Archives: Privacy & Data Security

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Exploring the EU Horizon for Pharma

The EU pharmaceutical industry landscape is in significant flux. There are many pressures to provide new therapies and to make them available more early and for as many qualifying patients as possible. In that context, the industry model and the role of exclusivity rights as a tool to stimulate innovation are being discussed. At the … Continue Reading

Article 29 Working Party Clarifies Scope of Health Data in Apps and Devices

Article originally posted on our sister blog InsidePrivacy The Article 29 Data Protection Working Party (Working Party), an independent EU advisory body on data protection and privacy, responded to a request from the European Commission made in the framework of the Commission’s  mHealth initiative to clarify the definition of data concerning health in relation to lifestyle and wellbeing … Continue Reading

EMA Transparency Policy – EMA Launches Public Consultation On The Publication Of Information Under The New EU Clinical Trials Regulation

On 21 January 2015, the European Medicines Agency (“EMA”) launched a public consultation on how the transparency rules of Regulation EU No 536/2014 (the “Clinical Trials Regulation”) should apply to the new clinical trials database.  The consultation document of the EMA discusses the practical application of the new transparency rules, sets different options on the … Continue Reading

Summary Report of European Commission’s mHealth Consultation Published

 This post originally appeared on our sister blog, Covington eHealth. The European Commission has finally published its summary of 211 responses to its mobile health (“mHealth”) consultation. The summary and original responses to the consultation have been made available on the Commission’s website at https://ec.europa.eu/digital-agenda/en/news/summary-report-public-consultation-green-paper-mobile-health… Continue Reading

E-Health Take Note: Standards Published For Personal Data In The Cloud

The health sector handles substantial quantities of personal information, including information that is deemed to be “sensitive” under European data protection regimes.  For that reason, health care providers sometimes question their ability to take advantage of increasingly popular e-health cloud services.  While EU lawmakers are contemplating a “European Privacy Seal” – which could, if done … Continue Reading

New ICO Statistics Show an Unhealthy Rise in Data breaches in the Healthcare Sector

By Helena Marttila-Bridge and Oliver Grazebrook Earlier this month, the UK’s Information Commissioner’s Office (“ICO”) released statistics showing that over 25% of the 335 data breaches reported between 1 April 2013 and 30 June 2013 came from the health sector.  This comes as no surprise considering that the last 12 months have seen a string … 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

Commission Issues Recommendations Aiming to Improve Costly Employee-Related Legislation for SMEs

As reported in an earlier post, the European Commission (EC) is conducting a study of the top ten most burdensome EU laws for SMEs. This is part of an initiative – the Regulatory Fitness and Performance Programme (REFIT) – launched by the Commission in 2012 to ease the regulatory burden on SMEs in Europe. On … 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

What You Need to Know about the Article 29 Working Party’s Opinion on Purpose Limitation

In its recent Opinion 03/2013 on purpose limitation (the “Opinion”), the Article 29 Data Protection Working Party, an EU advisory body on data protection, comprised of representatives of the Member States’ supervisory authorities, the European Data Protection Supervisor and the European Commission, analyzes the principle of purpose limitation and provides guidance for its practical application.  The principle of … Continue Reading

The Rise of mHealth and Privacy Considerations

By Helena Marttila-Bridge and Oliver Grazebrook In recent years healthcare providers around the world have been looking into mobile health or “mHealth” solutions to increase productivity and reduce costs.  Examples of mHealth practices include the increased use of mobile devices by doctors and nurses to access and transmit patient health data and the use of … Continue Reading

European Commission Set to Ease Regulatory Burden on SMEs: Key Implications for Life Sciences Employers

By Chris Bracebridge and Maria-Martina Yalamova In March 2013, the European Commission published preliminary results of its study of the top ten most burdensome EU laws for SMEs.  Employee-related legislation forms a significant part of that list, and is among the most costly and onerous. The “top ten” study is part of an initiative — … Continue Reading
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