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Description / Abstract:
This guide covers:
Defining a document structure for use by electronic signature
mechanisms (Section 4),
Describing the characteristics of an electronic signature
process (Section 5),
Defining minimum requirements for different electronic signature
mechanisms (Section 5),
Defining signature attributes for use with electronic signature
mechanisms (Section 6),
Describing acceptable electronic signature mechanisms and
technologies (Section 7),
Defining minimum requirements for user identification, access
control, and other security requirements for electronic signatures
(Section 9), and
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).
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.
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.