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ASTM E2147-01(2013)

(Specification)

Standard Specification for Audit and Disclosure Logs for Use in Health Information Systems (Withdrawn 2017)

Standard Specification for Audit and Disclosure Logs for Use in Health Information Systems (Withdrawn 2017)

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 must be archived to a secondary but retrievable medium. Audit logs should be retained, at a minimum, according to the statute governing medical records in the geographic area.  
4.2 The purpose of audit access and disclosure logs is to document and maintain a permanent record of all authorized and unauthorized access to and disclosure of confidential health care information in order that health care providers, organizations, and patients and others can retrieve evidence of that access to meet multiple needs. Examples are clinical, organizational, risk management, and patient rights' needs.  
4.3 Audit logs designed for system access provide a precise capability for organizations to see who has accessed patient information. Due to the significant risk in computing environments by authorized and unauthorized users, the audit log is an important management tool to monitor, access retrospectively. In addition, the access and disclosure log becomes a powerful support document for disciplinary action. Audit logs are essential components to comprehensive security programs in health care.  
4.4 Organizations are accountable for managing the disclosure of health information in a way that meets legal, regulatory, accreditation and licensing requirements and growing patient expectations for accountable privacy practices. Basic audit trail procedures should be applied, manually if necessary, in paper patient record systems to the extent feasible. Security in health information systems is an essential component to making progress in building and linking patient information. Successful implementation of large scale systems, the use of networks to transmit data, growing technical capability to address security issues and concerns about the confidentiality, and security provisions of patient information drive the focus on this topic. (See Guide E1384.)  
4.5 Consumer fears about confide...
SCOPE
1.1 This specification is for the development and implementation of security audit/disclosure logs for health information. 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 health information to external users for use in manual and computer systems. The process of information disclosure and auditing should conform, where relevant, with the Privacy Act of 1974 (1).2  
1.2 The first purpose of this specification is 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. In concert with organizational confidentiality and security policies and procedures, permanent audit logs can clearly identify all system application users who access patient identifiab...

General Information

Status
Historical
Publication Date
28-Feb-2013
Withdrawal Date
20-Apr-2017
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

Relations

Replaces
ASTM E2147-01(2009) - Standard Specification for Audit and Disclosure Logs for Use in Health Information Systems
Effective Date
01-Mar-2013

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ASTM E2147-01(2013) - Standard Specification for Audit and Disclosure Logs for Use in Health Information Systems (Withdrawn 2017)ASTM E2147-01(2013) - Standard Specification for Audit and Disclosure Logs for Use in Health Information Systems (Withdrawn 2017)
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ASTM E2147-01(2013) - Standard Specification for Audit and Disclosure Logs for Use in Health Information Systems (Withdrawn 2017)
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NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.
Contact ASTM International (www.astm.org) for the latest information
Designation:E2147 −01 (Reapproved 2013) An American National Standard
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 computer-based patient record coexist in parallel, security
oversight and access management should address both envi-
1.1 This specification is for the development and implemen-
ronments.
tation of security audit/disclosure logs for health information.
It specifies how to design an access audit log to record all
1.4 The second purpose of this specification is to identify
access to patient identifiable information maintained in com-
principles for establishing a permanent record of disclosure of
puter systems and includes principles for developing policies,
health information to external users and the data to be recorded
procedures, and functions of health information logs to docu-
in maintaining it. Security management of health information
ment all disclosure of health information to external users for
requires a comprehensive framework that incorporates man-
use in manual and computer systems. The process of informa-
dates and criteria for disclosing patient health information
tion disclosure and auditing should conform, where relevant,
found in federal and state laws, rules and regulations and
2
with the Privacy Act of 1974 (1).
ethical statements of professional conduct. Accountability for
such a framework should be established through a set of
1.2 The first purpose of this specification is to define the
standardprinciplesthatareapplicabletoallhealthcaresettings
nature, role, and function of system access audit logs and their
and health information systems.
use in health information systems as a technical and procedural
tool to help provide security oversight. In concert with orga-
1.5 Logs used to audit and oversee health information
nizational confidentiality and security policies and procedures,
access and disclosure are the responsibility of each health care
permanentauditlogscanclearlyidentifyallsystemapplication
organization, data intermediary, data warehouse, clinical data
users who access patient identifiable information, record the
repository, third party payer, agency, organization or corpora-
nature of the patient information accessed, and maintain a
tion that maintains or provides, or has access to individually-
permanent record of actions taken by the user. By providing a
identifiable data. Such logs are specified in and support policy
precise method for an organization to monitor and review who
on information access monitoring and are tied to disciplinary
hasaccessedpatientdata,auditlogshavethepotentialformore
sanctions that satisfy legal, regulatory, accreditation and insti-
effective security oversight than traditional paper record envi-
tutional mandates.
ronments. This specification will identify functionality needed
for audit log management, the data to be recorded, and the use
1.6 Organizations need to prescribe access requirements for
of audit logs as security and management tools by organiza-
aggregate data and to approve query tools that allow auditing
tional managers.
capability, or design data repositories that limit inclusion of
datathatprovidepotentialkeystoidentifiabledata.Inferencing
1.3 Intheabsenceofcomputerizedlogs,auditlogprinciples
patient identifiable data through analysis of aggregate data that
can be implemented manually in the paper patient record
contains limited identifying data elements such as birth date,
environment with respect to permanently monitoring paper
birth location, and family name, is possible using software that
patient record access. Where the paper patient record and the
matches data elements across data bases. This allows a
consistent approach to linking records into longitudinal cases
1
This specification is under the jurisdiction of ASTM Committee E31 on
for research purposes. Audit trails can be designed to work
Healthcare Informatics and is the direct responsibility of Subcommittee E31.25 on
with applications which use these techniques if the query
Healthcare Data Management, Security, Confidentiality, and Privacy.
Current edition approved March 1, 2013. Published March 2013. Originally
functions are part of a defined retrieval application but often
approved in 2001. Last previous edition approved in 2009 as E2147 – 01(2009).
standard query tools are not easily audited. This specification
DOI: 10.1520/E2147-01R13.
2
applies to the disclosure or transfer of health information
The
...

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ASTM E2147-18(Specification)
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.  
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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 ...
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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...

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4.1 Purpose—Practices to be employed for the radiographic examination of materials and components with neutrons using digital neutron detectors are outlined herein. They are intended as a guide for the assessment of a digital neutron radiograph’s characteristics. For information on neutron beam lines for imaging and film neutron radiography, refer to Guide E748.  
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Standard Practice for Digital Imaging and Communication in Nondestructive Evaluation (DICONDE) for Digital X-ray (DX) Test Methods

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5.1 Personnel that are responsible for the creation, transfer, and storage of digital X-ray test results will use this standard. This practice defines a set of information modules that, along with Practice E2339 and the DICOM standard, provides a standard means to organize digital X-ray test parameters and results. The digital X-ray test results may be displayed and analyzed on any device that conforms to this standard. Personnel wishing to view any digital X-ray inspection data stored according to Practice E2339 may use this document to help them decode and display the data contained in the DICONDE-compliant inspection record.
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1.1 This guide provides a listing and description of the fields that are recommended for inclusion in a digital radiological examination data base to facilitate the transfer of such data. This guide sets guidelines for the format of data fields for computerized transfer of digital image files obtained from radiographic, radioscopic, computed radiographic, or other radiological examination systems. The field listing includes those fields regarded as necessary for inclusion in the data base: (1) regardless of the radiological examination method (as indicated by Footnote C in Table 1), (2) for radioscopic examination (as indicated by Footnote F in Table 1), and (3) for radiographic examination (as indicated by Footnote D in Table 1). In addition, other optional fields are listed as a reminder of the types of information that may be useful for additional understanding of the data or applicable to a limited number of applications.  
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SCOPE
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5.1 The purpose of this practice is to provide data that can be used for evaluation of the accuracy of different CAS systems.  
5.2 The use of surgical navigation and robotic positioning systems is becoming increasingly common. In order to make informed decisions about the suitability of such systems for a given procedure, their accuracy capability needs to be evaluated under clinical application and compared to the requirements. As the performance of a whole system is constrained by those of its subparts, a preliminary step must be to objectively characterize the accuracy of the tracking subsystem in a controlled environment under controlled conditions.  
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Standard Practice for Digital Imaging and Communication in Nondestructive Evaluation (DICONDE) for X-ray Computed Tomography (CT) Test Methods

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5.1 Personnel that are responsible for the creation, transfer, and storage of X-ray tomographic NDE data will use this standard. This practice defines a set of information modules that along with Practice E2339 and the DICOM standard provide a standard means to organize X-ray tomography test parameters and results. The X-ray CT test results may be displayed and analyzed on any device that conforms to this standard. Personnel wishing to view any tomographic inspection data stored according to Practice E2339 may use this document to help them decode and display the data contained in the DICONDE-compliant inspection record.
SCOPE
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1.2 This practice has been developed to overcome the issues that arise when analyzing or archiving data from tomographic test equipment using proprietary data transfer and storage methods. As digital technologies evolve, data must remain decipherable through the use of open, industry-wide methods for data transfer and archival storage. This practice defines a method where all the X-ray CT technique parameters and test results are communicated and stored in a standard manner regardless of changes in digital technology.  
1.3 This practice does not specify:  
1.3.1 A testing or validation procedure to assess an implementation's conformance to the standard.  
1.3.2 The implementation details of any features of the standard on a device claiming conformance.  
1.3.3 The overall set of features and functions to be expected from a system implemented by integrating a group of devices each claiming DICONDE conformance.  
1.4 Units—Although this practice contains no values that require units, it does describe methods to store and communicate data that do require units to be properly interpreted. The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.  
1.5 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.  
1.6 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 E2891-20(Guide)
Standard Guide for Multivariate Data Analysis in Pharmaceutical Development and Manufacturing Applications

SIGNIFICANCE AND USE
4.1 A significant amount of data is generated during pharmaceutical development and manufacturing activities. The interpretation of such data is becoming increasingly difficult. Individual examination of the univariate process variables is relevant but can be significantly complemented by multivariate data analysis (MVDA). MVDA may be particularly appropriate for exploring and handling large sets of heterogenous data, mapping data of high dimensionality onto lower dimensional representations, exposing significant correlations among multivariate variables within a single data set or significant correlations among multivariate variables across data sets. MVDA may extract statistically significant information which may enhance process understanding, decision making in process development, process monitoring and control (including product release), product life-cycle management, and continuous improvement.  
4.2 MVDA is widely used in various industries including the pharmaceutical industry. To achieve a valid outcome, an MVDA model/application should incorporate the following:  
4.2.1 A predefined risk-based objective incorporating one or more relevant scientific hypotheses specific to the application;  
4.2.2 Sufficient relevant data of requisite quality covering the variance space encountered during intended use, that is, pharmaceutical development, or pharmaceutical manufacturing, or both;  
4.2.3 Appropriate data analysis and model utilization practices including considerations on testing, validation, and qualification of all new data prior to using a model to analyze it;  
4.2.4 Appropriately trained staff;  
4.2.5 Appropriate standard operating procedures; and  
4.2.6 Life-cycle management.  
4.3 This guide can be used to support data analysis activities associated with pharmaceutical development and manufacturing, process performance and product quality monitoring in manufacturing, as well as for troubleshooting and investigation events. Technical detai...
SCOPE
1.1 This guide covers the applications of multivariate data analysis (MVDA) to support pharmaceutical development and manufacturing activities. MVDA is one of the key enablers for process understanding and decision making in pharmaceutical development, and for the release of intermediate and final products after being validated appropriately using a science and risk-based approach.  
1.2 The scope of this guide is to provide general guidelines on the application of MVDA in the pharmaceutical industry. While MVDA refers to typical empirical data analysis, the scope is limited to providing a high level guidance and not intended to provide application-specific data analysis procedures. This guide provides considerations on the following aspects:  
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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