Identity Verification in Healthcare: Revamping a Framework

A 15-year-old identity framework originally designed for narrow use by pharmaceutical companies is being revamped and updated for broader use in healthcare, says Kyle Neuman, managing director of SAFE Identity, an industry consortium and certification body that’s coordinating the project.

Eventually, the revamped SAFE-Biopharma Trust Framework could be used to enhance trusted identification for suppliers, medical devices, clinical trials and eventually patients, he explains in an interview with Information Security Media Group.

The framework was built to serve a specific purpose - provide a mechanism to create trusted digital identities that could be verified by the Food and Drug Administration for processes related to the submission of electronic documents by pharmaceutical companies, Neuman explains.

“The reason why this was important was because in the past, with paper submissions, [biopharma companies] would sign with ink their clinical trial drug submissions to the FDA, and when the FDA got it, it was legally binding,” he says. “With electronic submissions, how do you know it comes from the source it claims to be coming from?”

The framework provided a cryptographic infrastructure so that the FDA knew “with a high degree of certainty who was submitting this document,” he says.