News & Analysis as of

Life Sciences Regulatory Agenda European Commission

American Conference Institute (ACI)

U.S. Implications of the EU AI Act

The European Union (EU) is leading the global charge with AI regulations. U.S. companies are not beyond their regulatory reach, however, and should be preparing their AI risk mitigation efforts accordingly....more

A&O Shearman

Commission proposal for a new European legal framework for GMOs

A&O Shearman on

In its two Confédération Paysanne decisions (cases C-528/161 and C-688/21), the Court of Justice of the European Union limited the exclusion of plants and products obtained by new genomic techniques (NGTs) from the...more

Dechert LLP

UK Life Sciences and Healthcare Newsletter - February 2021: Harnessing Big Data – Draft EU Data Governance Regulation Aims to...

Dechert LLP on

Key Takeaways - A new draft EU Regulation aims to encourage the sharing and re-use of data and foster a data-driven economy that shares the benefits of Big Data whilst respecting individuals’ rights in personal data and...more

Hogan Lovells

COVID-19 Report for Life Sciences and Health Care Companies (UPDATED)

Hogan Lovells on

In Tuesday's Report: European Commission proposes far-reaching pharmaceutical strategic plan, Biden names health care nominees, and warnings over Christmas COVID-19 spread....more

Hogan Lovells

EDPB Advises on Lawful Grounds for Processing Personal Data in Clinical Trials

Hogan Lovells on

With the coming into effect of the General Data Protection Regulation (GDPR), those conducting clinical trials in the EU face a complex set of rules ranging from lawful grounds for processing and transparency to restrictions...more

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