On 27 October 2021, the U.S. Food and Drug Administration (“FDA”), Health Canada, and the United Kingdom’s Medicines and Healthcare products Regulatory Agency (“MHRA”) (together the “Regulators”) jointly published 10 guiding principles to inform the development of Good Machine Learning Practice (“GMLP”) for medical devices that use artificial intelligence and machine learning (“AI/ML”).
Purpose
AI…
Date: October 29, 2021
In Case You Missed It: EU Privacy, Data and Consumer Legislative Updates of the Past Month
Date
Tag
News
Link to Source
October 29
Cybersecurity
The European Commission announced that it adopted a delegate act to the Radio Equipment Directive (Directive (EU) 2014/53). This act sets out measures to (1) improve…
Our Africa Anti-Corruption Practice has previously outlined key considerations for handling internal investigations and remediation of compliance issues in Africa. Here, we take a closer look at a particular aspect of remediation, the root cause analysis. After the dust settles on an investigation identifying misconduct, a root cause analysis can serve as the most effective…
Federal government contractors face many uncertainties as they implement President Biden’s COVID-19 vaccine mandate. This includes the distinct possibility of civil lawsuits arising out of their implementation of the mandate, including potential allegations of invasion of privacy, wrongful termination, lost wages, discrimination, personal injury or other common law claims or statutory violations. At least…
The fragility of Northern Ireland politics continues to prove problematic in dealing with Brexit. The on-going efforts of the UK government to redefine the Northern Ireland Protocol agreed with the EU last December is testament to that. Such efforts may be politically appealing in advance of UK local elections next May, but they too are…
On 19 October, alongside a number of other important strategy documents (over 2,000 pages in total), the UK Government published its ‘Net-Zero Strategy’ (NZS) which will help achieve the UK’s interim five yearly carbon targets leading up to net-zero by 2050.
The NZS focuses on eight key areas with priorities and policies set out under…
On October 11, 2021, the Covington Brussels office hosted a Webcast: “Fighting Inequality: Empowering Women and Girls” in honor of International Day of the Girl Child. London Partner Louise Nash moderated the impressive panel of women, comprising of Waris Dirie, founder of Desert Flower Foundation, and Kiera Chaplin, the President of Desert Flower Foundation France.…
Covington’s Senior Advisor Carl Bildt, former prime minister and foreign minister of Sweden, analyses the key trends expected to drive geopolitics and business over the near term.
Globally, strategic competition between the United States and China, and to some extent with a revisionist Russia, continues to be a source of geopolitical tensions. At the…
In a December 2020 speech, Deputy Assistant Attorney General Michael Granston warned that cybersecurity fraud could see enhanced enforcement under the False Claims Act (“FCA”). On October 6, 2021, Deputy Attorney General Lisa Monaco announced that the Department of Justice (“DOJ”) would be following through on that warning with the launch of the DOJ’s Civil…
On 12 October the House of Commons Science & Technology and Health and Social Care Committees published their report into the UK Government’s handling of the Coronavirus Pandemic (the Report).
The Report focused on six main areas
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