Data Set Module Data Access 2.16.840.1.113883.3.1937.777.64.1.7

What data in particular will be shared?

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.

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

Definitions in 'Rationale' developed by EK and perplexity AI.

Cardinality 1..*

Backbone element about access rights - who can request data, for which purposes?

FHIR Permission > rule > activity [ https://www.hl7.org/fhir/permission-definitions.html#Permission.rule.activity]

Cardinality: 0..*

Who can request access to data?

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]

DUO data use modification codes should be described in ODRL (Pandit & Esteves 2024 [ https://doi.org/10.3233/SW-243583])

Cardinality: 1..1

For which purposes can data be requested?

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]

DUO data use permission codes should be described in ODRL (Pandit & Esteves 2024 [ https://doi.org/10.3233/SW-243583])

Cardinality: 1..1

Conditions, obligations and limitations that apply for the use of the data

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]

DUO data use modification codes should be described in ODRL (Pandit & Esteves 2024 [ https://doi.org/10.3233/SW-243583])

Cardinality: 0..1

By what mechanism will the data be made available? Select all that apply.

Alter et al. 2020 [ https://doi.org/10.1093/gigascience/giz165]

Taichman et al. 2017 [ https://doi.org/10.1371/journal.pmed.1002315]

Cardinality: 0..*

Record linkage possible?

Description: Indication if record linkage with other data sources is possible.

NFDI4Health UC 5.3 requirements

Additional information: Record linkage refers to the merging of data on the same person from different databases.

Cardinality: 1..1, if Resource.provenance.dataSource == 'Manually collected'; otherwise 0..0

Cardinality: 1..1, if Resource.provenance.dataSource == '06'; otherwise 0..0

Link to data request application

Description: If existing, a link to the web page where the data request form and/or information on data reuse can be found.

NFDI4Health

Cardinality: 0..1

Data type in Excel version: url

Web page with additional information about data sharing

Description: If existing, a link to the web page where additional information about data sharing can be found.

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]

Cardinality: 0..1

Data type in Excel version: url

Backbone element describing conditions and limitations for the use of the data

FHIR Permission > rule > limit [ https://www.hl7.org/fhir/permission-definitions.html#Permission.rule.limit] (BUT it is not a backbone element!)

When and for how long will the data be available?

Description: Indication of the time period for which the data and, if applicable, supporting documents will be made available.

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]

Cardinality: 0..1, if Design.dataSharingPlan.generally == 'Yes, there is a plan to make data available'; otherwise 0..0

Cardinality: 0..1, if Design.dataSharingPlan.generally == 'C49488'; otherwise 0..0