Digital signatures are based on Public Key Infrastructure (PKI) and are a result of a cryptographic operation that guarantees signer authenticity, data integrity and non-repudiation of signed documents. The digital signature cannot be copied, tampered or altered. In addition, because they are based on standard PKI technology, signatures made within one application (e.g. Microsoft Word, Adobe PDF) can be validated by others using the same applications. On the other hand, an electronic signature is a proprietary format (there is no standard for electronic signatures) that is an electronic data, such as a digitized image of a handwritten signature, a symbol, voiceprint, etc., that identifies the author(s) of an electronic message. Electronic signatures are vulnerable to copying and tampering, making forgery easy. In many cases, they are not legally binding and will require proprietary software to validate the signature.
What legislation and regulations define the legality of digital signatures?
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. And, regulations such as FDA 21 CFR Part 11 for the Life Sciences industry have also recognized digital signatures as a replacement for handwritten signatures.
Legislation
For additional information on other countries, visit the Digital Signature Law Survey.
Industry Regulations and Standards
| » | Life Sciences - FDA's 21 CFR Part 11 |
| » | Healthcare - Health Insurance Portability and Accountability (HIPAA) |
| » | Homeland Security - Public Law 108-390 |
| » | Finance - Financial Services Modernization Act of 1999 (Gramm-Leach-Bliley) |
| » | Environmental - Cross-Media Electronic Reporting Regulation (CROMERR) |
| » | Public Companies - Sarbanes Oxley Act of 2002 |
| » | BioPharma - Signatures and Authentication for Everyone (SAFE) |
| » | Veterinary/Equine - USDA EIA (Coggins) Testing |
| » | Aviation - FAA's CFR Title 14 - This includes support for: air carriers, operators, persons performing airmen certification, individuals performing maintenance or preventive maintenance, repair stations, and aviation maintenance technical schools. |
| » | European Telecommunications Standards Institute (ETSI) |
| » | ISO (9001:2000) |

