SAFE-BioPharma Global Trust Framework

//SAFE-BioPharma Global Trust Framework
SAFE-BioPharma Global Trust Framework 2017-05-11T16:25:10+00:00


SAFE-BioPharma Association
82 N. Summit St., Suite 2
Tenafly, NJ 07670 USA

The SAFE-BioPharma Association is a non-profit collaborative of the global biopharmaceutical and healthcare industries, managed by Board of Directors from member firms. Association functions include: Maintaining and evolving authentication and digital signature credential standards for application to a wide variety of business processes, collaborations, federations; certifying commercial TSPs, applications and products; collaborating with regulators and policy authorities; providing a forum for best practices and shared use cases; operating a PKI “Bridge CA,” (SBCA) for interoperability; operating non-PKI credential Trust Frameworks to enable federated authentication interoperability at known levels of assurance, and representing the industry in national and international standards-development and global identity management policy-setting organizations. SAFE-BioPharma is affiliated with a broad range of governments and industry standards organizations.

Primary Contact:
Mollie Shields-Uehling
President and CEO
[email protected]

Alternate Contact:
Dr. Peter Alterman
Chief Operating Officer
[email protected]

SAFE-BioPharma Global Trust Framework

Open to all, the SAFE-BioPharma Global Trust Framework has been designed to function as a framework for Trust Service Providers of authentication credentials as described in EU Regulation 910/2014 (eIDAS). The Global Trust Framework is based on the authentication threat and mitigation model found in international standards ISO 27115 and ITU-T X.1254. For the SAFE-BioPharma Global Trust Framework, the candidate must demonstrate how it mitigates authentication threats and threat vectors, including showing how it satisfies the EU Data Protection directive and/or statutory privacy requirements of the geopolitical entity under which it operates.

The European Union regulations and directives related to online identity services (e.g., eIDAS Regulation – particularly Articles 6a and 7, EC Directive 95/46/EC regarding privacy and the current version of the EU Data Protection Directive, etc.) are incorporated by reference in the SAFE-BioPharma Global Trust Framework. There is no requirement for a member to assert any extended attributes for a Subscriber though there is no proscription against doing so either.

The Global Trust Framework will be sponsored under a recognized EU member state program.

Components of the SAFE-BioPharma Global Trust Framework

The SAFE-BioPharma Global Trust Framework recognizes five component options. They are Identity Manager, Token Manager, Attribute Manager, Full Service Credential Service Provider and Encryption Manager.

Credential Technologies

The SAFE-BioPharma-Global Trust Framework includes all credential technologies subsumed under the SAFE-BioPharma FICAM Trust Framework that can be found at: and also includes any other credential technology that can be demonstrated to be standards-based and to provide the necessary threat mitigation for the degree of trustworthiness applied for by the candidate. The eIDAS model includes three levels of trustworthiness: low, substantial and high.

To Apply

Send an email message to Dr. Peter Alterman, Chief Operating Officer, SAFE-BioPharma Association, [email protected] stating your interest in applying for membership in the SAFE-BioPharma Global Trust Framework and the component/Trust Framework you are interested in certifying against. Feel free to contact us about any issue or question you may have regarding the SAFE-BioPharma Global Trust Framework Program.