<implementationGuide id="2.16.840.1.113883.3.1937.99.60.7.29.1" effectiveDate="2025-11-19T12:28:24" name="demo7-20251119122824-implementationguide" statusCode="draft" lastModifiedDate="2026-01-19T19:33:02" projectId="2.16.840.1.113883.3.1937.99.60.7">
    <title language="en-US" lastTranslated="2025-11-19T12:28:36">Vaccination Certificates Document</title>
    <desc language="en-US" lastTranslated="2025-11-19T12:33:24">
        <p>This is a Demonstration of an Implementation Guide for "Vaccination".</p>
        <div class="__artdecor_box aswarning">
            <strong>Disclaimer</strong>
            <p>FOR TEST AND EXAMPLE PURPOSES ONLY! This <em>Implementation Guide</em> and derived publications pages are not intended to be used as a source of information on medicines or healthcare. The content is not necessarily kept up to date and is for demonstration purposes only. For up-to-date information on a healthcare topic, please consult the relevant reliable sources or an healthcare
                expert.</p>
        </div>
    </desc>
    <definition>
        <resource generated="true" artefact="AC" id="2.16.840.1.113883.3.1937.99.60.7.7.1" type="person">
            <name language="en-US" lastTranslated="2026-01-14T10:12:21">Physician performing the Vaccination</name>
        </resource>
        <resource generated="true" artefact="DS" id="2.16.840.1.113883.3.1937.99.60.7.1.1" effectiveDate="2013-10-10T00:00:00" statusCode="draft" lastModifiedDate="2025-03-18T11:42:01">
            <name language="en-US" lastTranslated="2026-01-14T10:12:21">Vaccination Certificates Document</name>
            <desc language="en-US" lastTranslated="2025-03-18T11:36:12">
                <p>This is the overarching dataset which logically defines the model and covers both scenarios in this project: <em>Vaccination Certificate</em> and <em>Proof of Covid-19 Vaccination or negative status</em>.</p>
            </desc>
        </resource>
        <resource generated="true" artefact="SC" id="2.16.840.1.113883.3.1937.99.60.7.3.1" effectiveDate="2013-10-10T00:00:00" statusCode="draft" lastModifiedDate="2025-03-18T11:43:15">
            <name language="en-US" lastTranslated="2026-01-14T10:12:21">Vaccination</name>
            <desc language="en-US" lastTranslated="2026-01-14T10:12:21">Vaccination</desc>
        </resource>
        <resource generated="true" artefact="TM" id="2.16.840.1.113883.10.12.151" effectiveDate="2005-09-07T00:00:00" statusCode="active">
            <name language="en-US" lastTranslated="2026-01-14T10:12:21">CDAOrganization</name>
            <desc language="en-US" lastTranslated="2026-01-14T10:12:21">Template CDA Organization (prototype, directly derived from POCD_RM000040 MIF)</desc>
            <desc language="de-DE" lastTranslated="2026-01-14T10:12:21">Template CDA Organization (Prototyp, direkt abgeleitet aus POCD_RM000040 MIF)</desc>
            <desc language="nl-NL" lastTranslated="2026-01-14T10:12:21">Template CDA Organization (prototype, direct afgeleid uit POCD_RM000040 MIF)</desc>
        </resource>
        <resource generated="true" artefact="TM" id="2.16.840.1.113883.10.12.152" effectiveDate="2005-09-07T00:00:00" statusCode="active">
            <name language="en-US" lastTranslated="2026-01-14T10:12:21">CDAPerson</name>
            <desc language="en-US" lastTranslated="2026-01-14T10:12:21">Template CDA Person (prototype, directly derived from POCD_RM000040 MIF)</desc>
            <desc language="de-DE" lastTranslated="2026-01-14T10:12:21">Template CDA Person (Prototyp, direkt abgeleitet aus POCD_RM000040 MIF)</desc>
            <desc language="nl-NL" lastTranslated="2026-01-14T10:12:21">Template CDA Person (prototype, direct afgeleid uit POCD_RM000040 MIF)</desc>
        </resource>
        <resource generated="true" artefact="TM" id="2.16.840.1.113883.10.12.315" effectiveDate="2005-09-07T00:00:00" statusCode="active">
            <name language="en-US" lastTranslated="2026-01-14T10:12:21">CDADevice</name>
            <desc language="en-US" lastTranslated="2026-01-14T10:12:21">Template CDA Device (prototype, directly derived from POCD_RM000040 MIF)</desc>
            <desc language="de-DE" lastTranslated="2026-01-14T10:12:21">Template CDA Device (Prototyp, direkt abgeleitet aus POCD_RM000040 MIF)</desc>
            <desc language="nl-NL" lastTranslated="2026-01-14T10:12:21">Template CDA Device (prototype, direct afgeleid uit POCD_RM000040 MIF)</desc>
        </resource>
        <resource generated="true" artefact="TM" id="2.16.840.1.113883.10.12.318" effectiveDate="2005-09-07T00:00:00" statusCode="active">
            <name language="en-US" lastTranslated="2026-01-14T10:12:21">CDAAuthorBody</name>
            <desc language="en-US" lastTranslated="2026-01-14T10:12:21">Template CDA Author (prototype, directly derived from POCD_RM000040 MIF)</desc>
            <desc language="de-DE" lastTranslated="2026-01-14T10:12:21">Template CDA Author (Prototyp, direkt abgeleitet aus POCD_RM000040 MIF)</desc>
            <desc language="nl-NL" lastTranslated="2026-01-14T10:12:21">Template CDA Author (prototype, direct afgeleid uit POCD_RM000040 MIF)</desc>
        </resource>
        <resource generated="true" artefact="TM" id="2.16.840.1.113883.3.1937.99.60.7.10.1.1" effectiveDate="2013-10-10T00:00:00" statusCode="draft" lastModifiedDate="2025-03-18T11:45:04">
            <name language="en-US" lastTranslated="2026-01-14T10:12:21">MinimalCDAVaccdocument</name>
            <desc language="en-US" lastTranslated="2025-03-18T11:45:04">
                <p>
                    <strong>Vaccination Certificate Document</strong>
                </p>
                <p>The document is a vaccination certificate. It comprises of a patient ("holder" of the certificate) and his or her list of vaccinations. This comes along with the typical CDA R2 attributes and relationships for the ClinicalDocument class:</p>
                <ul>
                    <li>
                        <p>typeId: fixed</p>
                    </li>
                    <li>
                        <p>id: unique id of the document instance</p>
                    </li>
                    <li>
                        <p>code: type of document</p>
                    </li>
                    <li>
                        <p>effectiveTime: creation date of the document</p>
                    </li>
                    <li>
                        <p>confidentialityCode: confidentiality level indication for this document</p>
                    </li>
                    <li>
                        <p>recordTarget: the record target (e.g. patient)</p>
                    </li>
                    <li>
                        <p>author: author of this document</p>
                    </li>
                    <li>
                        <p>custodian: custodian for this document</p>
                    </li>
                    <li>
                        <p>component: contains structured body</p>
                    </li>
                </ul>
                <p>.The body contains a section that holds the list of vaccinations both, in free text (table) and as structured entries (CDA class: SubstanceAdministration).</p>
                <p>It has the LOINC code 11369-6 History of immunization.</p>
            </desc>
        </resource>
        <resource generated="true" artefact="TM" id="2.16.840.1.113883.3.1937.99.60.7.10.1.2" effectiveDate="2022-01-31T00:00:00" statusCode="draft" lastModifiedDate="2025-03-18T11:46:24">
            <name language="en-US" lastTranslated="2026-01-14T10:12:21">MinimalCovid19VaccProofOrNegativeCDAdocument</name>
            <desc language="en-US" lastTranslated="2025-03-18T11:46:24">
                <p>
                    <strong>Proof of Covid-19 Vaccination or negative status document</strong>
                </p>
                <p>During the Covid-19 pandemic a "Proof of Covid-19 Vaccination or negative status" document, which is the so-called <em>Green Pass</em>, a document in digital or paper format that certifies vaccination against the Covid-19 disease or, alternatively, the recent negative test result or recent recovery from the infection.</p>
                <p>It contains the "holder" of this proof (patent) and an indication of whether there was an administration of vaccine product against severe acute respiratory syndrome coronavirus 2 (SNOMED 1156257007) or the disease caused by severe acute respiratory syndrome coronavirus 2 is absent (SNOMED 688232241000119100). The codes are included in a value set.</p>
                <p>This CDA document specification is just a test and example purpose definition and was not considered for real use.</p>
                <p>It has the LOINC code 97500-3.</p>
            </desc>
        </resource>
        <resource generated="true" artefact="TM" id="2.16.840.1.113883.3.1937.99.60.7.10.2.1" effectiveDate="2013-10-10T00:00:00" statusCode="draft">
            <name language="en-US" lastTranslated="2026-01-14T10:12:21">CDArecordTarget</name>
            <desc language="en-US" lastTranslated="2026-01-14T10:12:21">The patient / client</desc>
        </resource>
        <resource generated="true" artefact="TM" id="2.16.840.1.113883.3.1937.99.60.7.10.2.2" effectiveDate="2013-10-10T00:00:00" statusCode="draft">
            <name language="en-US" lastTranslated="2026-01-14T10:12:21">CDAauthor</name>
            <desc language="en-US" lastTranslated="2026-01-14T10:12:21">Author of the document</desc>
        </resource>
        <resource generated="true" artefact="TM" id="2.16.840.1.113883.3.1937.99.60.7.10.2.3" effectiveDate="2013-10-10T00:00:00" statusCode="draft">
            <name language="en-US" lastTranslated="2026-01-14T10:12:21">CDAcustodian</name>
            <desc language="en-US" lastTranslated="2026-01-14T10:12:21">Custodian of the document</desc>
        </resource>
        <resource generated="true" artefact="TM" id="2.16.840.1.113883.3.1937.99.60.7.10.3.1" effectiveDate="2014-11-18T12:18:00" statusCode="draft">
            <name language="en-US" lastTranslated="2026-01-14T10:12:21">ImmunizationSection</name>
            <desc language="en-US" lastTranslated="2026-01-14T10:12:21">Immunization Section</desc>
        </resource>
        <resource generated="true" artefact="TM" id="2.16.840.1.113883.3.1937.99.60.7.10.3.2" effectiveDate="2022-01-31T00:00:00" statusCode="draft">
            <name language="en-US" lastTranslated="2026-01-14T10:12:21">COVID-19ImmunizationOrNegativeStatusSection</name>
            <desc language="en-US" lastTranslated="2026-01-14T10:12:21">COVID-19 Immunization Or Negative Status Section</desc>
        </resource>
        <resource generated="true" artefact="TM" id="2.16.840.1.113883.3.1937.99.60.7.10.4.1" effectiveDate="2017-03-08T00:00:00" statusCode="draft" lastModifiedDate="2025-03-17T22:11:29">
            <name language="en-US" lastTranslated="2026-01-14T10:12:21">Immunization</name>
            <desc language="en-US" lastTranslated="2025-03-17T22:11:29">An Immunization entry describes immunization substance administrations that have actually occurred.<br/> (This template is actually a copy of the IPS Immunization 2.16.840.1.113883.10.22.4.15) </desc>
        </resource>
        <resource generated="true" artefact="TM" id="2.16.840.1.113883.3.1937.99.60.7.10.4.2" effectiveDate="2017-03-08T00:00:00" statusCode="draft" lastModifiedDate="2025-03-06T13:18:31">
            <name language="en-US" lastTranslated="2026-01-14T10:12:21">ImmunizationMedicationInformation</name>
            <desc language="en-US" lastTranslated="2025-03-06T13:18:31">The Immunization Medication Information represents product information about the immunization substance. The vaccine manufacturer and vaccine lot number are typically recorded in the medical record and should be included if known.<br/> (This template is actually a copy of the IPS Immunization
                2.16.840.1.113883.10.22.4.16)</desc>
        </resource>
        <resource generated="true" artefact="TM" id="2.16.840.1.113883.3.1937.99.60.7.10.4.3" effectiveDate="2022-01-31T00:00:00" statusCode="draft" lastModifiedDate="2025-03-18T11:47:32">
            <name language="en-US" lastTranslated="2026-01-14T10:12:21">COVID-19ImmunizationOrNegativeStatus</name>
        </resource>
        <resource generated="true" artefact="TM" id="2.16.840.1.113883.3.1937.99.60.7.10.9.1" effectiveDate="2013-10-10T00:00:00" statusCode="active">
            <name language="en-US" lastTranslated="2026-01-14T10:12:21">CDArealmCode</name>
            <desc language="en-US" lastTranslated="2026-01-14T10:12:21">Country specific context</desc>
        </resource>
        <resource generated="true" artefact="TM" id="2.16.840.1.113883.3.1937.99.60.7.10.9.2" effectiveDate="2013-10-10T00:00:00" statusCode="active">
            <name language="en-US" lastTranslated="2026-01-14T10:12:21">CDAtypeId</name>
            <desc language="en-US" lastTranslated="2026-01-14T10:12:21">The clinical document <tt>typeId</tt> identifies the constraints imposed by CDA R2 on the content, essentially acting as a version identifier. <p/> The <tt>@root</tt> and <tt>@extension</tt> values of this element are specified as shown in the <i>example</i> below. </desc>
        </resource>
        <resource generated="true" artefact="TM" id="2.16.840.1.113883.3.1937.99.60.7.10.9.3" effectiveDate="2013-10-10T00:00:00" statusCode="active">
            <name language="en-US" lastTranslated="2026-01-14T10:12:21">CDAId</name>
            <desc language="en-US" lastTranslated="2026-01-14T10:12:21">The clinical document <tt>id</tt> element is an instance identifier data type. The <tt>@root</tt> attribute is typically an OID. The <tt>@root</tt> uniquely identifies the scope of the <tt>@extension</tt>. The <tt>@root</tt> and <tt>@extension</tt> attributes uniquely identify the document.</desc>
        </resource>
        <resource generated="true" artefact="TM" id="2.16.840.1.113883.3.1937.99.60.7.10.9.4" effectiveDate="2013-10-10T00:00:00" statusCode="active">
            <name language="en-US" lastTranslated="2026-01-14T10:12:21">CDAeffectiveTime</name>
            <desc language="en-US" lastTranslated="2026-01-14T10:12:21">Date report was created, precise to the second</desc>
        </resource>
        <resource generated="true" artefact="TM" id="2.16.840.1.113883.3.1937.99.60.7.10.9.5" effectiveDate="2013-10-10T00:00:00" statusCode="draft">
            <name language="en-US" lastTranslated="2026-01-14T10:12:21">CDAconfidentialityCode</name>
        </resource>
        <resource generated="true" artefact="TM" id="2.16.840.1.113883.3.1937.99.60.7.10.9.6" effectiveDate="2011-12-19T00:00:00" statusCode="draft">
            <name language="en-US" lastTranslated="2026-01-14T10:12:21">CDAPersonElements</name>
            <desc language="en-US" lastTranslated="2026-01-14T10:12:21">This is a template with multiple elements on top level (use for inclusion)</desc>
        </resource>
        <resource generated="true" artefact="TM" id="2.16.840.1.113883.3.1937.99.60.7.10.9.7" effectiveDate="2011-12-19T00:00:00" statusCode="draft">
            <name language="en-US" lastTranslated="2026-01-14T10:12:21">CDAOrganizationElements</name>
            <desc language="en-US" lastTranslated="2026-01-14T10:12:21">This is a template with multiple elements on top level (use for inclusion)</desc>
        </resource>
        <resource generated="true" artefact="TM" id="2.16.840.1.113883.3.1937.99.60.7.10.9.8" effectiveDate="2013-01-31T00:00:00" statusCode="draft">
            <name language="en-US" lastTranslated="2026-01-14T10:12:21">NationalPatientIdentifier</name>
            <desc language="en-US" lastTranslated="2026-01-14T10:12:21">National Patient Identifier: this is an example of a National Citizen Identifier used in health care. In this project it is the real Dutch "Burgerservicenummer", the Citizen Service Numnber. The Burgerservicenummer (BSN) is a unique personal number issued to everyone registered in the 'Gemeentelijke Basisadministratie
                persoonsgegevens' (GBA), or the Personal Records Database of the municipality. The BSN was formerly known as the Social-Fiscal (So-Fi) number. <p/> (Citation: http://www.denhaag.nl/en/residents/to/Burgerservicenummer-BSN.htm) <p/> It has the following format: 9N, with preceding zeros if shorter than 9 characters. </desc>
        </resource>
        <resource generated="true" artefact="TR" id="2.16.840.1.113883.3.1937.99.60.7.4.1" effectiveDate="2013-10-10T00:00:00" statusCode="draft" type="group">
            <name language="en-US" lastTranslated="2026-01-14T10:12:21">Vaccination Certificate</name>
            <desc language="en-US" lastTranslated="2026-01-14T10:12:21">Vaccination Certificate</desc>
        </resource>
        <resource generated="true" artefact="TR" id="2.16.840.1.113883.3.1937.99.60.7.4.2" effectiveDate="2013-10-10T00:00:00" statusCode="draft" type="stationary" label="vacccda">
            <name language="en-US" lastTranslated="2026-01-14T10:12:21">Create a Vaccination Certificates Document</name>
            <desc language="en-US" lastTranslated="2026-01-14T10:12:21">Create a Vaccination Certificates Document</desc>
        </resource>
        <resource generated="true" artefact="TR" id="2.16.840.1.113883.3.1937.99.60.7.4.5" effectiveDate="2025-03-17T17:08:03" statusCode="draft" lastModifiedDate="2025-03-18T11:43:15" type="group">
            <name language="en-US" lastTranslated="2025-03-17T17:08:03">Proof of Vaccination or Negative status</name>
        </resource>
        <resource generated="true" artefact="TR" id="2.16.840.1.113883.3.1937.99.60.7.4.6" effectiveDate="2025-03-17T17:08:03" statusCode="draft" lastModifiedDate="2025-03-18T11:43:15" type="stationary" label="proof">
            <name language="en-US" lastTranslated="2025-03-17T17:08:03">Create a Proof of Vaccination or Negative status Document</name>
        </resource>
        <resource generated="true" artefact="VS" id="2.16.840.1.113883.1.11.1" effectiveDate="2016-06-23T00:00:00" statusCode="final">
            <name language="en-US" lastTranslated="2026-01-14T10:12:21">AdministrativeGender</name>
        </resource>
        <resource generated="true" artefact="VS" id="2.16.840.1.113883.1.11.10267" effectiveDate="2016-06-23T00:00:00" statusCode="final">
            <name language="en-US" lastTranslated="2026-01-14T10:12:21">ParticipationFunction</name>
        </resource>
        <resource generated="true" artefact="VS" id="2.16.840.1.113883.1.11.14581" effectiveDate="2014-03-26T00:00:00" statusCode="final" versionLabel="DEFN=UV=VO=1360-20160323">
            <name language="en-US" lastTranslated="2026-01-14T10:12:21">RouteOfAdministration</name>
            <desc language="en-US" lastTranslated="2026-01-14T10:12:21">
                <p><b>History description 2014-03-26: </b>Lock all vaue sets untouched since 2014-03-26 to trackingId 2014T1_2014_03_26</p>
                <b>description: </b>
                <p>The path the administered medication takes to get into the body or into contact with the body.</p>
            </desc>
        </resource>
        <resource generated="true" artefact="VS" id="2.16.840.1.113883.1.11.15999" effectiveDate="2014-03-26T00:00:00" statusCode="final" versionLabel="DEFN=UV=VO=1360-20160323">
            <name language="en-US" lastTranslated="2026-01-14T10:12:21">RoleStatus</name>
            <desc language="en-US" lastTranslated="2026-01-14T10:12:21">
                <p><b>History description 2014-03-26: </b>Lock all vaue sets untouched since 2014-03-26 to trackingId 2014T1_2014_03_26</p>
                <b>description: </b>
                <p>Codes representing the defined possible states of an Role, as defined by the Role class state machine.</p>
            </desc>
        </resource>
        <resource generated="true" artefact="VS" id="2.16.840.1.113883.1.11.16040" effectiveDate="2014-03-26T00:00:00" statusCode="final" versionLabel="DEFN=UV=VO=1360-20160323">
            <name language="en-US" lastTranslated="2026-01-14T10:12:21">EntityCode</name>
            <desc language="en-US" lastTranslated="2026-01-14T10:12:21">
                <p><b>History description 2014-03-26: </b>Lock all vaue sets untouched since 2014-03-26 to trackingId 2014T1_2014_03_26</p>
                <b>description: </b>
                <p>A value representing the specific kind of Entity the instance represents.</p>
                <p><i>Examples:</i> A medical building, a Doberman Pinscher, a blood collection tube, a tissue biopsy.</p>
                <p><i>Rationale:</i> For each Entity, the value for this attribute is drawn from one of several coding systems depending on the Entity classCode, such as living subjects (animal and plant taxonomies), chemical substance (e.g., IUPAC code), organizations, insurance company, government agency, hospital, park, lake, syringe, etc. It is possible that Entity.code may be so fine grained
                    that it represents a single instance. An example is the CDC vaccine manufacturer code, modeled as a concept vocabulary, when in fact each concept refers to a single instance.</p>
            </desc>
        </resource>
        <resource generated="true" artefact="VS" id="2.16.840.1.113883.1.11.16926" effectiveDate="2016-06-23T00:00:00" statusCode="final">
            <name language="en-US" lastTranslated="2026-01-14T10:12:21">HL7BasicConfidentialityKind</name>
        </resource>
        <resource generated="true" artefact="VS" id="2.16.840.1.113883.1.11.19709" effectiveDate="2014-03-26T00:00:00" statusCode="final" versionLabel="DEFN=UV=VO=1360-20160323">
            <name language="en-US" lastTranslated="2026-01-14T10:12:21">ActSubstanceAdministrationImmunizationCode</name>
            <desc language="en-US" lastTranslated="2026-01-14T10:12:21">
                <p><b>History description 2014-03-26: </b>Lock all vaue sets untouched since 2014-03-26 to trackingId 2014T1_2014_03_26</p>
                <b>description: </b>
                <p>The introduction of an immunogen with the intent of stimulating an immune response, aimed at preventing subsequent infections by more viable agents.</p>
            </desc>
        </resource>
        <resource generated="true" artefact="VS" id="2.16.840.1.113883.1.11.19717" effectiveDate="2011-07-26T00:00:00" statusCode="final" versionLabel="DEFN=UV=VO=1099-20110726">
            <name language="en-US" lastTranslated="2026-01-14T10:12:21">ActNoImmunizationReason</name>
            <desc language="en-US" lastTranslated="2026-01-14T10:12:21">
                <b>description: </b>
                <p>A coded description of the reason for why a patient did not receive a scheduled immunization.</p>
                <p>(important for public health strategy</p>
            </desc>
        </resource>
        <resource generated="true" artefact="VS" id="2.16.840.1.113883.11.22.44" effectiveDate="2024-08-02T11:41:23" statusCode="draft" lastModifiedDate="2024-08-02T11:42:07" canonicalUri="http://hl7.org/fhir/uv/ips/ValueSet/vaccines-uv-ips">
            <name language="en-US" lastTranslated="2026-01-14T10:12:21">IPSVaccines</name>
            <desc language="en-US" lastTranslated="2024-08-02T11:41:23">IPS Vaccine codes value set.</desc>
        </resource>
        <resource generated="true" artefact="VS" id="2.16.840.1.113883.3.1937.99.60.7.11.1" effectiveDate="2013-10-20T20:07:50" statusCode="deprecated">
            <name language="en-US" lastTranslated="2026-01-14T10:12:21">VaccineAdministered</name>
        </resource>
        <resource generated="true" artefact="VS" id="2.16.840.1.113883.3.1937.99.60.7.11.2" effectiveDate="2024-03-16T10:07:17" statusCode="draft">
            <name language="en-US" lastTranslated="2026-01-14T10:12:21">COVID-19ImmunizationOrNegativeStatusCodes</name>
            <desc language="en-US" lastTranslated="2026-01-14T10:12:21">Proof of COVID-19 immunization or negative status values</desc>
        </resource>
        <page id="749a625b-ec4d-45db-9a62-5bec4d85dbc6" lastModifiedDate="2026-01-10T17:23:34">
            <title language="en-US" lastTranslated="2025-11-19T12:34:49">Vaccination Templates (CDA)</title>
            <content language="en-US" lastTranslated="2025-11-19T12:28:36">
                <h2>Purpose of This Guide</h2>
                <p>This Implementation Guide (IG) defines a European, standards-based approach for representing vaccination records using HL7 CDA Release 2. Building on real-world experience gained during the COVID-19 pandemic—as well as decades of use of the WHO International Certificate of Vaccination (“Yellow Booklet”)—this guide provides:</p>
                <ul>
                    <li>
                        <p>A <strong>harmonized template set</strong> for documenting routine and travel vaccinations</p>
                    </li>
                    <li>
                        <p>A <strong>minimal, verifiable structure</strong> for COVID-19 vaccination attestations</p>
                    </li>
                    <li>
                        <p>A <strong>common core model</strong> supporting both detailed clinical documentation and lightweight public-health certification</p>
                    </li>
                </ul>
                <p>The templates and datasets are maintained and published via <strong>ART-DECOR</strong>, ensuring a transparent governance process and alignment with established European interoperability initiatives.</p>
                <div class="__artdecor_box aswarning">
                    <p>
                        <strong>Disclaimer</strong>
                    </p>
                    <h3>
                        <strong>This is a Demonstration of an <em>Implementation Guide</em> for "Vaccination".</strong>
                    </h3>
                    <p>FOR TEST AND EXAMPLE PURPOSES ONLY! This Implementation Guide and derived publications pages are not intended to be used as a sou rce of information on medicines or healthcare. The content is not necessarily kept up to date and is for demonstration purposes only. For up-to-date information on a healthcare topic, please consult the relevant reliable sources or an healthcare
                        expert.</p>
                </div>
                <h2>Audience</h2>
                <p>This guide is intended for:</p>
                <ul>
                    <li>
                        <p>National and regional eHealth programs</p>
                    </li>
                    <li>
                        <p>Immunization information systems</p>
                    </li>
                    <li>
                        <p>Vendors of clinical documentation and EHR systems</p>
                    </li>
                    <li>
                        <p>Public health authorities issuing vaccination certificates</p>
                    </li>
                    <li>
                        <p>Cross-border exchange platforms and verifier systems</p>
                    </li>
                </ul>
                <h2>Key Assets</h2>
                <p>All CDA templates, value sets, concept definitions, and example instances used in this IG are available in a browsable through the ART-DECOR® publication.</p>
            </content>
            <page id="f8a97101-a5f5-459c-a971-01a5f5359cb8" lastModifiedDate="2026-01-19T19:33:02">
                <title language="en-US" lastTranslated="2025-11-19T12:34:49">Introduction</title>
                <content language="en-US" lastTranslated="2025-11-19T12:34:49">
                    <p>Reliable and interoperable documentation of vaccinations is an essential cornerstone of public health. Vaccination records are required for clinical care, for international travel, for school and workplace requirements, and increasingly for cross-border digital health services. Across Europe, the COVID-19 pandemic has highlighted both the importance and the challenges of
                        exchanging trustworthy vaccination information. While numerous national formats exist, the absence of a harmonized, standards-based representation complicates reuse, verification, and secondary use.</p>
                    <p>To address this, this Implementation Guide (IG) describes a structured, CDA-based representation of vaccination documentation that supports established and emerging use cases. The underlying design aligns with European interoperability frameworks, relevant WHO specifications, and the HL7 Clinical Document Architecture (CDA) Release 2. It reuses components drawn from the
                        ART-DECOR dataset</p>
                    <p>This guide does <strong>not</strong> intend to define yet another proprietary certificate format. Instead, it provides a set of reusable CDA templates and constraints that allow implementers to capture vaccination evidence consistently—whether the source data originated from a paper-based card, a national immunization registry, or a digital certificate system.</p>
                    <p>The IG focuses on two primary use cases:</p>
                    <ol>
                        <li>
                            <p>
                                <strong>Documentation of routine vaccinations using the WHO International Certificate of Vaccination or Prophylaxis (“Yellow Booklet”).</strong>
                            </p>
                        </li>
                        <li>
                            <p><strong>Simple proof of COVID-19 vaccination</strong>, introduced during the pandemic as a minimal attestation mechanism, often restricted to a few essential data elements.</p>
                        </li>
                    </ol>
                    <p>
                        <img src="/exist/apps/api/project/demo7-/blob/476a2c82-dcd2-4f48-aa2c-82dcd2ef480c"/>
                    </p>
                    <p>
                        <em>Figure: The WHO International Certificate of Vaccination or Prophylaxis (“Yellow Booklet”) – German Edition</em>
                    </p>
                    <p>
                        <img src="/exist/apps/api/project/demo7-/blob/4b7fd979-76a6-4d3b-bfd9-7976a60d3bec"/>
                    </p>
                    <p>
                        <em>Figure: European Union EU Digital COVID Certificate</em>
                    </p>
                    <p>Although both use cases differ in their scope and level of detail, they share a common foundation. This IG therefore provides a harmonized CDA model that supports both, while enabling implementations that remain faithful to their original intent.</p>
                </content>
            </page>
            <page id="03d1dd57-37e8-4138-91dd-5737e8d13894" lastModifiedDate="2025-11-19T12:43:44">
                <title language="en-US" lastTranslated="2025-11-19T12:36:37">Use Cases</title>
                <content language="en-US" lastTranslated="2025-11-19T12:36:37">
                    <h2>WHO International Certificate of Vaccination or Prophylaxis (“Yellow Booklet”)</h2>
                    <p>The WHO “Yellow Booklet” is a globally recognized paper document used to record routine and travel-related vaccinations (e.g., yellow fever, hepatitis, polio). While traditionally paper-based, it remains the reference format for international travel and continues to play a role for European citizens who move across borders.</p>
                    <h3>History and Rationale</h3>
                    <p>The origins of the Yellow Booklet trace back to the International Sanitary Regulations of the mid-20th century—predecessors of today’s International Health Regulations (IHR). Its purpose was to provide a <strong>globally uniform, portable, and trustworthy</strong> means for travelers to demonstrate immunization against diseases of international concern, particularly yellow
                        fever. Over time, countries adopted the booklet as a practical record not only for travel vaccines but also for routine childhood and adult immunizations. Its simple layout, handwritten format, and long-standing international acceptance made it a <strong>de facto global standard</strong> for documenting vaccinations long before digital health records existed. Even today, it
                        remains legally recognized under the IHR and serves as a familiar, widely trusted proof of immunization.</p>
                    <h3>Scope and Characteristics</h3>
                    <ul>
                        <li>
                            <p>Contains a list of administered vaccines with limited but essential data: vaccine name, date, batch/lot number, administering center or clinician, and signature/stamp.</p>
                        </li>
                        <li>
                            <p>Serves as <strong>long-term historical record</strong>, sometimes spanning decades.</p>
                        </li>
                        <li>
                            <p>May contain heterogeneous entries, abbreviations, handwritten notes, and varying degrees of completeness.</p>
                        </li>
                        <li>
                            <p>Often requires <strong>transcription</strong> into clinical systems during encounters.</p>
                        </li>
                        <li>
                            <p>Does <strong>not</strong> contain structured clinical coding or digital identifiers.</p>
                        </li>
                    </ul>
                    <h3>Implications for CDA Representation</h3>
                    <p>The CDA representation should:</p>
                    <ul>
                        <li>
                            <p>Support <strong>free-text or minimally coded vaccine descriptions</strong>, consistent with paper entries.</p>
                        </li>
                        <li>
                            <p>Represent <strong>historical immunizations</strong> without requiring structured extensions unavailable in the paper form.</p>
                        </li>
                        <li>
                            <p>Capture <strong>source reliability</strong> (e.g., “patient-provided record”, “transcribed from paper”).</p>
                        </li>
                        <li>
                            <p>Allow for optional enrichment through standardized vocabularies (e.g., SNOMED CT, ATC) when available.</p>
                        </li>
                    </ul>
                    <p>The templates provided in this IG allow implementers to create a structured CDA document that mirrors the contents of the Yellow Booklet while enabling digital storage, archiving, and cross-border exchange.</p>
                    <h2>Simple Proof of COVID-19 Vaccination</h2>
                    <p>During the COVID-19 pandemic, many European countries introduced lightweight vaccination certificates to support public health measures and cross-border mobility. These certificates focused on <strong>minimum necessary information</strong>, optimized for verification and rapid issuance—not for comprehensive medical documentation.</p>
                    <h3>Scope and Characteristics</h3>
                    <ul>
                        <li>
                            <p>Typically contains only:</p>
                            <ul>
                                <li>
                                    <p>vaccine type/product</p>
                                </li>
                                <li>
                                    <p>date(s) of administration</p>
                                </li>
                                <li>
                                    <p>dose sequence (e.g., “2 of 2”)</p>
                                </li>
                                <li>
                                    <p>the issuing authority or vaccination center</p>
                                </li>
                                <li>
                                    <p>a unique certificate identifier</p>
                                </li>
                            </ul>
                        </li>
                        <li>
                            <p>May include a QR code or digital signature in national formats.</p>
                        </li>
                        <li>
                            <p>Strong focus on <strong>validation</strong>, <strong>interoperability</strong>, and <strong>fraud prevention</strong>.</p>
                        </li>
                        <li>
                            <p>Lifecycle often <strong>short-term</strong>, especially in the context of evolving public health rules.</p>
                        </li>
                        <li>
                            <p>Often derived from national immunization registries or point-of-care vaccination systems.</p>
                        </li>
                    </ul>
                    <h3>Implications for CDA Representation</h3>
                    <p>The CDA representation should:</p>
                    <ul>
                        <li>
                            <p>Support the <strong>minimal data set</strong> required for COVID vaccination attestation.</p>
                        </li>
                        <li>
                            <p>Support <strong>free-text or minimally coded vaccine descriptions</strong>, consistent with paper entries.</p>
                        </li>
                        <li>
                            <p>Represent <strong>historical immunizations</strong> without requiring structured extensions unavailable in the paper form.</p>
                        </li>
                        <li>
                            <p>Capture <strong>source reliability</strong> (e.g., “patient-provided record”, “transcribed from paper”).</p>
                        </li>
                        <li>
                            <p>Capture <strong>issuing authority</strong>, certificate identifiers, and optional digital signatures.Include <strong>dose sequence information</strong>, which is critical for COVID-19 series logic.</p>
                        </li>
                        <li>
                            <p>Allow representation of <strong>vaccine products</strong>, using EU-recognized coding systems (e.g., EU Digital COVID Certificate product codes, SNOMED CT or ATC as applicable).</p>
                        </li>
                        <li>
                            <p>Remain aligned with the European experience of the pandemic, ensuring compatibility with existing national verification frameworks.</p>
                        </li>
                    </ul>
                    <p>The CDA templates provided in this IG allow implementers to issue machine-readable, standardized COVID-19 vaccination attestations that can coexist with more comprehensive immunization records.</p>
                </content>
            </page>
            <page id="6b69af07-e1fb-47c8-a9af-07e1fba7c8e5" lastModifiedDate="2025-11-19T12:38:20">
                <title language="en-US" lastTranslated="2025-11-19T12:38:06">Relationship Between the Use Cases</title>
                <content language="en-US" lastTranslated="2025-11-19T12:38:06">
                    <p>Although the WHO Yellow Booklet and the COVID minimal certificate differ significantly in scope, both rely on the same <strong>core immunization data constructs</strong>:</p>
                    <ul>
                        <li>
                            <p>Vaccine description or product code</p>
                        </li>
                        <li>
                            <p>Date of administration</p>
                        </li>
                        <li>
                            <p>Batch/lot number (optional)</p>
                        </li>
                        <li>
                            <p>Administering professional or center</p>
                        </li>
                        <li>
                            <p>Supporting identifiers or metadata</p>
                        </li>
                    </ul>
                    <p>This Implementation Guide therefore defines a common set of CDA components—particularly within the Immunization Activity and supporting templates—that can be reused for both scenarios. Implementers may select only the templates required for their specific use case while maintaining full compatibility with the broader CDA ecosystem and European interoperability
                        guidelines.</p>
                </content>
            </page>
            <page id="c4a11831-fcb6-4b8c-a118-31fcb63b8c72" lastModifiedDate="2025-11-19T12:53:07">
                <title language="en-US" lastTranslated="2025-11-19T12:52:21">Electronic Vaccination Certificates in Europe – Overview</title>
                <content language="en-US" lastTranslated="2025-11-19T12:52:21">
                    <p>Over the past decade—and accelerated by the COVID-19 pandemic—many European countries have implemented or piloted electronic vaccination certificates to complement or replace paper-based records. While the functional purpose varies (travel, public health reporting, clinical documentation, patient access), these initiatives share a set of common architectural patterns and
                        technical components.</p>
                    <h3>General Characteristics Across Europe</h3>
                    <p>Electronic vaccination certificates in Europe typically exhibit the following features:</p>
                    <ul>
                        <li>
                            <p><strong>Structured, machine-readable data</strong><br/>Most solutions rely on internationally recognized data models (CDA, FHIR, national immunization registry schemas) for encoding vaccine type, date of administration, dose number, and issuing authority.</p>
                        </li>
                        <li>
                            <p><strong>Use of standardized terminologies</strong><br/>Vaccine products are often coded using ATC, SNOMED CT, CVX, or EU-authorized COVID product codes. Target diseases usually follow ICD-10 or SNOMED CT.</p>
                        </li>
                        <li>
                            <p><strong>Integration with national immunization registries (NIR)</strong><br/>In many Member States, electronic certificates are automatically generated from national registries or eHealth platforms, ensuring consistency and reducing transcription errors.</p>
                        </li>
                        <li>
                            <p><strong>Citizen-facing digital wallets or portals</strong><br/>Many countries provide citizen access to vaccination records through eHealth portals, mobile applications, or secure PDF certificates, frequently with QR codes for verification.</p>
                        </li>
                        <li>
                            <p><strong>Support for verification and authentication</strong><br/>COVID-era certificates demonstrated the need for strong cryptographic validation (digital signatures, public key infrastructures) to ensure authenticity and reduce fraud.</p>
                        </li>
                    </ul>
                    <h3>Examples of European Approaches</h3>
                    <p>While terminology and technology differ, several patterns can be seen across countries:</p>
                    <ul>
                        <li>
                            <p><strong>Nordic Countries</strong> (e.g., Denmark, Finland)<br/>Strong integration with national EHR infrastructures and long-standing immunization registries. Solutions tend to be registry-driven and tightly integrated with citizen digital identity.</p>
                        </li>
                        <li>
                            <p><strong>Central Europe</strong> (e.g., Germany, Austria)<br/>Solutions built during the pandemic emphasized signed QR codes and standardized minimal datasets. Many are transitioning toward more general digital vaccination records based on CDA or FHIR.</p>
                        </li>
                        <li>
                            <p><strong>Southern Europe</strong> (e.g., Italy, Spain, Portugal)<br/>Robust regional infrastructures with strong local autonomy. COVID certificates were often harmonized nationally, while broader immunization records remain regionally governed.</p>
                        </li>
                        <li>
                            <p><strong>Baltic Countries &amp; Eastern Europe</strong> (e.g., Estonia, Lithuania, Poland)<br/>Strong eGovernment ecosystems lead to digital-first approaches. Immunization data is often available through unified national health portals and interoperable with other public services.</p>
                        </li>
                    </ul>
                    <h3>Link to the Present Implementation Guide</h3>
                    <p>The experience from these electronic vaccination certificate initiatives provides several lessons incorporated into this CDA-based IG:</p>
                    <ul>
                        <li>
                            <p><strong>A minimal dataset can be sufficient</strong> for public health attestation (e.g., COVID certificates).</p>
                        </li>
                        <li>
                            <p><strong>Structured clinical documentation must remain flexible</strong> to support historical records such as the WHO Yellow Booklet.</p>
                        </li>
                        <li>
                            <p><strong>Terminology unification remains a challenge</strong>, especially across borders, which reinforces the importance of optional but strongly recommended coded elements.</p>
                        </li>
                        <li>
                            <p><strong>Interoperability requires stable templates and governance</strong>, which this IG provides via ART-DECOR.</p>
                        </li>
                        <li>
                            <p><strong>Digital certificates must coexist with paper records</strong>, especially for older vaccinations documented decades ago.</p>
                        </li>
                    </ul>
                    <p>By defining a common CDA representation, this IG bridges the gap between Europe’s heterogeneous national approaches, historic paper records, and future FHIR-based immunization infrastructures.</p>
                </content>
            </page>
            <page id="87ecc9f8-a191-4173-acc9-f8a191117321" lastModifiedDate="2025-11-19T12:51:36">
                <title language="en-US" lastTranslated="2025-11-19T12:44:38">Comparison of Paper vs. Digital Attributes</title>
                <content language="en-US" lastTranslated="2025-11-19T12:44:38">
                    <p>This table contrasts the key characteristics of the WHO Yellow Booklet (paper) and the CDA-based digital format.</p>
                    <table>
                        <tbody>
                            <tr>
                                <th>
                                    <p>
                                        <strong>Paper (WHO Yellow Booklet)</strong>
                                    </p>
                                </th>
                                <th>
                                    <p>
                                        <strong>Digital (CDA Representation)</strong>
                                    </p>
                                </th>
                            </tr>
                            <tr>
                                <td>
                                    <p>Handwritten entries</p>
                                </td>
                                <td>
                                    <p>Structured, machine-readable XML</p>
                                </td>
                            </tr>
                            <tr>
                                <td>
                                    <p>Free-text vaccine names</p>
                                </td>
                                <td>
                                    <p>Standardized codes (SNOMED, ATC) optional</p>
                                </td>
                            </tr>
                            <tr>
                                <td>
                                    <p>Stamps and signatures</p>
                                </td>
                                <td>
                                    <p>Provenance elements, author/performer</p>
                                </td>
                            </tr>
                            <tr>
                                <td>
                                    <p>No unique certificate identifier</p>
                                </td>
                                <td>
                                    <p>Unique identifiers (document + entry level)</p>
                                </td>
                            </tr>
                            <tr>
                                <td>
                                    <p>Long-term record kept by patient</p>
                                </td>
                                <td>
                                    <p>Long-term archival in EHR / national registry</p>
                                </td>
                            </tr>
                            <tr>
                                <td>
                                    <p>Variable completeness</p>
                                </td>
                                <td>
                                    <p>Defined cardinalities + validation rules</p>
                                </td>
                            </tr>
                            <tr>
                                <td>
                                    <p>Single physical copy</p>
                                </td>
                                <td>
                                    <p>Can be shared electronically, cross-border</p>
                                </td>
                            </tr>
                            <tr>
                                <td>
                                    <p>Not searchable</p>
                                </td>
                                <td>
                                    <p>Fully searchable (date, vaccine type, lot number)</p>
                                </td>
                            </tr>
                            <tr>
                                <td>
                                    <p>Vulnerable to loss or damage</p>
                                </td>
                                <td>
                                    <p>Can be digitally backed up &amp; verified</p>
                                </td>
                            </tr>
                        </tbody>
                    </table>
                    <p>
                        <em>Table: Comparison of Paper vs. Digital Vaccination Records</em>
                    </p>
                </content>
            </page>
        </page>
    </definition>
</implementationGuide>