May 2020

EPA on May 19 released a proposed rule that would put in place a set of regulations governing EPA’s issuance, modification, and withdrawal of guidance documents.  This proposal implements portions of Executive Order 13891, and builds on EPA’s previous efforts to create a comprehensive portal of guidance documents earlier this year.  Generally speaking, the…

In a 49-43 vote along party lines, the Senate confirmed Texas attorney James “Trey” Trainor to the Federal Election Commission today.  This gives the FEC a quorum for the first time since August 31, 2019, when former Commissioner Matt Petersen stepped down to enter private practice.  What effect will this have on the FEC and…

Two notices recently published in the Federal Register indicate the Federal Emergency Management Agency (“FEMA”) intends to exercise Defense Production Act (“DPA”) authority in novel ways during the current coronavirus pandemic.

On May 12th, FEMA announced that it plans to invoke DPA authority which permits the President to consult with representatives of industry, business, financing,

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In response to the ongoing COVID-19 pandemic, the European Commission (“EC”) is taking steps to stabilise the most affected sectors of the economy. As part of its efforts, the EC has announced its support for the agricultural and food sectors which are severely affected by the pandemic. This includes an exceptional derogation from the EU…

On May 11, 2020, the UK Information Commissioner’s Office (“ICO”) published guidance on how employers should handle data in the event they choose to test their employees for COVID-19.

The guidance provides a clear reminder that employers must comply with both the General Data Protection Regulation (“GDPR”) and the Data Protection Act 2018 (“DPA”), and…

Policymakers and other stakeholders continue to promote the development and adoption of artificial intelligence (“AI”) worldwide. For example, the European Commission recently released a white paper describing a proposed framework for regulating AI. In the United States, lawmakers have considered AI legislation and President Trump signed an Executive Order on AI that, among other things,…

The following guidance could be relevant to manufacturers of software as a medical device (SaMD).  The recently-enacted Coronavirus Aid, Relief, and Economic Security Act (CARES Act) added new section 506J to the Federal Food, Drug, and Cosmetic Act (FDCA). This section requires manufacturers of certain devices to notify FDA of an interruption or permanent discontinuance…