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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 Appendixes X1 through 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.

Keywords

Accountability; Authentication; Biometric authentication; CPR (computer-based patient record); Cryptography; Data integrity; Digital signature; Electronic signature; Non-repudiation; Patient biographical/medical data; Responsibility; Signature (electronic); Timestamp; electronic authentication-health care information, guide,; Trusted third party; User identification; electronic authentication-health care information,guide,;Order Form

To find similar documents by ASTM Volume:

14.01 (Healthcare Informatics)

To find similar documents by classification:

11.020 (Medical sciences and health care facilities in general Including quality and environmental management in health care technology IT application in health care technology, see 35.240.80)

35.240.80 (IT applications in health care technology Including computer tomography)

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