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-RI.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>Originate and Retain Record Entry (1 instance)</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>Occurs when an agent causes the system to: a) initiate capture of potential record content, and b) incorporate that content into the storage considered a permanent part of the health record.</p>\n<p>Reference: ISO 21089-2018, Section 15.1.</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#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 provide the ability to capture (originate) a Record Entry instance corresponding to an Action instance and context.</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#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 a unique instance identifier for each Record Entry.</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#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 the signature event (e.g., digital signature) of the origination entry Author, binding signature to 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#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 provide the ability to capture both structured and unstructured content in Record Entries.</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#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 capture Record Entries from information recorded during system downtime.</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#06</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 integrate Record Entries from Information recorded during system downtime.</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#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 capture the date/time an Action was taken or data was collected if different than date/time of the Record Entry.</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#08</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 metadata that identifies the source of non-originated Record Entry (e.g., templated, copied, duplicated, or boilerplate information).</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#09</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 provide the ability to tag unstructured Record Entry content to organize it according to need, for example, in a time-related fashion or by application-specific groups (such as photographs, handwritten notes, or auditory sounds), or by order of relative importance.</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#10</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 and maintain a Record Entry encoded as a standards-based data object (e.g., HL7 Continuity of Care, other HL7 CDA R2 Document, ISO 13606 artifact).</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#11</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 and maintain a standards-based data object to mirror (be duplicate and synchronous with) internal Record Entry representation.</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",
"version" : "0.16.0",
"name" : "RI_1_1_1_Originate_Retain_Record_Lifecycle_Event",
"title" : "RI.1.1.1 Originate/Retain Record Lifecycle Event (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" : "Originate and Retain Record Entry (1 instance)",
"purpose" : "Occurs when an agent causes the system to: a) initiate capture of potential record content, and b) incorporate that content into the storage considered a permanent part of the health record. \n\nReference: ISO 21089-2018, Section 15.1.",
"statement" : [
{
"extension" : [
{
"url" : "http://hl7.org/ehrs/StructureDefinition/requirements-dependent",
"valueBoolean" : false
}
],
"key" : "EHRSFMR2.1-RI.1.1.1-01",
"label" : "RI.1.1.1#01",
"conformance" : [
"SHALL"
],
"conditionality" : false,
"requirement" : "The system SHALL provide the ability to capture (originate) a Record Entry instance corresponding to an Action instance and context.",
"derivedFrom" : "EHR-LM_R1 14.1"
},
{
"extension" : [
{
"url" : "http://hl7.org/ehrs/StructureDefinition/requirements-dependent",
"valueBoolean" : false
}
],
"key" : "EHRSFMR2.1-RI.1.1.1-02",
"label" : "RI.1.1.1#02",
"conformance" : [
"SHALL"
],
"conditionality" : false,
"requirement" : "The system SHALL capture a unique instance identifier for each Record Entry.",
"derivedFrom" : "EHR-LM_R1 14.1"
},
{
"extension" : [
{
"url" : "http://hl7.org/ehrs/StructureDefinition/requirements-dependent",
"valueBoolean" : false
}
],
"key" : "EHRSFMR2.1-RI.1.1.1-03",
"label" : "RI.1.1.1#03",
"conformance" : [
"SHALL"
],
"conditionality" : false,
"requirement" : "The system SHALL capture the signature event (e.g., digital signature) of the origination entry Author, binding signature to Record Entry content.",
"derivedFrom" : "EHR-LM_R1 14.1"
},
{
"extension" : [
{
"url" : "http://hl7.org/ehrs/StructureDefinition/requirements-dependent",
"valueBoolean" : false
}
],
"key" : "EHRSFMR2.1-RI.1.1.1-04",
"label" : "RI.1.1.1#04",
"conformance" : [
"SHALL"
],
"conditionality" : false,
"requirement" : "The system SHALL provide the ability to capture both structured and unstructured content in Record Entries."
},
{
"extension" : [
{
"url" : "http://hl7.org/ehrs/StructureDefinition/requirements-dependent",
"valueBoolean" : false
}
],
"key" : "EHRSFMR2.1-RI.1.1.1-05",
"label" : "RI.1.1.1#05",
"conformance" : [
"SHALL"
],
"conditionality" : false,
"requirement" : "The system SHALL provide the ability to capture Record Entries from information recorded during system downtime."
},
{
"extension" : [
{
"url" : "http://hl7.org/ehrs/StructureDefinition/requirements-dependent",
"valueBoolean" : false
}
],
"key" : "EHRSFMR2.1-RI.1.1.1-06",
"label" : "RI.1.1.1#06",
"conformance" : [
"SHOULD"
],
"conditionality" : false,
"requirement" : "The system SHOULD provide the ability to integrate Record Entries from Information recorded during system downtime."
},
{
"extension" : [
{
"url" : "http://hl7.org/ehrs/StructureDefinition/requirements-dependent",
"valueBoolean" : false
}
],
"key" : "EHRSFMR2.1-RI.1.1.1-07",
"label" : "RI.1.1.1#07",
"conformance" : [
"SHALL"
],
"conditionality" : false,
"requirement" : "The system SHALL provide the ability to capture the date/time an Action was taken or data was collected if different than date/time of the Record Entry.",
"derivedFrom" : "EHR-LM_R1 14.1"
},
{
"extension" : [
{
"url" : "http://hl7.org/ehrs/StructureDefinition/requirements-dependent",
"valueBoolean" : false
}
],
"key" : "EHRSFMR2.1-RI.1.1.1-08",
"label" : "RI.1.1.1#08",
"conformance" : [
"SHOULD"
],
"conditionality" : false,
"requirement" : "The system SHOULD capture metadata that identifies the source of non-originated Record Entry (e.g., templated, copied, duplicated, or boilerplate information)."
},
{
"extension" : [
{
"url" : "http://hl7.org/ehrs/StructureDefinition/requirements-dependent",
"valueBoolean" : false
}
],
"key" : "EHRSFMR2.1-RI.1.1.1-09",
"label" : "RI.1.1.1#09",
"conformance" : [
"MAY"
],
"conditionality" : false,
"requirement" : "The system MAY provide the ability to tag unstructured Record Entry content to organize it according to need, for example, in a time-related fashion or by application-specific groups (such as photographs, handwritten notes, or auditory sounds), or by order of relative importance."
},
{
"extension" : [
{
"url" : "http://hl7.org/ehrs/StructureDefinition/requirements-dependent",
"valueBoolean" : false
}
],
"key" : "EHRSFMR2.1-RI.1.1.1-10",
"label" : "RI.1.1.1#10",
"conformance" : [
"MAY"
],
"conditionality" : false,
"requirement" : "The system MAY capture and maintain a Record Entry encoded as a standards-based data object (e.g., HL7 Continuity of Care, other HL7 CDA R2 Document, ISO 13606 artifact)."
},
{
"extension" : [
{
"url" : "http://hl7.org/ehrs/StructureDefinition/requirements-dependent",
"valueBoolean" : false
}
],
"key" : "EHRSFMR2.1-RI.1.1.1-11",
"label" : "RI.1.1.1#11",
"conformance" : [
"MAY"
],
"conditionality" : false,
"requirement" : "The system MAY capture and maintain a standards-based data object to mirror (be duplicate and synchronous with) internal Record Entry representation."
}
]
}