Implementation Guide
ePA Medication Service
Version 1.2.0-ballot.2 - draft

## Render API: Medikationsplan abrufen (eMP)

Die auf dieser Seite dargestellten Inhalte geben den Stand der Version 1.2.0-ballot.1 wieder. Rückmeldungen aus dem laufenden Kommentierungsverfahren sowie daraus resultierende fachliche oder technische Anpassungen sind in dieser Fassung noch nicht oder nur teilweise berücksichtigt.

Der Medication Service unterstützt die aufbereitete Generierung eines elektronischen Medikationsplans (eMP) im Datenformat PDF/A (d.h. hier kommt kein FHIR zum Einsatz). Intention ist eine für Versicherte verständliche und übersichtliche Darstellung des eMP, spezifisch an Leistungserbringer gerichtete Daten sind in der Ausgabe nicht enthalten.

### Nachricht

Die Nachricht zum Abruf des eMP im Format PDF/A wird als HTTP GET-Anfrage an den Medication Service gesendet, um den Medikationsplan im Format PDF/A zu erhalten.

#### Auslösung

Zum Abruf des eMP im Format PDF/A sendet ein ePA-Client eine Render API: Medikationsplan abrufen (eMP)-Nachricht an den Medication Service.

#### Render API

Ein ePA-Client kann über den folgenden URL-Aufruf den eMP im PDF/A abrufen:

        {"resourceType":"CapabilityStatement","id":"epa-medication-service-server","meta":{"profile":["https://gematik.de/fhir/ti/StructureDefinition/ti-capability-statement"]},"extension":[{"extension":[{"url":"name","valueString":"X-Request-ID"},{"url":"type","valueString":"string"},{"url":"description","valueString":"UUID of the request message"},{"url":"format","valueString":"uuid"},{"url":"required","valueBoolean":true}],"url":"https://gematik.de/fhir/ti/StructureDefinition/extension-http-header"},{"extension":[{"url":"name","valueString":"x-insurantid"},{"url":"type","valueString":"string"},{"url":"description","valueString":"Health Record Identifier"},{"url":"pattern","valueString":"^[A-Z]{1}\\d{9}$"},{"url":"required","valueBoolean":true}],"url":"https://gematik.de/fhir/ti/StructureDefinition/extension-http-header"},{"extension":[{"url":"name","valueString":"x-useragent"},{"url":"type","valueString":"string"},{"url":"description","valueString":"user agent 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the list of allowed user groups"},{"url":"responseType","valueString":"application/json"},{"url":"errorCode","valueString":"invalidOid"}],"url":"https://gematik.de/fhir/ti/StructureDefinition/extension-http-response-info"},{"extension":[{"url":"statusCode","valueString":"403"},{"url":"description","valueString":"Device registration does not exist (if requestor role is oid_versicherter only)"},{"url":"responseType","valueString":"application/json"},{"url":"errorCode","valueString":"unregisteredDevice"}],"url":"https://gematik.de/fhir/ti/StructureDefinition/extension-http-response-info"},{"extension":[{"url":"statusCode","valueString":"404"},{"url":"description","valueString":"Health record is in state UNKNOWN or 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error"},{"url":"responseType","valueString":"application/json"},{"url":"errorCode","valueString":"internalError"}],"url":"https://gematik.de/fhir/ti/StructureDefinition/extension-http-response-info"},{"url":"https://gematik.de/fhir/ti/StructureDefinition/extension-base-url","valueString":"http://epa4all/epa/medication/api/v1/fhir"},{"extension":[{"url":"statusCode","valueString":"423"},{"url":"description","valueString":"If the insurant objected to the medication process or objected to the submission of prescription and dispensation data into the ePA system, the Medication Service is locked."},{"url":"responseType","valueString":"application/json"},{"url":"errorCode","valueString":"locked"}],"url":"https://gematik.de/fhir/ti/StructureDefinition/extension-http-response-info"}],"url":"https://gematik.de/fhir/epa-medication/CapabilityStatement/epa-medication-service-server","version":"1.2.0-ballot.2","name":"EPAMedicationServiceServer","title":"EPA CapabilityStatement für den Medication 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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":"MEDICATIONSVC_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"}]}]}

Successful operation
Rendering led to empty list

#### Rückgabeformat

Der Medication Service MUSS bei der Erzeugung des eMP im Format PDF/A den Media Type (Content-Type) application/pdf setzen. Der Medication Service MUSS für die Render API: Medikationsplan abrufen die folgenden HTTP Status Codes zurückgeben, um den Erfolg oder mögliche Fehler bei der Verarbeitung einer Anfrage klar zu kommunizieren:

Status Code | Bedingung | Error Code | Anmerkung
--- | --- | --- | ---
200 | Successful operation |  |
404 | Rendering led to empty list | noEntries |

Tabelle: HTTP Status Codes für die Antwortnachricht

#### Schematischer Aufbau

Der Medication Service MUSS bei der Erzeugung des eMP im Format PDF/A folgendes berücksichtigen:

- die Ausrichtung im DIN A4 Querformat,
- alle Elemente in schwarzer Farbe,
- ringsherum ein Seitenrand von 0,85 cm,
- Abstand links- und rechtsseitig von jedem Spaltentrennstrich von 1,00 – 1,25 mm (um ein Verschmelzen von vertikalem Spaltentrennstrich und angrenzendem Text zu verhindern),
- Umrandungen und Spaltentrennstriche als durchgehende gerade schwarze Linien mit einer Dicke von 0,5 pt,
- weißer Hintergrund ohne Bilder, Muster, Wasserzeichen o.ä.,
- Schriftart Arial (ggf. artverwandt) einheitlich im gesamten Plan, sofern keine definierten Ausnahmen,
- Text linksbündig, sofern nicht anders angegeben,
- zwei direkt aneinanderliegende Umrandungslinien werden durch eine Linie ersetzt (ggf. die mit der höheren Strichstärke).

Der Medication Service MUSS sicherstellen, dass die folgenden Toleranzen eingehalten werden:

- Für die Spaltenbreite und Feldhöhe der Medikationstabelle wird eine Abweichungstoleranz von +/-1 mm festgelegt.
- Für die Gesamtbreite und die maximale Gesamthöhe der Blöcke gilt ebenfalls eine Abweichungstoleranz von +/-1 mm.

Der Medication Service MUSS bei der Erzeugung des eMP im Format PDF/A den Medikationsplan in folgende logische Abschnitte unterteilen:

- Identifikationsblock,
- Administrationsblock,
- Medikationstabelle,
- Fußbereich,

die es pro Seite genau nur einmal gibt.

Nachstehend ist die Aufteilung der Blöcke dargestellt. Die Aufteilung ist auch in Originalgröße als PDF und HTML herunterlad- bzw. anzeigbar. Normativ sind die Festlegungen in den Anforderungen. Diese Dateien erfüllen nur illustrative Zwecke.

Abbildung: Aufteilung der Blöcke des eMP
Der Medication Service MUSS bei der Erzeugung des eMP im Format PDF/A den Identifikationsblock wie folgt erstellen:

- Höhe von 4,0 cm,
- Breite von 7,0 cm,
- linksbündig oben auf der Seite,
- Block mit einem umlaufenden Strich umrandet,
- enthält die folgenden Bestandteile:

- Text "Medikationsplan" in Schriftgröße 20 pt fett, ohne Trennung obenliegend,
- Seitennummerierung unterhalb Text "Medikationsplan" inklusive der Gesamtseitenzahl in der Form „Seite X von Y“ in Schriftgröße 14 pt, mit X als Seitenzahl und Y als Gesamtseitenzahl.

Der Medication Service MUSS bei der Erzeugung des eMP im Format PDF/A den Administrationsblock wie folgt erstellen:

- Anordung des Blocks unmittelbar rechts neben dem Identifikationsblock,
- Höhe von 4,0 cm,
- Breite von 21 cm,
- unterteilt in sieben Zeilen,
- Schriftgröße 14 pt,
- enthält die folgenden Bestandteile:

- Name des Versicherten in der Form "Für: [Präfix] [Vorname] [Namenszusatz] [Vorsatzwort] [Nachname]" linksbündig oben angeordnet,
- ausschließlich [Vorname] und [Nachname] fett formatiert,
- Geburtsdatum in der Form "geb. am: TT.MM.JJJJ" rechtsbündig oben angeordnet, TT.MM.JJJJ fett formattiert,
- KVNR in der Form "Versichertennummer: X123456789" linksbündig unten angeordnet,
- Erstellungszeitpunkt in der Form "erstellt: TT.MM.JJJJ HH:MM" rechtsbündig unten angeordnet,

- Links und rechts angeordnete Texte in einer Zeile müssen so umgebrochen werden, dass ein deutlich durchgehender Trennungsbereich von ca. 1 cm Breite verbleibt.
- Wird der Name des Versicherten umgebrochen, so muss die neue Zeile so eingerückt werden, dass sie mit dem Namen nach dem einleitenden "Für:" der ersten Zeile auf gleicher Breite beginnt. Worttrennungen müssen dabei vermieden werden.

Der Medication Service MUSS bei der Erzeugung des eMP im Format PDF/A die Medikationstabelle wie folgt erstellen:

- vertikaler Abstand zwischen Kopfbereich (Identifikations- und Administrationsblock) und der Medikationstabelle von mindestens 3 mm,
- alle Felder mit Umrandung,
- Text in Tabellenfeldern vertikal zentriert,
- Schriftgröße von 12 pt falls nicht anders angegeben,
- Höhe von (21,0-2 x 0,85-4,0-0,3-1,0 =) 14,0 cm,
- Breite von (29,7-2 x 0,85) 28,0 cm,
- Höhe der Felder einer Medikationstabellenzeile von 0,875 cm,
- vertikale Gliederung in Spalten,
- erste Zeile, fett formatiert, in der Schrifthöhe 14 pt, als Tabellenüberschriftzeile mit folgenden Spaltenüberschriften:

- Text "Wirkstoff"; im ersten Feld mit der Breite 4,0 cm aufgebracht,
- Text "Handelsname"; im zweiten Feld mit der Breite 4,4 cm aufgebracht,
- Text "Stärke"; im dritten Feld mit der Breite 1,8 cm aufgebracht,
- Text "Form"; im vierten Feld mit der Breite 2 cm aufgebracht,
- Text "Was ist das?"; im fünften Feld mit der Breite 6 cm aufgebracht,
- Text "Verschrieben durch"; im sechsten Feld mit der Breite 9,8 cm aufgebracht.

- Es folgen die eMP-Einträge mit folgenden Festlegungen:

- Reihenfolge der eMP-Einträge entsprechend ihres Verfassungsdatums (neuestes oben) und bei gleichem Verfassungsdatum alphabetisch aufsteigend entsprechend Wirkstoff
- ein eMP-Eintrag erstreckt sich über die gesamte Breite der Medikationstabelle,
- 1. Zeile für Medikamenteninformation (Medikationszeile) ist wie folgt strukturiert:

- erste Spalte: Wirkstoff,
- zweite Spalte: Handelsname,
- dritte Spalte: Stärke rechtsbündig,
- vierte Spalte: Form,
- fünfte Spalte: Inhalt für das Feld "Was ist das?",
- sechste Spalte: Inhalt für das Feld "Verschrieben durch",

- 2. Zeile für Dosierinformation (Dosierungszeile) mit folgenden Festlegungen:

- Text "Dosierung: " gefolgt von Dosierinformation

- Dosierungszeile ist untrennbar an die vorausgehende Medikationszeile gebunden und muss mit dieser auf derselben Seite angezeigt werden.
- Die obere Umrandungslinie des eMP-Eintrags ist in der Strichstärke 2 pt auszuführen.

Der Medication Service MUSS bei der Erzeugung des eMP im Format PDF/A die folgenden Formatvorgaben umsetzen:

- Ist der Inhalt so lang, dass er nicht in die vorgebene Spaltenbreite passt, MUSS die Schriftgröße auf 10 pt verringert werden.
- Ist der Inhalt anschließend immer noch zu lang, MUSS er in zwei Zeilen innerhalb desselben Feldes dargestellt werden.
- Die Höhe des entsprechenden Feldes MUSS dabei unverändert bleiben.
- Ist der Inhalt anschließend immer noch zu lang, ist die Höhe des Feldes proportional zu den benötigten weiteren Zeilen zu vergrößern. Horizontal angrenzende Felder müssen auch entsprechend vergrößert werden.
- Bei mehrzeiliger Darstellung MÜSSEN Satzzeichen am Zeilenanfang und Worttrennungen vermieden werden.

Der Medication Service MUSS für den Medikationsplan im PDF/A-Format Daten aus den folgenden Quellen verwenden:

Bezeichnung | FHIR-Profil FHIR Element-ID | Beispiel
--- | --- | ---
Namenszusatz | [EPAPatient] `Patient.name:Name.family.extension:namenszusatz` | "Graf"
Präfix | [EPAPatient] `Patient.name:Name.prefix` | "Dr."
Vorname | [EPAPatient] `Patient.name:Name.given` | "Horst"
Vorsatzwort | [EPAPatient] `Patient.name:Name.family.extension:vorsatzwort` | "van"
Nachname | [EPAPatient] `Patient.name:Name.family` | "Himmelblau"
Erstellungszeitpunkt | Aktueller Systemzeitpunkt | "04.11.2025 10:13"
Geburtsdatum | [EPAPatient] `Patient.birthDate` |
Versichertennummer | [EPAPatient] `Patient.identifier:KVNR` |
Verfassungsdatum | EMPMedicationRequest `MedicationRequest.authoredOn` |
Wirkstoff | EMPMedication `Medication.ingredient.item[x]:itemCodeableConcept.text` |
Handelsname | EMPMedication `Medication.code.text` in `MedicationRequest.medicationReference` |
Stärke | EMPMedication `Medication.ingredient.strength` in `MedicationRequest.medicationReference` Falls vorhanden, sind `Numerator` und `Denominator` mit jeweils den Belegungen zu `value` und `unit` getrennt mit Bruchstrich anzugeben. |
Form | EMPMedication `Medication.form.coding` Die resultierende Zeichenkette darf nicht zu einer Vergrößerung der Höhe des Feldes führen. Sollte dies der Fall sein, muss sie soweit verkürzt werden, dass sie ins Feld passt und mit " ..." endet. |
Inhalt für das Feld "Was ist das?" | EMPMedicationRequest `MedicationRequest.extension:reasonPatientInstruction.valueString` |
Inhalt für das Feld "Verschrieben durch" | Falls vorhanden: [PractitionerDirectory] `Practitioner.name` Die resultierende Zeichenkette darf nicht zu einer Vergrößerung der Höhe des Feldes führen. Sollte dies der Fall sein, muss sie soweit verkürzt werden, dass sie ins Feld passt und mit " ..." endet. |
Dosierinformation | EMPMedicationRequest Falls vorhanden: `MedicationRequest.dosage.extension:generatedDosageInstructions.extension:text`, ansonsten falls vorhanden `MedicationRequest.dosage.text` Falls keine Angabe vorhanden bleibt dieses Feld leer. Mehrere Dosierinformationen werden durch ";" + Zeilenumbruch voneinander getrennt. Die neue Zeile muss so eingerückt werden, sodass sie mit der ersten Dosieranweisung nach dem einleitenden "Dosierung: " der ersten Zeile auf gleicher Breite beginnt. Die Schriftgröße muss in diesem Fall auf 10 pt verringert werden. |

Tabelle: Datenherkünfte des generierten elektronischen Medikationsplans (eMP)
Der Medication Service MUSS bei der Erzeugung des eMP im Format PDF/A den Fußbereich wie folgt erstellen:

- Der Fußbereich befindet sich unmittelbar über dem unteren Seitenrand,
- obere Umrandungslinie,
- Höhe 1,0 cm,
- Breite 28 cm,
- Schriftgröße 8 pt,
- in dieser Reihenfolge sind folgende Inhalte auf einer Zeile darzustellen:

1. linksbündig der Disclaimer: "Wichtiger Hinweis: Patientenausdruck aus der elektronischen Patientenakte (ePA). Dort befinden sich ggf. weitere oder aktuellere Informationen.", mit Text "Wichtiger Hinweis:" fett formatiert
2. rechtsbündig die Versionsangabe: "de-DE Version 1.0".

Nachstehend ist ein Beispiel des eMP abgebildet. Dieses Beispiel ist auch in Originalgröße als PDF und HTML herunterlad- bzw. anzeigbar. Normativ sind die Festlegungen in den Anforderungen. Die Beispiele erfüllen nur illustrative Zwecke.

Abbildung: Beispiel des eMP
Der Medication Service MUSS sicherstellen, dass das Ergebnis der Operation ausschließlich auf Daten basiert, die durch den aktuellen eMP-Chronologieeintrag referenziert werden. Für jeden durch den aktuellen eMP-Chronologieeintrag referenzierte Instanz des Profils EMPMedicationRequest sind u.a. Instanzen von folgenden Profilen relevant:

- EMPMedicationRequest im Status active,
- die vom ausgewählten EMPMedicationRequest referenzierte EMPMedication,
- Falls vorhanden, PractionerDirectory, welche wie folgt ermittelt wird:

- Suche die jüngste Instanz EPAMedicationStatement, welche die entsprechende Instanz des EMPMedicationRequest referenziert,
- Suche von diesem MedicationStatement den referenzierten MedicationRequest,
- Suche von diesem MedicationRequest die referenzierte PractitionerRole,
- Suche von dieser PractitionerRole die Instanz PractitionerDirectory,

- aktuelle EPAPatient-Instanz.

### Sicherheitsanforderungen

Generelle Sicherheitsanforderungen werden hier festgehalten.