The General Data Protection Regulation will create legal clarity for medical technology service providers across the EU through a single set of rules. This move was long-awaited by the industry. COCIR also welcomes the fact that the specificity of the healthcare sector was taken into account, compared to the current regime (Directive 44/95). However, we believe some areas could be improved to bring further clarity, legal certainty, feasibility and reduction of the administrative burden.
Today’s healthcare systems rely on data sharing to deliver quality care and continue to innovate in healthcare. An effective, clear and reliable data protection framework is therefore absolutely necessary.
COCIR Secretary General Nicole Denjoy said, “The Commission’s proposal is a good start. However, certain provisions could be fine-tuned. Our industry is calling for the exclusion of non-identifiable patient data such as
anonymised and pseudonymised data from the scope of the Regulation. This is essential if we want to keep innovating in healthcare,” she said, adding “This is a delicate balance to achieve, but we trust the Parliament, the Commission and Member States will recognise this important paradigm.”
(COCIR represents the European Medical Imaging, Electromedical and Healthcare ICT