CoSign Digital Signatures for Healthcare Organizations

Enacted in 1996 by the US Congress for the healthcare industry, HIPAA (the Health Insurance Portability and Accountability Act) details the requirements for correctly managing communications containing protected health information that is transmitted electronically over open networks. HIPAA calls for ensuring document confidentiality, integrity, and compliance with HIPAA throughout the organization. 

HIPAA strongly recommends organizations authenticate and manage digital identities to protect the confidentiality and integrity of personal health information both on and offline. Electronic signatures based on a mature and proven Public Key Infrastructure (PKI) technology are the best means to protect the integrity of information. In fact, HIPAA requires the protection of integrity "to corroborate that electronically protected health information has not been altered or destroyed in an unauthorized manner".

The CoSign digital signature solution enables compliance with two of the main provisions in HIPAA (the Privacy and Security Regulations). These two provisions address the release of individually identifiable Personal Health Information (PHI) and how the electronic information used by the healthcare industry should be stored, transferred, and used. Read more on how the CoSign digital signature solution allows organizations to comply with HIPAA.

In addition to HIPAA, CoSign enables compliance with the privacy and security requirements of the Joint Commission on Accreditation of Healthcare Organizations (JCAHO).

• U.S. - Electronic Signature in Global and National Commerce Act (ESIGN)
• U.S. - Uniform Electronic Transactions Act (UETA) - adopted by 48 states
• 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
• 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
• 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.