Privacy

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 because of perceived contradictions between the GDPR and the CTR, in particular in relation to the legal basis (e.g., the use of consent) and the further use of clinical trial data. (See also here).
Continue Reading European Data Protection Board releases Guidance on Intersection of the GDPR and the Clinical Trials Regulation

 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 medical device procurement policies, information governance and incident response processes, and an “end of life” policy for defunct/decommissioned devices.
Continue Reading UK Data Protection Regulator Surveys Use Of Smart Medical Devices

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 national data protection authorities as an element of controllers’ accountability and more importantly they also feature in the European Commission’s proposal for a new General Data Protection Regulation (see InsidePrivacy Vote on EU Data Protection Regulation Again Postponed, June 21, 2013).
Continue Reading Privacy Impact Assessments – Soon Compulsory for Companies in the Life Sciences Industry?

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 to forgo the less glamorous and often outdated technology assigned by their IT department and instead access corporate emails and data on their personal devices – a practice known as “bring your own device” to work, or “BYOD”.Continue Reading “Bring Your Own Device to Work” – Can Life Sciences Employers Safely Embrace the Trend?

 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