ISO/HL7 10781 - Electronic Health Record System Functional Model, Release 2.1
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: RI.1.1.1 Originate/Retain Record Lifecycle Event (Function) - JSON Representation

Active as of 2024-11-26

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{
  "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" : "2.1.0",
  "name" : "RI_1_1_1_Originate_Retain_Record_Lifecycle_Event",
  "title" : "RI.1.1.1 Originate/Retain Record Lifecycle Event (Function)",
  "status" : "active",
  "date" : "2024-11-26T16:30:50+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)",
  "jurisdiction" : [
    {
      "coding" : [
        {
          "system" : "http://unstats.un.org/unsd/methods/m49/m49.htm",
          "code" : "001",
          "display" : "World"
        }
      ]
    }
  ],
  "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."
    }
  ]
}