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Software Regulatory Reform

Mayer Brown

Brazil Passes ‘Legal Framework for Games’ Legislation

Mayer Brown on

In early May, Brazil’s Law No. 14,852/2024 (the “Legal Framework for Games” or the “Framework”) was published. Originating as Bill No. 2796/2021, the legislation provides the necessary legal framework for the burgeoning...more

Hogan Lovells

Children's rights in the digital world: new guidelines in the Netherlands

Hogan Lovells on

On 12 March 2021, the "Code for Children's Rights" ("Code voor Kinderrechten") was launched in the Netherlands. The Code was developed by the University of Leiden and the Waag organisation commissioned by the Dutch...more

Wilson Sonsini Goodrich & Rosati

FDA Reduces Regulatory Burden for Certain Medical Image Analyzers

The U.S. Food and Drug Administration (FDA) had regulated medical image analyzers for more than 20 years under the agency’s most stringent regulatory requirements. But the agency recently reclassified a subset of these device...more

Polsinelli

FDA Guidance on Software as Medical Devices Represents Broader Deregulation Trend

Polsinelli on

The FDA recently published two draft guidance documents to clarify which types of medical software, based on their functionality, are no longer considered medical devices as a result of the changes imposed under section 3060...more

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