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The FDA released the 5 actions it plans to take regarding oversight of #ArtificialIntelligence & #MachineLearning-based software as a medical device. Learn about the action plan & where to provide comments here: #OfDigitalInterest #AI #medicaldevices #SaMD

Are you aware of CMS’ new web portal permitting you to submit waiver requests and to confirm the presence of existing waivers? Learn about this new feature as it relates to healthcare regulatory requirements under Section 1135 here:

With many challenges and opportunities arising for both the #DigitalHealth and #LifeSciences industries around the world, we take a look at what operators and investors should consider when looking ahead at the post-pandemic landscape. Read more here:

Last week, the #IRS released regulations related to #excise taxes, published guidance concerning health reimbursement arrangements and issued other notices. Read more in our weekly roundup: