The Interaction of the Medical Device Regulation and the GDPR: Do European rules on privacy and scientific research impair the safety & performance of AI medical devices?
Research output: Chapter in Book/Report/Conference proceeding › Book chapter › Research › peer-review
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The Interaction of the Medical Device Regulation and the GDPR : Do European rules on privacy and scientific research impair the safety & performance of AI medical devices? . / Meszaros, Janos; Corrales Compagnucci, Marcelo; Minssen, Timo.
The Future of Medical Device Regulation: Innovation and Protection. ed. / I. Glenn Cohen; Timo Minssen; W. Nicholson Price II.; Christopher Robertson; Carmel Shachar. Cambridge : Cambridge University Press, 2022. p. 77-90.Research output: Chapter in Book/Report/Conference proceeding › Book chapter › Research › peer-review
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TY - CHAP
T1 - The Interaction of the Medical Device Regulation and the GDPR
T2 - Do European rules on privacy and scientific research impair the safety & performance of AI medical devices?
AU - Meszaros, Janos
AU - Corrales Compagnucci, Marcelo
AU - Minssen, Timo
PY - 2022
Y1 - 2022
N2 - Stipulations on de-identification and scientific research in the European General Data Protection Regulation (GDPR) help research organizations to use personal data with fewer restrictions compared to data collection for other purposes. Under these exemptions, organizations may process specific data for a secondary purpose without consent. However, the definition and legal requirements of scientific research differ among EU Member States. Since the new EU Medical Device Regulations 2017/745 and 2017/746 require compliance with the GDPR, the failure to come to grips with these concepts creates misunderstandings and legal issues. We argue that this might result in obstacles for the use and review of input data for medical devices. This could not only lead to forum shopping but also safety risks. The authors discuss to what extent scientific research should benefit from the research exemption and de-identification rules under the GDPR. Furthermore, this chapter analyzes recently released guidelines and discussion papers to examine how input data is reviewed by EU regulators. Ultimately, we call for more harmonized rules to balance individuals’ rights and the safety of medical devices.
AB - Stipulations on de-identification and scientific research in the European General Data Protection Regulation (GDPR) help research organizations to use personal data with fewer restrictions compared to data collection for other purposes. Under these exemptions, organizations may process specific data for a secondary purpose without consent. However, the definition and legal requirements of scientific research differ among EU Member States. Since the new EU Medical Device Regulations 2017/745 and 2017/746 require compliance with the GDPR, the failure to come to grips with these concepts creates misunderstandings and legal issues. We argue that this might result in obstacles for the use and review of input data for medical devices. This could not only lead to forum shopping but also safety risks. The authors discuss to what extent scientific research should benefit from the research exemption and de-identification rules under the GDPR. Furthermore, this chapter analyzes recently released guidelines and discussion papers to examine how input data is reviewed by EU regulators. Ultimately, we call for more harmonized rules to balance individuals’ rights and the safety of medical devices.
U2 - 10.1017/9781108975452.007
DO - 10.1017/9781108975452.007
M3 - Book chapter
SN - 9781108972055
SP - 77
EP - 90
BT - The Future of Medical Device Regulation
A2 - Cohen, I. Glenn
A2 - Minssen, Timo
A2 - Price II., W. Nicholson
A2 - Robertson, Christopher
A2 - Shachar, Carmel
PB - Cambridge University Press
CY - Cambridge
ER -
ID: 257550425