Implementation Guide
ePA Medication Service
Version 1.2.0 - release

Operation API: eML-Eintrag hinzufügen

Diese Operation eML-Eintrag hinzufügen ermöglicht das gezielte Hinzufügen (Nachtragen) eines Medikations-Eintrags zur elektronischen Medikationsliste (eML). Anhand der Eingangsdaten werden im Medication Service folgende FHIR-Artefakte erzeugt bzw. aktualisiert:

  • Eine Medikationsinformation als Instanz gemäß Profil EPAMedicationStatement, welche den Nachtrag einer Medikation und der Einnahmeinformation enthält – einschließlich Feldern wie dosage und effective[x].
  • Ein zugehöriges Arzneimittel als Instanz gemäß Profil EPAMedication.
  • Ein zugehöriger Änderungseintrag als Instanz gemäß Profil EPAActivityProvenance.
  • Eine zum Änderungseintrag zugehörige verordnende LEI als Instanz gemäß Profil TIOrganization.

Nachricht

Die Nachricht zum Hinzufügen eines Medikationseintrags zur eML wird als HTTP POST-Anfrage an den Medication Service gesendet.

Verwendung des HTTP Header X-Requesting-Organization

Bei der Ausführung dieser Operation ist der HTTP Header X-Requesting-Organization mitzugeben. Er enthält eine FHIR Organization-Ressource im Format FHIR+JSON, die Base64-kodiert übermittelt wird.

Die übermittelte Organisation dient zur Identifikation der anfragenden Leistungserbringerinstitution (LEI). Sie wird vom Service validiert, in jedem Änderungseintrag (Provenance nach dem Profil EPA Activity Provenance) der betroffenen Instanz referenziert und zusätzlich im Medication Service als Organization-Ressource dedupliziert gespeichert. Dadurch ist sichergestellt, dass alle Änderungen eindeutig einer LEI zugeordnet und auch über die Query API nachvollzogen werden können

Auslösung

Wenn das ePA-Client-System Medikationseinträge der elektronischen Medikationsliste ergänzen möchte, verwendet es diese Operation des Medication Service.

Antwort

Die Operation gibt den erzeugten Medikationseintrag mit den Instanzen gemäß EPAMedicationStatement und EPAMedication als Ergebnis zurück.

FHIR Operation API

Das Primärsystem MUSS die Operation API: eML-Eintrag hinzufügen implementieren, um einer Leistungserbringerinstitution den Nachtrag in eine eML zu ermöglichen. Das Primärsystem MUSS für die Ausführung der Operation eML-Eintrag hinzufügen den HTTP-Header X-Requesting-Organization übermitteln. Der Medication Service MUSS für die Operation eML-Eintrag hinzufügen die im HTTP-Header X-Requesting-Organization enthaltene Organization-Ressource validieren, im Änderungseintrag (Provenance nach dem Profil EPAActivityProvenance) referenzieren und als Organization-Instanz dedupliziert speichern. Der Medication Service MUSS die Operation API: eML-Eintrag hinzufügen gemäß der FHIR OperationDefinition eML-Eintrag hinzufügen implementieren.
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exists"},{"url":"responseType","valueString":"EPAMSOperationOutcome"},{"url":"errorCode","valueString":"MEDSVC_EMP_ENTRY_ALREADY_EXISTS"}],"url":"https://gematik.de/fhir/ti/StructureDefinition/extension-http-response-info"}],"name":"add-emp-entry","definition":"https://gematik.de/fhir/epa-medication/OperationDefinition/add-emp-entry-op"},{"extension":[{"url":"http://hl7.org/fhir/StructureDefinition/capabilitystatement-expectation","valueCode":"SHALL"},{"extension":[{"url":"name","valueString":"X-Requesting-Organization"},{"url":"type","valueString":"string"},{"url":"description","valueString":"Base64 encoded FHIR Organization resource in JSON format used to identify the originator of the request"},{"url":"format","valueString":"base64(fhir+json:Organization)"},{"url":"required","valueBoolean":true}],"url":"https://gematik.de/fhir/ti/StructureDefinition/extension-http-header"},{"extension":[{"url":"statusCode","valueString":"200"},{"url":"description","valueString":"Successful operation"},{"url":"responseType","valueString":"Parameters"}],"url":"https://gematik.de/fhir/ti/StructureDefinition/extension-http-response-info"},{"extension":[{"url":"statusCode","valueString":"403"},{"url":"description","valueString":"ID-Token or Insurant-ID mismatch"},{"url":"responseType","valueString":"EPAMSOperationOutcome"},{"url":"errorCode","valueString":"SVC_IDENTITY_MISMATCH"}],"url":"https://gematik.de/fhir/ti/StructureDefinition/extension-http-response-info"},{"extension":[{"url":"statusCode","valueString":"400"},{"url":"description","valueString":"Profile mismatch in header Organization"},{"url":"responseType","valueString":"EPAMSOperationOutcome"},{"url":"errorCode","valueString":"SVC_ORG_HEADER_PROFILE_MISMATCH"}],"url":"https://gematik.de/fhir/ti/StructureDefinition/extension-http-response-info"},{"extension":[{"url":"statusCode","valueString":"409"},{"url":"description","valueString":"Update Conflict (server current version = %s, client version referenced = %s)"},{"url":"responseType","valueString":"EPAMSOperationOutcome"},{"url":"errorCode","valueString":"MSG_VERSION_AWARE_CONFLICT"}],"url":"https://gematik.de/fhir/ti/StructureDefinition/extension-http-response-info"},{"extension":[{"url":"statusCode","valueString":"404"},{"url":"description","valueString":"Resource is not known"},{"url":"responseType","valueString":"EPAMSOperationOutcome"},{"url":"errorCode","valueString":"MSG_RESOURCE_ID_FAIL"}],"url":"https://gematik.de/fhir/ti/StructureDefinition/extension-http-response-info"},{"extension":[{"url":"statusCode","valueString":"400"},{"url":"description","valueString":"Invalid dosage structure or content"},{"url":"responseType","valueString":"EPAMSOperationOutcome"},{"url":"errorCode","valueString":"MEDSVC_DOSAGE_INVALID"}],"url":"https://gematik.de/fhir/ti/StructureDefinition/extension-http-response-info"},{"extension":[{"url":"statusCode","valueString":"400"},{"url":"description","valueString":"Invalid Data Structure in Medication Service"},{"url":"responseType","valueString":"EPAMSOperationOutcome"},{"url":"errorCode","valueString":"MEDSVC_NO_VALID_STRUCTURE"}],"url":"https://gematik.de/fhir/ti/StructureDefinition/extension-http-response-info"},{"extension":[{"url":"statusCode","valueString":"400"},{"url":"description","valueString":"Parameter with wrong status"},{"url":"responseType","valueString":"EPAMSOperationOutcome"},{"url":"errorCode","valueString":"MEDSVC_STATUS_INVALID"}],"url":"https://gematik.de/fhir/ti/StructureDefinition/extension-http-response-info"},{"extension":[{"url":"statusCode","valueString":"409"},{"url":"description","valueString":"Mismatch between acknowledged and current eMP chronology ID"},{"url":"responseType","valueString":"EPAMSOperationOutcome"},{"url":"errorCode","valueString":"MEDSVC_EMP_CHRONOLOGY_ID_MISMATCH"}],"url":"https://gematik.de/fhir/ti/StructureDefinition/extension-http-response-info"}],"name":"update-emp-entry","definition":"https://gematik.de/fhir/epa-medication/OperationDefinition/update-emp-entry-op"},{"extension":[{"url":"http://hl7.org/fhir/StructureDefinition/capabilitystatement-expectation","valueCode":"SHALL"},{"extension":[{"url":"name","valueString":"X-Requesting-Organization"},{"url":"type","valueString":"string"},{"url":"description","valueString":"Base64 encoded FHIR Organization resource in JSON format used to identify the originator of the request"},{"url":"format","valueString":"base64(fhir+json:Organization)"},{"url":"required","valueBoolean":true}],"url":"https://gematik.de/fhir/ti/StructureDefinition/extension-http-header"},{"extension":[{"url":"statusCode","valueString":"200"},{"url":"description","valueString":"Successful operation"},{"url":"responseType","valueString":"Bundle"}],"url":"https://gematik.de/fhir/ti/StructureDefinition/extension-http-response-info"},{"extension":[{"url":"statusCode","valueString":"400"},{"url":"description","valueString":"Invalid request"},{"url":"responseType","valueString":"EPAMSOperationOutcome"},{"url":"errorCode","valueString":"MSG_BAD_FORMAT"}],"url":"https://gematik.de/fhir/ti/StructureDefinition/extension-http-response-info"},{"extension":[{"url":"statusCode","valueString":"409"},{"url":"description","valueString":"Mismatch between acknowledged and current eMP chronology ID"},{"url":"responseType","valueString":"EPAMSOperationOutcome"},{"url":"errorCode","valueString":"MEDSVC_EMP_CHRONOLOGY_ID_MISMATCH"}],"url":"https://gematik.de/fhir/ti/StructureDefinition/extension-http-response-info"},{"extension":[{"url":"statusCode","valueString":"400"},{"url":"description","valueString":"Invalid dosage structure or content"},{"url":"responseType","valueString":"EPAMSOperationOutcome"},{"url":"errorCode","valueString":"MEDSVC_DOSAGE_INVALID"}],"url":"https://gematik.de/fhir/ti/StructureDefinition/extension-http-response-info"},{"extension":[{"url":"statusCode","valueString":"400"},{"url":"description","valueString":"Invalid Data Structure in Medication Service"},{"url":"responseType","valueString":"EPAMSOperationOutcome"},{"url":"errorCode","valueString":"MEDSVC_NO_VALID_STRUCTURE"}],"url":"https://gematik.de/fhir/ti/StructureDefinition/extension-http-response-info"},{"extension":[{"url":"statusCode","valueString":"400"},{"url":"description","valueString":"Parameter with wrong status"},{"url":"responseType","valueString":"EPAMSOperationOutcome"},{"url":"errorCode","valueString":"MEDSVC_STATUS_INVALID"}],"url":"https://gematik.de/fhir/ti/StructureDefinition/extension-http-response-info"},{"extension":[{"url":"statusCode","valueString":"409"},{"url":"description","valueString":"Update Conflict (server current version = %s, client version referenced = %s)"},{"url":"responseType","valueString":"EPAMSOperationOutcome"},{"url":"errorCode","valueString":"MSG_VERSION_AWARE_CONFLICT"}],"url":"https://gematik.de/fhir/ti/StructureDefinition/extension-http-response-info"},{"extension":[{"url":"statusCode","valueString":"404"},{"url":"description","valueString":"Resource is not known"},{"url":"responseType","valueString":"EPAMSOperationOutcome"},{"url":"errorCode","valueString":"MSG_RESOURCE_ID_FAIL"}],"url":"https://gematik.de/fhir/ti/StructureDefinition/extension-http-response-info"}],"name":"batch-emp","definition":"https://gematik.de/fhir/epa-medication/OperationDefinition/batch-emp-entries-op"},{"extension":[{"url":"http://hl7.org/fhir/StructureDefinition/capabilitystatement-expectation","valueCode":"SHALL"},{"extension":[{"url":"name","valueString":"X-Requesting-Organization"},{"url":"type","valueString":"string"},{"url":"description","valueString":"Base64 encoded FHIR Organization resource in JSON format used to identify the originator of the request"},{"url":"format","valueString":"base64(fhir+json:Organization)"},{"url":"required","valueBoolean":true}],"url":"https://gematik.de/fhir/ti/StructureDefinition/extension-http-header"},{"extension":[{"url":"statusCode","valueString":"200"},{"url":"description","valueString":"Successful operation"},{"url":"responseType","valueString":"Parameters"}],"url":"https://gematik.de/fhir/ti/StructureDefinition/extension-http-response-info"},{"extension":[{"url":"statusCode","valueString":"405"},{"url":"description","valueString":"The operation can only be executed within a batch context"},{"url":"responseType","valueString":"EPAMSOperationOutcome"},{"url":"errorCode","valueString":"MEDSVC_OPERATION_OUTSIDE_BATCH"}],"url":"https://gematik.de/fhir/ti/StructureDefinition/extension-http-response-info"},{"extension":[{"url":"statusCode","valueString":"409"},{"url":"description","valueString":"Mismatch between acknowledged and current eMP chronology ID"},{"url":"responseType","valueString":"EPAMSOperationOutcome"},{"url":"errorCode","valueString":"MEDSVC_EMP_CHRONOLOGY_ID_MISMATCH"}],"url":"https://gematik.de/fhir/ti/StructureDefinition/extension-http-response-info"}],"name":"emp-commit","definition":"https://gematik.de/fhir/epa-medication/OperationDefinition/emp-commit-op"}]}]}
    
      {"resourceType":"OperationDefinition","id":"add-eml-entry-op","meta":{"profile":["https://gematik.de/fhir/ti/StructureDefinition/ti-operationdefinition"]},"text":{"status":"generated","div":"<div xmlns=\"http://www.w3.org/1999/xhtml\"><p class=\"res-header-id\">Generated Narrative: OperationDefinition add-eml-entry-op</p><a name=\"add-eml-entry-op\"> </a><a name=\"hcadd-eml-entry-op\"> </a><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\"/><p style=\"margin-bottom: 0px\">Profile: <a href=\"https://simplifier.net/resolve?scope=de.gematik.ti@1.1.1&canonical=https://gematik.de/fhir/ti/StructureDefinition/ti-operationdefinition\">OperationDefinition Profil für TI FHIR Data Service</a></p></div>

URL: [base]/MedicationStatement/$add-eml-entry

Input parameters Profile:<a href=\"StructureDefinition-epa-op-add-eml-entry-input-parameters.html\">EPA Operation addEMLEntry Input-Parameters</a>

Output parameters Profile:<a href=\"StructureDefinition-epa-op-eml-entry-output-parameters.html\">EPA Operation EMLEntry Output-Parameters</a>

Parameters

<table class=\"grid\">UseNameScopeCardinalityTypeBindingDocumentation</table></div>"},"extension":[{"url":"https://gematik.de/fhir/ti/StructureDefinition/extension-http-method","valueCode":"POST"}],"url":"https://gematik.de/fhir/epa-medication/OperationDefinition/add-eml-entry-op","version":"1.2.0","name":"addEMLEntry_MedicationSvc","title":"Add Medication List Entry","status":"active","kind":"operation","date":"2025-09-12","publisher":"gematik GmbH","contact":[{"name":"gematik GmbH","telecom":[{"system":"url","value":"https://www.gematik.de"},{"system":"email","value":"patientteam [ at ] gematik.de"}]}],"description":"Diese Operation ermöglicht das gezielte Hinzufügen einer neuen Medikation zur elektronischen Medikationsliste (eML).","jurisdiction":[{"coding":[{"system":"urn:iso:std:iso:3166","code":"DE"}]}],"affectsState":true,"code":"add-eml-entry","resource":["MedicationStatement"],"system":false,"type":true,"instance":false,"inputProfile":"https://gematik.de/fhir/epa-medication/StructureDefinition/epa-op-add-eml-entry-input-parameters","outputProfile":"https://gematik.de/fhir/epa-medication/StructureDefinition/epa-op-eml-entry-output-parameters"}
{
  "resourceType" : "Parameters",
  "id" : "example-epa-op-add-eml-entry-input-parameters-1",
  "meta" : {
    "profile" : [
      🔗 "https://gematik.de/fhir/epa-medication/StructureDefinition/epa-op-add-eml-entry-input-parameters"
    ]
  },
  "parameter" : [
    {
      "name" : "medicationStatement",
      "resource" : {
        "resourceType" : "MedicationStatement",
        "id" : "36581a11-806e-4455-a1c9-9173b7d247fd",
        "meta" : {
          "profile" : [
            🔗 "https://gematik.de/fhir/epa-medication/StructureDefinition/epa-medication-statement"
          ]
        },
        "extension" : [
          {
            "url" : "https://gematik.de/fhir/epa-medication/StructureDefinition/context-extension",
            "valueCode" : "MANUAL"
          },
          {
            "url" : "http://hl7.org/fhir/5.0/StructureDefinition/extension-MedicationStatement.renderedDosageInstruction",
            "valueMarkdown" : "1-0-1-0 Stück"
          },
          {
            "extension" : [
              {
                "url" : "algorithmVersion",
                "valueString" : "1.0.0"
              },
              {
                "url" : "language",
                "valueCode" : "de-DE"
              }
            ],
            "url" : "http://ig.fhir.de/igs/medication/StructureDefinition/GeneratedDosageInstructionsMeta"
          }
        ],
        "status" : "unknown",
        "medicationReference" : {
          "reference" : "Medication/fe79ff64-42e5-4cf8-a8d1-5ce527323dcc"
        },
        "subject" : {
          "identifier" : {
            "system" : "http://fhir.de/sid/gkv/kvid-10",
            "value" : "X110411319"
          }
        },
        "effectivePeriod" : {
          "start" : "2026-02-10"
        },
        "dosage" : [
          {
            "timing" : {
              "repeat" : {
                "frequency" : 2,
                "period" : 1,
                "periodUnit" : "d",
                "when" : [
                  "MORN",
                  "EVE"
                ]
              }
            },
            "doseAndRate" : [
              {
                "doseQuantity" : {
                  "value" : 1,
                  "unit" : "Stück",
                  "system" : "https://fhir.kbv.de/CodeSystem/KBV_CS_SFHIR_BMP_DOSIEREINHEIT",
                  "code" : "1"
                }
              }
            ]
          }
        ]
      }
    },
    {
      "name" : "medication",
      "resource" : {
        "resourceType" : "Medication",
        "id" : "fe79ff64-42e5-4cf8-a8d1-5ce527323dcc",
        "meta" : {
          "profile" : [
            🔗 "https://gematik.de/fhir/epa-medication/StructureDefinition/epa-medication"
          ]
        },
        "extension" : [
          {
            "url" : "https://gematik.de/fhir/epa-medication/StructureDefinition/epa-medication-type-extension",
            "valueCoding" : {
              "system" : "http://snomed.info/sct",
              "code" : "781405001",
              "display" : "Medicinal product package (product)"
            }
          },
          {
            "url" : "http://fhir.de/StructureDefinition/normgroesse",
            "valueCode" : "N1"
          }
        ],
        "code" : {
          "coding" : [
            {
              "system" : "http://fhir.de/CodeSystem/ifa/pzn",
              "code" : "14170042",
              "display" : "Diclo-ratiopharm® bei Schmerzen und Fieber 25 mg Filmtabletten"
            }
          ],
          "text" : "Diclo-ratiopharm® bei Schmerzen und Fieber 25 mg Filmtabletten"
        },
        "status" : "active",
        "form" : {
          "coding" : [
            {
              "system" : "https://fhir.kbv.de/CodeSystem/KBV_CS_SFHIR_KBV_DARREICHUNGSFORM",
              "code" : "TAB"
            }
          ]
        },
        "amount" : {
          "numerator" : {
            "extension" : [
              {
                "url" : "https://gematik.de/fhir/epa-medication/StructureDefinition/medication-total-quantity-formulation-extension",
                "valueString" : "20 St."
              }
            ],
            "value" : 20,
            "unit" : "St"
          },
          "denominator" : {
            "value" : 1
          }
        }
      }
    }
  ]
}

<Parameters xmlns="http://hl7.org/fhir">
  <id value="example-epa-op-add-eml-entry-input-parameters-1"/>
  <meta>
    <profile
             value="https://gematik.de/fhir/epa-medication/StructureDefinition/epa-op-add-eml-entry-input-parameters"/>
  </meta>
  <parameter>
    <name value="medicationStatement"/>
    <resource>
      <MedicationStatement>
        <id value="36581a11-806e-4455-a1c9-9173b7d247fd"/>
        <meta>
          <profile
                   value="https://gematik.de/fhir/epa-medication/StructureDefinition/epa-medication-statement"/>
        </meta>
        <extension
                   url="https://gematik.de/fhir/epa-medication/StructureDefinition/context-extension">
          <valueCode value="MANUAL"/>
        </extension>
        <extension
                   url="http://hl7.org/fhir/5.0/StructureDefinition/extension-MedicationStatement.renderedDosageInstruction">
          <valueMarkdown value="1-0-1-0 Stück"/>
        </extension>
        <extension
                   url="http://ig.fhir.de/igs/medication/StructureDefinition/GeneratedDosageInstructionsMeta">
          <extension url="algorithmVersion">
            <valueString value="1.0.0"/>
          </extension>
          <extension url="language">
            <valueCode value="de-DE"/>
          </extension>
        </extension>
        <status value="unknown"/>
        <medicationReference>
          <reference value="Medication/fe79ff64-42e5-4cf8-a8d1-5ce527323dcc"/>
        </medicationReference>
        <subject>
          <identifier>
            <system value="http://fhir.de/sid/gkv/kvid-10"/>
            <value value="X110411319"/>
          </identifier>
        </subject>
        <effectivePeriod>
          <start value="2026-02-10"/>
        </effectivePeriod>
        <dosage>
          <timing>
            <repeat>
              <frequency value="2"/>
              <period value="1"/>
              <periodUnit value="d"/>
              <when value="MORN"/>
              <when value="EVE"/>
            </repeat>
          </timing>
          <doseAndRate>
            <doseQuantity>
              <value value="1"/>
              <unit value="Stück"/>
              <system
                      value="https://fhir.kbv.de/CodeSystem/KBV_CS_SFHIR_BMP_DOSIEREINHEIT"/>
              <code value="1"/>
            </doseQuantity>
          </doseAndRate>
        </dosage>
      </MedicationStatement>
    </resource>
  </parameter>
  <parameter>
    <name value="medication"/>
    <resource>
      <Medication>
        <id value="fe79ff64-42e5-4cf8-a8d1-5ce527323dcc"/>
        <meta>
          <profile
                   value="https://gematik.de/fhir/epa-medication/StructureDefinition/epa-medication"/>
        </meta>
        <extension
                   url="https://gematik.de/fhir/epa-medication/StructureDefinition/epa-medication-type-extension">
          <valueCoding>
            <system value="http://snomed.info/sct"/>
            <code value="781405001"/>
            <display value="Medicinal product package (product)"/>
          </valueCoding>
        </extension>
        <extension url="http://fhir.de/StructureDefinition/normgroesse">
          <valueCode value="N1"/>
        </extension>
        <code>
          <coding>
            <system value="http://fhir.de/CodeSystem/ifa/pzn"/>
            <code value="14170042"/>
            <display
                     value="Diclo-ratiopharm® bei Schmerzen und Fieber 25 mg Filmtabletten"/>
          </coding>
          <text
                value="Diclo-ratiopharm® bei Schmerzen und Fieber 25 mg Filmtabletten"/>
        </code>
        <status value="active"/>
        <form>
          <coding>
            <system
                    value="https://fhir.kbv.de/CodeSystem/KBV_CS_SFHIR_KBV_DARREICHUNGSFORM"/>
            <code value="TAB"/>
          </coding>
        </form>
        <amount>
          <numerator>
            <extension
                       url="https://gematik.de/fhir/epa-medication/StructureDefinition/medication-total-quantity-formulation-extension">
              <valueString value="20 St."/>
            </extension>
            <value value="20"/>
            <unit value="St"/>
          </numerator>
          <denominator>
            <value value="1"/>
          </denominator>
        </amount>
      </Medication>
    </resource>
  </parameter>
</Parameters>
{
  "resourceType" : "Parameters",
  "id" : "example-epa-op-eml-entry-output-parameters-1",
  "meta" : {
    "profile" : [
      🔗 "https://gematik.de/fhir/epa-medication/StructureDefinition/epa-op-eml-entry-output-parameters"
    ]
  },
  "parameter" : [
    {
      "name" : "medicationStatement",
      "resource" : {
        "resourceType" : "MedicationStatement",
        "id" : "71601cdb-8a53-4f26-b5d5-e5457b498e76",
        "meta" : {
          "versionId" : "1",
          "lastUpdated" : "2026-02-22T14:43:33.444Z",
          "profile" : [
            🔗 "https://gematik.de/fhir/epa-medication/StructureDefinition/epa-medication-statement"
          ]
        },
        "extension" : [
          {
            "url" : "https://gematik.de/fhir/epa-medication/StructureDefinition/context-extension",
            "valueCode" : "MANUAL"
          },
          {
            "url" : "http://hl7.org/fhir/5.0/StructureDefinition/extension-MedicationStatement.renderedDosageInstruction",
            "valueMarkdown" : "1-0-1-0 Stück"
          },
          {
            "extension" : [
              {
                "url" : "algorithmVersion",
                "valueString" : "1.0.0"
              },
              {
                "url" : "language",
                "valueCode" : "de-DE"
              }
            ],
            "url" : "http://ig.fhir.de/igs/medication/StructureDefinition/GeneratedDosageInstructionsMeta"
          }
        ],
        "status" : "unknown",
        "medicationReference" : {
          🔗 "reference" : "Medication/2571d29b-e213-40ec-b817-a1490718f491"
        },
        "subject" : {
          "identifier" : {
            "system" : "http://fhir.de/sid/gkv/kvid-10",
            "value" : "X110411319"
          }
        },
        "effectivePeriod" : {
          "start" : "2026-02-10"
        },
        "dateAsserted" : "2026-02-22",
        "dosage" : [
          {
            "timing" : {
              "repeat" : {
                "frequency" : 2,
                "period" : 1,
                "periodUnit" : "d",
                "when" : [
                  "MORN",
                  "EVE"
                ]
              }
            },
            "doseAndRate" : [
              {
                "doseQuantity" : {
                  "value" : 1,
                  "unit" : "Stück",
                  "system" : "https://fhir.kbv.de/CodeSystem/KBV_CS_SFHIR_BMP_DOSIEREINHEIT",
                  "code" : "1"
                }
              }
            ]
          }
        ]
      }
    },
    {
      "name" : "medication",
      "resource" : {
        "resourceType" : "Medication",
        "id" : "2571d29b-e213-40ec-b817-a1490718f491",
        "meta" : {
          "versionId" : "1",
          "lastUpdated" : "2026-02-22T14:43:33.244Z",
          "profile" : [
            🔗 "https://gematik.de/fhir/epa-medication/StructureDefinition/epa-medication"
          ]
        },
        "extension" : [
          {
            "url" : "https://gematik.de/fhir/epa-medication/StructureDefinition/epa-medication-type-extension",
            "valueCoding" : {
              "system" : "http://snomed.info/sct",
              "code" : "781405001",
              "display" : "Medicinal product package (product)"
            }
          },
          {
            "url" : "http://fhir.de/StructureDefinition/normgroesse",
            "valueCode" : "N1"
          }
        ],
        "identifier" : [
          {
            "system" : "https://gematik.de/fhir/epa-medication/sid/epa-medication-unique-identifier",
            "value" : "B849184C973EA5FA7D9751E6FAA6AFCFFD100183596239F84DD2C0FG4C751D67"
          }
        ],
        "code" : {
          "coding" : [
            {
              "system" : "http://fhir.de/CodeSystem/ifa/pzn",
              "code" : "14170042",
              "display" : "Diclo-ratiopharm® bei Schmerzen und Fieber 25 mg Filmtabletten"
            }
          ],
          "text" : "Diclo-ratiopharm® bei Schmerzen und Fieber 25 mg Filmtabletten"
        },
        "status" : "active",
        "form" : {
          "coding" : [
            {
              "system" : "https://fhir.kbv.de/CodeSystem/KBV_CS_SFHIR_KBV_DARREICHUNGSFORM",
              "code" : "TAB"
            }
          ]
        },
        "amount" : {
          "numerator" : {
            "extension" : [
              {
                "url" : "https://gematik.de/fhir/epa-medication/StructureDefinition/medication-total-quantity-formulation-extension",
                "valueString" : "20 St."
              }
            ],
            "value" : 20,
            "unit" : "St"
          },
          "denominator" : {
            "value" : 1
          }
        }
      }
    },
    {
      "name" : "relatedActivity",
      "resource" : {
        "resourceType" : "Provenance",
        "id" : "a36b3ae8-1c1d-4dbb-b209-ee2ee9fc31e6",
        "meta" : {
          "profile" : [
            🔗 "https://gematik.de/fhir/epa/StructureDefinition/epa-activity-provenance"
          ]
        },
        "target" : [
          {
            "reference" : "MedicationStatement/71601cdb-8a53-4f26-b5d5-e5457b498e76/_history/1"
          }
        ],
        "recorded" : "2026-08-18T14:43:33.344Z",
        "activity" : {
          "coding" : [
            {
              "system" : "http://terminology.hl7.org/CodeSystem/v3-DataOperation",
              "code" : "CREATE"
            }
          ]
        },
        "agent" : [
          {
            "type" : {
              "coding" : [
                {
                  "system" : "http://terminology.hl7.org/CodeSystem/provenance-participant-type",
                  "code" : "author"
                }
              ]
            },
            "who" : {
              🔗 "reference" : "Organization/8B421590-9F7F-46BE-BD1E-C987063AC4F5",
              "identifier" : {
                "type" : {
                  "coding" : [
                    {
                      "system" : "http://terminology.hl7.org/CodeSystem/v2-0203",
                      "code" : "PRN"
                    }
                  ]
                },
                "system" : "https://gematik.de/fhir/sid/telematik-id",
                "value" : "9-2.58.00000060"
              },
              "display" : "Die Apotheke"
            }
          }
        ]
      }
    }
  ]
}

<Parameters xmlns="http://hl7.org/fhir">
  <id value="example-epa-op-eml-entry-output-parameters-1"/>
  <meta>
    <profile
             value="https://gematik.de/fhir/epa-medication/StructureDefinition/epa-op-eml-entry-output-parameters"/>
  </meta>
  <parameter>
    <name value="medicationStatement"/>
    <resource>
      <MedicationStatement>
        <id value="71601cdb-8a53-4f26-b5d5-e5457b498e76"/>
        <meta>
          <versionId value="1"/>
          <lastUpdated value="2026-02-22T14:43:33.444Z"/>
          <profile
                   value="https://gematik.de/fhir/epa-medication/StructureDefinition/epa-medication-statement"/>
        </meta>
        <extension
                   url="https://gematik.de/fhir/epa-medication/StructureDefinition/context-extension">
          <valueCode value="MANUAL"/>
        </extension>
        <extension
                   url="http://hl7.org/fhir/5.0/StructureDefinition/extension-MedicationStatement.renderedDosageInstruction">
          <valueMarkdown value="1-0-1-0 Stück"/>
        </extension>
        <extension
                   url="http://ig.fhir.de/igs/medication/StructureDefinition/GeneratedDosageInstructionsMeta">
          <extension url="algorithmVersion">
            <valueString value="1.0.0"/>
          </extension>
          <extension url="language">
            <valueCode value="de-DE"/>
          </extension>
        </extension>
        <status value="unknown"/>
        <medicationReference>🔗 
          <reference value="Medication/2571d29b-e213-40ec-b817-a1490718f491"/>
        </medicationReference>
        <subject>
          <identifier>
            <system value="http://fhir.de/sid/gkv/kvid-10"/>
            <value value="X110411319"/>
          </identifier>
        </subject>
        <effectivePeriod>
          <start value="2026-02-10"/>
        </effectivePeriod>
        <dateAsserted value="2026-02-22"/>
        <dosage>
          <timing>
            <repeat>
              <frequency value="2"/>
              <period value="1"/>
              <periodUnit value="d"/>
              <when value="MORN"/>
              <when value="EVE"/>
            </repeat>
          </timing>
          <doseAndRate>
            <doseQuantity>
              <value value="1"/>
              <unit value="Stück"/>
              <system
                      value="https://fhir.kbv.de/CodeSystem/KBV_CS_SFHIR_BMP_DOSIEREINHEIT"/>
              <code value="1"/>
            </doseQuantity>
          </doseAndRate>
        </dosage>
      </MedicationStatement>
    </resource>
  </parameter>
  <parameter>
    <name value="medication"/>
    <resource>
      <Medication>
        <id value="2571d29b-e213-40ec-b817-a1490718f491"/>
        <meta>
          <versionId value="1"/>
          <lastUpdated value="2026-02-22T14:43:33.244Z"/>
          <profile
                   value="https://gematik.de/fhir/epa-medication/StructureDefinition/epa-medication"/>
        </meta>
        <extension
                   url="https://gematik.de/fhir/epa-medication/StructureDefinition/epa-medication-type-extension">
          <valueCoding>
            <system value="http://snomed.info/sct"/>
            <code value="781405001"/>
            <display value="Medicinal product package (product)"/>
          </valueCoding>
        </extension>
        <extension url="http://fhir.de/StructureDefinition/normgroesse">
          <valueCode value="N1"/>
        </extension>
        <identifier>
          <system
                  value="https://gematik.de/fhir/epa-medication/sid/epa-medication-unique-identifier"/>
          <value
                 value="B849184C973EA5FA7D9751E6FAA6AFCFFD100183596239F84DD2C0FG4C751D67"/>
        </identifier>
        <code>
          <coding>
            <system value="http://fhir.de/CodeSystem/ifa/pzn"/>
            <code value="14170042"/>
            <display
                     value="Diclo-ratiopharm® bei Schmerzen und Fieber 25 mg Filmtabletten"/>
          </coding>
          <text
                value="Diclo-ratiopharm® bei Schmerzen und Fieber 25 mg Filmtabletten"/>
        </code>
        <status value="active"/>
        <form>
          <coding>
            <system
                    value="https://fhir.kbv.de/CodeSystem/KBV_CS_SFHIR_KBV_DARREICHUNGSFORM"/>
            <code value="TAB"/>
          </coding>
        </form>
        <amount>
          <numerator>
            <extension
                       url="https://gematik.de/fhir/epa-medication/StructureDefinition/medication-total-quantity-formulation-extension">
              <valueString value="20 St."/>
            </extension>
            <value value="20"/>
            <unit value="St"/>
          </numerator>
          <denominator>
            <value value="1"/>
          </denominator>
        </amount>
      </Medication>
    </resource>
  </parameter>
  <parameter>
    <name value="relatedActivity"/>
    <resource>
      <Provenance>
        <id value="a36b3ae8-1c1d-4dbb-b209-ee2ee9fc31e6"/>
        <meta>
          <profile
                   value="https://gematik.de/fhir/epa/StructureDefinition/epa-activity-provenance"/>
        </meta>
        <target>
          <reference
                     value="MedicationStatement/71601cdb-8a53-4f26-b5d5-e5457b498e76/_history/1"/>
        </target>
        <recorded value="2026-08-18T14:43:33.344Z"/>
        <activity>
          <coding>
            <system
                    value="http://terminology.hl7.org/CodeSystem/v3-DataOperation"/>
            <code value="CREATE"/>
          </coding>
        </activity>
        <agent>
          <type>
            <coding>
              <system
                      value="http://terminology.hl7.org/CodeSystem/provenance-participant-type"/>
              <code value="author"/>
            </coding>
          </type>
          <who>🔗 
            <reference
                       value="Organization/8B421590-9F7F-46BE-BD1E-C987063AC4F5"/>
            <identifier>
              <type>
                <coding>
                  <system
                          value="http://terminology.hl7.org/CodeSystem/v2-0203"/>
                  <code value="PRN"/>
                </coding>
              </type>
              <system value="https://gematik.de/fhir/sid/telematik-id"/>
              <value value="9-2.58.00000060"/>
            </identifier>
            <display value="Die Apotheke"/>
          </who>
        </agent>
      </Provenance>
    </resource>
  </parameter>
</Parameters>

Geschäftslogik

Der Medication Service MUSS bei der Ausführung der Operation eML-Eintrag hinzufügen sicherstellen, dass jede neu erzeugte MedicationStatement-Instanz die Extension https://gematik.de/fhir/epa-medication/StructureDefinition/context-extension mit dem Wert MANUAL enthält. Der Medication Service MUSS die Geschäftlogik der Operation eML-Eintrag hinzufügen gemäß dem Aktivitätsdiagramm mit der ID IG-MED-BL-ADD-EML-ENTRY-V2 ausführen. Dabei sind alle mit transaction gekennzeichneten Abschnitte entsprechend den Transaktionssicherheitsregeln der ePA umzusetzen, sodass diese Abschnitte mit ihren Verarbeitungsschritten atomar, konsistent und isoliert durchgeführt werden.
IG-MED-BL-ADD-EML-ENTRY-V2Check whether theOrganizationresource from theX-Requesting-OrganizationHTTP headerconforms to theTIOrganizationprofileReturn errorOperationOutcomewith codestructureand detailsSVC_ORG_HEADER_PROFILE_MISMATCH(HTTP 400)noOrganization is valid?yesCheck whether the KVNR-based logical reference(s) in thesubjectelement match thex-insurantvalue from the HTTP header,and whether the Telematics ID from theX-Requesting-Organizationheader matches the Telematics ID from the ID tokenReturn errorOperationOutcomewith codeforbiddenand detailsSVC_IDENTITY_MISMATCH(HTTP 403)noidentity information is valid?yesValidateInput-Parameters(medicationStatement and medication) according toEPAOpAddEmlEntryInputParametersprofileReturn errorOperationOutcomewith codestructureand detailsMEDSVC_NO_VALID_STRUCTURE(HTTP 400)noValidation successfullyesCheck if thestatusof the inputMedicationis equal toactiveReturn errorOperationOutcomewith codeprocessingand detailsMEDSVC_STATUS_INVALID(HTTP 400)nostatus is equal to activeyesCheck if thestatusof the inputMedicationStatementis equal tounknownReturn errorOperationOutcomewith codeprocessingand detailsMEDSVC_STATUS_INVALID(HTTP 400)nostatus is equal to unknownyesCheck whetherDosageis present inInput-Parameters.parameter[medicationStatement].resource.dosageValidate theextension[renderedDosageInstruction]within theDosageelement according to the HL7 DeutschlandDosageDgMPprofile rules OR check whether it is a free-text dosage instructionReturn errorOperationOutcomewith codestructureand detailsMEDSVC_DOSAGE_INVALID(HTTP 400)notext is valid according to IG or is free-text?yesyesDosage is presentnotransactionCheck for existingOrganizationwith TelematikID from the X-Requesting-Organization HTTP headerOrganization exists?yesno«Update»Organizationderived from X-Requesting-Organization header,conforming to theTIOrganizationprofileidentifier[TelematikID] = value from headerReplace all other elements with the provided instance«Create»Organizationderived from X-Requesting-Organization header,conforming to theTIOrganizationprofileidentifier[TelematikID] = value from headerSet all other elements with the provided instanceGenerate forEPAMedicationUniqueIdentifierfrom hashedInput-Parameters.parameter[medication].resource(Medication)«Create»MedicationfromInput-Parameters.parameter[medication].resourceconforming to theEPAMedicationprofileSet identifier[EPAMedicationUniqueIdentifier] to the provided valueSet status toactive  Copy all other available elements from the input resource«Create»MedicationStatementfromInput-Parameters.parameter[medicationStatement].resource,conforming to theEPAMedicationStatementprofileUse IdentifierKvid10 as subject, reference the previously createdMedication,set dateAsserted to the current date, set extension[context] toMANUAL,and copy all other available data (e.g., status, effective[x], dosage, extension[renderedDosageInstruction], extension[generatedDosageInstructionsMeta], etc.)from the input resource Note:agent.who = Reference(Organization)incl. display and TelematikID identifier alslogical reference «Create»Provenanceconforming to theEPAActivityProvenanceprofileactivity =CREATE  agent.type =author  agent.who = Organization instance derived from X-Requesting-Organization headertarget = versioned reference to the newly createdMedicationStatementinstanceReturnOutput-Parameterscontaining the newly createdMedicationStatement,MedicationandProvenance,as resources inparameter[medicationStatement],parameter[medication]andparameter[relatedActivity],conforming to the profileEPAOpEmlEntryOutputParameters(HTTP 200)
Abbildung: Geschäftslogik für die Operation eML-Eintrag hinzufügen

Sicherheitsanforderungen

Generelle Sicherheitsanforderungen werden hier festgehalten.