SAFE-BioPharma Creates First Electronic Trusted Identity Link Between Pharma And Healthcare Industries And US Government Agencies
SAFE-BioPharma Association recently announced activation of the first electronic bridge enabling trusted transactions between many of the world's largest pharmaceutical companies and key US government agencies, including the FDA, Health and Human Services, Department of Defense, Homeland Security and the US Patent and Trademark Office. SAFE-BioPharma Association is the non-profit association that created and manages the SAFE-BioPharma digital identity and digital signature standard for the pharmaceutical and healthcare industries.
SAFE-BioPharma's link to the Federal Bridge Certificate Authority (FBCA) creates a network of trust that will allow people responsible for a broad range of functions within the pharmaceutical and healthcare industries to exchange information securely with government agencies and with the growing number of other entities that have linked through the FBCA.
The SAFE-BioPharma digital identity and signature standard is designed and used to mitigate legal, regulatory and other business risk associated with business-to-business and business-to-regulator electronic transactions. It provides users with a secure, enforceable, and regulatory-compliant way to verify identities of parties involved in electronic transactions and to apply their digital signatures to electronic documents. By using SAFE-BioPharma digital signatures, companies are able to dispense with paper originals and other cumbersome forms of back up.
"Crossing the Federal Bridge allows SAFE-BioPharma to streamline business and regulatory transactions between industry and the government. It is a major step toward improving productivity in both the private and public sectors," said Dr. Peter Alterman, Chair, Federal PKI Policy Authority.
The new capability will allow officials in Health and Human Services, the Food and Drug Administration, Department of Defense, and other government agencies to trust the origins of electronic documents received from corporate managers who are credentialed to digitally sign documents with SAFE-BioPharma digital signatures.
"SAFE-BioPharma is repaving the fast lane of the electronic communications highway. We are committed to transforming the biopharmaceutical and healthcare communities to a fully electronic business environment as rapidly as possible," said Gary Secrest, Chairman, SAFE-BioPharma Association and Director, Worldwide Information Security, Johnson & Johnson.
Among the current users of SAFE-BioPharma digital signatures, AstraZeneca signs all submissions to the FDA's eSubmissions Gateway with SAFE-BioPharma digital signatures. Other companies are preparing to use SAFE-BioPharma digital signatures to sign electronic documents that will be submitted to Federal entities. While potential uses are wide-ranging, those currently under consideration include the following:
- Submitting a broad range of regulatory documents
- Signing NIH grants
- Managing contracts with the Veterans Administration
- Submitting documents to Homeland Security associated with managing biological threats
SAFE-BioPharma digital signatures are legally binding and help eliminate the need for paper-based business processes and paper backup copies. Individuals who are credentialed via processes compliant with the SAFE-BioPharma industry standard have had their identity verified in a strongly trusted manner. When they digitally "sign" documents using any of several approaches offered by SAFE-BioPharma, the identity of the signer is clearly verified and the integrity of the document is cryptographically guaranteed.
To date, FDA inspectors have received training to recognize electronic documents signed with SAFE-BioPharma digital signatures. SAFE-BioPharma plans to initiate educational programs that will acquaint personnel within other Federal agencies with SAFE-BioPharma digital signatures.
About SAFE-BioPharma Association
SAFE-BioPharma Association is the non-profit association that created and manages the SAFE-BioPharma digital identity and signature standard for the pharmaceutical and healthcare industries. The SAFE-BioPharma industry standard is used to mitigate legal, regulatory and other business risk associated with business-to-business and business-to-regulator electronic transactions. It facilitates interoperability by providing a secure, enforceable, and regulatory-compliant way to verify identities of parties involved in electronic transactions. SAFE-BioPharma's vision is to be a catalyst in transforming the biopharmaceutical and healthcare communities to a fully electronic business environment by 2012. The Association's members include Amgen, AstraZeneca, Bristol-Myers Squibb, Genzyme, GlaxoSmithKline, Johnson & Johnson, Merck, Pfizer, Procter & Gamble, Roche and Sanofi-Aventis. For more information, visit www.safe-biopharma.org.
SOURCE: SAFE-BioPharma Association