Implementation Guide
ePA Medication Service
Version 1.3.3 - release

## Operation API: Hinzufügen einer eML-eMP-Verknüpfung

Die Operation Hinzufügen einer eML-eMP-Verknüpfung dient der Verknüpfung einer bestehenden MedicationStatement Instanz (d.h. Medikationsinformation eines eML-Eintrags) mit einem bereits dokumentierten Eintrag im elektronischen Medikationsplan (eMP). Dabei wird die Operation direkt auf die zu verknüpfende MedicationStatement-Instanz aufgerufen. Als Eingabeparameter wird der eindeutige Identifier des Ziel-eMP-Eintrags übergeben. Die Geschäftslogik des Medication Service stellt daraufhin die Verbindung her und erzeugt eine neue Version des eMP. Im Zuge dessen wird die medicationReference des betroffenen eMP-Eintrags auf die in der Verknüpfung referenzierte Medication gesetzt. Eine Ausnahme bilden hierbei Kombipackungen (kbvDarreichungsform = KPG). Kombipackungen werden im Rahmen einer eML-eMP-Verknüpfung nicht automatisch als medicationReference in den eMP-Eintrag übernommen.

Die Verknüpfung stellt sicher, dass Informationen aus eML und eMP eindeutig zugeordnet sind und gemeinsam aus derselben Quelle im Medication Service stammen. So wird vermieden, dass widersprüchliche Dosierangaben oder doppelte Medikationen auftreten. Diese Verbindung ist insbesondere dann notwendig, wenn ein eML-Eintrag unabhängig vom eMP erstellt wurde – z.B. weil keine eMP-Einträge vorlagen oder ein E-Rezept außerhalb der ePA erstellt wurde. Als Ergebnis gibt die Operation die aktualisierte MedicationStatement-Instanz sowie optional Informationen über die neue eMP-Version in Form einer Provenance-Instanz gemäß des Profils EMPChronologyProvenance zurück.

### Nachricht

Die Nachricht zur Verknüpfung eines eML-Eintrags mit einem eMP-Eintrag wird als HTTP POST-Anfrage an den Medication Service auf die betreffende MedicationStatement-Instanz 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

Die Nachricht wird vom ePA-Client-System gesendet, wenn festgestellt wird, dass ein eML-Eintrag inhaltlich einem bestehenden eMP-Eintrag entspricht und diese Beziehung im System nachvollziehbar dokumentiert werden soll.

#### Antwort

Die Operation gibt den aktualisierten eML-Eintrag (MedicationStatement) sowie optional die zugehörige Provenance-Instanz der neuen eMP-Version als Ergebnis zurück.

#### FHIR Operation API

Das Primärsystem MUSS die Operation Hinzufügen einer eML-eMP-Verknüpfung implementieren, um einen eML-Eintrag mit einem eMP-Eintrag zu verknüpfen. Das Primärsystem MUSS für die Ausführung der Operation Hinzufügen einer eML-eMP-Verknüpfung den HTTP Header X-Requesting-Organization übermitteln. Der Medication Service MUSS für die Operation Hinzufügen einer eML-eMP-Verknüpfung 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 Hinzufügen einer eML-eMP-Verknüpfung gemäß der FHIR OperationDefinition eMP-Eintrag verknüpfen implementieren.

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###

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      "resourceType" : "Parameters",
      "id" : "example-epa-op-link-emp-entry-parameters-1",
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          "name" : "acknowledgedChronologyId",
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        },
        {
          "name" : "medicationPlanIdentifier",
          "valueIdentifier" : {
            "system" : "https://gematik.de/fhir/sid/emp-identifier",
            "value" : "266620a9-2c26-41c1-b0cb-a10947b867f5"
          }
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      ]
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    <Parameters xmlns="http://hl7.org/fhir">
      <id value="example-epa-op-link-emp-entry-parameters-1"/>
      <meta>
        <profile
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      <parameter>
        <name value="acknowledgedChronologyId"/>
        <valueId value="0b383501-f078-464b-b984-9fdb6751601b"/>
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      <parameter>
        <name value="medicationPlanIdentifier"/>
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          <system value="https://gematik.de/fhir/sid/emp-identifier"/>
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      </parameter>
    </Parameters>

    {
      "resourceType" : "Parameters",
      "id" : "example-epa-op-link-emp-entry-output-parameters-1",
      "meta" : {
        "profile" : [
          🔗 "https://gematik.de/fhir/epa-medication/StructureDefinition/epa-op-link-emp-entry-output-parameters|1.3.0"
        ]
      },
      "parameter" : [
        {
          "name" : "medicationStatement",
          "resource" : {
            "resourceType" : "MedicationStatement",
            "id" : "3afe43bc-8b57-417f-9e84-a70ea5062a6c",
            "meta" : {
              "versionId" : "2",
              "lastUpdated" : "2026-11-01T15:43:33.244Z",
              "profile" : [
                🔗 "https://gematik.de/fhir/epa-medication/StructureDefinition/epa-medication-statement|1.3.0"
              ]
            },
            "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" : "1-0-0-0 Stück"
              },
              {
                "extension" : [
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                    "url" : "algorithmVersion",
                    "valueString" : "1.0.1"
                  },
                  {
                    "url" : "language",
                    "valueCode" : "de-DE"
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                ],
                "url" : "http://ig.fhir.de/igs/medication/StructureDefinition/GeneratedDosageInstructionsMeta"
              }
            ],
            "basedOn" : [
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                🔗 "extension" : [
                  {
                    "url" : "https://gematik.de/fhir/epa-medication/StructureDefinition/is-emp-extension",
                    "valueBoolean" : true
                  }
                ],
                "reference" : "MedicationRequest/266620a9-2c26-41c1-b0cb-a10947b867f5"
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            "status" : "unknown",
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            "subject" : {
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                "system" : "http://fhir.de/sid/gkv/kvid-10",
                "value" : "X110411319"
              }
            },
            "effectivePeriod" : {
              "start" : "2026-11-01"
            },
            "dateAsserted" : "2026-11-01",
            "dosage" : [
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                "timing" : {
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                    "period" : 1,
                    "periodUnit" : "d",
                    "when" : [
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                },
                "doseAndRate" : [
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                    "doseQuantity" : {
                      "value" : 1,
                      "unit" : "Stück",
                      "system" : "https://fhir.kbv.de/CodeSystem/KBV_CS_SFHIR_BMP_DOSIEREINHEIT",
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                "url" : "https://gematik.de/fhir/epa-medication/StructureDefinition/context-extension",
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                    "url" : "reference",
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                    "url" : "addedOn",
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              },
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                "url" : "https://gematik.de/fhir/epa-medication/StructureDefinition/emp-origin-medication-extension",
                "valueReference" : {
                  "reference" : "Medication/d6508f13-9314-4e54-a0c3-3eafe1f356ff"
                }
              },
              {
                "url" : "https://gematik.de/fhir/epa-medication/StructureDefinition/reason-patient-instruction-extension",
                "valueString" : "Kopfschmerzen"
              },
              {
                "url" : "https://gematik.de/fhir/epa-medication/StructureDefinition/patient-note-extension",
                "valueAnnotation" : {
                  "text" : "Alkohol: das Risiko für Magen-Darm-Geschwüre und -Blutungen ist erhöht."
                }
              },
              {
                "url" : "http://hl7.org/fhir/5.0/StructureDefinition/extension-MedicationRequest.effectiveDosePeriod",
                "valuePeriod" : {
                  "start" : "2026-11-02"
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              },
              {
                "url" : "http://hl7.org/fhir/5.0/StructureDefinition/extension-MedicationRequest.renderedDosageInstruction",
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              },
              {
                "extension" : [
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                    "url" : "algorithmVersion",
                    "valueString" : "1.0.1"
                  },
                  {
                    "url" : "language",
                    "valueCode" : "de-DE"
                  }
                ],
                "url" : "http://ig.fhir.de/igs/medication/StructureDefinition/GeneratedDosageInstructionsMeta"
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            "status" : "active",
            "intent" : "plan",
            "medicationReference" : {
              "reference" : "Medication/b43cb3c2-552a-4da1-9eaa-605ac532a83d"
            },
            "subject" : {
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              }
            },
            "authoredOn" : "2026-11-01",
            "note" : [
              {
                "text" : "Hinweis für den LE"
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            ],
            "dosageInstruction" : [
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                "timing" : {
                  "repeat" : {
                    "frequency" : 1,
                    "period" : 1,
                    "periodUnit" : "d",
                    "when" : [
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                "doseAndRate" : [
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                    "doseQuantity" : {
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                      "unit" : "Stück",
                      "system" : "https://fhir.kbv.de/CodeSystem/KBV_CS_SFHIR_BMP_DOSIEREINHEIT",
                      "code" : "1"
                    }
                  }
                ]
              }
            ]
          }
        },
        {
          "name" : "relatedActivity",
          "resource" : {
            "resourceType" : "Provenance",
            "id" : "b6fb1655-820e-4d7e-9255-c76b02e4d085",
            "meta" : {
              "profile" : [
                🔗 "https://gematik.de/fhir/epa/StructureDefinition/epa-activity-provenance|1.3.0"
              ]
            },
            "target" : [
              {
                "reference" : "MedicationStatement/3afe43bc-8b57-417f-9e84-a70ea5062a6c/_history/2"
              },
              {
                "reference" : "MedicationRequest/266620a9-2c26-41c1-b0cb-a10947b867f5/_history/2"
              }
            ],
            "recorded" : "2026-11-01T15:43:33.244Z",
            "activity" : {
              "coding" : [
                {
                  "system" : "http://terminology.hl7.org/CodeSystem/v3-DataOperation",
                  "code" : "UPDATE"
                }
              ]
            },
            "agent" : [
              {
                "type" : {
                  "coding" : [
                    {
                      "system" : "http://terminology.hl7.org/CodeSystem/provenance-participant-type",
                      "code" : "author"
                    }
                  ]
                },
                "who" : {
                  🔗 "reference" : "Organization/450a9511-53e5-4af7-be36-a18444bb8dd2",
                  "identifier" : {
                    "type" : {
                      "coding" : [
                        {
                          "system" : "http://terminology.hl7.org/CodeSystem/v2-0203",
                          "code" : "PRN"
                        }
                      ]
                    },
                    "system" : "https://gematik.de/fhir/sid/telematik-id",
                    "value" : "9-2.58.00000089"
                  },
                  "display" : "Die Hausarztpraxis"
                }
              }
            ]
          }
        },
        {
          "name" : "relatedChronology",
          "resource" : {
            "resourceType" : "Provenance",
            "id" : "a8ebdbfb-c525-4ab0-a518-bcca6b2df45a",
            "meta" : {
              "profile" : [
                🔗 "https://gematik.de/fhir/epa-medication/StructureDefinition/emp-chronology-provenance|1.3.0"
              ]
            },
            "extension" : [
              {
                "url" : "https://gematik.de/fhir/epa-medication/StructureDefinition/is-emp-chronology-extension",
                "valueBoolean" : true
              }
            ],
            "target" : [
              {
                "reference" : "MedicationRequest/266620a9-2c26-41c1-b0cb-a10947b867f5/_history/2"
              }
            ],
            "occurredDateTime" : "2026-11-01T15:43:33.244Z",
            "recorded" : "2026-11-01T15:43:33.244Z",
            "activity" : {
              "coding" : [
                {
                  "system" : "http://terminology.hl7.org/CodeSystem/v3-DataOperation",
                  "code" : "UPDATE"
                }
              ]
            },
            "agent" : [
              {
                "type" : {
                  "coding" : [
                    {
                      "system" : "http://terminology.hl7.org/CodeSystem/provenance-participant-type",
                      "code" : "author"
                    }
                  ]
                },
                "who" : {
                  🔗 "reference" : "Organization/450a9511-53e5-4af7-be36-a18444bb8dd2",
                  "identifier" : {
                    "type" : {
                      "coding" : [
                        {
                          "system" : "http://terminology.hl7.org/CodeSystem/v2-0203",
                          "code" : "PRN"
                        }
                      ]
                    },
                    "system" : "https://gematik.de/fhir/sid/telematik-id",
                    "value" : "9-2.58.00000089"
                  },
                  "display" : "Die Hausarztpraxis"
                }
              }
            ]
          }
        }
      ]
    }

    <Parameters xmlns="http://hl7.org/fhir">
      <id value="example-epa-op-link-emp-entry-output-parameters-1"/>
      <meta>
        <profile
                 value="https://gematik.de/fhir/epa-medication/StructureDefinition/epa-op-link-emp-entry-output-parameters|1.3.0"/>
      </meta>
      <parameter>
        <name value="medicationStatement"/>
        <resource>
          <MedicationStatement>
            <id value="3afe43bc-8b57-417f-9e84-a70ea5062a6c"/>
            <meta>
              <versionId value="2"/>
              <lastUpdated value="2026-11-01T15:43:33.244Z"/>
              <profile
                       value="https://gematik.de/fhir/epa-medication/StructureDefinition/epa-medication-statement|1.3.0"/>
            </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="1-0-0-0 Stück"/>
            </extension>
            <extension
                       url="http://ig.fhir.de/igs/medication/StructureDefinition/GeneratedDosageInstructionsMeta">
              <extension url="algorithmVersion">
                <valueString value="1.0.1"/>
              </extension>
              <extension url="language">
                <valueCode value="de-DE"/>
              </extension>
            </extension>
            <basedOn>🔗
              <extension
                         url="https://gematik.de/fhir/epa-medication/StructureDefinition/is-emp-extension">
                <valueBoolean value="true"/>
              </extension>
              <reference
                         value="MedicationRequest/266620a9-2c26-41c1-b0cb-a10947b867f5"/>
            </basedOn>
            <status value="unknown"/>
            <medicationReference>
              <reference value="Medication/b43cb3c2-552a-4da1-9eaa-605ac532a83d"/>
            </medicationReference>
            <subject>
              <identifier>
                <system value="http://fhir.de/sid/gkv/kvid-10"/>
                <value value="X110411319"/>
              </identifier>
            </subject>
            <effectivePeriod>
              <start value="2026-11-01"/>
            </effectivePeriod>
            <dateAsserted value="2026-11-01"/>
            <dosage>
              <timing>
                <repeat>
                  <frequency value="1"/>
                  <period value="1"/>
                  <periodUnit value="d"/>
                  <when value="MORN"/>
                </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="empEntry"/>
        <resource>
          <MedicationRequest>
            <id value="266620a9-2c26-41c1-b0cb-a10947b867f5"/>
            <meta>
              <versionId value="2"/>
              <lastUpdated value="2026-11-01T15:43:33.244Z"/>
              <profile
                       value="https://gematik.de/fhir/epa-medication/StructureDefinition/emp-medication-request|1.3.1"/>
            </meta>
            <extension
                       url="https://gematik.de/fhir/epa-medication/StructureDefinition/context-extension">
              <valueCode value="EMP"/>
            </extension>
            <extension
                       url="https://gematik.de/fhir/epa-medication/StructureDefinition/emp-medicationrequest-activity-extension">
              <extension url="reference">
                <valueReference>
                  <reference
                             value="MedicationStatement/3afe43bc-8b57-417f-9e84-a70ea5062a6c"/>
                </valueReference>
              </extension>
              <extension url="addedOn">
                <valueDateTime value="2026-11-01T15:43:33.244Z"/>
              </extension>
            </extension>
            <extension
                       url="https://gematik.de/fhir/epa-medication/StructureDefinition/emp-origin-medication-extension">
              <valueReference>
                <reference
                           value="Medication/d6508f13-9314-4e54-a0c3-3eafe1f356ff"/>
              </valueReference>
            </extension>
            <extension
                       url="https://gematik.de/fhir/epa-medication/StructureDefinition/reason-patient-instruction-extension">
              <valueString value="Kopfschmerzen"/>
            </extension>
            <extension
                       url="https://gematik.de/fhir/epa-medication/StructureDefinition/patient-note-extension">
              <valueAnnotation>
                <text
                      value="Alkohol: das Risiko für Magen-Darm-Geschwüre und -Blutungen ist erhöht."/>
              </valueAnnotation>
            </extension>
            <extension
                       url="http://hl7.org/fhir/5.0/StructureDefinition/extension-MedicationRequest.effectiveDosePeriod">
              <valuePeriod>
                <start value="2026-11-02"/>
              </valuePeriod>
            </extension>
            <extension
                       url="http://hl7.org/fhir/5.0/StructureDefinition/extension-MedicationRequest.renderedDosageInstruction">
              <valueMarkdown value="1-0-0-0 Stück"/>
            </extension>
            <extension
                       url="http://ig.fhir.de/igs/medication/StructureDefinition/GeneratedDosageInstructionsMeta">
              <extension url="algorithmVersion">
                <valueString value="1.0.1"/>
              </extension>
              <extension url="language">
                <valueCode value="de-DE"/>
              </extension>
            </extension>
            <identifier>
              <system value="https://gematik.de/fhir/sid/emp-identifier"/>
              <value value="266620a9-2c26-41c1-b0cb-a10947b867f5"/>
            </identifier>
            <status value="active"/>
            <intent value="plan"/>
            <medicationReference>
              <reference value="Medication/b43cb3c2-552a-4da1-9eaa-605ac532a83d"/>
            </medicationReference>
            <subject>
              <identifier>
                <system value="http://fhir.de/sid/gkv/kvid-10"/>
                <value value="X110411319"/>
              </identifier>
            </subject>
            <authoredOn value="2026-11-01"/>
            <note>
              <text value="Hinweis für den LE"/>
            </note>
            <dosageInstruction>
              <timing>
                <repeat>
                  <frequency value="1"/>
                  <period value="1"/>
                  <periodUnit value="d"/>
                  <when value="MORN"/>
                </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>
            </dosageInstruction>
          </MedicationRequest>
        </resource>
      </parameter>
      <parameter>
        <name value="relatedActivity"/>
        <resource>
          <Provenance>
            <id value="b6fb1655-820e-4d7e-9255-c76b02e4d085"/>
            <meta>
              <profile
                       value="https://gematik.de/fhir/epa/StructureDefinition/epa-activity-provenance|1.3.0"/>
            </meta>
            <target>
              <reference
                         value="MedicationStatement/3afe43bc-8b57-417f-9e84-a70ea5062a6c/_history/2"/>
            </target>
            <target>
              <reference
                         value="MedicationRequest/266620a9-2c26-41c1-b0cb-a10947b867f5/_history/2"/>
            </target>
            <recorded value="2026-11-01T15:43:33.244Z"/>
            <activity>
              <coding>
                <system
                        value="http://terminology.hl7.org/CodeSystem/v3-DataOperation"/>
                <code value="UPDATE"/>
              </coding>
            </activity>
            <agent>
              <type>
                <coding>
                  <system
                          value="http://terminology.hl7.org/CodeSystem/provenance-participant-type"/>
                  <code value="author"/>
                </coding>
              </type>
              <who>🔗
                <reference
                           value="Organization/450a9511-53e5-4af7-be36-a18444bb8dd2"/>
                <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="9-2.58.00000089"/>
                </identifier>
                <display value="Die Hausarztpraxis"/>
              </who>
            </agent>
          </Provenance>
        </resource>
      </parameter>
      <parameter>
        <name value="relatedChronology"/>
        <resource>
          <Provenance>
            <id value="a8ebdbfb-c525-4ab0-a518-bcca6b2df45a"/>
            <meta>
              <profile
                       value="https://gematik.de/fhir/epa-medication/StructureDefinition/emp-chronology-provenance|1.3.0"/>
            </meta>
            <extension
                       url="https://gematik.de/fhir/epa-medication/StructureDefinition/is-emp-chronology-extension">
              <valueBoolean value="true"/>
            </extension>
            <target>
              <reference
                         value="MedicationRequest/266620a9-2c26-41c1-b0cb-a10947b867f5/_history/2"/>
            </target>
            <occurredDateTime value="2026-11-01T15:43:33.244Z"/>
            <recorded value="2026-11-01T15:43:33.244Z"/>
            <activity>
              <coding>
                <system
                        value="http://terminology.hl7.org/CodeSystem/v3-DataOperation"/>
                <code value="UPDATE"/>
              </coding>
            </activity>
            <agent>
              <type>
                <coding>
                  <system
                          value="http://terminology.hl7.org/CodeSystem/provenance-participant-type"/>
                  <code value="author"/>
                </coding>
              </type>
              <who>🔗
                <reference
                           value="Organization/450a9511-53e5-4af7-be36-a18444bb8dd2"/>
                <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="9-2.58.00000089"/>
                </identifier>
                <display value="Die Hausarztpraxis"/>
              </who>
            </agent>
          </Provenance>
        </resource>
      </parameter>
    </Parameters>

### Geschäftslogik

Der Medication Service MUSS die Geschäftlogik der Operation Hinzufügen einer eML-eMP-Verknüpfung gemäß dem Aktivitätsdiagramm mit der ID IG-MED-BL-LINK-EMP-ENTRY-V1 ausführen. Dabei sind alle mit transaction gekennzeichneten Abschnitte entsprechend den Transaktionssicherheitsregeln des ePA-Aktensystems umzusetzen, sodass diese Abschnitte mit ihren Verarbeitungsschritten atomar, konsistent und isoliert durchgeführt werden.

Das folgende Aktivitätsdiagramm illustriert die Geschäftslogik der Operation Hinzufügen einer eML-eMP-Verknüpfung im Medication Service.

Abbildung: Geschäftslogik für die Operation Hinzufügen einer eML-eMP-Verknüpfung

### Sicherheitsanforderungen

Generelle Sicherheitsanforderungen werden hier festgehalten.