A standard for High-Assurance Identity for Healthcare and Pharmaceutical e-transactions

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1 A standard for High-Assurance Identity for Healthcare and Pharmaceutical e-transactions Viky Manaila Managing Director, Trans Sped SRL ETSI ESI Workshop 3rd December 2013 Sophia-Antipolis

2 What is SAFE-BioPharma? A non-profit membership association formed by the worlds leading Pharmaceutical companies to create and manage the Digital Identity and Signature standard for Life Sciences and Healthcare The only industry-designed solution interoperable with NIH, FDA and other US federal agencies, and European Medicines Agency The only industry-designed standard that meets advanced e-signature requirements of the EU Directive 1999/93/EC and is compliant with HIPAA and DEA Federated identity across Federal Bridge Certification Authority SAFE-BioPharma Trust Authority maintains two trust standards and certifies identity providers to those standards (PKI and non-pki) PKI (Federal Bridge CA compliant) Level 3; compliant with ETSI standards on q- Certificates ; Trans Sped SAFE CA the root for q-certificates since 2008 Non-PKI SAFE-BioPharma is a Federal Identity Credentialing and Access Management (FICAM) Trust Framework Provider - NIST Levels 2, 3 Objective: to help industry protect its substantial information assets, move its business processes online, and become paperless in order to improve productivity, reduce costs, and lower time to market 2

3 FBCA cross-certified Identrust SA AZ Verizon Merck Lockhee d Martin Boeing EADS Raytheon CertiPath Bridge CA REBCA SAFE Bridge CA J&J SAFE:Verizon Symantec GSK Pharmas Northrop Grumman ARINC SITA CertiPath Common Policy Root CA DoE GPO DoJ Federal Bridge CA VeriSign Fed Common Policy Root CA VeriSign GPO US Treasury Entrust GSA MSO ORC DoL Exostar VDoT US PTO DoJ E-Commerce DoD Interoperability Root HUD NRC DoT DHS SSA NASA EOP Verizon Bus EPA HHS DEA USPS ACES Dept. of State State of Illinois DoD VA 3

4 SAFE-BioPharma Members, ie major global pharmaceutical companies, by creating SAFE BIO, acknowledged the enormous return on investment they can realize by shifting in-house, business-to-business and business-to-regulator transactions from paper-based to electronic. Data must be easily and quickly available, yet complaint with legal and regulatory requirements. This requires the use of legally enforceable, verifiable digital signatures and identity assurance mechanisms. Knowing that the identity of a business partner is valid, and that their signature will hold up in a court of law, is at the core of any business transaction and is critical to creating information liquidity. Documents/transactions shared with external parties in Europe or within the US federal government need the strength of a digital signature that is tightly bound to the identity of the signer. SAFE-BioPharma Association 4

5 significant administrative cost to the industry considerable complexity for external development partners and regulatory agencies does not support the rapid, cost-effective development of the services Bad timing with existing technologies/solutions; not correlated with the market needs Signatures in cloud/roaming zero footprint digital signatures should develop policy frameworks for operational interoperability should provide certifications to grow trust in the standards, products, and service deployments SAFE-BioPharma Association 5

6 Contact information Viky Manaila Mollie Shields Uehling CEO, SAFE-BioPharma biopharma.org/ org/ Watch the SAFE-BioPharma introductory video: 6