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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…

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 …

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

  • the UK’s pandemic preparedness;
  • the use of border controls, social distancing and lockdowns to control the pandemic;
  • the

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On Wednesday, October 6th, Governor Gavin Newsom signed SB 41, the Genetic Information Privacy Act, which expands genetic privacy protections for consumers in California, including those interacting with direct-to-consumer (“DTC”) genetic testing companies.  In a recent Inside Privacy blog post, our colleagues discussed SB 41 and the growing patchwork of state genetic privacy laws

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Last Friday, October 1, the Protecting DNA Privacy Act (HB 833), a new genetic privacy law, went into effect in the state of Florida establishing four new crimes related to the unlawful use of another person’s DNA.  While the criminal penalties in HB 833 are notable, Florida is not alone in its focus…

On September 15, 2021, CMS published a proposed rule to repeal the Medicare Coverage of Innovative Technology (MCIT) and Definition of “Reasonable and Necessary” Final Rule (“MCIT/RN Rule”), which was published on January 14, 2021 and was set to take effect on December 15, 2021.  The MCIT/RN Rule would have created a pathway to provide…

 On January 21, 2021, the European Commission opened two public consultations on the review of the EU Blood Directive and the EU Tissues and Cells Directive.  Both Directives are more than fifteen years old, and their implementation diverges widely across the member states.  The rules on human blood and tissue gain increasing importance for…

A growing number of African countries have begun to ease COVID-19 related regulatory restrictions. Some countries, such as Kenya, Rwanda, and Senegal resumed international flights in August, while other countries like South Africa and Nigeria are only now opening their borders. For a continent that slipped into recession for the first time in a quarter

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