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GDPR and Digital Health
New Standard Contractual Clauses published
GDPR permits data transfers to countries outside the EU / EEA only if certain safeguards are implemented to ensure an adequate level of data protection in the country of the data importer. The most common safeguard for securing such transfers are the so-called ‘standard contractual clauses’ (“SCCs”). On 4 June 2021, the EU Commission published […]
Launching a Health App in Europe and the USA – Key Points to Consider
The COVID-19 crisis has affected multiple industry sectors and disrupted economic processes. Because of the increased burden that the pandemic has placed on the medical device industry, the application of the Medical Device Regulation (“MDR”) was postponed by one year. It will now apply from May 26 2021 (instead of 2020). Since the MDR also […]