Tune into the first episode of Covington’s Talking Life Sciences Audiocast, where Grant Castle, Peter Bogaert and Marie Doyle-Rossi discuss key developments and trends in the pharma sector. Our speakers review the major issues of 2022, including the Clinical Trials Regulation, the Health Technology Assessment Regulation, European Health Data Space proposal and Brexit.
The 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 “Can GDPR Work for Health Research.” In the first session, the workshop discussed the implications of the General Data Protection Regulation (“GDPR”) on clinical trials in…
May 2015 EU mHealth Round-Up
This article was originally published on our sister blog InsidePrivacy
May 2015 saw a number of developments in the EU mHealth sector worthy of a brief mention. The European Commission announced that it would work on new guidance for mHealth apps, despite the European Data Protection Supervisor and British Standards Institution publishing their own just weeks earlier. In parallel, the French data protection authority announced a possible crackdown on mHealth app non-compliance with European data protection legislation. This post briefly summarizes these developments.
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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 apps. (See more here, and here for our blog post on the European Commission’s Summary Report of the mHealth consultation.)
In its latest paper on health data in apps and devices, the Working Party supports a broad definition of health data, distinguishing the following three categories of health data:
- The data are inherently/clearly medical data, especially those generated in a professional, medical context.
- The data are raw sensor data that can be used in itself or in combination with other data to draw a conclusion about the actual health status or health risk of a person.
- Conclusions are drawn about a person’s health status or health risk (irrespective of whether these conclusions are accurate, legitimate or otherwise adequate or not).
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