By David Nettleton, Janet Gough
Overlaying the lately handed forty five CFR, and the parallel CFR 21 half eleven and HIPAA rules one hundred sixty, 162, and 164, this ebook offers assistance for getting, fitting, validating, and handling advertisement off-the-shelf software program facts for assortment and retention. Addressing the interface among those rules and the way to be in compliance with them, the authors hide audit trails, validation, documentation, education, and the way to set up and continue defense and responsibility. They speak about what the laws suggest by way of commonplace, clarify the audit functionality for amenities which are topic to the more moderen HIPAA rules, and current the criteria for documentation.
Read or Download Electronic Record Keeping: Achieving and Maintaining Compliance with 21 CFR Part 11 and 45 CFR Parts 160, 162, and 164 PDF
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Extra resources for Electronic Record Keeping: Achieving and Maintaining Compliance with 21 CFR Part 11 and 45 CFR Parts 160, 162, and 164
Implement procedures for removal of electronic protected health information from electronic media before the media are made available for re-use. (iii) Accountability (Addressable). Maintain a record of the movements of hardware and electronic media and any person responsible therefore. (iv) Data backup and storage (Addressable). Create a retrievable, exact copy of electronic protected health information, when needed, before movement of equipment. SEC. 312 TECHNICAL SAFEGUARDS A covered entity must, in accordance with Sec.
Identify the security official responsible for the development and implementation of the policies and procedures required by this subpart for the entity. (3)(i) Standard: Workforce security. Implement policies and procedures to ensure that all members of its workforce have appropriate access to electronic protected health information, as provided under paragraph (a)(4) of this section and to prevent those workforce members who do not have access under paragraph (a)(4) of this section from obtaining access to electronic protected health information.
C) Standards. A covered entity must comply with the standards as provided in this section and in Sec. 308, Sec. 310, Sec. 312, Sec. 314 and Sec. 316 with respect to all electronic protected health information. (d) Implementation specifications. In this subpart: (1) Implementation specifications are required or addressable. fm Page 34 Wednesday, November 19, 2003 9:41 AM 34 Achieving and Maintaining Compliance cation. If an implementation specification is addressable, the word “Addressable’’ appears in parentheses after the title of the implementation specification.