1.1This guide covers:

1.1.1Defining a document structure for use by electronic signature mechanisms (Section 4),

1.1.2Describing the characteristics of an electronic signature process (Section 5),

1.1.3Defining minimum requirements for different electronic signature mechanisms (Section 5),

1.1.4Defining signature attributes for use with electronic signature mechanisms (Section 6),

1.1.5Describing acceptable electronic signature mechanisms and technologies (Section 7),

1.1.6Defining minimum requirements for user identification, access control, and other security requirements for electronic signatures (Section 9), and

1.1.7Outlining 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).

1.2This 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.

1.3Organizations 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.