Privacy Analytics, a provider of data anonymization solutions for the healthcare industry, has launched a new solution to enable pharma companies to share clinical trials data while protecting the privacy of individual participants. The new offering accelerates the ability of pharma companies to meet increasing requests for individual-level participant data and clinical study reports by academic institutions, patients and other third parties.
Privacy Analytics’ Open Clinical Trials Data Review compares customers’ existing anonymization approaches to contemporary international standards and industry best practices to identify privacy gaps in sharing clinical trials data. The solution relies on the company’s PARAT software, which automates the risk assessment of individual data requests in accordance with HIPAA and other regulatory and legal requirements. With a standard approach to evaluating risk, pharma companies can apply scalable anonymization practices to data sets that can be shared under various scenarios, such as through on-line portal access or the release of individual data files.
In January, the European Federation of Pharmaceutical Industries and Associations (EFPIA) and the Pharmaceutical Research and Manufacturers of America (PhRMA) jointly created a new policy seeking to enhance public health through responsible sharing of clinical data. GlaxoSmithKline, Sanofi and Johnson & Johnson, among others, have taken steps to operationalize these principles.
“Our solution provides pharmaceutical companies with a pragmatic, repeatable way to comprehensively measure and manage the risk of sharing their clinical trials data with third-parties securely,” said Khaled El Emam, CEO, Privacy Analytics. “This enables companies to respond more quickly to reasonable data requests with standard protocols that can be applied throughout the organization. As a result, organizations that release data can set the level of anonymization within a responsible risk threshold that allows for maximum analytic utility of the requested information—all the while protecting the personal identity of trial participants.”
For privacy, regulatory and medical affairs executives, Privacy Analytics provides an assessment of current in-house approaches for clinical trials data anonymization; common standards and practices for evaluating and managing the risk of clinical trials data for release to third parties; and enterprise-level automation solutions for scaling clinical trial data anonymization.
Using a risk-based approach to anonymize personal information in accordance with HIPAA and other legal requirements, PARAT automates the de-identification of data in standard database tables and in text documents, such as discharge notes and text fields. All indirect identifiers that can potentially compromise the identity of participants are protected while ensuring high analytic utility of the data.