Tag Archives: Privacy

European Data Protection Board releases Guidance on Intersection of the GDPR and the Clinical Trials Regulation

The European Data Protection Board (“Board”) released an opinion on January 23, 2019, on the intersection between the EU General Data Protection Regulation (“GDPR”) and the Clinical Trials Regulation (“CTR”).  The opinion considers a Q&A on this topic prepared by the European Commission’s Directorate General for Health.  The Directorate General decided to create this Q&A … Continue Reading

UK Data Protection Regulator Surveys Use Of Smart Medical Devices

 This post originally appeared on our sister blog, InsideMedicalDevices. The UK Information Commissioner’s Office (ICO) has launched an informal survey of current practices relating to the use of data-enabled medical devices and apps. The short and anonymous survey explores whether organisations have put in place specific policies and procedures, asset registers, IT security requirements for … Continue Reading

Privacy Impact Assessments – Soon Compulsory for Companies in the Life Sciences Industry?

Privacy Impact Assessments (PIAs) or  data protection impact assessments used to be discussed in the context of specific technologies or industry sectors (see, for instance, the European Commission’s recommendations in relation to  applications supported by radio-frequency identification (RFID) and the development of smart grids). However, this situation is about to change. PIAs are increasingly being promoted by … Continue Reading

“Bring Your Own Device to Work” – Can Life Sciences Employers Safely Embrace the Trend?

Since Apple launched the first iPhone in 2007, the popularity of smart phones and tablets has sky-rocketed.  These devices, with their sleek design, touch screens and easy access to a myriad of entertainment options, have fast become the preferred method of communication for executives. In recent years, a growing number of companies have allowed employees … Continue Reading

Medical Nanotechnology in Europe

 Article originally published in RAJ Pharma in July 2008 By 2015 nanotechnology-based medicines and medical devices are expected to flood the global market. Brian Kelly and Peter Bogaert discuss the regulatory and legal implications of medical nanotechnology in Europe. Nanotechnologies are the design, characterisation, production and application of structures, devices and systems by controlling shape and size … Continue Reading
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