This Practice Note discusses the regulatory implications of the coronavirus (COVID-19) pandemic for the UK and European life sciences industry. It provides guidance as to the response of UK and EU regulators in the areas of clinical trials, inspections and the continuity of supply in medicinal products and medical devices, as well as the postponement of implementation of the Medical Devices Regulation (MDR). It also summarises key research and development (R&D) initiatives at a UK and EU level and European Commission guidance on the collection and transfusion of convalescent COVID-19 plasma.
The Payment Systems Regulator (PSR) was established under the Financial Services (Banking Reform) Act 2013 (FS(BR)A 2013) and became fully operational in April 2015. This Practice Note provides details of the PSR’s approach to supervising payment systems as set out in the PSR’s policy statement (PS 15/1) as well as its concurrent competition guidance and approach to monitoring and enforcing the Interchange Fee Regulation (Regulation (EU) 2015/751). It also provides information on general and specific directions issued by the PSR, market reviews and super-complaints.
This Practice Note explores the data protection implications of conducting clinical research. In particular, this Practice Note considers the responsibility for data protection compliance in the context of clinical research, the relevant legal grounds for processing personal data for research purposes, transparency requirements, collaborative research and data sharing as well as exceptions to data subject rights when processing personal data in the context of research. Finally, this Practice Note provides a checklist of practical data protection considerations to bear in mind when planning research activities.
This Practice Note sets out the passporting rights and related notification requirements of insurance undertakings established in the European Economic Area (the EEA).
This Practice Note focuses on the data protection considerations and implications of mobile health (mHealth). mHealth is a subset of eHealth (ie the use of information and communication technologies for health) and refers to the use of mobile applications to allow users to monitor, evaluate and improve their health using their mobile devices.
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