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Code Red: The FDA’s Artificial Intelligence/Machine Learning Action Plan Poses Potential Risks for Medical Device Makers

Q: The FDA’s stance on a regulatory framework for artificial intelligence and machine learning (AI/ML) software as a medical device is continuously evolving. Could you explain the history? A: Artificial intelligence (AI) is...more

FBI Warns of Upcoming Major Ransomware Attacks

Yesterday officials from the FBI, U.S. Department of Homeland Security, and Cybersecurity and Infrastructure Security Agency issued a joint alert that the agencies possessed “credible information of an increased and imminent...more

Code Blue: Cybersecurity Vulnerabilities for Medical Device Makers Require Urgent Care

Q: How is the shift of medical devices moving to the Internet of Things affecting the health care industry? A: Connected medical devices routinely record sensitive health information about a patient. This critical...more

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