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Description of ASTM-E1762 2013ASTM E1762 - 95(2013)Standard Guide for Electronic Authentication of Health Care InformationActive Standard ASTM E1762 | Developed by Subcommittee: E31.25 Book of Standards Volume: 14.01 ASTM E1762Significance 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. 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.
ISO Standards 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 Standards 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)Keywords accountability; authentication; authorization; biometric authentication; certificate; cryptography; data integrity; digital signature; electronic signature; non-repudiation; responsibility; timestamp; trusted third party; user identification ; ICS Code ICS Number Code 11.020 (Medical sciences and health care facilities in general); 35.240.80 (IT applications in health care technology) DOI: 10.1520/E1762-95R13 ASTM International is a member of CrossRef. ASTM E1762This book also exists in the following packages...Subscription InformationMADCAD.com ASTM Standards subscriptions are annual and access is unlimited concurrency based (number of people that can access the subscription at any given time) from single office location. For pricing on multiple office location ASTM Standards Subscriptions, please contact us at info@madcad.com or +1 800.798.9296.
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About ASTMASTM International, formerly known as the American Society for Testing and Materials (ASTM), is a globally recognized leader in the development and delivery of international voluntary consensus standards. Today, some 12,000 ASTM standards are used around the world to improve product quality, enhance safety, facilitate market access and trade, and build consumer confidence. ASTM’s leadership in international standards development is driven by the contributions of its members: more than 30,000 of the world’s top technical experts and business professionals representing 150 countries. Working in an open and transparent process and using ASTM’s advanced electronic infrastructure, ASTM members deliver the test methods, specifications, guides, and practices that support industries and governments worldwide. |
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