ASTM E1762

This guide serves three purposes:

To serve as a guide for developers of computer software providing, or interacting with, electronic signature processes,

To serve as a guide to healthcare providers who are implementing electronic signature mechanisms, and

To be a consensus standard on the design, implementation, and use of electronic signatures.

1. Scope

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

ISO Standards
ISO10036 1994: Contactless IC Cards
ANSI Standards
ANSIX9F1, ANSI X9.45: Enhanced Management Controls Using Attribute Certificates, September 1994 (draft)
Other Standards
PKCS#7: Cryptographic Message Syntax Standard, 1994

Index Terms

accountability; authentication; authorization; biometric authentication; certificate; cryptography; data integrity; digital signature; electronic signature; non-repudiation; responsibility; timestamp; trusted third party; user identification; Accountability; Authentication; Computer-based patient record (CPR); Cryptography; Data integrity; Digital signature; Electronic authentication; Health knowledge/information systems; Nonrepudiation; Patient biographical/medical data; Responsibility; Signature (electronic); 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)

Citing ASTM Standards

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