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-RI.1.1.1.1",
"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>Maintain Evidence of Record Entry Originate/Retain Event</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>Evidence of Record Entry Originate/Retain Event includes key metadata, ensures health record integrity (and trust) and enables record audit.</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>RI.1.1.1.1#01</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 audit each occurrence when a Record Entry is originated and retained.</p>\n</div></span>\n \n \n </td>\n </tr>\n \n <tr>\n <td style=\"padding-left: 4px;\">\n \n <span>RI.1.1.1.1#02</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 identity of the organization where Record Entry content is originated.</p>\n</div></span>\n \n \n </td>\n </tr>\n \n <tr>\n <td style=\"padding-left: 4px;\">\n \n <span>RI.1.1.1.1#03</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 identity of the patient who is subject of Record Entry content.</p>\n</div></span>\n \n \n </td>\n </tr>\n \n <tr>\n <td style=\"padding-left: 4px;\">\n \n <span>RI.1.1.1.1#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 identity of the individual(s) who performed the Action documented in Record Entry content.</p>\n</div></span>\n \n \n </td>\n </tr>\n \n <tr>\n <td style=\"padding-left: 4px;\">\n \n <span>RI.1.1.1.1#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 capture identity of the user who entered/authored Record Entry content.</p>\n</div></span>\n \n \n </td>\n </tr>\n \n <tr>\n <td style=\"padding-left: 4px;\">\n \n <span>RI.1.1.1.1#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 capture identity of the system application which originated Record Entry content.</p>\n</div></span>\n \n \n </td>\n </tr>\n \n <tr>\n <td style=\"padding-left: 4px;\">\n \n <span>RI.1.1.1.1#07</span>\n \n </td>\n <td style=\"padding-left: 4px;\">\n \n \n <i>conditional</i>\n \n \n <span>SHALL</span>\n \n </td>\n <td style=\"padding-left: 4px;\" class=\"requirement\">\n \n <span><div><p>IF the source of Record Entry content is a device, THEN the system SHALL capture identity of the device.</p>\n</div></span>\n \n \n </td>\n </tr>\n \n <tr>\n <td style=\"padding-left: 4px;\">\n \n <span>RI.1.1.1.1#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 capture the Action as evidenced by Record Entry content.</p>\n</div></span>\n \n \n </td>\n </tr>\n \n <tr>\n <td style=\"padding-left: 4px;\">\n \n <span>RI.1.1.1.1#09</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 type of Record Event trigger (i.e., originate/retain).</p>\n</div></span>\n \n \n </td>\n </tr>\n \n <tr>\n <td style=\"padding-left: 4px;\">\n \n <span>RI.1.1.1.1#10</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 date and time of Action occurrence as evidenced by Record Entry content.</p>\n</div></span>\n \n \n </td>\n </tr>\n \n <tr>\n <td style=\"padding-left: 4px;\">\n \n <span>RI.1.1.1.1#11</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 date and time Record Entry content is originated.</p>\n</div></span>\n \n \n </td>\n </tr>\n \n <tr>\n <td style=\"padding-left: 4px;\">\n \n <span>RI.1.1.1.1#12</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 capture the duration of the Action evidenced by Record Entry content.</p>\n</div></span>\n \n \n </td>\n </tr>\n \n <tr>\n <td style=\"padding-left: 4px;\">\n \n <span>RI.1.1.1.1#13</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 capture the physical location of the Action evidenced by Record Entry content.</p>\n</div></span>\n \n \n </td>\n </tr>\n \n <tr>\n <td style=\"padding-left: 4px;\">\n \n <span>RI.1.1.1.1#14</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 capture identity of the location (i.e., network address) where Record Entry content is originated.</p>\n</div></span>\n \n \n </td>\n </tr>\n \n <tr>\n <td style=\"padding-left: 4px;\">\n \n <span>RI.1.1.1.1#15</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 capture the rationale for the Action evidenced by Record Entry content.</p>\n</div></span>\n \n \n </td>\n </tr>\n \n <tr>\n <td style=\"padding-left: 4px;\">\n \n <span>RI.1.1.1.1#16</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 capture the rationale for originating Record Entry content.</p>\n</div></span>\n \n \n </td>\n </tr>\n \n <tr>\n <td style=\"padding-left: 4px;\">\n \n <span>RI.1.1.1.1#17</span>\n \n </td>\n <td style=\"padding-left: 4px;\">\n \n \n <i>conditional</i>\n \n \n <span>SHOULD</span>\n \n </td>\n <td style=\"padding-left: 4px;\" class=\"requirement\">\n \n <span><div><p>IF Record Entry content includes templates (boilerplate information) or copied (duplicated) information, THEN the system SHOULD capture the source of such content.</p>\n</div></span>\n \n \n </td>\n </tr>\n \n </table>\n</div>"
},
"url" : "http://hl7.org/ehrs/Requirements/EHRSFMR2.1-RI.1.1.1.1",
"version" : "2.1.0",
"name" : "RI_1_1_1_1_Evidence_of_Record_Entry_Originate_Retain_Event",
"title" : "RI.1.1.1.1 Evidence of Record Entry Originate/Retain Event (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" : "Maintain Evidence of Record Entry Originate/Retain Event",
"jurisdiction" : [
{
"coding" : [
{
"system" : "http://unstats.un.org/unsd/methods/m49/m49.htm",
"code" : "001",
"display" : "World"
}
]
}
],
"purpose" : "Evidence of Record Entry Originate/Retain Event includes key metadata, ensures health record integrity (and trust) and enables record audit.",
"statement" : [
{
"extension" : [
{
"url" : "http://hl7.org/ehrs/StructureDefinition/requirements-dependent",
"valueBoolean" : false
}
],
"key" : "EHRSFMR2.1-RI.1.1.1.1-01",
"label" : "RI.1.1.1.1#01",
"conformance" : [
"SHALL"
],
"conditionality" : false,
"requirement" : "The system SHALL audit each occurrence when a Record Entry is originated and retained.",
"derivedFrom" : "EHR-LM_R1 14.1"
},
{
"extension" : [
{
"url" : "http://hl7.org/ehrs/StructureDefinition/requirements-dependent",
"valueBoolean" : false
}
],
"key" : "EHRSFMR2.1-RI.1.1.1.1-02",
"label" : "RI.1.1.1.1#02",
"conformance" : [
"SHALL"
],
"conditionality" : false,
"requirement" : "The system SHALL capture identity of the organization where Record Entry content is originated.",
"derivedFrom" : "EHR-LM_R1 14.1"
},
{
"extension" : [
{
"url" : "http://hl7.org/ehrs/StructureDefinition/requirements-dependent",
"valueBoolean" : false
}
],
"key" : "EHRSFMR2.1-RI.1.1.1.1-03",
"label" : "RI.1.1.1.1#03",
"conformance" : [
"SHALL"
],
"conditionality" : false,
"requirement" : "The system SHALL capture identity of the patient who is subject of Record Entry content.",
"derivedFrom" : "EHR-LM_R1 14.1"
},
{
"extension" : [
{
"url" : "http://hl7.org/ehrs/StructureDefinition/requirements-dependent",
"valueBoolean" : false
}
],
"key" : "EHRSFMR2.1-RI.1.1.1.1-04",
"label" : "RI.1.1.1.1#04",
"conformance" : [
"SHALL"
],
"conditionality" : false,
"requirement" : "The system SHALL capture identity of the individual(s) who performed the Action documented in Record Entry content.",
"derivedFrom" : "EHR-LM_R1 14.1"
},
{
"extension" : [
{
"url" : "http://hl7.org/ehrs/StructureDefinition/requirements-dependent",
"valueBoolean" : false
}
],
"key" : "EHRSFMR2.1-RI.1.1.1.1-05",
"label" : "RI.1.1.1.1#05",
"conformance" : [
"SHALL"
],
"conditionality" : false,
"requirement" : "The system SHALL capture identity of the user who entered/authored Record Entry content.",
"derivedFrom" : "EHR-LM_R1 14.1"
},
{
"extension" : [
{
"url" : "http://hl7.org/ehrs/StructureDefinition/requirements-dependent",
"valueBoolean" : false
}
],
"key" : "EHRSFMR2.1-RI.1.1.1.1-06",
"label" : "RI.1.1.1.1#06",
"conformance" : [
"SHALL"
],
"conditionality" : false,
"requirement" : "The system SHALL capture identity of the system application which originated Record Entry content."
},
{
"extension" : [
{
"url" : "http://hl7.org/ehrs/StructureDefinition/requirements-dependent",
"valueBoolean" : false
}
],
"key" : "EHRSFMR2.1-RI.1.1.1.1-07",
"label" : "RI.1.1.1.1#07",
"conformance" : [
"SHALL"
],
"conditionality" : true,
"requirement" : "IF the source of Record Entry content is a device, THEN the system SHALL capture identity of the device.",
"derivedFrom" : "EHR-LM_R1 14.1"
},
{
"extension" : [
{
"url" : "http://hl7.org/ehrs/StructureDefinition/requirements-dependent",
"valueBoolean" : false
}
],
"key" : "EHRSFMR2.1-RI.1.1.1.1-08",
"label" : "RI.1.1.1.1#08",
"conformance" : [
"SHALL"
],
"conditionality" : false,
"requirement" : "The system SHALL capture the Action as evidenced by Record Entry content."
},
{
"extension" : [
{
"url" : "http://hl7.org/ehrs/StructureDefinition/requirements-dependent",
"valueBoolean" : false
}
],
"key" : "EHRSFMR2.1-RI.1.1.1.1-09",
"label" : "RI.1.1.1.1#09",
"conformance" : [
"SHALL"
],
"conditionality" : false,
"requirement" : "The system SHALL capture the type of Record Event trigger (i.e., originate/retain)."
},
{
"extension" : [
{
"url" : "http://hl7.org/ehrs/StructureDefinition/requirements-dependent",
"valueBoolean" : false
}
],
"key" : "EHRSFMR2.1-RI.1.1.1.1-10",
"label" : "RI.1.1.1.1#10",
"conformance" : [
"SHALL"
],
"conditionality" : false,
"requirement" : "The system SHALL capture the date and time of Action occurrence as evidenced by Record Entry content.",
"derivedFrom" : "EHR-LM_R1 14.1"
},
{
"extension" : [
{
"url" : "http://hl7.org/ehrs/StructureDefinition/requirements-dependent",
"valueBoolean" : false
}
],
"key" : "EHRSFMR2.1-RI.1.1.1.1-11",
"label" : "RI.1.1.1.1#11",
"conformance" : [
"SHALL"
],
"conditionality" : false,
"requirement" : "The system SHALL capture the date and time Record Entry content is originated.",
"derivedFrom" : "EHR-LM_R1 14.1"
},
{
"extension" : [
{
"url" : "http://hl7.org/ehrs/StructureDefinition/requirements-dependent",
"valueBoolean" : false
}
],
"key" : "EHRSFMR2.1-RI.1.1.1.1-12",
"label" : "RI.1.1.1.1#12",
"conformance" : [
"MAY"
],
"conditionality" : false,
"requirement" : "The system MAY capture the duration of the Action evidenced by Record Entry content."
},
{
"extension" : [
{
"url" : "http://hl7.org/ehrs/StructureDefinition/requirements-dependent",
"valueBoolean" : false
}
],
"key" : "EHRSFMR2.1-RI.1.1.1.1-13",
"label" : "RI.1.1.1.1#13",
"conformance" : [
"MAY"
],
"conditionality" : false,
"requirement" : "The system MAY capture the physical location of the Action evidenced by Record Entry content.",
"derivedFrom" : "EHR-LM_R1 14.1"
},
{
"extension" : [
{
"url" : "http://hl7.org/ehrs/StructureDefinition/requirements-dependent",
"valueBoolean" : false
}
],
"key" : "EHRSFMR2.1-RI.1.1.1.1-14",
"label" : "RI.1.1.1.1#14",
"conformance" : [
"SHOULD"
],
"conditionality" : false,
"requirement" : "The system SHOULD capture identity of the location (i.e., network address) where Record Entry content is originated.",
"derivedFrom" : "EHR-LM_R1 14.1"
},
{
"extension" : [
{
"url" : "http://hl7.org/ehrs/StructureDefinition/requirements-dependent",
"valueBoolean" : false
}
],
"key" : "EHRSFMR2.1-RI.1.1.1.1-15",
"label" : "RI.1.1.1.1#15",
"conformance" : [
"MAY"
],
"conditionality" : false,
"requirement" : "The system MAY capture the rationale for the Action evidenced by Record Entry content."
},
{
"extension" : [
{
"url" : "http://hl7.org/ehrs/StructureDefinition/requirements-dependent",
"valueBoolean" : false
}
],
"key" : "EHRSFMR2.1-RI.1.1.1.1-16",
"label" : "RI.1.1.1.1#16",
"conformance" : [
"MAY"
],
"conditionality" : false,
"requirement" : "The system MAY capture the rationale for originating Record Entry content."
},
{
"extension" : [
{
"url" : "http://hl7.org/ehrs/StructureDefinition/requirements-dependent",
"valueBoolean" : false
}
],
"key" : "EHRSFMR2.1-RI.1.1.1.1-17",
"label" : "RI.1.1.1.1#17",
"conformance" : [
"SHOULD"
],
"conditionality" : true,
"requirement" : "IF Record Entry content includes templates (boilerplate information) or copied (duplicated) information, THEN the system SHOULD capture the source of such content."
}
]
}