RULES FOR THE PURPOSE OF POPULATING THE EU DIGITAL COVID CERTIFICATE
ANNEX IISupplementary provisions
ANNEX II RULES FOR THE PURPOSE OF POPULATING THE EU DIGITAL COVID CERTIFICATE The general rules concerning the value sets established in this Annex aim to ensure interoperability on semantic level and shall allow uniform technical implementations for the DCC. Elements contained in this Annex may be used for the three different settings (vaccination/testing/recovery), as provided for in Regulation (EU) 2021/953. Only elements with the necessity of semantic standardisation through coded value sets are listed in this Annex. Translation of the coded elements into the national language are under the responsibility of the Member States. For all data fields not mentioned in the following value set descriptions, encoding in UTF-8 is recommended (name, testing centre, certificate issuer). Data fields containing calendar dates (date of birth, date of vaccination, date of test sample collection, date of first positive test result, certificate validity dates) are recommended to be encoded following the ISO 8601. If for any reason the preferred code systems listed below cannot be used, other international code systems may be used and advice on how to map the codes from the other code system to the preferred code system should be put in place. Text (display names) may be used in exceptional cases as a backup mechanism when a suitable code is not available in the defined value sets. Member States using other coding in their systems should map such codes to the described value sets. Member States are responsible for any such mappings. The value sets shall be regularly updated by the Commission with the support of the eHealth Network and the Health Security Committee. The updated value sets shall be published on the relevant website of the Commission, as well as on the webpage of the eHealth Network. A history of changes should be provided. 1. Disease or agent targeted/Disease or agent from which the holder has recovered: COVID-19 (SARS-CoV-2 or one of its variants) Preferred Code System: SNOMED CT. To be used in certificate 1, 2 and 3. The selected codes shall refer to COVID-19 or, if more detailed information on the genetic variant of SARS-CoV-2 is needed, to these variants if such detailed information is needed due to epidemiological reasons. Example of a code that should be used is the SNOMED CT code 840539006 (COVID-19). 2. COVID-19 vaccine or prophylaxis Preferred Code System: SNOMED CT or ATC Classification. To be used in certificate 1. Examples of codes that should be used from the preferred code systems are the SNOMED CT code 1119305005 (SARS-CoV-2 antigen vaccine), 1119349007 (SARS-CoV-2 mRNA vaccine) or J07BX03 (covid-19 vaccines). The value set should be extended when new vaccine types are developed and put into use. 3. COVID-19 vaccine medicinal product Preferred Code Systems (in the order of preference): — Union Register of medicinal products for vaccines with EU-wide authorisation (authorisation numbers) — A global vaccine register such as one that could be established by the World Health Organisation — Name of the vaccine medicinal product in other cases. If the name includes whitespaces, these should be replaced by a hyphen (-). Name of the Value Set: Vaccine. To be used in certificate 1. An example of a code that should be used from the preferred code systems is EU/1/20/1528 (Comirnaty). An example of the name of the vaccine to be used as a code: Sputnik-V (standing for Sputnik V). 4. COVID-19 vaccine marketing authorisation holder or manufacturer Preferred Code System: — Organisation code from EMA (SPOR system for ISO IDMP) — A global vaccine marketing authorisation holder or manufacturer register, such as one that could be established by the World Health Organisation — Name of the organisation in other cases. If the name includes whitespaces, these should be replaced by a hyphen (-). To be used in certificate 1. Example of a code that should be used from the preferred code system is ORG-100001699 (AstraZeneca AB). An example of the name of the organisation to be used as a code: Sinovac-Biotech (standing for Sinovac Biotech). 5. Number in a series of doses as well as the overall number of doses in the series To be used in certificate 1. Two fields: (1) Number of dose administered in a cycle (2) Number of expected doses for a complete cycle (specific for a person at the time of administration) For example, 1/1, 2/2 will be presented as completed; including the option 1/1 for vaccines including two doses, but for which the protocol applied by the Member State is to administer one dose to citizens that were diagnosed with COVID-19 prior to the vaccination. The overall number of doses in the series should be indicated as per information available at the time when the dose is administered. For example, if a specific vaccine requires a third shot (booster) at the time of the latest administered shot, the second field number shall reflect this (for example 2/3, 3/3 etc.). 6. Member State or third country in which the vaccine was administered/test was carried out Preferred Code System: ISO 3166 Country Codes. To be used in certificates 1, 2 and 3. Value set content: the complete list of 2-letter codes, available as a value set defined in FHIR (http://hl7.org/fhir/ValueSet/iso3166-1-2) 7. The type of test Preferred Code System: LOINC. To be used in certificate 2, and certificate 3 if support for the issuance of recovery certificates based on types of test other than NAAT is introduced through a delegated act. The codes in this value set shall refer to the method of the test and shall be selected at least to separate the NAAT tests from RAT tests as expressed in Regulation (EU) 2021/953. An example of a code that should be used from the preferred code system is LP217198-3 (Rapid immunoassay). 8. Manufacturer and commercial name of the test used (optional for NAAT test) Preferred Code System: List from the HSC of Rapid Antigen Tests as maintained by the JRC (COVID-19 In Vitro Diagnostic Devices and Test Methods Database. To be used in certificate 2. The content of the Value Set shall include the selection of rapid antigen test as listed in the common and updated list of COVID-19 rapid antigen tests, established on the basis of Council Recommendation 2021/C 24/01 and agreed by the Health Security Committee. The list is maintained by the JRC in the COVID-19 In Vitro Diagnostic Devices and Test Methods Database at: https://covid-19-diagnostics.jrc.ec.europa.eu/devices/hsc-common-recognition-rat For this code system, relevant fields such as the identifier of the test device, name of the test and manufacturer shall be used, following the JRC structured format available at https://covid-19-diagnostics.jrc.ec.europa.eu/devices 9. Result of the test Preferred Code System: SNOMED CT. To be used in certificate 2. The codes selected shall allow distinguishing between positive and negative test results (detected or not detected). Additional values (like undetermined) may be added if the use cases do require this. Examples of codes that should be used from the preferred code system are 260415000 (Not detected) and 260373001 (Detected).