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.2.1.3",
"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 System 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>System Audit Triggers are designed to capture system related events, both routine and exceptional, including key metadata (who, what, when, where, why).</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.2.1.3#01</span>\n \n </td>\n <td style=\"padding-left: 4px;\">\n \n \n \n <span>SHOULD</span>\n \n </td>\n <td style=\"padding-left: 4px;\" class=\"requirement\">\n \n <span><div><p>The system SHOULD provide the ability to log system maintenance events for loading new versions of, or changes to, the clinical system.</p>\n</div></span>\n \n \n </td>\n </tr>\n \n <tr>\n <td style=\"padding-left: 4px;\">\n \n <span>TI.2.1.3#02</span>\n \n </td>\n <td style=\"padding-left: 4px;\">\n \n \n \n <span>SHOULD</span>\n \n </td>\n <td style=\"padding-left: 4px;\" class=\"requirement\">\n \n <span><div><p>The system SHOULD provide the ability to store system maintenance events for loading new versions of codes and knowledge bases.</p>\n</div></span>\n \n \n </td>\n </tr>\n \n <tr>\n <td style=\"padding-left: 4px;\">\n \n <span>TI.2.1.3#03</span>\n \n </td>\n <td style=\"padding-left: 4px;\">\n \n \n \n <span>SHOULD</span>\n \n </td>\n <td style=\"padding-left: 4px;\" class=\"requirement\">\n \n <span><div><p>The system SHOULD provide the ability to log system maintenance events for creating and restoring of backup.</p>\n</div></span>\n \n \n </td>\n </tr>\n \n <tr>\n <td style=\"padding-left: 4px;\">\n \n <span>TI.2.1.3#04</span>\n \n </td>\n <td style=\"padding-left: 4px;\">\n \n \n \n <span>SHOULD</span>\n \n </td>\n <td style=\"padding-left: 4px;\" class=\"requirement\">\n \n <span><div><p>The system SHOULD provide the ability to audit events in the case of detection of corrupt or dirty data.</p>\n</div></span>\n \n \n </td>\n </tr>\n \n <tr>\n <td style=\"padding-left: 4px;\">\n \n <span>TI.2.1.3#05</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 provide the ability to audit the access and usage of systems, data, and organizational resources.</p>\n</div></span>\n \n \n </td>\n </tr>\n \n <tr>\n <td style=\"padding-left: 4px;\">\n \n <span>TI.2.1.3#06</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 provide the ability to log system events at the hardware and software architecture level.</p>\n</div></span>\n \n \n </td>\n </tr>\n \n <tr>\n <td style=\"padding-left: 4px;\">\n \n <span>TI.2.1.3#07</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 provide the ability to log system maintenance events for entry to, and exit from, the EHR system.</p>\n</div></span>\n \n \n </td>\n </tr>\n \n <tr>\n <td style=\"padding-left: 4px;\">\n \n <span>TI.2.1.3#08</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 provide the ability to log system maintenance events for remote access connections including those for system support and maintenance activities for security and access purposes.</p>\n</div></span>\n \n \n </td>\n </tr>\n \n </table>\n</div>"
},
"url" : "http://hl7.org/ehrs/Requirements/EHRSFMR2.1-TI.2.1.3",
"version" : "2.1.0",
"name" : "TI_2_1_3_System_Audit_Triggers",
"title" : "TI.2.1.3 System Audit Triggers (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" : "Manage System Audit Triggers",
"jurisdiction" : [
{
"coding" : [
{
"system" : "http://unstats.un.org/unsd/methods/m49/m49.htm",
"code" : "001",
"display" : "World"
}
]
}
],
"purpose" : "System Audit Triggers are designed to capture system related events, both routine and exceptional, including key metadata (who, what, when, where, why).",
"statement" : [
{
"extension" : [
{
"url" : "http://hl7.org/ehrs/StructureDefinition/requirements-dependent",
"valueBoolean" : false
}
],
"key" : "EHRSFMR2.1-TI.2.1.3-01",
"label" : "TI.2.1.3#01",
"conformance" : [
"SHOULD"
],
"conditionality" : false,
"requirement" : "The system SHOULD provide the ability to log system maintenance events for loading new versions of, or changes to, the clinical system.",
"derivedFrom" : "EHR-S_FM_R1.1 IN.2.2#16"
},
{
"extension" : [
{
"url" : "http://hl7.org/ehrs/StructureDefinition/requirements-dependent",
"valueBoolean" : false
}
],
"key" : "EHRSFMR2.1-TI.2.1.3-02",
"label" : "TI.2.1.3#02",
"conformance" : [
"SHOULD"
],
"conditionality" : false,
"requirement" : "The system SHOULD provide the ability to store system maintenance events for loading new versions of codes and knowledge bases.",
"derivedFrom" : "EHR-S_FM_R1.1 IN.2.2#17"
},
{
"extension" : [
{
"url" : "http://hl7.org/ehrs/StructureDefinition/requirements-dependent",
"valueBoolean" : false
}
],
"key" : "EHRSFMR2.1-TI.2.1.3-03",
"label" : "TI.2.1.3#03",
"conformance" : [
"SHOULD"
],
"conditionality" : false,
"requirement" : "The system SHOULD provide the ability to log system maintenance events for creating and restoring of backup.",
"derivedFrom" : "EHR-S_FM_R1.1 IN.2.2#19"
},
{
"extension" : [
{
"url" : "http://hl7.org/ehrs/StructureDefinition/requirements-dependent",
"valueBoolean" : false
}
],
"key" : "EHRSFMR2.1-TI.2.1.3-04",
"label" : "TI.2.1.3#04",
"conformance" : [
"SHOULD"
],
"conditionality" : false,
"requirement" : "The system SHOULD provide the ability to audit events in the case of detection of corrupt or dirty data."
},
{
"extension" : [
{
"url" : "http://hl7.org/ehrs/StructureDefinition/requirements-dependent",
"valueBoolean" : false
}
],
"key" : "EHRSFMR2.1-TI.2.1.3-05",
"label" : "TI.2.1.3#05",
"conformance" : [
"SHALL"
],
"conditionality" : false,
"requirement" : "The system SHALL provide the ability to audit the access and usage of systems, data, and organizational resources.",
"derivedFrom" : "EHR-S_FM_R1.1 IN.2.2#1"
},
{
"extension" : [
{
"url" : "http://hl7.org/ehrs/StructureDefinition/requirements-dependent",
"valueBoolean" : false
}
],
"key" : "EHRSFMR2.1-TI.2.1.3-06",
"label" : "TI.2.1.3#06",
"conformance" : [
"SHALL"
],
"conditionality" : false,
"requirement" : "The system SHALL provide the ability to log system events at the hardware and software architecture level.",
"derivedFrom" : "EHR-S_FM_R1.1 IN.2.2#12"
},
{
"extension" : [
{
"url" : "http://hl7.org/ehrs/StructureDefinition/requirements-dependent",
"valueBoolean" : false
}
],
"key" : "EHRSFMR2.1-TI.2.1.3-07",
"label" : "TI.2.1.3#07",
"conformance" : [
"SHALL"
],
"conditionality" : false,
"requirement" : "The system SHALL provide the ability to log system maintenance events for entry to, and exit from, the EHR system.",
"derivedFrom" : "EHR-S_FM_R1.1 IN.2.2#22"
},
{
"extension" : [
{
"url" : "http://hl7.org/ehrs/StructureDefinition/requirements-dependent",
"valueBoolean" : false
}
],
"key" : "EHRSFMR2.1-TI.2.1.3-08",
"label" : "TI.2.1.3#08",
"conformance" : [
"SHALL"
],
"conditionality" : false,
"requirement" : "The system SHALL provide the ability to log system maintenance events for remote access connections including those for system support and maintenance activities for security and access purposes.",
"derivedFrom" : "EHR-S_FM_R1.1 IN.2.2#23"
}
]
}