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ASTM E2147-18

(Specification)

Standard Specification for Audit and Disclosure Logs for Use in Health Information Systems

Standard Specification for Audit and Disclosure Logs for Use in Health Information Systems

ABSTRACT
This specification describes the security requirements involved in the development and implementation of audit and disclosure logs used in health information systems. It specifies how to design an access audit log to record all access to patient identifiable information maintained in computer systems, and includes principles for developing policies, procedures, and functions of health information logs to document all disclosure of confidential health care information to external users for use in manual and computer systems. This specification provides for two main purposes, namely: to define the nature, role, and function of system access audit logs and their use in health information systems as a technical and procedural tool to help provide security oversight; and to identify principles for establishing a permanent record of disclosure of health information to external users and the data to be recorded in maintaining it.
SIGNIFICANCE AND USE
4.1 Data that document health services in health care organizations are business records and shall be archived to a secondary but retrievable medium, and readily accessible, such as data that would be archived in a server or cloud storage. Audit data shall be retained for as long as the medical record is maintained, and may not be destroyed before the medical record may legally be destroyed, and in any event, for at least 10 years or for two years after the legal age of majority, unless a longer period of record retention is prescribed by state, federal or other law or regulation.  
4.2 The purpose of audit data and disclosure logs is to document and maintain a permanent, trustworthy, and immutable record of all authorized and unauthorized activities of any nature whatsoever and disclosure of confidential health information {except exclusions per federal and state law [21 CFR 11 Subpart B(e)]}. This further facilitates the purpose that patients, healthcare providers, organizations, and others can obtain a verifiable, self-authenticating record documenting all activities with respect to that record. The process of information disclosure and auditing shall also conform, where relevant, with the Privacy Act of 1974 (3).  
4.3 Audit reports designed for system access provide a precise capability for healthcare providers, organizations, patients, patient representatives, and advocates to see who has accessed and/or manipulated patient information. Because of the significant risk of medical information manipulation in computing environments by authorized and unauthorized users, the audit report is an important management tool to monitor access and any such manipulation retrospectively. In addition, the access and disclosure logs become powerful support documents for disciplinary and legal actions. Moreover, audit reports are essential components to comprehensive security programs in healthcare and vital for the privacy rights of the individual. A patient has a right to ...
SCOPE
1.1 This specification is for the development and implementation of secure audit data and logs for electronically stored health information. It specifies how to design the audit log to record all activities impacting a medical record, for example, creating a new record, entering data into a record, changing or deleting an existing record, and all additional user access data (for example, identification, location, and date and time) to patient-identifiable information maintained in computer systems. Such audit logs shall track not only data entry and modifications, but also simple access and viewing of the patient record, and whether any modifications are made during that access. This specification also includes principles for developing policies, procedures, and functions of health information logs to document all actions regarding identifiable health information for use in both manually entered (paper record) and computer systems.  
1.2 The first purpose of this specification is to defin...

General Information

Status
Published
Publication Date
30-Apr-2018
ICS
35.240.80 - IT applications in health care technology
Technical Committee
E31 - Healthcare Informatics
Drafting Committee
E31.25 - Healthcare Data Management, Security, Confidentiality, and Privacy
Current Stage
Ref Project

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ASTM E2147-18 - Standard Specification for Audit and Disclosure Logs for Use in Health Information SystemsASTM E2147-18 - Standard Specification for Audit and Disclosure Logs for Use in Health Information Systems
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ASTM E2147-18 - Standard Specification for Audit and Disclosure Logs for Use in Health Information Systems
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This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the
Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
Designation: E2147 − 18
Standard Specification for
Audit and Disclosure Logs for Use in Health Information
1
Systems
This standard is issued under the fixed designation E2147; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
1. Scope entries and actions that create, change, or delete electronic
records or other patient information. Full transparency of
1.1 This specification is for the development and implemen-
modifications or deletions or both is mandatory. For example,
tation of secure audit data and logs for electronically stored
record changes shall not obscure previously recorded informa-
health information. It specifies how to design the audit log to
tion. Such audit data and documentation shall be retained for a
record all activities impacting a medical record, for example,
period at least as long as that required for the subject paper and
creating a new record, entering data into a record, changing or
electronic records (together, “records”), including any time
deleting an existing record, and all additional user access data
period required by evidence preservation or litigation hold
(for example, identification, location, and date and time) to
requirements and applicable state or applicable federal laws
patient-identifiable information maintained in computer sys-
pertaining to the subject records. In no event shall the audit
tems. Such audit logs shall track not only data entry and
data or medical records in hard copy or electronic format be
modifications, but also simple access and viewing of the
destroyed in advance of that date prescribed by state, federal or
patient record, and whether any modifications are made during
other law or regulation, when such records may be legally
that access. This specification also includes principles for
destroyed; and in any case, not before ten years or, in the case
developing policies, procedures, and functions of health infor-
of a minor child, before two years after that child’s eighteenth
mation logs to document all actions regarding identifiable
birthday. If such records are for any reason maintained beyond
health information for use in both manually entered (paper
this minimum requirement, then the audit logs, and the data
record) and computer systems.
contained therein, must be maintained as long as the records
1.2 The first purpose of this specification is to define the
are maintained. Audit logs and healthcare information shall be
nature, purpose, and function of system access audit logs and
provided when specifically requested by authorized healthcare
their use in health information systems as a technical and
providers; the patient, his personal representative, advocate,
procedural tool to help provide privacy and security oversight
and/or designee; researchers; quality control personnel; and
and produce a self-authenticating record that would, when
organizational managers or administrators or both; and other
maintained together with its audit logs, speak to and confirm its
persons authorized to have access to patient records or patient-
own integrity and accuracy of the medical and other data
identifiable information or both in any form.
within the record. Moreover, in concert with organizational
1.3 In the absence of computerized logs, audit log principles
confidentiality and security policies and procedures, permanent
can be implemented manually in the paper patient record
audit logs can clearly identify all system application users who
environment with respect to permanently monitoring paper
accessed and acted on patient identifiable information or both,
patient record access, data entry, and data modification. Where
and identify the location of the user, identify patient informa-
the paper patient record and the computer-based patient record
tion accessed, and maintain a permanent record of actions
coexist in parallel, security oversight and access and data
taken by the user. Accomplishing the purpose of creating a
management shall address both environments with the under-
trustworthy record thus requires the use of secure, automatic,
lying and unifying principle being transparency regarding the
computer-generated, time-stamped audit logs, which shall be
identity of the individual accessing or acting upon data in the
used to independently record the identity of the user as well as
record or both; the location of the individual when doing so;
the date, time, and location of user access, and also record
...

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1.2.1 Use of a risk-based approach (understanding the objective requirements and assessing the fit-for-use status);  
1.2.2 Considerations on the data collection and diagnostics used for MVDA (including data preprocessing and outliers);  
1.2.3 Considerations on the different types of data analysis, model testing, and validation;  
1.2.4 Qualified and competent personnel; and  
1.2.5 Life-cycle management of MVDA model.  
1.3 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.  
1.4 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

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ASTM
ASTM E1935-97(2019)(Test Method)
Standard Test Method for Calibrating and Measuring CT Density

SIGNIFICANCE AND USE
5.1 This test method allows specification of the density calibration procedures to be used to calibrate and perform material density measurements using CT image data. Such measurements can be used to evaluate parts, characterize a particular system, or compare different systems, provided that observed variations are dominated by true changes in object density rather than by image artifacts. The specified procedure may also be used to determine the effective X-ray energy of a CT system.  
5.2 The recommended test method is more accurate and less susceptible to errors than alternative CT-based approaches, because it takes into account the effective energy of the CT system and the energy-dependent effects of the X-ray attenuation process.
FIG. 1 Density Calibration Phantom  
5.3 This (or any) test method for measuring density is valid only to the extent that observed CT-number variations are reflective of true changes in object density rather than image artifacts. Artifacts are always present at some level and can masquerade as density variations. Beam hardening artifacts are particularly detrimental. It is the responsibility of the user to determine or establish, or both, the validity of the density measurements; that is, they are performed in regions of the image which are not overly influenced by artifacts.  
5.4 Linear attenuation and mass attenuation may be measured in various ways. For a discussion of attenuation and attenuation measurement, see Guide E1441 and Practice E1570.
SCOPE
1.1 This test method covers instruction for determining the density calibration of X- and γ-ray computed tomography (CT) systems and for using this information to measure material densities from CT images. The calibration is based on an examination of the CT image of a disk of material with embedded specimens of known composition and density. The measured mean CT values of the known standards are determined from an analysis of the image, and their linear attenuation coefficients are determined by multiplying their measured physical density by their published mass attenuation coefficient. The density calibration is performed by applying a linear regression to the data. Once calibrated, the linear attenuation coefficient of an unknown feature in an image can be measured from a determination of its mean CT value. Its density can then be extracted from a knowledge of its mass attenuation coefficient, or one representative of the feature.  
1.2 CT provides an excellent method of nondestructively measuring density variations, which would be very difficult to quantify otherwise. Density is inherently a volumetric property of matter. As the measurement volume shrinks, local material inhomogeneities become more important; and measured values will begin to vary about the bulk density value of the material.  
1.3 All values are stated in SI units.  
1.4 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.  
1.5 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

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ASTM
ASTM E2920-19(Guide)
Standard Guide for Recording Occupational Injuries and Illnesses

SIGNIFICANCE AND USE
4.1 This guide is intended to define work-related injuries and illnesses in a way that can be easily understood and measured across countries. These injuries and illnesses can be used to evaluate, compare, and continually improve management systems and programs related to worker safety and health. Although several levels of severity may be defined, the primary objective is to identify cases with meaningful connection to work and cases with such potential consequence that they have value for prevention purposes. The resultant data and incidence rates should improve global benchmarking consistency.  
4.2 This guide defines recording criteria for Level One cases—cases that have a clear connection to the workplace and consequences that are significant for driving injury and illness prevention and efforts.  
4.3 While not mandated by this guide, recording of Level Two cases is encouraged and will still be mandatory in many jurisdictions. Level Two cases are those cases currently required to be reported by countries, states, and other jurisdictions.
SCOPE
1.1 This guide is intended to establish definitions and criteria for recording occupational injuries and illnesses to be used for measuring safety performance, evaluating safety program performance, and improving consistency when comparing international performance. A measurement system is desired that is precise and accurate, difficult to manipulate, significant and meaningful for safety program evaluation, and appropriate for accountability purposes in a global environment.  
1.2 Objectives of the occupational injury and illness measurement guide are as follows:  
1.2.1 Provide a uniform and objective framework for recording work-related injuries and illnesses,  
1.2.2 Facilitate use of injury and illness rates as a means of evaluating programs designed to control such injuries and illnesses, and  
1.2.3 Establish a basis for meaningful comparison of injury and illness rates across industries and countries.  
1.3 In this guide, definitions and procedures necessary to maintain work-related injury and illness records and incidence rates are covered.  
1.4 Key elements of this guide include work relationship, definition of injuries and illnesses, levels of severity of occupational incidents, accountability for contractor relationships, and specifications for injury and illness rate calculations.  
1.5 Units—The values stated in English (or Imperial) units are to be regarded as the standard. The values given in parentheses are mathematical conversions to SI units that are provided for information only.  
1.6 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use. This standard is not a substitute for any legally required injury and illness recordkeeping obligations.  
1.7 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

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