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Jamie Foster of Hill Dickinson LLP and I wrote this article to raise the awareness of U.S and EU cybersecurity regulation, that is moving rapidly to regulate cybersecurity risk management. In this instance regulation that affects Critical National Infrastructure (CNI) providers that includes the health industry.
At the end of 2023 the U.S Food and Drug Administration moved to introduce cyber regulation, requiring the manufacturers of covered medical devices to implement cybersecurity. The EU has introduced EU NIS 2.0 that includes cybersecurity risk management for covered medical device manufactures.
#cybersecurity #cyberriskmanagement #cyberregulation #eunis2 #fda
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