBM’s work in developing and advancing blockchain technology, Ebadollahi adds. For example, IBM is a founding member and key contributor to the Linux Foundation's Hyperledger project, a key underpinning for blockchain.

Under the research agreement, the FDA will work directly with IBM Watson Health. It will leverage the agency’s technical and organizational resources from its Information Exchange and Data Transformation (INFORMED) initiative. “That’s an FDA big data initiative designed to support novel scientific research using large clinical trial datasets and emerging pipelines of data from sources such as electronic medical record systems, biometric monitoring devices and wearable technologies,” Khozin says.

IBM Watson Health and the FDA plan to share initial research findings by the end of 2017, he adds.

The federal agency sees a variety of potential benefits from investigating how blockchain could be used in healthcare and focusing efforts on demonstrating its value in specific use cases, Khozin adds.

“Vast amounts of patient data are generated in the public health sector,” he notes. “This data has the potential to help researchers develop more effective and safer treatments for patients, especially in life-threatening disease areas like cancer, which has seen a huge rise in the use of personalized and targeted therapies for disease treatment.

“Blockchain technology has the potential to support secure exchange of large volumes of data while ensuring patient privacy and maintaining data integrity,” he adds. “These are critical features of a scalable data exchange ecosystem that can support high-quality research while safeguarding against breaches of sensitive patient-level data.”

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The initiative gives IBM and its Watson Health division an opportunity to show whether blockchain can live up to the hype that’s growing around its potential to meet vexing issues in healthcare IT.

As the promise of blockchain in healthcare becomes clearer, IBM will work to define and build the technological solution for a scalable and decentralized data sharing ecosystem, Ebadollahi

“The healthcare industry is undergoing significant changes due to the vast amounts of disparate data being generated. Blockchain technology provides a highly secure, decentralized framework for data sharing that will accelerate innovation throughout the industry,” he says.

The initial focus on oncology with the FDA make sense because it’s “a domain to test the technology and see how it maps to various use cases,” he adds. “We’re looking to build a patient-mediated electronic health data exchange. There’s many reasons for doing this, chief among them the issue of trust—can you put faith in the data you’re looking at. With blockchain, we feel it can be a remedy for that.

“We’re very excited about this, and there’s no better partner for us than the FDA,” Ebadollahi says. “They know about our knowledge of blockchain, and this gives us a matter of mutual interest from which the public can gain benefit.”

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