The Food and Drug Administration (FDA) and IBM Watson Health are establishing a partnership to examine potential ways that blockchain technology can be utilized in healthcare.
The agency and IBM subsidiary have signed a 2-year contract that will enable them to jointly investigate ways to use the emerging technology. Initial attempts will concentrate on oncology-related data.
Proponents of blockchain technology consider that it could have wide applicability in healthcare. It enables the collection of information from a variety of sources, and keeps an audit trail of transactions, thus developing accountability and transparency in the data exchange procedure.
The FDA and IBM Watson Health will look at ways blockchain technology can enable healthcare entities to work together with more trust. They consider the technology can support the exchange of “owner-mediated data from various sources,” like electronic health records (EHRs), clinical trials, genomic data and information collected from presently untapped information sources, like mobile devices, wearable’s and Internet of Thing devices.
Initial attempts of the partners will focus on how a blockchain framework can help public health efforts.
“One aspect of the role of FDA as a regulatory science agency is to conduct research that informs the development of latest tools, standards, and approaches to assess the safety, efficacy, quality, and performance of all FDA-regulated products,” claimed 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 investing to the advancement of clinical research by testing novel frameworks for protective exchange of worthy patient-level health data at scale.”
It is this wider view of patient data that will help researchers in making better research initiatives, states Shahram Ebadollahi, vice president for innovations and chief science officer for IBM Watson Health.
“One of the problems in research is the availability of a longitudinal record of patient information that gives a 360 degree view of the patient,” Ebadollahi claims. “There is been no central place to put the data. Blockchain provides the chance to produce value and outcomes on the distributed ledger, interoperability, privacy and security, while putting the sufferer in the center.
The initiative will be constructed on IBM’s work in establishing and advancing blockchain technology, Ebadollahi adds. For instance, IBM is a founding member and key contributor to the Linux Foundation's Hyperledger project, a key underpinning for blockchain.
Under the research contract, the FDA will work straightly with IBM Watson Health. It will leverage the agency’s technical and organizational resources from its Information Exchange and Data Transformation (INFORMED) initiative. “That is an FDA big data initiative created to support novel scientific research using huge clinical trial datasets and emerging pipelines of data from sources like electronic medical record systems, biometric monitoring devices and wearable technologies,” Khozin asserts.
IBM Watson Health and the FDA plan to share earlier or initial research findings by the end of 2017 year, he adds.
The federal agency observes a variety of potential benefits from inquiring how blockchain could be used in healthcare and focusing efforts on indicating its value in specific use cases, Khozin adds.
“Huge amounts of patient data are generated in the public health sector,” he notes. “This data has the potential to assist researchers to develop more effective and safer treatments for sufferers, particularly in life-threatening disease areas such as cancer, which has observed a huge rise in the use of personalized and targeted therapies for disease treatment.
“Blockchain technology has the potential to support secure exchange of huge volumes of data while ensuring sufferer privacy and maintaining data integrity,” he adds. “These are crucial features of a scalable data exchange ecosystem that can support high-quality research while protecting against breaches of sensitive patient-level information.”
The initiative offers IBM and its Watson Health division a chance to demonstrate whether blockchain can live up to the hype that is growing around its potential to meet vexing problems in healthcare IT.
As the promise of blockchain in healthcare becomes more obvious, IBM will work to define and develop the technological solution for a scalable and decentralized information sharing ecosystem, Ebadollahi says.
“The healthcare industry is undergoing important modifications because of the vast amounts of disparate data being generated. Blockchain technology gives a greatly secure, decentralized framework for information sharing that will accelerate innovation throughout the industry,” he claims.
The initial focus on oncology with the FDA makes sense because it is “a domain to test the technology and observe how it maps to several use cases,” he further adds. “We are looking to build a patient-mediated electronic health data exchange. There are several reasons for doing this, chief among them the problem of trust—can you put faith in the data you are looking at. With blockchain, we feel it can be a remedy for that.
“We are very excited about this, and there is no better partner for us than the FDA,” Ebadollahi claims. “They know about our information of blockchain, and this offers us a matter of mutual interest from which the public can gain benefit.”
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