Research Data Sharing IG
1.0.0 - CI Build
Research Data Sharing IG
1.0.0 - CI Build
Research Data Sharing IG, published by IEHR-Workgroup. This guide is not an authorized publication; it is the continuous build for version 1.0.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/InteropEHRate-project/research-data-sharing/ and changes regularly. See the Directory of published versions
<Bundle xmlns="http://hl7.org/fhir">
<id value="877311"/>
<language value="en"/>
<type value="collection"/>
<timestamp value="2022-05-10T10:17:40.803+02:00"/>
<entry>
<fullUrl
value="http://interopEHRate.eu/fhir-resource/ResearchStudy/exampleResearchStudy"/>
<resource>
<ResearchStudy>
<id value="exampleResearchStudy"/>
<meta>
<profile
value="http://interopehrate.eu/fhir/StructureDefinition/ResearchStudy-IEHR"/>
</meta>
<language value="en"/>
<text>
<status value="extensions"/>
<div xmlns="http://www.w3.org/1999/xhtml">To Prevent Error</div>
</text>
<extension
url="http://interopehrate.eu/fhir/StructureDefinition/EnrollmentPeriodExtension-IEHR">
<valuePeriod>
<start value="2020-01-01"/>
<end value="2020-07-01"/>
</valuePeriod>
</extension>
<extension
url="http://interopehrate.eu/fhir/StructureDefinition/AnonymizationExtension-IEHR">
<valueCoding>
<system
value="http://interopehrate.eu/fhir/CodeSystem/AnonymizationType-IEHR"/>
<code value="anonymization"/>
<display value="Anonymization"/>
</valueCoding>
</extension>
<extension
url="http://interopehrate.eu/fhir/StructureDefinition/DataSetDefinitionExtension-IEHR">
<extension url="DataRequirement">
<valueDataRequirement>
<extension
url="http://interopehrate.eu/fhir/StructureDefinition/FrequencyExtension-IEHR">
<valueTiming>
<repeat>
<frequency value="2"/>
<period value="1"/>
<periodUnit value="mo"/>
</repeat>
</valueTiming>
</extension>
<type value="Observation"/>
<codeFilter>
<path value="category"/>
<code>
<system value="http://loinc.org"/>
<code value="8716-3"/>
<display value="Vital Signs"/>
</code>
</codeFilter>
<dateFilter>
<path value="effectivePeriod"/>
<valuePeriod>
<start value="2015-09-14"/>
<end value="2025-09-14"/>
</valuePeriod>
</dateFilter>
</valueDataRequirement>
</extension>
<extension url="DataRequirement">
<valueDataRequirement>
<extension
url="http://interopehrate.eu/fhir/StructureDefinition/FrequencyExtension-IEHR">
<valueTiming>
<repeat>
<frequency value="2"/>
<period value="1"/>
<periodUnit value="mo"/>
</repeat>
</valueTiming>
</extension>
<type value="Observation"/>
<codeFilter>
<path value="code"/>
<code>
<system value="http://loinc.org"/>
<code value="29463-7"/>
<display value="Body weight"/>
</code>
</codeFilter>
<dateFilter>
<path value="effectivePeriod"/>
<valuePeriod>
<start value="2015-09-14"/>
<end value="2025-09-14"/>
</valuePeriod>
</dateFilter>
</valueDataRequirement>
</extension>
<extension url="DataRequirement">
<valueDataRequirement>
<type value="Medication"/>
<codeFilter>
<path value="medicationCodeableConcept"/>
<code>
<system value="http://snomed.info/sct"/>
<code value="3142009"/>
<display value="Azacyclonol"/>
</code>
</codeFilter>
<dateFilter>
<path value="effectivePeriod"/>
<valuePeriod>
<start value="2020-09-14"/>
<end value="2025-09-14"/>
</valuePeriod>
</dateFilter>
</valueDataRequirement>
</extension>
</extension>
<identifier>
<system value="urn:oid:1.11.111.1.1.11.111.11"/>
<value value="ResearchStudy/exampleResearchStudy"/>
</identifier>
<title value="ResearchStudyIHR Example"/>
<status value="active"/>
<primaryPurposeType>
<coding>
<system
value="http://terminology.hl7.org/CodeSystem/research-study-prim-purp-type"/>
<code value="diagnostic"/>
<display value="Diagnostic"/>
</coding>
</primaryPurposeType>
<contact>
<name value="Mr Alberto Milano"/>
<telecom>
<system value="phone"/>
<value value="11111111"/>
</telecom>
</contact>
<location>
<coding>
<system value="urn:iso:std:iso:3166"/>
<code value="IT"/>
<display value="Italy"/>
</coding>
</location>
<description
value="This is an exampleResearchStudy that is used to show the realisation of the constraints in a FHIR-Resource:
-pseudo-anonymization is in the ResearchStudys Anonymization Extension
-constraints on the patients diagnosis is in Group.characteristic. The second characteristic specifies, that only patients with a heart failure between 2019-05-04 and 2020-05-04 can be chosen. If the exclude attribute would be flipped to true it would exclude patients with this diagnosis
-constraints on patient's drug therapy is in Group.characteristic. The third characteristic specifies, that only patients that took Methanthelinium in the period from 2019-05-04 and 2020-05-04
-drug treatment plan within data set definition is in the third DataRequirement. It requests MedicationStatements from 2020-09-14 until 2025-09-14 where Azacyclonol was prescribed
-specification of period within dataset definition is shown in all DataRequirement with the dateFilter
-evaluation data (blood tests, vital signs, visits, instrumental examination) within data set definition is shown in the first and second DataRequirement. If the type is set to Observation the path can be set to category to request a category of Observations ( all vital signs in the first) or to code if a specific observation is required (only body weight in the second)
-constraints on min and max value of patient's attributes within enrollment criteria are shown in the second Group.characteristic, that specifies that only people between the ages of 30 and 60 can take part
-name within publishable research protocol, the name of the study can be displayed in the ResearchStudy.title Attribute. Additional information about the study can be added in the ResearchStudy.description
-machine interpretable research protocol for publication"/>
<enrollment>🔗
<reference value="Group/1"/>
</enrollment>
<period>
<start value="2020-07-09"/>
<end value="2025-09-14"/>
</period>
<site>🔗
<reference value="Location/1"/>
</site>
</ResearchStudy>
</resource>
</entry>
<entry>
<fullUrl value="http://interopEHRate.eu/fhir-resource/Group/1"/>
<resource>
<Group>
<id value="1"/>
<meta>
<profile
value="http://interopehrate.eu/fhir/StructureDefinition/Group-Cohort-IEHR"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="Group_1"> </a><p><b>Generated Narrative: Group</b><a name="1"> </a><a name="hc1"> </a></p><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px">Resource Group "1" </p><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-Group-Cohort-IEHR.html">Cohort</a></p></div><p><b>type</b>: person</p><p><b>actual</b>: false</p><blockquote><p><b>characteristic</b></p><p><b>code</b>: Sex [HL7.v3] <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="https://loinc.org/">LOINC</a>#72143-1)</span></p><p><b>value</b>: Male <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://hl7.org/fhir/R4/codesystem-administrative-gender.html">AdministrativeGender</a>#male)</span></p><p><b>exclude</b>: false</p></blockquote><blockquote><p><b>characteristic</b></p><p><b>code</b>: Age <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="https://loinc.org/">LOINC</a>#30525-0)</span></p><p><b>value</b>: 30-60</p><p><b>exclude</b>: false</p></blockquote><blockquote><p><b>characteristic</b></p><p><b>code</b>: Observation <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-GroupCharacteristic-Code.html">Possible codes for GroupCharacteristic</a>#observation)</span></p><p><b>value</b>: Heart failure <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://terminology.hl7.org/5.3.0/CodeSystem-icd10CM.html">International Classification of Diseases, 10th Revision, Clinical Modification (ICD-10-CM)</a>#I50)</span></p><p><b>exclude</b>: false</p><p><b>period</b>: 2019-05-04 --> 2020-05-04</p></blockquote><blockquote><p><b>characteristic</b></p><p><b>code</b>: Medications <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="https://loinc.org/">LOINC</a>#52471-0)</span></p><p><b>value</b>: Methanthelinium <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="https://browser.ihtsdotools.org/">SNOMED CT</a>#2796008)</span></p><p><b>exclude</b>: false</p></blockquote></div>
</text>
<type value="person"/>
<actual value="false"/>
<characteristic>
<code>
<coding>
<system value="http://loinc.org"/>
<code value="72143-1"/>
<display value="Sex [HL7.v3]"/>
</coding>
</code>
<valueCodeableConcept>
<coding>
<system value="http://hl7.org/fhir/administrative-gender"/>
<code value="male"/>
<display value="Male"/>
</coding>
</valueCodeableConcept>
<exclude value="false"/>
</characteristic>
<characteristic>
<code>
<coding>
<system value="http://loinc.org"/>
<code value="30525-0"/>
<display value="Age"/>
</coding>
</code>
<valueRange>
<low>
<value value="30"/>
</low>
<high>
<value value="60"/>
</high>
</valueRange>
<exclude value="false"/>
</characteristic>
<characteristic>
<code>
<coding>
<system
value="http://interopehrate.eu/fhir/CodeSystem/GroupCharacteristic-Code"/>
<code value="observation"/>
<display value="Observation"/>
</coding>
</code>
<valueCodeableConcept>
<coding>
<system value="http://hl7.org/fhir/sid/icd-10-cm"/>
<code value="I50"/>
<display value="Heart failure"/>
</coding>
</valueCodeableConcept>
<exclude value="false"/>
<period>
<start value="2019-05-04"/>
<end value="2020-05-04"/>
</period>
</characteristic>
<characteristic>
<code>
<coding>
<system value="http://loinc.org"/>
<code value="52471-0"/>
<display value="Medications"/>
</coding>
</code>
<valueCodeableConcept>
<coding>
<system value="http://snomed.info/sct"/>
<code value="2796008"/>
<display value="Methanthelinium"/>
</coding>
</valueCodeableConcept>
<exclude value="false"/>
</characteristic>
</Group>
</resource>
</entry>
<entry>
<fullUrl value="http://interopEHRate.eu/fhir-resource/Location/1"/>
<resource>
<Location>
<id value="1"/>
<meta>
<profile
value="http://interopehrate.eu/fhir/StructureDefinition/Location-ReferenceResearchCenter-IEHR"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="Location_1"> </a><p><b>Generated Narrative: Location</b><a name="1"> </a><a name="hc1"> </a></p><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px">Resource Location "1" </p><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-Location-ReferenceResearchCenter-IEHR.html">ResearchLocation</a></p></div><p><b>identifier</b>: <code>urn:oid:1.11.111.1.1.11.111.11</code>/exampleLocation</p><p><b>name</b>: Cardiovascular practice Milano</p><p><b>type</b>: Cardiovascular diagnostics or therapeutics unit <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://terminology.hl7.org/5.3.0/CodeSystem-v3-RoleCode.html">RoleCode</a>#CVDX)</span></p><p><b>telecom</b>: ph: 11111111</p><p><b>address</b>: Viale Certosa, 27111111 Milano 20019 Italy </p><p><b>endpoint</b>: See on this page: Endpoint/exampleEndpoint</p></div>
</text>
<identifier>
<system value="urn:oid:1.11.111.1.1.11.111.11"/>
<value value="exampleLocation"/>
</identifier>
<name value="Cardiovascular practice Milano"/>
<type>
<coding>
<system
value="http://terminology.hl7.org/CodeSystem/v3-RoleCode"/>
<code value="CVDX"/>
<display value="Cardiovascular diagnostics or therapeutics unit"/>
</coding>
</type>
<telecom>
<system value="phone"/>
<value value="11111111"/>
</telecom>
<address>
<type value="postal"/>
<line value="Viale Certosa, 27111111"/>
<city value="Milano"/>
<postalCode value="20019"/>
<country value="Italy"/>
</address>
<endpoint>
<reference value="Endpoint/exampleEndpoint"/>
</endpoint>
</Location>
</resource>
</entry>
<entry>
<fullUrl
value="http://interopEHRate.eu/fhir-resource/Endpoint/exampleEndpoint"/>
<resource>
<Endpoint>
<id value="exampleEndpoint"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="Endpoint_exampleEndpoint"> </a><p><b>Generated Narrative: Endpoint</b><a name="exampleEndpoint"> </a><a name="hcexampleEndpoint"> </a></p><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px">Resource Endpoint "exampleEndpoint" </p></div><p><b>status</b>: off</p><p><b>connectionType</b>: HL7 FHIR (Details: http://terminology.hl7.org/CodeSystem/endpoint-connection-type code hl7-fhir-rest = 'HL7 FHIR', stated as 'HL7 FHIR')</p><p><b>payloadType</b>: Any <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://terminology.hl7.org/5.3.0/CodeSystem-endpoint-payload-type.html">Endpoint Payload Type</a>#any)</span></p><p><b>address</b>: <a href="http://interopEHRate.eu/fhir-resource/">http://interopEHRate.eu/fhir-resource/</a></p></div>
</text>
<status value="off"/>
<connectionType>
<system
value="http://terminology.hl7.org/CodeSystem/endpoint-connection-type"/>
<code value="hl7-fhir-rest"/>
<display value="HL7 FHIR"/>
</connectionType>
<payloadType>
<coding>
<system
value="http://terminology.hl7.org/CodeSystem/endpoint-payload-type"/>
<code value="any"/>
<display value="Any"/>
</coding>
</payloadType>
<address value="http://interopEHRate.eu/fhir-resource/"/>
</Endpoint>
</resource>
</entry>
</Bundle>