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...
View ArticleWhat You Need to Know about the Article 29 Working Party’s Opinion on Purpose...
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...
View Article“Bring Your Own Device to Work” – Can Life Sciences Employers Safely Embrace...
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...
View ArticleCommission Issues Recommendations Aiming to Improve Costly Employee-Related...
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...
View ArticlePrivacy Impact Assessments – Soon Compulsory for Companies in the Life...
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...
View ArticleNew ICO Statistics Show an Unhealthy Rise in Data breaches in the Healthcare...
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...
View ArticleE-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...
View ArticleSummary 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...
View ArticleEMA Transparency Policy – EMA Launches Public Consultation On The Publication...
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...
View ArticleArticle 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...
View ArticleExploring 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....
View ArticleThe Implications of the GDPR on Clinical Trials in Europe
On October 22, 2018, the European Federation of Pharmaceutical Industries in cooperation with the Future of Privacy Forum and the Center for Information Policy Leadership organized a workshop entitled...
View ArticleEuropean Data Protection Board releases Guidance on Intersection of the GDPR...
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...
View ArticleFrench medicines regulator produces first in Europe medical devices...
France’s medicines regulator, the Agence Nationale de Sécurité du Médicament et des Produits de Santé (ANSM), has released draft guidelines, currently subject to a public consultation, setting out...
View ArticleEuropean Commission publishes Strategic Forum’s recommendations on Smart Health
On November 5, 2019, the European Commission published a report entitled “Strengthening Strategic Value Chains for a future-ready EU Industry”, which was prepared by the Strategic Forum on Important...
View ArticleGermany Prepares New Law for Patient Data Protection and Increased...
On 3 July 2020, the German parliament passed a draft bill (German language) for patient data protection and for more digitalisation in the German healthcare system (Patientendaten-Schutz-Gesetz). The...
View ArticleProposed New EU Cyber Rules Introduce More Onerous Requirements and Extend to...
In addition to releasing the new EU Cybersecurity Strategy before the holidays (see our post here), the Commission published a revised Directive on measures for high common level of cybersecurity...
View ArticleMajor Cyber-Attack on Irish Health System Causes Commercial Concern
On May 20, 2021 there was a major ransomware attack on the Irish health system. The centralized HSE (Health Service Executive) which provides and manages healthcare for the Irish population was...
View ArticleEMA Transparency Policy – EMA Launches Public Consultation On The Publication...
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...
View ArticleArticle 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...
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