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On January 12, the U.S. Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) Digital Health Center of Excellence released its new five-part “Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD) Action Plan,”......

The Alabama Department of Environmental Management (“ADEM”) issued a Proposed Administrative Order (“AO”) to Clear Properties Albertville, LLC (“Clear Properties”) for an alleged violation related to certain ADEM Admin. Code provisions related to asbestos-containing material.

As my colleague Tom wrote about in a recent post, the Centers for Medicare & Medicaid Services (CMS) has finally responded to a growing chorus of stakeholders that government price reporting requirements, particularly Medicaid Best Price (BP), are stifling innovative value-based contracting a

In a webinar held on 10 December 2020, Skadden partners Sonia Nijjar, Simon Toms and Ingrid Vandenborre were joined by Charles River Associates (CRA) Senior Adviser and Deputy Chair of the Bank of England’s Enforcement Decision Making Committee Philip Marsden and CRA Vice President Oliver Latham

In response to the changes in the transmission of COVID-19, both domestically and across the globe, the UK government has announced that passengers from all international destinations will now be required to present a negative COVID-19 test result before departing for England....

If proposed amendments are adopted, the use and benefit of short-form on-product warnings will be significantly limited. The use of short-form for internet and catalog warnings will be completely eliminated.

Ubiquiti, a manufacturer of products used for networks such as routers, webcams and mesh networks, announced this week that an unauthorized access to its systems hosted by a third-party cloud provider may have compromised customers’ name, email address and “the one-way encrypted password to your

I rarely talk about legislation because so many bills over the years get proposed with zero action by Congress. It took more than 4 years for Roth 401(k) plans to be a thing. However, I want to take time to talk about something near to my heart....

Risk Management Question - What precautions can lawyers, staff, and law firms as a whole take to mitigate the risk of falling victim to the latest COVID-19 scam involving phishing for personal information by dangling eligibility for bogus government-sponsored loan programs as bait?...

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