EHRS-FM IG

ISO/HL7 10781 - Electronic Health Record System Functional Model, Release 2.1
0.16.0 - CI Build

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: RI.1.1.6.1 Evidence of Record Entry Output/Report Event (Function) - JSON Representation

Active as of 2024-08-12

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{
  "resourceType" : "Requirements",
  "id" : "EHRSFMR2.1-RI.1.1.6.1",
  "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 Output/Report 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 Output/Report 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.1.1.6.1#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 an output (e.g., report, screen shot) is generated from 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.1.1.6.1#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 output/report is generated from 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.1.1.6.1#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 the Record Entry(ies) populating the output/report generated.</p>\n</div></span>\n                \n                \n            </td>\n        </tr>\n        \n        <tr>\n            <td style=\"padding-left: 4px;\">\n                \n                <span>RI.1.1.6.1#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 user who generated the output/report 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.1.1.6.1#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 system application from which the output/report is generated.</p>\n</div></span>\n                \n                \n            </td>\n        </tr>\n        \n        <tr>\n            <td style=\"padding-left: 4px;\">\n                \n                <span>RI.1.1.6.1#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 the type of Record Event trigger (i.e., output/report).</p>\n</div></span>\n                \n                \n            </td>\n        </tr>\n        \n        <tr>\n            <td style=\"padding-left: 4px;\">\n                \n                <span>RI.1.1.6.1#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 capture the date and time the output/report is generated.</p>\n</div></span>\n                \n                \n            </td>\n        </tr>\n        \n        <tr>\n            <td style=\"padding-left: 4px;\">\n                \n                <span>RI.1.1.6.1#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 identity of the location (i.e., network address) where the output/report is generated.</p>\n</div></span>\n                \n                \n            </td>\n        </tr>\n        \n        <tr>\n            <td style=\"padding-left: 4px;\">\n                \n                <span>RI.1.1.6.1#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 capture the rationale for generating the output/report.</p>\n</div></span>\n                \n                \n            </td>\n        </tr>\n        \n        <tr>\n            <td style=\"padding-left: 4px;\">\n                \n                <span>RI.1.1.6.1#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 the data, document, or other identifier for the output/report generated.</p>\n</div></span>\n                \n                \n            </td>\n        </tr>\n        \n        <tr>\n            <td style=\"padding-left: 4px;\">\n                \n                <span>RI.1.1.6.1#11</span>\n                \n            </td>\n            <td style=\"padding-left: 4px;\">\n                \n                <i>dependent</i>\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 when a Record Entry content output/report occurrence is known to be a disclosure, according to scope of practice, organizational policy, and/or jurisdictional law.</p>\n</div></span>\n                \n                \n            </td>\n        </tr>\n        \n        <tr>\n            <td style=\"padding-left: 4px;\">\n                \n                <span>RI.1.1.6.1#12</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 known and applicable permissions regarding Record Entry content output/reported including confidentiality codes, patient consent authorizations, privacy policy pointers.</p>\n</div></span>\n                \n                \n            </td>\n        </tr>\n        \n    </table>\n</div>"
  },
  "url" : "http://hl7.org/ehrs/Requirements/EHRSFMR2.1-RI.1.1.6.1",
  "version" : "0.16.0",
  "name" : "RI_1_1_6_1_Evidence_of_Record_Entry_Output_Report_Event",
  "title" : "RI.1.1.6.1 Evidence of Record Entry Output/Report 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" : "Maintain Evidence of Record Entry Output/Report Event",
  "purpose" : "Evidence of Record Entry Output/Report 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.1.1.6.1-01",
      "label" : "RI.1.1.6.1#01",
      "conformance" : [
        "SHALL"
      ],
      "conditionality" : false,
      "requirement" : "The system SHALL audit each occurrence when an output (e.g., report, screen shot) is generated from Record Entry content."
    },
    {
      "extension" : [
        {
          "url" : "http://hl7.org/ehrs/StructureDefinition/requirements-dependent",
          "valueBoolean" : false
        }
      ],
      "key" : "EHRSFMR2.1-RI.1.1.6.1-02",
      "label" : "RI.1.1.6.1#02",
      "conformance" : [
        "SHALL"
      ],
      "conditionality" : false,
      "requirement" : "The system SHALL capture identity of the organization where output/report is generated from Record Entry content."
    },
    {
      "extension" : [
        {
          "url" : "http://hl7.org/ehrs/StructureDefinition/requirements-dependent",
          "valueBoolean" : false
        }
      ],
      "key" : "EHRSFMR2.1-RI.1.1.6.1-03",
      "label" : "RI.1.1.6.1#03",
      "conformance" : [
        "SHALL"
      ],
      "conditionality" : false,
      "requirement" : "The system SHALL capture identity of the patient who is subject of the Record Entry(ies) populating the output/report generated."
    },
    {
      "extension" : [
        {
          "url" : "http://hl7.org/ehrs/StructureDefinition/requirements-dependent",
          "valueBoolean" : false
        }
      ],
      "key" : "EHRSFMR2.1-RI.1.1.6.1-04",
      "label" : "RI.1.1.6.1#04",
      "conformance" : [
        "SHALL"
      ],
      "conditionality" : false,
      "requirement" : "The system SHALL capture identity of the user who generated the output/report of Record Entry content."
    },
    {
      "extension" : [
        {
          "url" : "http://hl7.org/ehrs/StructureDefinition/requirements-dependent",
          "valueBoolean" : false
        }
      ],
      "key" : "EHRSFMR2.1-RI.1.1.6.1-05",
      "label" : "RI.1.1.6.1#05",
      "conformance" : [
        "SHALL"
      ],
      "conditionality" : false,
      "requirement" : "The system SHALL capture identity of the system application from which the output/report is generated."
    },
    {
      "extension" : [
        {
          "url" : "http://hl7.org/ehrs/StructureDefinition/requirements-dependent",
          "valueBoolean" : false
        }
      ],
      "key" : "EHRSFMR2.1-RI.1.1.6.1-06",
      "label" : "RI.1.1.6.1#06",
      "conformance" : [
        "SHALL"
      ],
      "conditionality" : false,
      "requirement" : "The system SHALL capture the type of Record Event trigger (i.e., output/report)."
    },
    {
      "extension" : [
        {
          "url" : "http://hl7.org/ehrs/StructureDefinition/requirements-dependent",
          "valueBoolean" : false
        }
      ],
      "key" : "EHRSFMR2.1-RI.1.1.6.1-07",
      "label" : "RI.1.1.6.1#07",
      "conformance" : [
        "SHALL"
      ],
      "conditionality" : false,
      "requirement" : "The system SHALL capture the date and time the output/report is generated."
    },
    {
      "extension" : [
        {
          "url" : "http://hl7.org/ehrs/StructureDefinition/requirements-dependent",
          "valueBoolean" : false
        }
      ],
      "key" : "EHRSFMR2.1-RI.1.1.6.1-08",
      "label" : "RI.1.1.6.1#08",
      "conformance" : [
        "SHOULD"
      ],
      "conditionality" : false,
      "requirement" : "The system SHOULD capture identity of the location (i.e., network address) where the output/report is generated."
    },
    {
      "extension" : [
        {
          "url" : "http://hl7.org/ehrs/StructureDefinition/requirements-dependent",
          "valueBoolean" : false
        }
      ],
      "key" : "EHRSFMR2.1-RI.1.1.6.1-09",
      "label" : "RI.1.1.6.1#09",
      "conformance" : [
        "MAY"
      ],
      "conditionality" : false,
      "requirement" : "The system MAY capture the rationale for generating the output/report."
    },
    {
      "extension" : [
        {
          "url" : "http://hl7.org/ehrs/StructureDefinition/requirements-dependent",
          "valueBoolean" : false
        }
      ],
      "key" : "EHRSFMR2.1-RI.1.1.6.1-10",
      "label" : "RI.1.1.6.1#10",
      "conformance" : [
        "MAY"
      ],
      "conditionality" : false,
      "requirement" : "The system MAY capture the data, document, or other identifier for the output/report generated."
    },
    {
      "extension" : [
        {
          "url" : "http://hl7.org/ehrs/StructureDefinition/requirements-dependent",
          "valueBoolean" : true
        }
      ],
      "key" : "EHRSFMR2.1-RI.1.1.6.1-11",
      "label" : "RI.1.1.6.1#11",
      "conformance" : [
        "SHALL"
      ],
      "conditionality" : false,
      "requirement" : "The system SHALL capture when a Record Entry content output/report occurrence is known to be a disclosure, according to scope of practice, organizational policy, and/or jurisdictional law."
    },
    {
      "extension" : [
        {
          "url" : "http://hl7.org/ehrs/StructureDefinition/requirements-dependent",
          "valueBoolean" : false
        }
      ],
      "key" : "EHRSFMR2.1-RI.1.1.6.1-12",
      "label" : "RI.1.1.6.1#12",
      "conformance" : [
        "SHOULD"
      ],
      "conditionality" : false,
      "requirement" : "The system SHOULD capture known and applicable permissions regarding Record Entry content output/reported including confidentiality codes, patient consent authorizations, privacy policy pointers."
    }
  ]
}