ISO/HL7 10781 - Electronic Health Record System Functional Model, Release 2.1
2.1.0 - local
ISO/HL7 10781 - Electronic Health Record System Functional Model, Release 2.1
2.1.0 - local
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| Active as of 2024-11-26 |
{
"resourceType" : "Requirements",
"id" : "EHRSFMR2.1-TI.2",
"meta" : {
"profile" : [
🔗 "http://hl7.org/ehrs/StructureDefinition/FMFunction"
]
},
"text" : {
"status" : "extensions",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\">\n <span id=\"description\"><b>Statement <a href=\"https://hl7.org/fhir/versions.html#std-process\" title=\"Normative Content\" class=\"normative-flag\">N</a>:</b> <div><p>Audit Key Record, Security, System and Clinical Events</p>\n</div></span>\n\n \n <span id=\"purpose\"><b>Description <a href=\"https://hl7.org/fhir/versions.html#std-process\" title=\"Informative Content\" class=\"informative-flag\">I</a>:</b> <div><p>EHR Systems have built in audit triggers to capture key events in real-time, including events related to record management, security, system operations or performance or clinical situations.</p>\n<p>Event details, including key metadata (who, what, when, where), are captured in an Audit Log.</p>\n<p>Audit Review functions allow various methods of critical event notification as well as routine log review.</p>\n<p>Audit functions implement requirements according to scope of practice, organizational policy, and jurisdictional law.</p>\n</div></span>\n \n\n \n\n \n <span id=\"requirements\"><b>Criteria <a href=\"https://hl7.org/fhir/versions.html#std-process\" title=\"Normative Content\" class=\"normative-flag\">N</a>:</b></span>\n \n <table id=\"statements\" class=\"grid dict\">\n \n <tr>\n <td style=\"padding-left: 4px;\">\n \n <span>TI.2#01</span>\n \n </td>\n <td style=\"padding-left: 4px;\">\n \n <i>dependent</i>\n \n \n \n <span>SHALL</span>\n \n </td>\n <td style=\"padding-left: 4px;\" class=\"requirement\">\n \n <span><div><p>The system SHALL conform to function [[TI.1.3]] (Entity Access Control) to limit access to, or modification of, audit record information to appropriate entities according to scope of practice, organizational policy, and/or jurisdictional law.</p>\n</div></span>\n \n \n </td>\n </tr>\n \n <tr>\n <td style=\"padding-left: 4px;\">\n \n <span>TI.2#02</span>\n \n </td>\n <td style=\"padding-left: 4px;\">\n \n <i>dependent</i>\n \n \n \n <span>SHALL</span>\n \n </td>\n <td style=\"padding-left: 4px;\" class=\"requirement\">\n \n <span><div><p>The system SHALL conform to function [[TI.1.3]] (Entity Access Control) to limit access to audit record information for purposes of deletion according to scope of practice, organizational policy, and/or jurisdictional law (e.g., limit access to only allow a specific system administrator to delete audit record information).</p>\n</div></span>\n \n \n </td>\n </tr>\n \n </table>\n</div>"
},
"url" : "http://hl7.org/ehrs/Requirements/EHRSFMR2.1-TI.2",
"version" : "2.1.0",
"name" : "TI_2_Audit",
"title" : "TI.2 Audit (Function)",
"status" : "active",
"date" : "2024-11-26T16:30:50+00:00",
"publisher" : "EHR WG",
"contact" : [
{
"telecom" : [
{
"system" : "url",
"value" : "http://www.hl7.org/Special/committees/ehr"
}
]
}
],
"description" : "Audit Key Record, Security, System and Clinical Events",
"jurisdiction" : [
{
"coding" : [
{
"system" : "http://unstats.un.org/unsd/methods/m49/m49.htm",
"code" : "001",
"display" : "World"
}
]
}
],
"purpose" : "EHR Systems have built in audit triggers to capture key events in real-time, including events related to record management, security, system operations or performance or clinical situations.\n\nEvent details, including key metadata (who, what, when, where), are captured in an Audit Log.\n\nAudit Review functions allow various methods of critical event notification as well as routine log review.\n\nAudit functions implement requirements according to scope of practice, organizational policy, and jurisdictional law.",
"statement" : [
{
"extension" : [
{
"url" : "http://hl7.org/ehrs/StructureDefinition/requirements-dependent",
"valueBoolean" : true
}
],
"key" : "EHRSFMR2.1-TI.2-01",
"label" : "TI.2#01",
"conformance" : [
"SHALL"
],
"conditionality" : false,
"requirement" : "The system SHALL conform to function [[TI.1.3]] (Entity Access Control) to limit access to, or modification of, audit record information to appropriate entities according to scope of practice, organizational policy, and/or jurisdictional law.",
"derivedFrom" : "EHR-S_FM_R1.1 IN.2.2#13"
},
{
"extension" : [
{
"url" : "http://hl7.org/ehrs/StructureDefinition/requirements-dependent",
"valueBoolean" : true
}
],
"key" : "EHRSFMR2.1-TI.2-02",
"label" : "TI.2#02",
"conformance" : [
"SHALL"
],
"conditionality" : false,
"requirement" : "The system SHALL conform to function [[TI.1.3]] (Entity Access Control) to limit access to audit record information for purposes of deletion according to scope of practice, organizational policy, and/or jurisdictional law (e.g., limit access to only allow a specific system administrator to delete audit record information)."
}
]
}