Secure storage and controlled access to sensitive patient data are critical aspects of the clinical trial process. Investigators may need to access huge data sets shared across national and international sites. The amount and sheer number of types of data is rapidly increasing as the use of mobile and wearable devices and the querying of genomic databases are incorporated into trial design.

Recently the FDA and IBM Watson Health announced a joint two-year research initiative that takes data sharing even further. The goal is to allow not only healthcare researchers but also providers access to patient data from even more sources, including Electronic Medical Records (EMRs), clinical trials, genomic data and health data from mobile devices, wearables and the “Internet of Things.” The initial focus will be on oncology-related data.

The collaboration will use a blockchain framework, the technology underlying the digital currency bitcoin. Shahram Ebadollahi, vice president for Innovations and chief science officer, IBM Watson Health, explained, “Blockchain maintains a record (ledger) of transactions and protects it with cryptographic techniques to ensure that past information cannot be modified, and only new information can be appended. Moreover, the ledger is shared in a way that any update to the ledger requires all participants in the network to approve it. The combination of cryptographic protection and shared ownership ensures that all transactions are secure, authenticated, verifiable and highly trusted.”

Ebadollahi continued, “Blockchain brings a new level of auditability and trust to the process of data collection and access."

Sean Khozin, M.D., MPH, senior medical officer, office of Hematology and Oncology Products, Center for Drug Evaluation and Research, FDA, added, “Blockchain technology has the potential to support the secure exchange of large volumes of data while ensuring patient privacy and maintaining data integrity. 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 partnership is focusing on oncology data initially. Khozin said, “Oncology is the ideal starting point because of the large volume of data that is being generated in the field. For example, organizations that are currently producing large volumes of 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."

Ebadollahi stated, “The initial collaboration with the FDA will include patient medical records, lab reports, vitals and genomic data, among others. The use of wearable devices in clinical trials is still not widespread, but as its adoption increases we see blockchain technology playing a central role in managing access and enabling advanced patient monitoring scenarios.”

Steve Broadbent, COO of Critical Path Institute (C-Path), a nonprofit organization that promotes collaboration among the FDA, industry and academia, stated, “It costs a lot of money to run clinical trials, and to generate data. This data is often considered proprietary information, and the owners of clinical trial data want assurances that the data will not be used in a way that may interfere with the organization’s goal of developing new therapies.”

Basic medical research also requires access to data from trials. Aggregated health data sets from completed trials can be a powerful tool when shared widely. Broadbent said, “Larger datasets are more useful in determining disease progression, the amount and cause of variability, the value of different endpoints and the strength of different biomarkers, etc.” To maintain security, Broadbent said that C-Path uses “well-vetted legal documents that govern the sharing of data, specifying who may have access, and ensure the anonymity and de-identification of the data. [We] use state of the art IT technology and encryption to ensure protection of the data while at rest and in transmission.”

Another increasingly common aspect of clinical data sharing involves an individual agreeing to give a researcher access to a specific portion of their genetic data. Ali Mostashari, Ph.D., CEO of LifeNome, a wellness genomics company, said, “Personal genetic data is categorized within HIPAA as Protected Health Information (PHI). As more and more digital health applications require the exchange of sensitive genetic and phenotypic data, the ability to store and exchange data securely, such that data is not compromised, is critical.”

LifeNome and Infoshield, a cybersecurity company, are partnering to develop and deploy a secure solution to this problem called homomorphic encryption. Mostashari explained, “This technology allows a part of a person’s genetic data to be queried and processed. That means your genetic data file will be stored on a cloud, totally encrypted. If a service provider needs to know if there is a genetic variation present within your genes, they will send a query that is encrypted and receive an answer without decrypting your genetic data at any point.”

Mostashari continued, “Making sure that the right people have access to only that portion of the data they need to provide an individual with digital health services is not a trivial task. At the end we are trying to maximize the flexibility of digital health applications without compromising security.” 

This article was reprinted from Volume 21, Issue 03, of CWWeekly, a leading clinical research industry newsletter providing expanded analysis on breaking news, study leads, trial results and more. Subscribe »