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# Data Set Module Data Access 2.16.840.1.113883.3.1937.777.64.1.7

Name | Id
--- | ---
Module Data Access (V3.4) | 2.16.840.1.113883.3.1937.777.64.1.7
Effective date | Expiration date
2024‑10‑18 09:21:50 |
Description
Module about Access to Data
Name | Details [‑] |
--- | --- | ---
datasetType nfdhtfcov19-dataelement-267 |
Id | nfdhtfcov19-dataelement-267 (2024‑10‑18 09:21:50)
Description | What data in particular will be shared?
Rationale | Anonymous aggregated data: The data are grouped or summarized in a way that prevents the identification of individual subjects. This type of data is therefore not considered personal data. Pseudonymised personal-level data: Personal data that has been collected or processed in a way that removes direct identifiers, making it difficult to attribute the data to a specific individual without the use of additional information. Synthetic personal-level data: Data that is artificially generated to mimic the characteristics and statistical properties of real personal data while ensuring that no identifiable information about individuals is included.
Source | Taichman et al. 2017 [ https://doi.org/10.1371/journal.pmed.1002315] EHDS HealthData@EU Pilot D7.1 (1.4. Type of data access) [ https://ehds2pilot.eu/wp-content/uploads/2024/04/HealthData@EU-Pilot-Deliverable-7.1_FIN.docx-1-1.pdf] HealthDCAT-AP Dataset.type [ https://healthdcat-ap.github.io/#Dataset.type] (linked to a dataset, therefore their cardinality is 1..1!) NFDI4Health
Comment | Definitions in 'Rationale' developed by EK and perplexity AI.
Comment | Cardinality 1..*
Operationalization | Select all that apply.
Value Domain | Code
Choice list |
Concept List
Concept | Description
anonymous aggregated data | EHDS HealthData@EU Pilot D7.1
pseudonymised personal-level data | EHDS HealthData@EU Pilot D7.1
synthetic personal-level data | NFDI4Health
accessRights nfdhtfcov19-dataelement-270 | link
Id | nfdhtfcov19-dataelement-270 (2024‑11‑15 15:05:22)
Description | Backbone element about access rights - who can request data, for which purposes?
Source | FHIR Permission > rule > activity [ https://www.hl7.org/fhir/permission-definitions.html#Permission.rule.activity]
Comment | Cardinality: 0..*
actor nfdhtfcov19-dataelement-271 |
Id | nfdhtfcov19-dataelement-271 (2024‑11‑15 15:13:40)
Description | Who can request access to data?
Source | FHIR Permission > rule > activity > actor [ https://www.hl7.org/fhir/permission-definitions.html#Permission.rule.activity.actor] (BUT not matching its type!) Taichman et al. 2017 [ https://doi.org/10.1371/journal.pmed.1002315] HealthDCAT-AP Dataset > access rights [ https://healthdcat-ap.github.io/#Dataset.accessrights], [ https://w3c.github.io/dxwg/dcat/#Property:resource_access_rights] DUO codes: Lawson et al. 2021 [ https://doi.org/10.1016/j.xgen.2021.100028]
Comment | DUO data use modification codes should be described in ODRL (Pandit & Esteves 2024 [ https://doi.org/10.3233/SW-243583])
Comment | Cardinality: 1..1
Value Domain | String
Property |
default
anyone
Example | Geographical restriction (DUO:0000022), Project specific restriction (DUO:0000027), Institution specific restriction (DUO:0000028), User specific restriction (DUO:0000026)
action nfdhtfcov19-dataelement-272 |
Id | nfdhtfcov19-dataelement-272 (2024‑11‑15 15:22:07)
Description | action
Value Domain | String
purpose nfdhtfcov19-dataelement-273 |
Id | nfdhtfcov19-dataelement-273 (2024‑11‑15 15:22:31)
Description | For which purposes can data be requested?
Source | FHIR Permission > rule > activity > purpose [ https://www.hl7.org/fhir/permission-definitions.html#Permission.rule.activity.purpose] (BUT not matching its type!) HealthDCAT-AP Dataset > purpose [ https://healthdcat-ap.github.io/#Dataset.haspurpose] DUO codes: Lawson et al. 2021 [ https://doi.org/10.1016/j.xgen.2021.100028]
Comment | DUO data use permission codes should be described in ODRL (Pandit & Esteves 2024 [ https://doi.org/10.3233/SW-243583])
Comment | Cardinality: 1..1
Value Domain | String
Example | No restriction (DUO:0000004), General research use (DUO:0000042), Health or medical or biomedical research (DUO:0000006), Disease-specific research (DUO:0000007)
limit nfdhtfcov19-dataelement-275 |
Id | nfdhtfcov19-dataelement-275 (2024‑11‑15 16:14:22)
Description | Conditions, obligations and limitations that apply for the use of the data
Source | FHIR Permission > rule > limit [ https://www.hl7.org/fhir/permission-definitions.html#Permission.rule.limit] (BUT it's a codeable concept!) HealthDCAT-AP rights statement [ https://healthdcat-ap.github.io/#Rightsstatement] DUO codes: Lawson et al. 2021 [ https://doi.org/10.1016/j.xgen.2021.100028]
Comment | DUO data use modification codes should be described in ODRL (Pandit & Esteves 2024 [ https://doi.org/10.3233/SW-243583])
Comment | Cardinality: 0..1
Value Domain | String
Example | Time limit on use (DUO:0000025), Ethics approval required (DUO:0000021), Publication required (DUO:0000019), Collaboration required (DUO:0000020), Return to database or resource (DUO:0000029), Publication moratorium (DUO:0000024)
mechanism nfdhtfcov19-dataelement-276 |
Id | nfdhtfcov19-dataelement-276 (2024‑11‑15 16:22:37)
Description | By what mechanism will the data be made available? Select all that apply.
Source | Alter et al. 2020 [ https://doi.org/10.1093/gigascience/giz165] Taichman et al. 2017 [ https://doi.org/10.1371/journal.pmed.1002315]
Comment | Cardinality: 0..*
Value Domain | Code
Choice list |
Concept List
Concept | Description
Download | The data are available for download. A license may be required (Alter et al. 2020 [https://doi.org/10.1093/gigascience/giz165])
API | Interaction with the data may be automated via defined communication protocols, i.e., APIs (Alter et al. 2020 [https://doi.org/10.1093/gigascience/giz165])
Remote access | Users may access the data in a secure remote environment (“virtual data enclave”). Individual-level data may not be downloaded, only approved results (Alter et al. 2020 [https://doi.org/10.1093/gigascience/giz165])
Remote service | A user may submit program code or the script for a software package to be executed in a secure data center. The remote site returns outputs. It may perform a review before releasing the results (Alter et al. 2020 [https://doi.org/10.1093/gigascience/giz165])
Enclave | Access is provided to approved users within a secure facility without remote access. Results may remain at the enclave or be released after review (Alter et al. 2020 [https://doi.org/10.1093/gigascience/giz165])
recordLinkage nfdhtfcov19-dataelement-277 |
Id | nfdhtfcov19-dataelement-277 (2024‑11‑15 16:45:49)
Concept inherits from | nfdhtfcov19-dataelement-150 (2023‑12‑07 09:59:45)
Description | Record linkage possible?
### Properties
Design.dataSharingPlan.recordLinkage | Design.dataSharingPlan.recordLinkage
Rationale | Description: Indication if record linkage with other data sources is possible.
Source | NFDI4Health UC 5.3 requirements
Comment | Additional information: Record linkage refers to the merging of data on the same person from different databases.
Comment | Cardinality: 1..1, if Resource.provenance.dataSource == 'Manually collected'; otherwise 0..0
Comment | Cardinality: 1..1, if Resource.provenance.dataSource == '06'; otherwise 0..0
Value Domain | Boolean
requestData nfdhtfcov19-dataelement-278 |
Id | nfdhtfcov19-dataelement-278 (2024‑11‑15 16:46:56)
Concept inherits from | nfdhtfcov19-dataelement-149 (2023‑12‑07 09:56:48)
Description | Link to data request application
### Properties
Design.dataSharingPlan.requestData | Design.dataSharingPlan.requestData
Rationale | Description: If existing, a link to the web page where the data request form and/or information on data reuse can be found.
Source | NFDI4Health
Comment | Cardinality: 0..1
Comment | Data type in Excel version: url
Value Domain | String
url nfdhtfcov19-dataelement-279 |
Id | nfdhtfcov19-dataelement-279 (2024‑11‑15 16:47:29)
Concept inherits from | (2023‑12‑04)
Description | Web page with additional information about data sharing
### Properties
Design.dataSharingPlan.url | Design.dataSharingPlan.url
Relationship | Specialization url ( - 2022‑11‑28)
Rationale | Description: If existing, a link to the web page where additional information about data sharing can be found.
Source | CT.gov [ https://prsinfo.clinicaltrials.gov/definitions.html], [ https://www.clinicaltrials.gov/ct2/about-studies/glossary] Taichman DB, et al. [doi:10.1001/jama.2017.6514]
Comment | Cardinality: 0..1
Comment | Data type in Excel version: url
Value Domain | String
limits nfdhtfcov19-dataelement-274 |
Id | nfdhtfcov19-dataelement-274 (2024‑11‑15 16:01:51)
Description | Backbone element describing conditions and limitations for the use of the data
Source | FHIR Permission > rule > limit [ https://www.hl7.org/fhir/permission-definitions.html#Permission.rule.limit] (BUT it is not a backbone element!)
timeFrame nfdhtfcov19-dataelement-269 |
Id | nfdhtfcov19-dataelement-269 (2024‑11‑14 18:04:08)
Concept inherits from | (2023‑12‑04)
Description | When and for how long will the data be available?
### Properties
Design.dataSharingPlan.timeFrame | Design.dataSharingPlan.timeFrame
Relationship | Specialization timeFrame ( - 2022‑11‑28)
Rationale | Description: Indication of the time period for which the data and, if applicable, supporting documents will be made available.
Source | CT.gov [ https://prsinfo.clinicaltrials.gov/definitions.html], [ https://www.clinicaltrials.gov/ct2/about-studies/glossary] Taichman DB, et al. [doi:10.1001/jama.2017.6514]
Comment | Cardinality: 0..1, if Design.dataSharingPlan.generally == 'Yes, there is a plan to make data available'; otherwise 0..0
Comment | Cardinality: 0..1, if Design.dataSharingPlan.generally == 'C49488'; otherwise 0..0
Value Domain | String