Observational health research in Europe: understanding the General Data Protection Regulation and underlying debate

Veen, Evert-Ben van

doi:10.1016/j.ejca.2018.09.032

Cited by 59 publications

(52 citation statements)

References 58 publications

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“…With the implementation of the General Data Protection Regulation (GDPR) in the European Union, cancer registries are amidst an on-going debate on its implications 6 . The GDPR may be one of the arguments for data processing entities such as cancer registries to be reticent in data sharing initiatives.…”

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confidence: 99%

Prognostic factors analysis for oral cavity cancer survival in the Netherlands and Taiwan using a privacy-preserving federated infrastructure

Geleijnse

Chiang

Sieswerda

et al. 2020

Sci Rep

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The difference in incidence of oral cavity cancer (OCC) between Taiwan and the Netherlands is striking. Different risk factors and treatment expertise may result in survival differences between the two countries. However due to regulatory restrictions, patient-level analyses of combined data from the Netherlands and Taiwan are infeasible. We implemented a software infrastructure for federated analyses on data from multiple organisations. We included 41,633‬ patients with single-tumour OCC between 2004 and 2016, undergoing surgery, from the Taiwan Cancer Registry and Netherlands Cancer Registry. Federated Cox Proportional Hazard was used to analyse associations between patient and tumour characteristics, country, treatment and hospital volume with survival. Five factors showed differential effects on survival of OCC patients in the Netherlands and Taiwan: age at diagnosis, stage, grade, treatment and hospital volume. The risk of death for OCC patients younger than 60 years, with advanced stage, higher grade or receiving adjuvant therapy after surgery was lower in the Netherlands than in Taiwan; but patients older than 70 years, with early stage, lower grade and receiving surgery alone in the Netherlands were at higher risk of death than those in Taiwan. The mortality risk of OCC in Taiwanese patients treated in hospitals with higher hospital volume (≥ 50 surgeries per year) was lower than in Dutch patients. We conducted analyses without exchanging patient-level information, overcoming barriers for sharing privacy sensitive information. The outcomes of patients treated in the Netherlands and Taiwan were slightly different after controlling for other prognostic factors.

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confidence: 99%

Prognostic factors analysis for oral cavity cancer survival in the Netherlands and Taiwan using a privacy-preserving federated infrastructure

Geleijnse

Chiang

Sieswerda

et al. 2020

Sci Rep

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“…The protocol should also contain an elaborated statistical analysis plan and data sharing and authorship agreements [Hofer and Piccinin, 2009]. Further important points in terms of data sharing that should be addressed early in the course of such a pooling project are the legal regulations in the cooperating countries and the General Data Protection Regulation (GDPR) [van Veen, 2018].…”

Section: Strength and Limitations Of A Pooled Analysismentioning

confidence: 99%

Occupational Exposure to Extremely Low‐Frequency Magnetic Fields and Risk of Amyotrophic Lateral Sclerosis: Results of a Feasibility Study for a Pooled Analysis of Original Data

Baaken

Dechent

Blettner

et al. 2021

Bioelectromagnetics

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Previous meta-analyses have suggested an increased risk of amyotrophic lateral sclerosis (ALS) associated with occupational exposure to extremely low-frequency magnetic fields (ELF-MF). However, results should be interpreted with caution since studies were methodologically heterogeneous. Here, we assessed the feasibility of a pooling study to harmonize and re-analyze available original data. A systematic literature search was conducted. Published epidemiological studies were identified in PubMed and EMF-Portal from literature databases′ inception dates until January 2019. The characteristics of all studies were described, including exposure metrics, exposure categories, and confounders. A survey among the principal investigators (PI) was carried out to assess their willingness to provide their original data. The statistical power of a pooling study was evaluated. We identified 15 articles published between 1997 and 2019. Studies differed in terms of outcome, study population, exposure assessment, and exposure metrics. Most studies assessed ELF-MF as average magnetic flux density per working day; however, exposure categories varied widely. The pattern of adjustment for confounders was heterogeneous between studies, with age, sex, and socioeconomic status being most frequent. Eight PI expressed their willingness to provide original data. A relative risk of ≥1.14 for ALS and occupational exposure to ELF-MF can be detected with a power of more than 80% in a pooled study. The pooling of original data is recommended and could contribute to a better understanding of ELF-MF in the etiology of ALS based on a large database and reduced heterogeneity due to a standardized analysis protocol with harmonized exposure metrics and exposure categories.

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“…Scholars identify also the management of research data like a joint controllership in the case i.f. of observational research, when patient data derive from different healthcare systems 15 are essential facilities for medical research 16 : "in that case, the custodian of the centrally assembled research data should be the sole controller, and data transfer agreements (DTAs) should regulate the processing through that database. The data protection officer of the receiving centre should assure that the conditions are indeed met, next to potential other governance mechanisms of the project such as decision procedures about the use of the database for specific protocols when applicable."…”

Section: Joint Controllers Some Examplesmentioning

confidence: 99%

Joint Controller Agreement Under GDPR

Colcelli

2019

Eu and Member States – Legal and Economic Issues

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The GDPR obliges organisations to keep watch for potential instances of joint controllership of personal data. Where those instances arise, organisations must enter into suitable "arrangements" that apportion data protection compliance responsibilities between joint data controllers. The controller means the natural or legal person, public authority, agency or any other body which alone or jointly with others determines the purposes and means of the processing of personal data. But, f.i. in the case of the case of a Biobank, more than one public bodies are the controllers of personal data, and their processing takes place in an intra-group context. The paper will analyse elements established by art. 26 GDPR for Joint Controller Agreement for managing personal data under GDPR, the respective roles and relationships of the joint controllers vis-à-vis the data subjects, as well as responsibility and liability of controllers and processors.

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Observational health research in Europe: understanding the General Data Protection Regulation and underlying debate

Cited by 59 publications

References 58 publications

Prognostic factors analysis for oral cavity cancer survival in the Netherlands and Taiwan using a privacy-preserving federated infrastructure

Prognostic factors analysis for oral cavity cancer survival in the Netherlands and Taiwan using a privacy-preserving federated infrastructure

Occupational Exposure to Extremely Low‐Frequency Magnetic Fields and Risk of Amyotrophic Lateral Sclerosis: Results of a Feasibility Study for a Pooled Analysis of Original Data

Joint Controller Agreement Under GDPR

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