Stricter requirements are looming in many regions. The FDA has been aware of the challenge for more than a decade, ever since it published a guidance document titled, “ Cybersecurity for Networked Medical Devices Containing Off-the-Shelf (OTS) Software.” Now, regulatory developments appear to be catching up. According to the International Medical Device Regulators Forum, medical device manufacturers also bear a shared responsibility. However, the onus of securing devices and data goes beyond healthcare organizations. These and other factors have combined to increase healthcare cybersecurity risks. As the medical Internet of Things (IoT) grows and becomes increasingly complex, so does the amount of data created. Malicious actors increasingly target sensitive patient data - and organizations must manage more of it every day. Healthcare IoT Devices Need More Protection Manufacturers must also demonstrate reasonable assurance that the device and related systems are cybersecure.
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