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....
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 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 ArticleThe New Italian Sunshine Act: What Companies Should Know And How To Get Ready
On 31 May 2022, the Italian Parliament approved Law 62/2022, also known as the Sunshine Act. The Sunshine Act entered into force on 26 June 2022. However, it will become fully enforceable once the...
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