A scalable, secure data exchange ecosystem can support high-quality research while safeguarding against breaches of sensitive patient data.
Blockchain technology has been popping up everywhere from the financial industry to supply-chain management to authentication -- and most recently (and perhaps most influentially) in how public agencies manage health records.
Blockchain, the shared ledger technology that notably underpins the Bitcoin online currency, has been finding its own notoriety in the past couple of years as a critical building block for how several different industries plan to reshape the way they share, store and secure critical information. Earlier this year, IBM Watson Health announced a joint research initiative with the Food and Drug Administration, aimed at leveraging blockchain technology to create a secure, efficient and scalable exchange of health data.
Although work will initially focus on oncology-related data, the partners will also be exploring the use of blockchain for exchanging data from electronic medical records, clinical trials, genomic data and even mobile devices, wearables and internet of things-type IP-connected devices. IBM and FDA plan to share their initial research findings in 2017 under their two-year agreement.
“Blockchain technology has the potential to support secure exchange of large volumes of data while ensuring patient privacy and maintaining data integrity,” said Angela Stark, press officer for the Office of External Affairs at the FDA. “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.”
The initiative leverages the FDA’s technical and organizational resources from its Information Exchange and Data Transformation initiative, a big data project 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,” she explained.
“The health care industry is undergoing significant changes due to the vast amounts of disparate data being generated,” Shahram Ebadollahi, vice president for innovations and chief science officer for IBM Watson Health, said in IBM’s release on its work with the FDA. “Blockchain technology provides a highly secure, decentralized framework for data sharing that will accelerate innovation throughout the industry.”
Indeed, according to a December 2016 Deloitte report, blockchain technology may well transform health care’s IT infrastructure and increase the security, privacy and interoperability of electronic health records by changing the way health care organizations exchange EHR data.
“The current state of health care records is disjointed and stovepiped due to a lack of common architectures and standards that would allow the safe transfer of sensitive information among stakeholders in the system,” according to the Deloitte report. “This flow of information originating from the patient through the health care organization each time a service is performed does not need to stop at the individual organizational level.”
Medical and pharmaceutical researchers stand to benefit from increased access to patients’ medical information. The vast amounts of data generated in the public health sector “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,” Stark said.
“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,” she said. “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.”
Scott Lundstrom, group vice president and general manager for the software, health and public sector for IDC, believes that blockchain technology “will exist in many sectors,” including supply chain, medical records and pharmaceutical, because it creates an “immutable” record, he said. He believes an increasing number of health care trials will investigate the use of this technology.
Blockchain busts out
Blockchain technology is not just having an impact on the FDA. The shared-ledger technology is “on the Department of Veterans Affairs’ list of emerging technologies that may eventually prove of value to our health care line of business,” Terrence L. Hayes, spokesperson for the VA’s Office of Public and Intergovernmental Affairs, said. The Veterans Health Administration is tracking this trend and is currently examining potential applications of blockchain ledgers related to security and privacy within VHA-supported health care standards development organizations (SDOs), according to Hayes.
“From the patient or veterans’ point of view, the use of blockchain may give them greater control of their own medical data and would meet VHA goals of putting veterans first,” Hayes said. “Within SDOs, blockchain may have use along with security-labeling-services support to access control and audit. These are both already major areas of health care line-of-business interest and ongoing development.”
Going forward, there are myriad uses for blockchain in managing health care records, given the technology’s ability to protect and share data. “Oncology is the ideal starting point because of the large volume of data that is being generated in the field,” Stark said. For example, organizations that are currently producing cancer genomics data can potentially use the blockchain framework as a medium for conducting collaborative research with a global community of big data analytics experts, she said. A secure medium such as blockchain can enable exchange of data from multiple sources, including new pipelines such as electronic health records and wearables in support of developing more personalized cancer therapies for patients with advanced malignancies whose current medical needs are unmet, Stark said.
IDC’s Lundstrom said that while the distributed-ledger technology has the ability to allow health care concerns to create “longitudinal records with very high security” and potentially even automate the claims process, there are potential drawbacks -- namely that blockchain is still not well-understood.
“Organizations often struggle with establishing secure connections through traditional data exchanges and need to trust the organizations they are exchanging data with,” the Deloitte report found. “Blockchain operates entirely different because it eliminates the need for trust between organizations because of the way it’s designed with no central hub of information.”
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