SAFE-BioPharma Association is a US Government-approved Trust Framework Provider (TFP). As such, we develop and maintain policies and practices used by identity credential issuers.
We are authorized to examine and certify that the identity proofing, credential issuance, and credential management policies and practices of electronic identity credential issuers are comparable to Federal Identity, Credential, and Access Management (FICAM) requirements.
Certification means that identities and/or credentials can be trusted and used at known levels of assurance by US federal entities such as NIH, VA, and FDA.
SAFE-BioPharma is approved by FICAM to provide policy and practice oversight for full-service Credential Service Providers (CSP), Identity Proofing (IdP) component members, and Credential Provider (CCP) component members.
Certification means that identity credentials can be trusted and used at known levels of assurance by US federal entities such as NIH, VA, and FDA.
- a Global Trust Framework aligned with EU Regulations, ISO and ITU-T standards at eIAS Low, Substantial and High
- an internationally recognized PKI (asymmetric cryptography-based) bridge certification authority and Trusted Third Party issuer of digital certificates. PKI credentials are used for high identity trust authentication and for applying digital signatures
- a federally-approved (FICAM) non-PKI Trust Framework certifying Credential Service Providers and Identity Proofing Providers at NIST Levels of Assurance (LOA) 2 and 3. FICAM credentials are used for trusted authentication
- LOA 2 satisfies identity-proofing and credential issuing practices acceptable for access to systems where risk of identity fraud is minimized; for example, patient access to read-only medical records, and veteran access to read-only military medical records.
- LOA 3 is considered the minimum level of assurance required to authenticate most transactions in regulated industries such as pharmaceuticals and healthcare.
The following Service Providers have been approved as members of the SAFE-BioPharma Trust Framework:
|SAFE-BioPharma FICAM Trust Framework 1.0||SAFE-BioPharma FICAM Trust Framework 2.0|
|Identity Manager/Identity Proofing Member||LexisNexis, LOA 1,2,3||
TransUnion LOA 2, 3
|Credential Service Providers|| Exostar, LOA 3
Zentry a Synchronoss Venture, LOA 2,3
Trans Sped, LOA 3
The following are certified assessors for our Trust Frameworks and PKI services: Cygnacom Solutions, Inc.; Elfsec, LLC; eValid8; Jimmy Jung; Kuma, LLC; Libra Security, Inc.; Scott S. Perry CPA, PLLC; Zygma LLC.
SAFE-BioPharma FICAM Trust Framework Documents