ISO/HL7 10781 - Electronic Health Record System Functional Model, Release 2.1
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: RI.1.1.1.1 Evidence of Record Entry Originate/Retain Event (Function) - JSON Representation

Active as of 2024-11-23

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{
  "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" : "2024-11-23T08:20:40+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",
  "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."
    }
  ]
}