Clinical trials data transparency & GDPR compliance: What are the effects on data sharing and open innovation?

Publikation: Bidrag til tidsskrift › Tidsskriftartikel › Forskning › fagfællebedømt

Standard

Clinical trials data transparency & GDPR compliance: What are the effects on data sharing and open innovation? / Minssen, Timo; Rajam, Neethu; Bogers, Marcel.

I: Science and Public Policy, Bind 47, Nr. 5, 04.04.2020, s. 616-626.

Publikation: Bidrag til tidsskrift › Tidsskriftartikel › Forskning › fagfællebedømt

Harvard

Minssen, T, Rajam, N & Bogers, M 2020, 'Clinical trials data transparency & GDPR compliance: What are the effects on data sharing and open innovation?', Science and Public Policy, bind 47, nr. 5, s. 616-626. https://doi.org/10.1093/scipol/scaa014

APA

Minssen, T., Rajam, N., & Bogers, M. (2020). Clinical trials data transparency & GDPR compliance: What are the effects on data sharing and open innovation? Science and Public Policy, 47(5), 616-626. https://doi.org/10.1093/scipol/scaa014

Vancouver

Minssen T, Rajam N, Bogers M. Clinical trials data transparency & GDPR compliance: What are the effects on data sharing and open innovation? Science and Public Policy. 2020 apr. 4;47(5):616-626. https://doi.org/10.1093/scipol/scaa014

Author

Minssen, Timo ; Rajam, Neethu ; Bogers, Marcel. / Clinical trials data transparency & GDPR compliance: What are the effects on data sharing and open innovation?. I: Science and Public Policy. 2020 ; Bind 47, Nr. 5. s. 616-626.

Bibtex

@article{86c08d1127a94759b383271dda283a2a,
title = "Clinical trials data transparency & GDPR compliance: What are the effects on data sharing and open innovation?",
abstract = "Recent EU initiatives and legislation considerably increases public access to clinical trials data (CTD). These are generally much welcomed developments for the enhancement of science, trust and open innovation. However, they also raise many questions and concerns. Many of these emerge at the interface of CTD transparency with other areas of evolving EU law concerning the protection of trades secrets, IPRs, and privacy. This paper focuses on the privacy issues by analyzing the interrelation between the transparency developments and the EU{\textquoteright}s new General Data Protection Regulation 2016/679 (GDPR). More specifically, this paper examines (1) the genesis of the EU transparency regulations, including the incidents, developments and policy concerns that have shaped them; (2) the features and implications of the GDPR in the context of clinical trials; and (3) the practical difficulties and risks for tensions between the GDPR and the policy goals of CTD transparency and open innovation. Ultimately, we stress that such factors must be carefully considered and addressed to reap the full benefits of CTD transparency.",
author = "Timo Minssen and Neethu Rajam and Marcel Bogers",
year = "2020",
month = apr,
day = "4",
doi = "10.1093/scipol/scaa014",
language = "English",
volume = "47",
pages = "616--626",
journal = "Science and Public Policy",
issn = "0302-3427",
publisher = "Oxford University Press",
number = "5",

}

RIS

TY - JOUR

T1 - Clinical trials data transparency & GDPR compliance: What are the effects on data sharing and open innovation?

AU - Minssen, Timo

AU - Rajam, Neethu

AU - Bogers, Marcel

PY - 2020/4/4

Y1 - 2020/4/4

N2 - Recent EU initiatives and legislation considerably increases public access to clinical trials data (CTD). These are generally much welcomed developments for the enhancement of science, trust and open innovation. However, they also raise many questions and concerns. Many of these emerge at the interface of CTD transparency with other areas of evolving EU law concerning the protection of trades secrets, IPRs, and privacy. This paper focuses on the privacy issues by analyzing the interrelation between the transparency developments and the EU’s new General Data Protection Regulation 2016/679 (GDPR). More specifically, this paper examines (1) the genesis of the EU transparency regulations, including the incidents, developments and policy concerns that have shaped them; (2) the features and implications of the GDPR in the context of clinical trials; and (3) the practical difficulties and risks for tensions between the GDPR and the policy goals of CTD transparency and open innovation. Ultimately, we stress that such factors must be carefully considered and addressed to reap the full benefits of CTD transparency.

AB - Recent EU initiatives and legislation considerably increases public access to clinical trials data (CTD). These are generally much welcomed developments for the enhancement of science, trust and open innovation. However, they also raise many questions and concerns. Many of these emerge at the interface of CTD transparency with other areas of evolving EU law concerning the protection of trades secrets, IPRs, and privacy. This paper focuses on the privacy issues by analyzing the interrelation between the transparency developments and the EU’s new General Data Protection Regulation 2016/679 (GDPR). More specifically, this paper examines (1) the genesis of the EU transparency regulations, including the incidents, developments and policy concerns that have shaped them; (2) the features and implications of the GDPR in the context of clinical trials; and (3) the practical difficulties and risks for tensions between the GDPR and the policy goals of CTD transparency and open innovation. Ultimately, we stress that such factors must be carefully considered and addressed to reap the full benefits of CTD transparency.

U2 - 10.1093/scipol/scaa014

DO - 10.1093/scipol/scaa014

M3 - Journal article

VL - 47

SP - 616

EP - 626

JO - Science and Public Policy

JF - Science and Public Policy

SN - 0302-3427

IS - 5

ER -

ID: 202483122