Medical devices

WP 29 releases an extensive opinion on data processing at work

Inge Vanderreken

The EU’s “Article 29 Working Party” (WP29) has adopted new guidance on the processing of personal data in the employment context (the New Opinion). This New Opinion complements their 2001 opinion and 2002 working document. WP29 is the Data Protection Working Party established by Article 29 of Directive 95/46/EC. It is an independent European advisory Read More

UK ICO investigation into the Royal Free’s use of patient data used as an opportunity to educate

Charlotte Mullarkey

In a case which has wide implications for the health care sector, the UK Information Commissioner’s Office (ICO) has ruled that the Royal Free NHS Foundation Trust failed to comply with the UK Data Protection Act when it provided personal data of about 1.6 million patients to Google DeepMind.  The personal data was provided as Read More

European Commission seeks public views on health and care in the Digital Single Market

Patricia Carmona Botana

Last week, the European Commission (EC) launched a public consultation which main purpose is to define potential policy measures on digital initiatives (i) supporting the transition from a hospital-based healthcare model to a person-centred and integrated model and (ii) contributing to the sustainability of EU Member States’ healthcare systems.  The EC considers that digital innovation Read More

Portugal and Spain strengthen collaboration with pilot project for the joint procurement of medicines

Patricia Carmona Botana

Last week, the Health Ministers of Portugal and Spain signed a letter of intent that marks the beginning of a joint procurement, funding and price negotiation initiative for medicines and medical devices in the Iberian region.  The initiative seeks to enhance cooperation in order to improve patients’ safety, patient’s access to innovative treatments, as well Read More

New circular clarifies revised French transparency requirements

Eveline Van Keymeulen

The French General Directorate of Health (DGS) recently published a new circular relating to the transparency of relationships between life sciences companies and healthcare actors. The circular replaces its 2013 predecessor, and provides further guidance with respect to the revised transparency provisions introduced by the December 2016 Decree and March 2017 Order, now requiring life Read More