1、Designation:E201799(Reapproved 2010)An American National StandardStandard Guide forAmendments to Health Information1This standard is issued under the fixed designation E2017;the number immediately following the designation indicates the year oforiginal adoption or,in the case of revision,the year of
2、 last revision.A number in parentheses indicates the year of last reapproval.Asuperscript epsilon()indicates an editorial change since the last revision or reapproval.1.Scope1.1 This guide addresses the criteria for amendingindividually-identifiable health information.Certain criteria foramending he
3、alth information is found in federal and state laws,rules and regulations,and in ethical statements of professionalconduct.Although there are several sources for guidance,thereis no current national standard on this topic.2.Referenced Documents2.1 ASTM Standards:2E1762 Guide for Electronic Authentic
4、ation of Health CareInformationE1869 Guide for Confidentiality,Privacy,Access,and DataSecurity Principles for Health Information Including Elec-tronic Health Records3.Terminology3.1 Definitions:3.1.1 amendment,nalteration of health information bymodification,correction,addition,or deletion.3.1.2 aut
5、hentication,nprovision of assurance of theclaimed identity of an entity,receiver,or object.(E1869,E1762,CPRI3)3.1.3 author,nperson(s)who is(are)responsible andaccountable for the health information creation,content,accu-racy,and completeness for each documented event or healthrecord entry.3.1.4 comm
6、ission,nact of doing,performing,or commit-ting something.(Websters 1993)3.1.5 confidential,adj(1)status accorded to data or infor-mation indicating that it is sensitive for some reason and needsto be protected against theft,disclosure,or improper use,or allthree,and must be disseminated only to auth
7、orized individualsor organizations with an approved need to know;(2)privateinformation,which is entrusted to another with the confidencethat unauthorized disclosure that will be prejudicial to theindividual will not occur.(E1869)3.1.6 delete,v(1)to eliminate by blotting out,cutting outor erasing;(2)
8、to remove or eliminate,as to erase data from afield or to eliminate a record from a file,a method of erasingdata.(Websters 1993,Websters New World Dictionary ofComputer Terms,1994)3.1.7 error,nact involving an unintentional deviationfrom truth or accuracy.3.1.8 health information,nany information,wh
9、ether oralor recorded,in any form or medium(1)that is created orreceived by a health care practitioner;a health plan;healthresearcher,public health authority,instructor,employer,schoolor university,health information service or other entity thatcreates,receives,obtains,maintains,uses or transmits he
10、althinformation;a health oversight agency,a health informationservice organization,or(2)that relates to the past,present,orfuture physical or mental health or condition of an individual,the provision of health care to an individual,or the past,presentor future payments for the provision of health ca
11、re to aprotected individual;and,(3)that identifies the individual withrespect to which there is a reasonable basis to believe that theinformation can be used to identify the individual.(HIPAA4,E1869)3.1.9 information,ndata to which meaning is assigned,according to context and assumed conventions(E18
12、69)3.1.10 omission,nsomething neglected or left undone,theact of omitting.(Websters 1993)3.1.11 permanence,nquality of being in a constant,con-tinuous state.4.Significance and Use4.1 The purpose of this guide is to assure comparabilitybetween paper-based and computer-based amendments.Paper-based and
13、 computer-based amendments must have comparable1This guide is under the jurisdiction of ASTM Committee E31 on HealthcareInformatics and is the direct responsibility of Subcommittee E31.25 on HealthcareData Management,Security,Confidentiality,and Privacy.Current edition approved March 1,2010.Publishe
14、d August 2010.Originallyapproved in 1999.Last previous edition approved in 2005 as E201799(2005).DOI:10.1520/E2017-99R10.2For referenced ASTM standards,visit the ASTM website,www.astm.org,orcontact ASTM Customer Service at serviceastm.org.For Annual Book of ASTMStandards volume information,refer to
15、the standards Document Summary page onthe ASTM website.3CPRI(Computer-Based Record Institute),4915 Saint Elmo Ave.,Suite 401,Bethesda,MD 20814(http:/www.cpri.org).4HIPAA(Health Insurance Portability and Accountability Act),1996(http:/www.hcfa.gov/hipaa/hipaahm.htm).Copyright ASTM International,100 B
16、arr Harbor Drive,PO Box C700,West Conshohocken,PA 19428-2959.United States1 methods,practices and policies,in order to assure an unam-biguous representation of the sequence and timing of docu-mented events.Original and amended health informationentries and documents must both be displayed and must beconsistent across both domains.Comparability does not ruleout,however,the use of capabilities specific to the electronicworld,which do not have paper-based counterparts,for ex-ample,displaying the am