To What Extent Does the EU General Data Protection Regulation (GDPR) Apply to Citizen Scientist-Led Health Research with Mobile Devices?

Chen, Jiahong

doi:10.1177/1073110520917046

Cited by 6 publications

(3 citation statements)

References 9 publications

(4 reference statements)

Supporting

Mentioning

Contrasting

Order By: Relevance

“…While several studies have addressed the issue of governance of big data in clinical research from the legal perspective [10][11][12] or ethical perspective [13][14][15][16], the perspective of institutional research ethics committee (REC) members is underrepresented in the current body of literature [17]. Research ethics committees (RECs) enforce research governance through a review mechanism, reviewing the study design and protocols, inclusion and exclusion criteria for participants, informed consent procedures and data safety, management and monitoring plans.…”

Section: Introductionmentioning

confidence: 99%

Ethical challenges of using remote monitoring technologies for clinical research: A case study of the role of local research ethics committees in the RADAR-AD study

Muurling,

Pasmooij,

Koychev

et al. 2023

PLoS ONE

View full text Add to dashboard Cite

Introduction Clinical research with remote monitoring technologies (RMTs) has multiple advantages over standard paper-pencil tests, but also raises several ethical concerns. While several studies have addressed the issue of governance of big data in clinical research from the legal or ethical perspectives, the viewpoint of local research ethics committee (REC) members is underrepresented in the current literature. The aim of this study is therefore to find which specific ethical challenges are raised by RECs in the context of a large European study on remote monitoring in all syndromic stages of Alzheimer’s disease, and what gaps remain. Methods Documents describing the REC review process at 10 sites in 9 European countries from the project Remote Assessment of Disease and Relapse–Alzheimer’s Disease (RADAR-AD) were collected and translated. Main themes emerging in the documents were identified using a qualitative analysis approach. Results Four main themes emerged after analysis: data management, participant’s wellbeing, methodological issues, and the issue of defining the regulatory category of RMTs. Review processes differed across sites: process duration varied from 71 to 423 days, some RECs did not raise any issues, whereas others raised up to 35 concerns, and the approval of a data protection officer was needed in half of the sites. Discussion The differences in the ethics review process of the same study protocol across different local settings suggest that a multi-site study would benefit from a harmonization in research ethics governance processes. More specifically, some best practices could be included in ethical reviews across institutional and national contexts, such as the opinion of an institutional data protection officer, patient advisory board reviews of the protocol and plans for how ethical reflection is embedded within the study.

show abstract

Section: Introductionmentioning

confidence: 99%

Ethical challenges of using remote monitoring technologies for clinical research: A case study of the role of local research ethics committees in the RADAR-AD study

Muurling,

Pasmooij,

Koychev

et al. 2023

PLoS ONE

View full text Add to dashboard Cite

show abstract

“…AI-based medical devices often rely on vast amounts of patient data for training and decision-making. Therefore, it is essential to evaluate whether these devices adhere to relevant data protection laws, such as the General Data Protection Regulation in the European Union [ 75 , 76 ]. HTA examines the measures taken by AI-based medical device manufacturers to safeguard patient privacy, including data anonymization, encryption, and secure data storage practices [ 37 ].…”

Section: Resultsmentioning

confidence: 99%

Suitability of the Current Health Technology Assessment of Innovative Artificial Intelligence-Based Medical Devices: Scoping Literature Review

Farah,

Borget,

Martelli

et al. 2024

J Med Internet Res

View full text Add to dashboard Cite

Background Artificial intelligence (AI)–based medical devices have garnered attention due to their ability to revolutionize medicine. Their health technology assessment framework is lacking. Objective This study aims to analyze the suitability of each health technology assessment (HTA) domain for the assessment of AI-based medical devices. Methods We conducted a scoping literature review following the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) methodology. We searched databases (PubMed, Embase, and Cochrane Library), gray literature, and HTA agency websites. Results A total of 10.1% (78/775) of the references were included. Data quality and integration are vital aspects to consider when describing and assessing the technical characteristics of AI-based medical devices during an HTA process. When it comes to implementing specialized HTA for AI-based medical devices, several practical challenges and potential barriers could be highlighted and should be taken into account (AI technological evolution timeline, data requirements, complexity and transparency, clinical validation and safety requirements, regulatory and ethical considerations, and economic evaluation). Conclusions The adaptation of the HTA process through a methodological framework for AI-based medical devices enhances the comparability of results across different evaluations and jurisdictions. By defining the necessary expertise, the framework supports the development of a skilled workforce capable of conducting robust and reliable HTAs of AI-based medical devices. A comprehensive adapted HTA framework for AI-based medical devices can provide valuable insights into the effectiveness, cost-effectiveness, and societal impact of AI-based medical devices, guiding their responsible implementation and maximizing their benefits for patients and health care systems.

show abstract

“…It is more rigorous to strengthen the protection of personal information from the administrative law level. Administrative law can clearly and specifically stipulate the right to request correction and relief of personal information, and the scope of regulation is more targeted [5,6]. The concept of BD was first put forward in the 1990s, then swept like a tsunami, and was widely known in recent years.…”

Section: Introductionmentioning

confidence: 99%

A Protection Model of Citizen Personal Information Administrative Law Based on BD Analysis and Edge Computing

Fang

2022

Wireless Communications and Mobile Computing

View full text Add to dashboard Cite

With the continued advancement and popularization of the Internet and Edge Computing, the right to privacy of big data has taken on new meanings, and the tools available to protect citizens’ personal information under administrative law have grown in number. In the context of big data, infringers frequently use the Internet as a natural barrier and medium, making it difficult to collect evidence once personal information has been leaked. This paper investigates the administrative law protection of citizens’ personal information using big data analysis. In comparison to traditional society, information technology innovation has created massive information storage equipment, efficient information processing equipment, and rapid information dissemination means for human beings to protect their legitimate rights and interests. Sharing goes far beyond traditional societal competition. The study of administrative law protection of citizens’ personal information in the big data era has the potential to not only advance the study of administrative law protection of citizens’ personal information but also to reveal the characteristics of administrative law protection of citizens’ personal information in the big data era.

show abstract

To What Extent Does the EU General Data Protection Regulation (GDPR) Apply to Citizen Scientist-Led Health Research with Mobile Devices?

Cited by 6 publications

References 9 publications

Ethical challenges of using remote monitoring technologies for clinical research: A case study of the role of local research ethics committees in the RADAR-AD study

Ethical challenges of using remote monitoring technologies for clinical research: A case study of the role of local research ethics committees in the RADAR-AD study

Suitability of the Current Health Technology Assessment of Innovative Artificial Intelligence-Based Medical Devices: Scoping Literature Review

A Protection Model of Citizen Personal Information Administrative Law Based on BD Analysis and Edge Computing

Contact Info

Product

Resources

About