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

Standard

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

Harvard

Meszaros, J, Corrales Compagnucci, M & Minssen, T 2022, 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? . in IG Cohen, T Minssen, WN Price II., C Robertson & C Shachar (eds), The Future of Medical Device Regulation: Innovation and Protection. Cambridge University Press, Cambridge, pp. 77-90. https://doi.org/10.1017/9781108975452.007

APA

Meszaros, J., Corrales Compagnucci, M., & Minssen, T. (2022). 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? . In I. G. Cohen, T. Minssen, W. N. Price II., C. Robertson, & C. Shachar (Eds.), The Future of Medical Device Regulation: Innovation and Protection (pp. 77-90). Cambridge University Press. https://doi.org/10.1017/9781108975452.007

Vancouver

Meszaros J, Corrales Compagnucci M, Minssen T. 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? . In Cohen IG, Minssen T, Price II. WN, Robertson C, Shachar C, editors, The Future of Medical Device Regulation: Innovation and Protection. Cambridge: Cambridge University Press. 2022. p. 77-90 https://doi.org/10.1017/9781108975452.007

Author

Meszaros, Janos ; Corrales Compagnucci, Marcelo ; Minssen, Timo. / 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? . The Future of Medical Device Regulation: Innovation and Protection. editor / I. Glenn Cohen ; Timo Minssen ; W. Nicholson Price II. ; Christopher Robertson ; Carmel Shachar. Cambridge : Cambridge University Press, 2022. pp. 77-90

Bibtex

@inbook{4c9490ea718443dcada9a52ef4b1a4a1,
title = "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? ",
abstract = "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{\textquoteright} rights and the safety of medical devices.",
author = "Janos Meszaros and {Corrales Compagnucci}, Marcelo and Timo Minssen",
year = "2022",
doi = "10.1017/9781108975452.007",
language = "English",
isbn = "9781108972055",
pages = "77--90",
editor = "Cohen, {I. Glenn} and Minssen, {Timo } and {Price II.}, {W. Nicholson} and Christopher Robertson and Carmel Shachar",
booktitle = "The Future of Medical Device Regulation",
publisher = "Cambridge University Press",
address = "United Kingdom",

}

RIS

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