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Robert Klepinski is an Officer with Fredrikson & Byron and practices in the Food, Drug & Medical Device Regulation, Health Care Fraud & Compliance […]
The FDA recommends that medical device manufacturers and health care facilities take steps to evaluate their network security and to assure that appropriate safeguards are in place to reduce the risk of failure due to cyber attack, which could be initiated by the introduction of malware into the medical equipment or unauthorized access to configuration settings in medical devices and hospital networks.