Secondary Use of Personal Health Data: When is it “Further Processing” Under the Gdpr, and What are the Implications for Data Controllers?

Becker, Regina; Chokoshvili, Davit; Comandè, Giovanni; Hall, Alison; Mitchell, Colin; Molnár-Gábor, Fruzsina; Tervo, Sini; Thorogood, Adrian

doi:10.2139/ssrn.4070715

Cited by 6 publications

(2 citation statements)

References 0 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…The lack of harmonization was discussed in three main respects: (1) the divergent national implementation of the GDPR, (2) the unharmonized interpretation of the GDPR, and (3) the contradictory advice provided by ethics committees (national and local ones). This finding is fully supported by key literature on the topic ( 1 – 12 , 21 , 34 , 41 , 48 ). As regards the way forward, interviewees emphasized the need for a harmonized interpretation of the regulation, instead of the introduction of changes into hard law.…”

Section: Discussionsupporting

confidence: 78%

“…According to Verhenneman et al, this favorable position for scientific research is created by “ limiting the compatibility assessment to an assessment of the appropriate safeguards ” ( 33 ). The emphasis on conducting an assessment of the appropriate safeguards is echoed by other scholars as well ( 46 – 48 ), and it is supported by the European Data Protection Supervisor (EDPS), which stated that: “ The presumption is not a general authorization to further process data in all cases for historical, statistical or scientific purposes. Each case must be considered on its own merits and circumstances.…”

Section: Discussionmentioning

confidence: 99%

See 1 more Smart Citation

Challenges related to data protection in clinical research before and during the COVID-19 pandemic: An exploratory study

et al. 2022

View full text Add to dashboard Cite

BackgroundThe COVID-19 pandemic brought global disruption to health, society and economy, including to the conduct of clinical research. In the European Union (EU), the legal and ethical framework for research is complex and divergent. Many challenges exist in relation to the interplay of the various applicable rules, particularly with respect to compliance with the General Data Protection Regulation (GDPR). This study aimed to gain insights into the experience of key clinical research stakeholders [investigators, ethics committees (ECs), and data protection officers (DPOs)/legal experts working with clinical research sponsors] across the EU and the UK on the main challenges related to data protection in clinical research before and during the pandemic.Materials and methodsThe study consisted of an online survey and follow-up semi-structured interviews. Data collection occurred between April and December 2021. Survey data was analyzed descriptively, and the interviews underwent a framework analysis.Results and conclusionIn total, 191 respondents filled in the survey, of whom fourteen participated in the follow-up interviews. Out of the targeted 28 countries (EU and UK), 25 were represented in the survey. The majority of stakeholders were based in Western Europe. This study empirically elucidated numerous key legal and ethical issues related to GDPR compliance in the context of (cross-border) clinical research. It showed that the lack of legal harmonization remains the biggest challenge in the field, and that it is present not only at the level of the interplay of key EU legislative acts and national implementation of the GDPR, but also when it comes to interpretation at local, regional and institutional levels. Moreover, the role of ECs in data protection was further explored and possible ways forward for its normative delineation were discussed. According to the participants, the pandemic did not bring additional legal challenges. Although practical challenges (for instance, mainly related to the provision of information to patients) were high due to the globally enacted crisis measures, the key problematic issues on (cross-border) health research, interpretations of the legal texts and compliance strategies remained largely the same.

show abstract

Section: Discussionsupporting

confidence: 78%

Section: Discussionmentioning

confidence: 99%

Challenges related to data protection in clinical research before and during the COVID-19 pandemic: An exploratory study

et al. 2022

View full text Add to dashboard Cite

show abstract

Technical and Legal Aspects Relating to the (Re)Use of Health Data When Repurposing Machine Learning Models in the EU

El Mestari,

Doğan,

Maria Botes

2023

Privacy Symposium 2023

View full text Add to dashboard Cite

Conceptualizing fairness in the secondary use of health data for research: A scoping review

Cervera de la Cruz,

Shabani

2023

Accountability in Research

View full text Add to dashboard Cite

Tension between individual and public interestsDuty to share vs individual control: while some believe there is a duty to share health data, to others, maintaining control over their data and the ability to decide whether or not to participate in secondary use research overrides any public interest arguments. Need to substantiate public interest arguments: authors argue that there needs to be evidence to support public interest arguments.

show abstract

Secondary Use of Personal Health Data: When is it “Further Processing” Under the Gdpr, and What are the Implications for Data Controllers?

Cited by 6 publications

References 0 publications

Challenges related to data protection in clinical research before and during the COVID-19 pandemic: An exploratory study

Challenges related to data protection in clinical research before and during the COVID-19 pandemic: An exploratory study

Technical and Legal Aspects Relating to the (Re)Use of Health Data When Repurposing Machine Learning Models in the EU

Conceptualizing fairness in the secondary use of health data for research: A scoping review

Contact Info

Product

Resources

About