ISO/HL7 10781 - Electronic Health Record System Functional Model, Release 2.1
0.16.0 - CI Build
ISO/HL7 10781 - Electronic Health Record System Functional Model, Release 2.1
0.16.0 - CI Build
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| Active as of 2024-08-12 |
{
"resourceType" : "Requirements",
"id" : "EHRSFMR2.1-TI.2.1",
"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>Manage Audit Triggers</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. Audit triggers signal key:</p>\n<ul>\n<li>Record management and lifecycle events;</li>\n<li>Security events related to system and data safeguards, both routine and exceptional;</li>\n<li>System events related to performance and operations, both routine and exceptional.</li>\n<li>Clinical events with special log requirements.</li>\n</ul>\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.2.1#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 audit key events, as specified in function [[TI.2.1]] (Audit Triggers) and child functions, 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.2.1#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 capture key Audit Metadata at each Audit Trigger, as specified in [[TI.2.1]] (Audit Triggers) and child functions, 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.2.1#03</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 capture an Audit Log Entry at each Audit Trigger as specified in [[TI.2.1]] (Audit Triggers) 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.2.1#04</span>\n \n </td>\n <td style=\"padding-left: 4px;\">\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 capture the current master clock time to establish valid record date and time metadata.</p>\n</div></span>\n \n \n </td>\n </tr>\n \n <tr>\n <td style=\"padding-left: 4px;\">\n \n <span>TI.2.1#05</span>\n \n </td>\n <td style=\"padding-left: 4px;\">\n \n \n \n <span>MAY</span>\n \n </td>\n <td style=\"padding-left: 4px;\" class=\"requirement\">\n \n <span><div><p>The system MAY manage Audit Trigger logging using a common audit engine (e.g., using schema and transports such as specified in the Audit Log specification of IHE Audit Trails and Node Authentication (ATNA) Profile).</p>\n</div></span>\n \n \n </td>\n </tr>\n \n </table>\n</div>"
},
"url" : "http://hl7.org/ehrs/Requirements/EHRSFMR2.1-TI.2.1",
"version" : "0.16.0",
"name" : "TI_2_1_Audit_Triggers",
"title" : "TI.2.1 Audit Triggers (Function)",
"status" : "active",
"date" : "2024-08-12T10:56:01+00:00",
"publisher" : "EHR WG",
"contact" : [
{
"telecom" : [
{
"system" : "url",
"value" : "http://www.hl7.org/Special/committees/ehr"
}
]
}
],
"description" : "Manage Audit Triggers",
"purpose" : "EHR Systems have built in audit triggers to capture key events in real-time. Audit triggers signal key:\n- Record management and lifecycle events;\n- Security events related to system and data safeguards, both routine and exceptional;\n- System events related to performance and operations, both routine and exceptional.\n- Clinical events with special log requirements.",
"statement" : [
{
"extension" : [
{
"url" : "http://hl7.org/ehrs/StructureDefinition/requirements-dependent",
"valueBoolean" : true
}
],
"key" : "EHRSFMR2.1-TI.2.1-01",
"label" : "TI.2.1#01",
"conformance" : [
"SHALL"
],
"conditionality" : false,
"requirement" : "The system SHALL audit key events, as specified in function [[TI.2.1]] (Audit Triggers) and child functions, according to scope of practice, organizational policy, and/or jurisdictional law."
},
{
"extension" : [
{
"url" : "http://hl7.org/ehrs/StructureDefinition/requirements-dependent",
"valueBoolean" : true
}
],
"key" : "EHRSFMR2.1-TI.2.1-02",
"label" : "TI.2.1#02",
"conformance" : [
"SHALL"
],
"conditionality" : false,
"requirement" : "The system SHALL capture key Audit Metadata at each Audit Trigger, as specified in [[TI.2.1]] (Audit Triggers) and child functions, according to scope of practice, organizational policy, and/or jurisdictional law."
},
{
"extension" : [
{
"url" : "http://hl7.org/ehrs/StructureDefinition/requirements-dependent",
"valueBoolean" : true
}
],
"key" : "EHRSFMR2.1-TI.2.1-03",
"label" : "TI.2.1#03",
"conformance" : [
"SHALL"
],
"conditionality" : false,
"requirement" : "The system SHALL capture an Audit Log Entry at each Audit Trigger as specified in [[TI.2.1]] (Audit Triggers) according to scope of practice, organizational policy, and/or jurisdictional law."
},
{
"extension" : [
{
"url" : "http://hl7.org/ehrs/StructureDefinition/requirements-dependent",
"valueBoolean" : false
}
],
"key" : "EHRSFMR2.1-TI.2.1-04",
"label" : "TI.2.1#04",
"conformance" : [
"SHALL"
],
"conditionality" : false,
"requirement" : "The system SHALL capture the current master clock time to establish valid record date and time metadata.",
"derivedFrom" : "EHR-S_FM_R1.1 IN.2.2#18"
},
{
"extension" : [
{
"url" : "http://hl7.org/ehrs/StructureDefinition/requirements-dependent",
"valueBoolean" : false
}
],
"key" : "EHRSFMR2.1-TI.2.1-05",
"label" : "TI.2.1#05",
"conformance" : [
"MAY"
],
"conditionality" : false,
"requirement" : "The system MAY manage Audit Trigger logging using a common audit engine (e.g., using schema and transports such as specified in the Audit Log specification of IHE Audit Trails and Node Authentication (ATNA) Profile)."
}
]
}