Overcoming ethical and legal obstacles to data linkage in health research: stakeholder perspectives.

Introduction: Data linkage for health research purposes enables the answering of countless new research questions, is said to be cost effective and less intrusive than other means of data collection. Nevertheless, health researchers are currently dealing with a complicated, fragmented, and inconsistent regulatory landscape with regard to the processing of data, and progress in health research is hindered.

Aim: We designed a qualitative study to assess what different stakeholders perceive as ethical and legal obstacles to data linkage for health research purposes, and how these obstacles could be overcome.

Sharing Medical Big Data While Preserving Patient Confidentiality in Innovative Medicines Initiative: A Summary and Case Report from BigData@Heart.

Sharing individual patient data (IPD) is a simple concept but complex to achieve due to data privacy and data security concerns, underdeveloped guidelines, and legal barriers. Sharing IPD is additionally difficult in big data-driven collaborations such as Bigdata@Heart in the Innovative Medicines Initiative, due to competing interests between diverse consortium members. One project within BigData@Heart, case study 1, needed to pool data from seven heterogeneous data sets: five randomized controlled trials from three different industry partners, and two disease registries.

Specific measures for data-intensive health research without consent: a systematic review of soft law instruments and academic literature.

It is a common misunderstanding of current European data protection law that when consent is not being used as lawful basis, the processing of personal data is prohibited. Article 9(2)(j) of the European General Data Protection Regulation (GDPR) permits Member States to establish a legal basis in national law that allows for the processing of personal data for scientific research purposes without consent. However, the European legislator has formulated this "research exemption" as an opening clause, rendering the GDPR not specific as to what measures exactly are required to comply with the research exemption.

Dynamic consent, communication and return of results in large-scale health data reuse: Survey of public preferences.

Dynamic consent forms a comprehensive, tailored approach for interacting with research participants. We conducted a survey study to inquire how research participants evaluate the elements of consent, information provision, communication and return of results within dynamic consent in a hypothetical health data reuse scenario. We distributed a digital questionnaire among a purposive sample of patient panel members.

Integrated surveillance of human respiratory viruses in addition to SARS-CoV-2 in a public testing facility in the Netherlands.

Background: SARS-CoV-2 prevention measures impact the circulation of other respiratory viruses. Surveillance in the network of general practitioners is hampered by widespread testing for SARS-CoV-2 in public testing facilities.

Objectives: To evaluate integrated community surveillance of SARS-CoV-2 and other respiratory viruses and describe epidemiological trends.