The FDA announced that on October 1, 2023, it would begin to Refuse to Accept (RTA) medical device premarket submissions that do not comply with PATCH Act requirements. Erez Kaminski, former head of AI with Amgen and founder of Ketryx, and Paul Jones, former FDA official and Executive Vice President of Ketryx, provide an overview of challenges companies face as they work to comply with the new cybersecurity regulations and standards.
Connectivity in medical devices creates new diagnostic and treatment opportunities, yet at the same time increases the risks of cyberattacks—including their consequences for patient safety and data privacy. Now the new IEC 81001-5-1 standard provides clear technical requirements for manufacturers and developers to ensure the cybersecurity of their products across their life cycle.
Remote care in the home relies both on the quality of patient monitoring and on the insights provided to the care team. There is a real danger that data overload and alert fatigue will undermine otherwise well-designed remote patient monitoring (RPM) and Hospital at Home programs. The software platform and algorithms tasked with integrating and evaluating data must identify the data that matters, when it matters.
Devices by themselves don’t improve outcomes. Better lifestyle integration is key to driving changes in patient compliance—embedding sensors into the sorts of devices people can use every day to increase opportunities for passive biometric capture and to facilitate therapeutics.
Medical device security needs to address the cyber-physical threats, not just patient health information risk.
Devices in healthcare facilities support mission critical processes. Any issue that degrades network performance can have serious consequences.
Across our industry, IoMT will enable us to conduct research in ways that would never previously have been possible.
Operating with an antiquated QMS raises your risk. Here’s what to consider when modernizing your system.
As the proliferation of connected and complex medical devices grows, healthcare providers are more susceptible to cyberattacks.
Networks enable the use of critical resources, including telehealth services, medical IoT technology,and staff and personal devices. It is critical to have a reliable WiFi network to support these devices.