By

Josefine Sommer

03 May 2021

Part II – Digital Health Passports in Europe: Amended Proposal for a Digital Green Certificate and Eligible Testing Methods

In March 2021, the European Commission released a proposal for the creation of a “Digital Green Certificate,” which will allow EU citizens to travel easier throughout the EU during the COVID-19 pandemic. Last week, the EU Member States agreed on some proposed changes to the proposal, including strengthening of the … Read More

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09 March 2021

European Commission Releases Assessment of the EU Member States’ Rules on Health Data in Light of GDPR

On February 12, 2021, the European Commission (Commission) published an “Assessment of the EU Member States’ rules on health data in the light of GDPR” (the Assessment). The Assessment concludes, amongst other things, that there are variations in the implementation of the EU General Data Protection Regulation … Read More

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18 February 2021

European Medicines Agency Issues Updated Good Clinical Practice Q&A

On February 17, 2021 the European Medicines Agency (EMA) published an updated version of its good clinical practice questions and answers (GCP Q&A).  The updated section relates to access to patient medical records by GCP inspectors from European Economic Area (EEA) Member States.  It … Read More

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21 January 2021

A Digital Europe – Digital Health and other Recent EU Data Initiatives

Taking a step into the digital age, the European Commission announced that the 2020s shall become the EU’s Digital Decade.  The EU’s digitalization, including in the area of health, is one of the Commission’s key priorities and covers a wide range of actions and related initiatives.

Building on prior initiatives, … Read More

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20 January 2020

New Guidance Published Addressing Scientific Research and the GDPR

A recent opinion from the European Data Protection Supervisor (EDPS) on data protection and scientific research builds on an opinion from January 2019 from the European Data Protection Board on the GDPR and clinical trials. The Opinion from the EDPS should be taken into account by life sciences companies in Read More

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13 January 2020

New Guidance Published on Cybersecurity and Medical Devices

New European medical device guidance will require manufacturers to carefully review cybersecurity and IT security requirements in relation to their devices and in their product literature. This new guidance comes at the same time as a draft guidance on privacy by design has been published by the European Data Protection Read More

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01 November 2019

European Commission Provides Important Guidance on Qualification and Classification of Software Under New Medical Devices Regulations

The European Commission’s Medical Devices Coordination Group (MDCG) has published a much-anticipated guidance on the qualification and classification of software devices as medical devices (MDSW)1  under the new Medical Devices Regulation (MDR) and In Vitro Diagnostic Regulations (IVDR) (the Guidance, available here). The Guidance seeks to provide clarification … Read More

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