CoSign Digital Signatures - Regulatory Compliance

In recent years, most countries worldwide have adopted legislation and regulations that recognize the legality of a digital signature (standard electronic signatures) and deem it a binding signature. In addition to governments, many industries have established regulations (e.g., FDA 21 CFR Part 11 in the Life Sciences industry) that define digital signatures as a replacement for handwritten signatures.

The CoSign digital signature solution supports compliance with numerous regulations even in the most tightly regulated industries and geographies. With the proper standard operating procedures in place, CoSign complies with ESIGN, EU directives and VAT law, HIPAA (and JCAHO), the FDA's 21 CFR Part 11, USDA, the Sarbanes-Oxley Act, and many more. CoSign will also support the new EU regulations on digital signatures that are expected to be established this year by the EU commission.

Related Legislation on Digital Signatures in the US and Worldwide:

• U.S. - Electronic Signature in Global and National Commerce Act (ESIGN)
• U.S. - Uniform Electronic Transactions Act (UETA)
• U.S. - Digital Signature And Electronic Authentication Law (SEAL)
• U.S. - Government Paperwork Elimination Act (GPEA)
• U.S. - The Uniform Commercial Code (UCC)
• Canada - Uniform Electronic Commerce Act (UECA)
• UK - Electronic Communications Act 2000 (chapter 7)
• Europe - EU Directive for Electronic Signatures (1999/93/EC)
• Europe - EU VAT Directive
• Europe- EU Draft Regulation
• China - Electronic Signature Law of the People's Republic of China

• U.S. - Electronic Signature in Global and National Commerce Act (ESIGN)
• U.S. - Uniform Electronic Transactions Act (UETA)
• U.S. - Digital Signature And Electronic Authentication Law (SEAL)
• U.S. - Government Paperwork Elimination Act (GPEA)
• U.S. - The Uniform Commercial Code (UCC)
• Canada - Uniform Electronic Commerce Act (UECA)
• UK - Electronic Communications Act 2000 (chapter 7)
• Europe - EU Directive for Electronic Signatures (1999/93/EC)
• Europe - EU VAT Directive
• Europe- EU Draft Regulation
• China - Electronic Signature Law of the People's Republic of China

For additional information on other countries, visit the Digital Signature Law Survey.

• Life Sciences - FDA's 21 CFR Part 11
• Healthcare - Health Insurance Portability and Accountability Act  (HIPAA)
• Homeland Security - Public Law 108-390
• Homeland Security - ICE Final Rule for Employment Eligibility Verification Form (I-9)
• Engineering - PE Board Regulations
• Finance - Financial Services Modernization Act of 1999 (Gramm-Leach-Bliley)
• Environmental - Cross-Media Electronic Reporting Regulation (CROMERR)
• Public Companies - Sarbanes-Oxley Act of 2002
• Veterinary/Equine - USDA EIA (Coggins) Testing
• Aviation - FAA's CFR Title 14
• European Telecommunications Standards Institute (ETSI)
• ISO (9001:2000)
• Joint Commission on Accreditation of Healthcare Organizations (JCAHO)

• CoSign® is FIPS 140-2 Level 3 validated. 

Digital signature regulations vary from country to country. Taking the European Electronic Signature Directive (EC Directive 99/93 on Electronic Signatures) as an example, the requirements for a standard (advanced) Electronic Signature are:

• It is uniquely linked to the signatory. 
• The signature-creation-data used for signature generation cannot, with reasonable assurance, be derived, and the signature is protected against forgery using currently available technology.
• It is created using means that the signatory can maintain under his sole control.
• It is linked to the data to which it relates in such a manner that any subsequent change of the data is detectable.

The European Directive (EC Directive 99/93 on Electronic Signatures) defines SSCD as:

1. Secure signature-creation devices must, by appropriate technical and procedural means, ensure:
• The signature-creation-data used for signature generation can practically occur only once, and that their secrecy is reasonably assured.
• The signature-creation-data used for signature generation cannot, with reasonable assurance, be derived and the signature is protected against forgery using currently available technology. 
• The signature-creation data used for signature generation can be reliably protected by the legitimate signatory against the use of others.
2. Secure signature-creation devices must not alter data to be signed or prevent such data from being presented to the signatory prior to the signature process.
   

CoSign complies with the SSCD requirements defined by the EU electronic signature directive in the following ways:

• CoSign is available as FIPS 140-2 level 3 validated for those EU member states requiring such a certification for SSCD devices. 
• The CoSign SSCD model includes CWA approved smartcards for EU member states requiring this specific certification for SSCD devices.