Recepta elektroniczna w FHIR
Recepta elektroniczna to priorytetowa kategoria Europejskiej Przestrzeni Danych dotyczących Zdrowia (art. 14 ust. 1 lit. (b) rozporządzenia (UE) 2025/327). Stosuje się ją od 26 marca 2029. HL7 Europe obejmuje ją przewodnikami: mpd 1.0.0.
- Rozporządzenie
- Regulation (EU) 2025/327, Article 14(1)(b), Annex I
- Stosuje się od
- 26 marca 2029
- Przewodniki HL7 Europe
- hl7.fhir.eu.mpd 1.0.0, opublikowany
- Modele logiczne Xt-EHR
- EHDSMedicationPrescription
- Walidator
- Otwórz walidator profili EHDS
Co mówi rozporządzenie
Załącznik I do rozporządzenia opisuje główne cechy tej kategorii. Tekst jest angielskim oryginałem.
Electronic prescriptionsElectronic health data constituting a prescription for a medicinal product as defined in Article 3, point (k), of Directive 2011/24/EU.
Profile FHIR 3
Profile zdefiniowane przez powyższe przewodniki. Kolumna reguł liczy elementy, w których profil wykracza poza bazowy FHIR (wymagane, zakazane lub ograniczone) i które sprawdza walidator; spośród slice’ów sprawdzane są tylko wymagane, które odróżnia stała wartość lub typ zasobu.
| Profil | Zasób | Przewodnik HL7 Europe | Sprawdzane reguły | Slice’y sprawdzane / zdefiniowane |
|---|---|---|---|---|
Medication: MPD http://hl7.eu/fhir/mpd/StructureDefinition/Medication-eu-mpd | Medication | mpd | 0 | 0 / 12 |
MedicationDispense: MPD http://hl7.eu/fhir/mpd/StructureDefinition/MedicationDispense-eu-mpd | MedicationDispense | mpd | 2 | 0 / 3 |
MedicationRequest: MPD http://hl7.eu/fhir/mpd/StructureDefinition/MedicationRequest-eu-mpd | MedicationRequest | mpd | 2 | 0 / 7 |
Powiązania terminologiczne 0
Value sets, z którymi profile tej kategorii wiążą elementy powiązaniem required lub extensible. Powiązanie required dopuszcza tylko kody z value set; extensible oczekuje ich, chyba że żaden nie pasuje. Value sets definiowane w pakietach HL7 Europe są wypisane z kodami w wykazie value sets.
Profile tej kategorii nie określają własnych powiązań required ani extensible. Profile określają też powiązania: preferred – 0, example – 4.
Rozszerzenia 1
Rozszerzenia HL7 Europe, które zawierają profile tej kategorii, z elementem, który je przechowuje.
| Rozszerzenie | Kontekst | Wartość | Użyte w |
|---|---|---|---|
Medication: Package type http://hl7.eu/fhir/StructureDefinition/medication-package-type | Medication | CodeableConcept | MedicationEuMpd extension:packageType 0..1 |
Model logiczny EHDSMedicationPrescription 30
Elementy modelu logicznego Xt-EHR z licznością i obowiązkami. Obowiązki mówią producentom i odbiorcom danych, co system MUSI lub POWINIEN robić z każdym elementem.
Obowiązki według uczestnika
Ile elementów EHDSMedicationPrescription niesie dany obowiązek dla danego uczestnika.
| Obowiązek | Uczestnik | Elementy |
|---|---|---|
SHALL:able-to-populate | producent | 11 |
SHALL:process | odbiorca | 11 |
SHOULD:able-to-populate | producent | 5 |
SHOULD:display | odbiorca | 2 |
SHOULD:process | odbiorca | 3 |
Elementy 30
| Element | Licz. | Obowiązki | Opis |
|---|---|---|---|
header | 1..1 | Prescription header | |
subject | 1..1 | SHALL:able-to-populate producentSHALL:process odbiorcaSystem SHALL process the patient information for identification purposes. | The person for whom the medication is prescribed/ordered. [Used for searching] |
identifier | 1..* | SHALL:able-to-populate producentFor a single-item prescription these identifiers SHALL match prescriptionItem.identifier. SHALL:process odbiorcaSystem SHALL use this prescription identifier for reference in the dispense record. | Business identifier(s) for the prescription. [Used for searching] |
author[x] | 1..* | SHALL:able-to-populate producentSystem SHALL support at least EHDSHealthProfessional data type for the element. SHALL:process odbiorca | The prescriber, the person who made the prescription, and who takes the responsibility for the treatment. [Used for searching] |
date | 1..1 | SHALL:able-to-populate producentSHALL:process odbiorca | Time of issuing (signing) the prescription by health care professional. [Used for searching] |
status | 1..1 | SHALL:able-to-populate producentSHALL:process odbiorcaSystem SHALL process the prescription status together with other information to determine dispensability. | Status of authorisation for dispensing the prescription items. This should not be the status of treatment. For a multiple-item prescription, this conveys the aggregate status of the entire prescription. In case of a single-item prescription, prescriptionItem.status shall be the same as EHDSMedicationPrescription.header.status. [Used for searching] |
source | 0..0 | Source of information (e.g. patient, patient's proxy). Used in case the patient has authored the information or the author has submitted patient-stated information. | |
language | 0..1 | Language in which the resource is written. Language is expressed by the IETF language tag. | |
statusReason[x] | 0..1 | Reason for the current status of prescription, for example the reason why the prescription was made invalid or changed from a previous state. | |
presentedForm | 0..* | SHOULD:able-to-populate producentSystem SHOULD be able to provide a rendered, human-readable version of the prescription. SHOULD:display odbiorca | Entire prescription as issued. Various formats could be provided, PDF format is recommended. |
prescriptionItem | 1..* | SHALL:able-to-populate producentSHALL:process odbiorca | Prescription line for one medication. In many countries, only one item is allowed and there shall be no expectation to be able to manage multiple items. In case multiple medications are allowed, all items need to be authored together. |
identifier | 1..* | SHALL:able-to-populate producentFor a single-item prescription these identifiers SHALL match .identifier. SHALL:process odbiorcaSystem SHALL use this prescription identifier for reference in the dispense record. | Identifier for a single item on prescription, if exists. In case of single-item prescription, this identifier is typically the same as prescription identifier. [Used for searching] |
status | 1..1 | SHALL:able-to-populate producentSHALL:process odbiorcaSystem SHALL process the prescription status together with other information to determine dispensability. | Status of a single item of a multi-item prescription. In case of single-item prescriptions, the status of prescription has the same meaning as the status of the item. [Used for searching] |
statusReason[x] | 0..1 | Reason for the current status of prescription, for example the reason why the prescription was made invalid or why the prescription was changed from previous | |
medication | 1..1 | SHALL:able-to-populate producentSHALL:process odbiorca | Prescribed product, branded, generic, virtual, extemporal, etc |
indication[x] | 0..* | Reason for the prescription (typically diagnosis, or a procedure) | |
intendedUseType | 0..1 | Intent of the prescription - prophylaxis, treatment, anesthesia, etc | |
periodOfUse | 0..1 | Period over which the medication is to be taken (in case of multiple dosage schemes, this would be the overall period of all dosages.) | |
quantityPrescribed | 0..1 | SHOULD:able-to-populate producentSHOULD:process odbiorca | Overall quantity of prescribed product (e.g number of packages or number of tablets). |
dosageInstructions | 1..1 | SHALL:able-to-populate producentSHALL:process odbiorca | Dosage and administration instructions |
validityPeriod | 0..1 | SHOULD:able-to-populate producentSHOULD:process odbiorca | The period over which the prescription is considered valid and dispensable. validityPeriod.start is, if missing, is assumed to be the date of issuing the prescription. |
substitution | 0..1 | SHOULD:able-to-populate producentSHOULD:process odbiorca | Whether and which type of substitution is allowed for this prescription. The legislation in the country of dispense applies, e.g. if this information is missing. |
allowed[x] | 0..1 | SHALL:able-to-populate producentSystem SHALL support at least the boolean data type. SHALL:process odbiorcaSystem SHALL support at least the boolean data type. | Whether and to what extent substitution is allowed. |
reason[x] | 0..1 | Reason for the substitution requirement (e.g. Biological product, Patient allergic to an excipient in alternative products, etc) | |
numberOfRepeats | 0..1 | Number of refills authorised - how many times the prescription item can be dispensed in addition to the original dispense. The default value is 0 (no repeats). | |
minimumDispenseInterval | 0..1 | Minimum dispense interval. If a prescription allows for repeated dispensations, the interval between dispensations shall be stated here. | |
offLabel | 0..1 | Indicates that the prescriber has knowingly prescribed the medication for an indication, age group, dosage, or route of administration that is not approved by the regulatory agencies and is not mentioned in the prescribing information for the drug | |
isOffLabelUse | 1..1 | Indicates off-label use. Must be 'true' when .reason is provided. | |
reason[x] | 0..* | Reason or related clarification for off-label use | |
note | 0..1 | SHOULD:able-to-populate producentSHOULD:display odbiorca | Additional information or comments, e.g. message to the dispenser |
Odwzorowanie EHDSMedicationPrescription na FHIR 29
Jak każdy element logiczny trafia do FHIR, według przewodnika HL7 Europe. Odwzorowane na: MedicationRequestEuMpd.
| Element | Relacja | Zasób FHIR | Element FHIR | Uwagi |
|---|---|---|---|---|
header | powiązany z | MedicationRequest | . | Backbone element |
subject | równoważny | MedicationRequest | subject | Reference to Patient. |
identifier | węższy niż cel | MedicationRequest | identifier | Prescription identifier and prescription item identifier are usually the same in environments using single-item prescriptions. |
identifier | węższy niż cel | MedicationRequest | groupIdentifier | Use as the shared prescription identifier for MedicationRequest instances that belong to the same multi-item prescription. |
author[x] | równoważny | MedicationRequest | requester | |
date | równoważny | MedicationRequest | authoredOn | |
status | równoważny | MedicationRequest | status | |
statusReason[x] | równoważny | MedicationRequest | statusReason | The model also allows string data type which maps to CodeableConcept.text , but note element may also be used for additional clarifications. |
presentedForm | brak odwzorowania | MedicationRequest | Reference a DocumentReference containing the rendered prescription. | |
prescriptionItem | równoważny | MedicationRequest | . | Create one MedicationRequest per prescription item. |
identifier | równoważny | MedicationRequest | identifier | |
status | równoważny | MedicationRequest | status | For single-item prescriptions, same meaning as header.status. |
statusReason[x] | równoważny | MedicationRequest | statusReason | The model also allows string data type which maps to CodeableConcept.text , but note element may also be used for additional clarifications. |
medication | równoważny | MedicationRequest | medication[x] 〔R4〕 medication 〔R5〕 | |
indication[x] | równoważny | MedicationRequest | reasonCode 〔R4〕 reason 〔R5〕 | The model also allows string data type which maps to CodeableConcept.text , but note element may also be used for additional clarifications. |
intendedUseType | węższy niż cel | MedicationRequest | category | Use dedicated category code or custom extension if additional granularity is required. |
periodOfUse | powiązany z | MedicationRequest | extension:effectiveDosePeriod 〔R4〕 effectiveDosePeriod 〔R5〕 | |
quantityPrescribed | równoważny | MedicationRequest | dispenseRequest.extension:prescribedQuantity | |
dosageInstructions | równoważny | MedicationRequest | dosageInstruction | Map each EHDSDosage entry to dosageInstruction . |
validityPeriod | równoważny | MedicationRequest | dispenseRequest.validityPeriod | |
substitution | równoważny | MedicationRequest | substitution | |
allowed[x] | równoważny | MedicationRequest | substitution.allowed[x] | The guide requires support for at least Boolean data type. |
reason[x] | równoważny | MedicationRequest | substitution.reason | The model also allows string data type which maps to CodeableConcept.text , but note element may also be used for additional clarifications. |
numberOfRepeats | równoważny | MedicationRequest | dispenseRequest.numberOfRepeatsAllowed | |
minimumDispenseInterval | równoważny | MedicationRequest | dispenseRequest.dispenseInterval | |
offLabel | powiązany z | MedicationRequest | extension:offLabelUse | |
isOffLabelUse | powiązany z | MedicationRequest | extension:offLabelUse | |
reason[x] | powiązany z | MedicationRequest | extension:offLabelUse.reason | The model also allows string data type which maps to CodeableConcept.text , but note element may also be used for additional clarifications. |
note | równoważny | MedicationRequest | note.text | Use note.author / note.time if available. |
Dokumenty CDA (eHDSI)
Tę samą kategorię niosą w CDA te szablony dokumentów eHDSI. Ich struktura, zbiory wartości i walidator dokumentów CDA są w przewodniku CDA.
Źródła
Rozporządzenie (UE) 2025/327, Dziennik Urzędowy Unii Europejskiej; przewodniki wdrożeniowe FHIR HL7 Europe; modele logiczne Xt-EHR (xtehr.eu.ehds.models). Przewodniki w ballocie mogą się jeszcze zmienić. Ten przewodnik ma charakter informacyjny: nie jest poradą prawną ani certyfikacją zgodności.