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Belgian report shows limited success in screening of health insurance funds

Veerle Pissierssens

A recent report from the Belgian Court of Audit reportedly shows that the information that health insurance funds must disclose pursuant to the requirements set in the 2016 “Future Pact” (Toekomstpact), which mainly pertain to internal inspections and accountancy, is too fragmented and therefore of little use. The report also recommends granting inspection services access to Read More

Processing of health data: first implementing decree on French Personal Data Protection Act

Eveline Van Keymeulen

Decree 2018-687 implementing Act 2018-493 of 20 June 2018 on the Protection of Personal Data was recently published in the French Official Journal. The decree amends Decree 2005-1309, which implemented the 1978 French Data Protection Act. In particular, it amends the provisions concerning the processing of personal health data by including operating provisions on the processing of Read More

Getting ready for the EU MDR: Requirements for identification and traceability of medical devices

Eveline Van Keymeulen

In this post of our “Getting ready for the MDR” series, we analyse the most important requirements for device identification and traceability that will be imposed on manufacturers and other economic operators placing medical devices on the EU market. MedTech Europe, the association representing the European medical technology industry, estimates that approximately 500,000 different medical devices Read More

ECJ: organisms obtained by new mutagenesis plant breeding techniques are not exempted from the GMO Directive

Sophie ten Bosch

Today, the European Court of Justice (ECJ) has decided in case C-528/16 that organisms obtained by new mutagenesis plant breeding techniques are genetically modified organisms (GMOs) and subject to the obligations laid down in the GMO-Directive (Directive 2001/18/EC). This decision interprets the GMO-Directive in light of new plant breeding techniques such as CRISPR-Cas9. Mutagenesis is Read More

Dutch Data Protection Agency issues guidance on large-scale data processing in healthcare

Iradj Nazaryar

Last month, the Data Protection Agency (DPA) issued guidance on large-scale healthcare data processing. The General Data Protection Regulation requires organisations involved in large-scale processing of data to appoint a Data Protection Officer (DPO) and in certain cases to conduct a Data Protection Impact Assessment (DPIA). In this respect, the guidance clarifies when healthcare providers are Read More