Significance and Use
4.1 This guide serves three purposes:
4.1.1 To serve as a guide for developers of computer software providing, or interacting with, electronic signature processes,
4.1.2 To serve as a guide to healthcare providers who are implementing electronic signature mechanisms, and
4.1.3 To be a consensus standard on the design, implementation, and use of electronic signatures.
1.1 This guide covers:
1.1.1 Defining a document structure for use by electronic signature mechanisms (Section 4),
1.1.2 Describing the characteristics of an electronic signature process (Section 5),
1.1.3 Defining minimum requirements for different electronic signature mechanisms (Section 5),
1.1.4 Defining signature attributes for use with electronic signature mechanisms (Section 6),
1.1.5 Describing acceptable electronic signature mechanisms and technologies (Section 7),
1.1.6 Defining minimum requirements for user identification, access control, and other security requirements for electronic signatures (Section 9), and
1.1.7 Outlining technical details for all electronic signature mechanisms in sufficient detail to allow interoperability between systems supporting the same signature mechanism (Section 8 and Appendix X1-Appendix X4).
1.2 This guide is intended to be complementary to standards under development in other organizations. The determination of which documents require signatures is out of scope, since it is a matter addressed by law, regulation, accreditation standards, and an organization's policy.
1.3 Organizations shall develop policies and procedures that define the content of the medical record, what is a documented event, and what time constitutes event time. Organizations should review applicable statutes and regulations, accreditation standards, and professional practice guidelines in developing these policies and procedures.
2. Referenced Documents (purchase separately) The documents listed below are referenced within the subject standard but are not provided as part of the standard.
ISO 10036 1994: Contactless IC Cards
ISO 7816 1993: IC Cards with Contacts
ISO 8825-1 1993: Specification of Basic Encoding Rules for ASN.1
ISO 9594-8 1993: The Directory: Authentication Framework (also available as ITU-S X.509) Available from ISO, 1 Rue de Varembe, Case Postale 56, CH 1211, Geneve, Switzerland.
ANSI X9.30 Part 1: Digital Signature Algorithm, July 1994 (ballot copy) (technically aligned with NIST FIPS PUB 186)
ANSI X9.30 Part 3: Certificate Management for DSA, November 1994 (ballot copy) Available from American National Standards Institute (ANSI), 25 W. 43rd St., 4th Floor, New York, NY 10036, http://www.ansi.org.
ANSI X9.31 Part 1: RSA Signature Algorithm, July 1994 (ballot copy) (technically aligned with ISO/IEC 9796)
ANSI X9.31 Part 3: Certificate Management for RSA, July 1994 (draft)
ANSI X9F1, ANSI X9.45: Enhanced Management Controls Using Attribute Certificates, September 1994 (draft)
accountability; authentication; authorization; biometric authentication; certificate; cryptography; data integrity; digital signature; electronic signature; non-repudiation; responsibility; timestamp; trusted third party; user identification ;
ICS Number Code 11.020 (Medical sciences and health care facilities in general); 35.240.80 (IT applications in health care technology)
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Citing ASTM Standards
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