SAFE Identity Trust Framework will be integrated into DirectTrust; the combination of these assets will generate new potential to revolutionize the identity landscape for secure healthcare interoperability.
FREMONT, CA: DirectTrust has purchased SAFE Identity's assets, including its Trust Framework. DirectTrust's capabilities and services will be significantly extended due to the acquisition, which is intended to enable new and expanded interoperability use cases. SAFE Identity (SAFE) is a healthcare industry organization and certification body dedicated to advancing identity assurance and cryptography. DirectTrust is a not-for-profit organization that promotes secure, identity-verified electronic exchanges of protected health information (PHI) between provider organizations and between clinicians and patients to improve care coordination.
DirectTrust has established a new division, DirectTrust Identity, to house the SAFE Trust Framework. Both organizations’ new and existing members may rely on DirectTrust to manage the policies and infrastructure necessary to sustain a community that issues safe and identity-assured credentials for electronic transactions in healthcare. Members of the SAFE Policy Management Authority (PMA) will join DirectTrust Identity, which will operate the SAFE infrastructure used by multiple large pharmaceutical companies to interact with federal agencies securely (as defined in 21 CFR Part 11) and business partners in the United States and around the world.
“Our acquisition of SAFE Identity’s assets is truly a groundbreaking moment for DirectTrust and the entire electronic healthcare information industry,” says Scott Stuewe, President and CEO of DirectTrust. “SAFE Identity and DirectTrust are like-minded organizations with memberships that share common goals. Since our inception, DirectTrust has focused on instilling trust in electronic health communication with the goal of improving health for individuals and populations. Both the DirectTrust and SAFE Identity trust framework communities seek to enable safe and secure transactions through the use of identity-assured credentials backed by a public key infrastructure and consensus-based policies.”
Stuewe continues, “Further, the newly expanded DirectTrust ecosystem will extend the breadth of healthcare stakeholders it serves and enable additional capabilities, as well as exciting new use cases where the two groups of stakeholders connect. For example, members will be able to interact with federal agencies for signing documents and authenticating to systems. Potential new use cases could include universally trusted healthcare credentials for consumers; identity assurance and security for the pharmaceutical supply chain (DSCSA), possibly all the way to clinical pharmacy; as well as medical device security and identification.”
“SAFE sustained a pedigree in the digital identity assurance and government interoperability spaces by maintaining one of the longest-standing Trust Frameworks in healthcare,” says Kyle Neuman, incoming Director of Trust Framework Development at DirectTrust. “With its incorporation into DirectTrust, the SAFE community is about to embark on a new chapter to remain in lockstep with the progress being made in the realm of digital identity across healthcare. Neuman is currently Managing Director at SAFE Identity and will continue in his role as Chief Information Security Officer at Zeva Incorporated.”
“I’m excited to help DirectTrust facilitate better communication and better data sharing within a particular industry—such as biopharmaceuticals or healthcare delivery, as was the case in the past—and perhaps more profoundly, between all of the industries that make up healthcare. With DirectTrust carrying the torch into the future, our goal is to support modern identity challenges, including meeting the requirements of the Drug Supply Chain Security Act, clinical research, medical IoT, and patient matching,” Neuman concludes.
In response to the growing demand for high-assurance digital signatures, many multinational pharmaceutical corporations formed SAFE as a legal framework to facilitate the confidence and interoperability of digital identities with government agencies such as the FDA, DEA, and European Medicines Agency. SAFE-BioPharma (predecessor to SAFE Identity) was created in response to the FDA’s need for a safe and scalable mechanism for submitting digital reports to the agency. DirectTrust, best known for Direct Secure Messaging and the Direct StandardTM it supports and promotes, was founded with support from the ONC as a trust framework based on critical public infrastructure (PKI) to enable scalable healthcare interoperability. While SAFE Identity and DirectTrust have expanded their goals since their inception, both owe their existence to collaborations with government agencies and continue to have significant contacts and roles with them.
“DirectTrust’s acquisition will return SAFE Identity to its roots as a not-for-profit trade association. We welcome SAFE Identity’s members to the DirectTrust community and invite biopharma companies, certificate authorities, medical device manufacturers, and identity providers that want to transform how identity is managed and assured in the highly-regulated and sensitive healthcare industry to come work with us at DirectTrust,” concludes Stuewe.
On Wednesday, September 29, 2021, at 11:00 a.m. EDT, DirectTrust will host an informative session regarding DirectTrust Identity. All parties interested in learning more about DirectTrust Identity are welcome to attend this event.