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ASTM E2211-02

(Specification)

Standard Specification for Relationship Between a Person (Consumer) and a Supplier of an Electronic Personal (Consumer) Health Record

Standard Specification for Relationship Between a Person (Consumer) and a Supplier of an Electronic Personal (Consumer) Health Record

ABSTRACT
This specification covers the relationship between a person (consumer), organization, or custodian (or other authorized representative) and a managing (storing) organization (such as a web site or other organization). This will provide guidance to consumers, suppliers of personal (consumer) health records (PCHR) applications, and the public at large regarding the PCHR. Because the PCHR is distinct from the provider-based patient health record (PHR), the laws and conventions for provider-based patient health records may not apply to the PCHR. The PCHR supplier shall allow a consumer or other authorized individual easy access at any point in the PCHR application to the policies and standards to which the PCHR supplier site adheres, as well as their associated charges, if any. In a PCHR application, a consumer has the right to know about the following: the PCHR supplier's business model or a general outline of how its revenues are generated; how PCHR information is handled; how to get a copy of the PCHR; the extent of data mining, whether it is in aggregate or de-identified form, as well as options for opting-out of such data mining activities; PCHR supplier's privacy policy; options for transferring the PCHR to another supplier or elsewhere; provisions for identifying the audit trail for access to the consumer record when suppliers change and when changes occur in the business enterprise under which the supplier and record keeper operates; in case the business enterprise changes, the reissuance of privacy statements and positive reconfirmation of postal and mail address by the consumer following any corporate changes is recommended; and how to request deletion or destruction, or both, of a personal file at a PCHR supplier's system.
SCOPE
1.1 This specification covers the relationship between a person (consumer), organization, or custodian (or other authorized representative) and a managing (storing) organization (such as a web site or other organization). However, web-based personal (consumer) health records that are created by healthcare providers or health plans are not within the scope of this specification. Further, this specification will not address personal (consumer) health records (PCHR) that are created and managed by patients on paper records, on personal computers, or on other media offline.

General Information

Status
Historical
Publication Date
09-May-2002
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

Replaced By
ASTM E2211-02(2010) - Standard Specification for Relationship Between a Person (Consumer) and a Supplier of an Electronic Personal (Consumer) Health Record (Withdrawn 2014)
Effective Date
01-Mar-2010

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ASTM E2211-02 - Standard Specification for Relationship Between a Person (Consumer) and a Supplier of an Electronic Personal (Consumer) Health RecordASTM E2211-02 - Standard Specification for Relationship Between a Person (Consumer) and a Supplier of an Electronic Personal (Consumer) Health Record
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ASTM E2211-02 - Standard Specification for Relationship Between a Person (Consumer) and a Supplier of an Electronic Personal (Consumer) Health Record
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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
An American National Standard
Designation: E2211 – 02
Standard Specification for
Relationship Between a Person (Consumer) and a Supplier
of an Electronic Personal (Consumer) Health Record
This standard is issued under the fixed designation E2211; 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 3.1.2 disclosure statement—a prominent notice that de-
scribes an organization’s policies in order to enable a person to
1.1 This specification covers the relationship between a
decide whether (s)he can trust this organization with health
person (consumer), organization, or custodian (or other autho-
information.
rized representative) and a managing (storing) organization
3.1.3 Gramm-Leach-Bliley Act—federal legislation enacted
(such as a web site or other organization). However, web-based
in 1999 as part of the Financial Services Modernization Act
personal (consumer) health records that are created by health-
that specifies for web activities that “opt-out” is the norm.
care providers or health plans are not within the scope of this
3.1.4 individually identifiable health information—
specification. Further, this specification will not address per-
information that is a subset of health information, including
sonal (consumer) health records (PCHR) that are created and
demographic information collected from an individual, and
managed by patients on paper records, on personal computers,
that: (1) is created or received by a healthcare provider, health
or on other media offline.
plan, employer, or healthcare clearinghouse; and (2) relates to
2. Referenced Documents
the past, present, or future physical or mental health or
condition of an individual; the provision of healthcare to an
2.1 Other References:
individual; or the past, present, or future payment for the
Internet Healthcare Coalition
provision of healthcare to an individual; and (1) that identifies
Health on the Net (HON)
theindividual;or (2)withrespecttowhichthereisareasonable
Federal Trade Commission FTC
basis to believe the information can be used to identify the
Hi Ethics Alliance
individual. HIPAA
MedCertain
3.1.5 patient health record (PHR)—theprimarylegalrecord
American Medical Association Guidelines for Medical and
created and maintained by the healthcare provider document-
Health Information Sites on the Internet
ing the healthcare services provided to a person, in any aspect
AHIMA E-health Tenets
of healthcare delivery. This term is synonymous with medical
URAC (also known as the American Accreditation
record, health record, patient care record (primary patient care
HealthCare/Commission)
record), client record, and resident record. The term includes
3. Terminology
routine clinical or office records, records of care in any
health-related setting, preventive care, wellness, lifestyle
3.1 Definitions:
evaluation, research protocols, special study records, and
3.1.1 consumer—thepersonwhoprovidesinformationtobe
various clinical databases. The records may be in paper-based
stored by the personal (consumer) health record (PCHR)
or electronic form.
supplier.
3.1.6 personal (consumer) health record (PCHR)—an elec-
tronic application through which individuals can maintain and
This specification is under the jurisdiction of ASTM Committee E31 on
manage their health information, and that of others for whom
Healthcare Informatics and is the direct responsibility of Subcommittee E31.25 on
they are authorized, in a private, secure, and confidential
Healthcare Data Management, Security, Confidentiality, and Privacy.
environment that allows the individual or other authorized
Current edition approved May 10, 2002. PublishedAugust 2002. DOI: 10.1520/
E2211-02.
persons to access and share such information.
http://www.ihealthcoalition.org/
http://www.hon.ch/HONcode/Conduct.html
http://www.ftc.gov/reports/privacy3/fairinfo.htm
http://www.ihealthcoalition.org/ethics/ethics.html
http://www.medcertain.org/
7 10
http://www.ama-assn.org/ama/pub/category/1905.html For a summary of the act, see www.senate.gov/~banking/conf/grmleach.htm.
8 11
www.ahima.org Information on legislation and standards can be found at http://aspe.hhs.gov/
www.urac.org admnsimp .
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
E2211 – 02
3.1.7 personal (consumer) health record (PCHR) 6.3 Such a disclosure shall be clearly stated, shall be posted
supplier—the company or organization that maintains or man- in a prominent location, and shall be readily accessible from
ages, or both, the personal (consumer) health record (PCHR) boththesite’shomepageandanyWebpagewhereinformation
online service. is collected from the consumer. It gives consumers meaningful
3.1.8 personal identifiable information (PII)—individually
and effective notice of what will happen to the personal
identifiable information about an individual collected online, information they divulge.
including:(1) a first and last name; (2) a home or other physical
6.4 The PHR supplier shall state its policies regarding its
address, including street name and name of a city or town; (3)
sharing and use of information from an individual’s PHR (for
an e-mail address or other online contact information, includ-
example, are there any conditions under which individually
ing but not limited to an instant-messaging user identifier, or a
identifiable information is made available to or used by third
screen name that reveals an individual’s e-mail address; (4) a
parties?). PCHR suppliers shall also state their policies regard-
telephone number; (5) a Social Security number; (6) a persis-
ing access to the consumer’s PHCR by others than the
tent identifier, such as a customer number held in a cookie or
consumer, for example, how a child’s record is handled when
a processor serial number, where such identifier is associated
the child reaches the age of majority, and how an individual
with individually identifiable information; or a combination of
gains authorization to serve as custodian to a parent’s record
a last name or photograph of the individual with other
when that parent is no longer competent to do so himself or
information such that the combination permits physical or
herself.
online contacting; or (7) information concerning the child or
6.5 Choice/Consent:
the parents of that child that the operator collects online from
6.5.1 The PCHR contains both personal identifier informa-
the child and combines with an identifier described in this
11 tion (PII) and individually identifiable health information
definition. COPPA
(IIHI). The standard for PII is generally used as opt-out,
NOTE 1—This standard is based on the current Gramm-Leach-Bliley
meaning that a consumer must specifically request that such
Act which specifies “opt-out” as the standard for e-commerce (and
information is not shared.
e-health) in the United States. The alternative of “opt-in” was considered
6.5.2 For IIHI, PCHR suppliers shall allow consumers to
for this standard but has not been adopted because it would not conform
to current e-health legal considerations, practices, and accepted industry choose if and how any personally identifiable information
thinking.
collected from them may be used. These choices shall be
presented in a manner requiring that the consumer give specific
4. Significance and Use
permission for use of such data. Options for secondary uses of
4.1 The purpose of this standard is to provide guidance to
information shall be provided, that is, uses beyond the PCHR
consumers, suppliers of PCHR applications, and the public at
storageandmanagementapplication.Suchsecondaryusesmay
large regarding the PCHR. Because the PCHR is distinct from
be internal, such as placing the consumer on a sponsor’s or
the provider-based PHR, the laws and conventions for
other organization’s mailing list in order to market additional
provider-based patient health records may not apply to the
products or promotions, or external, such as the transfer of
PCHR.
information to third parties.
6.6 Access/Corrections:
5. Terms and Conditions
6.6.1 APCHR supplier shall provide the consumer with the
5.1 The PCHR supplier shall allow a consumer or other
ability to access data within the PCHR in order to verify its
authorized individual easy access at any point in the PCHR
correctness or to contest its accuracy and completeness, or
application to the policies and standards to which the PCHR
both.Access policies shall describe the turnaround time related
supplier site adheres, as well as their associated charges, if any.
to such requests (time from request to access), shall specify
associatedcharges,andshallincludeinstructionsforcontesting
6. Privacy, Security, and Confidentiality Notice/
and correcting inaccurate or incomplete data.
Awareness / Disclosure of Policies
6.6.2 The PCHR supplier shall disclose its policies regard-
6.1 The PCHR supplier shall disclose its policies for estab-
ingwhenandhowthePHRdatamaybeaccessed.Inparticular,
lishing authorization to create, ma
...

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SCOPE
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3.2 Although the recommended field listing includes more than 100 field numbers, only about half of those are regarded as essential and are marked Footnote C in Table 1. Fields so marked must be included in the data base. The other fields recommended provide additional information that a user will find helpful in understanding the radiological image and examination result. These header field items will, in most cases, make up only a very small part of a radiological examination file. The actual stream of radiological data that make up the image will take up the largest part of the data base. Since a radiological image file will normally be large, the concept of data compression will be considered in many cases. Compressed data should be noted, along with a description of the compression method, as indicated in Field No. 92 (see Table 1). (A) Field numbers are for reference only. They do not imply a necessity to include all these fields in any specific data base nor imply a requirement that fields used be in this particular order.(B) Units listed first are SI; those in parentheses are inch-pound (English).(C) Denotes essential field for computerization of examination results, regardless of examination method.(D) Denotes essential field for radiogra...
SCOPE
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.  
1.2 It is recognized that organizations may have in place an internal format for the storage and retrieval of radiological examination data. This guide should not impede the use of such formats since it is probable that the necessary fields are already included in such internal data bases, or that the few additions can easily be made. The numerical listing and its order indicated in this guide is only for convenience; the specific numbers and their order carry no inherent significance and are not part of the data file.  
1.3 Current users of Guide E1475 do not have to change their software. First time users should use the XML structure of Table A1.1 for their data.  
1.4 The types of radiological examination systems that appear useful in relation to this guide include radioscopic systems as described in Guide E1000, Practices E1255, E1411, E2597, E2698 and E2737, and radiographic systems as described in Guide E94 and Practices E748, E1742, E2033, E2445, and E2446. Many of the terms used are def...

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ASTM F3107-14(2023)(Test Method)
Standard Test Method for Measuring Accuracy After Mechanical Disturbances on Reference Frames of Computer Assisted Surgery Systems

SIGNIFICANCE AND USE
5.1 The purpose of this practice is to provide data that can be used for comparison and evaluation of the accuracy of different CAS systems.  
5.2 The use of CAS systems and robotic tracking systems is becoming increasingly common and requires a degree of trust by the user that the data provided by the system meets necessary accuracy requirements. In order to evaluate the potential use of these systems, and to make informed decisions about suitability of a system for a given procedure, objective performance data of such systems are necessary. While the end user will ultimately want to know the accuracy parameters of a system under clinical application, the first step must be to characterize the digitization accuracy of the tracking subsystem in a controlled environment under controlled conditions.  
5.3 In order to make comparisons within and between systems, a standardized way of measuring and reporting point accuracy is needed. Parameters such as coordinate system, units of measure, terminology, and operational conditions must be standardized.
SCOPE
1.1 This standard will measure the effects on the accuracy of computer assisted surgery (CAS) systems of the environmental influences caused by equipment utilized for bone preparation during the intended clinical application for the system. The environmental vibration effect covered in this standard will include mechanical vibration from: cutting saw (sagittal or reciprocating), burrs, drills, and impact loading. The change in accuracy from detaching and re-attaching or disturbing a restrained connection that does not by design require repeating the registration process of a reference base will also be measured.  
1.2 It should be noted that one system may need to undergo multiple iterations (one for each clinical application) of this standard to document its accuracy during different clinical applications since each procedure may have different exposure to outside forces given the surgical procedure variability from one procedure to the next.  
1.3 All units of measure will be reported as millimeters for this standard.  
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 F2554-22(Practice)
Standard Practice for Measurement of Positional Accuracy of Computer-Assisted Surgical Systems

SIGNIFICANCE AND USE
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.  
5.3 In order to make comparisons within and between systems, a standardized way of measuring and reporting accuracy is needed. Parameters such as coordinate system, units of measurement, terminology, and operational conditions must be standardized.
SCOPE
1.1 This document provides procedures for measurement and reporting of basic static performance of surgical navigation and/or robotic positioning devices under defined conditions. They can be performed on a subsystem (for example, tracking only) or a full computer-aided surgery system as would be used clinically. Testing a subsystem does not mean that the whole system has been tested. The functionality to be tested based on this practice is limited to the performance (accuracy in terms of bias and precision) of the system regarding point localization in space by means of a pointer. A point in space has no orientation; only multidimensional objects have orientation. Therefore, orientation of objects is not within the scope of this practice. However, in localizing a point the different orientations of the pointer can produce errors. These errors and the pointer orientation are within the scope of this practice. The aim is to provide a standardized measurement of performance variables by which end users can compare within a system (for example, with different reference elements or pointers) and between different systems (for example, from different manufacturers). Parameters to be evaluated include (based upon the features of the system being evaluated):
(1) Accuracy of a single point relative to a coordinate system.
(2) Sensitivity of tracking accuracy due to changes in pointer orientation.
(3) Relative point-to-point accuracy.  
1.1.1 This method covers all configurations of the evaluated system as well as extreme placements across the measurement volume.  
1.2 This practice defines a standardized reporting format, which includes definition of the coordinate systems to be used for reporting the measurements, and statistical measures (for example, mean, RMS, and maximum error).  
1.3 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard, except for angular measurements, which may be reported in terms of radians or degrees.  
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 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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