Tag Archives: connectivity

Cybersecurity

Preparing for the PATCH Act and RTA

By MedTech Intelligence Staff
Cybersecurity

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.

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Dr. Abtin Rad

New Cybersecurity Standards for Medical Applications

By Dr. Abtin Rad
Dr. Abtin Rad

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.

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Jennifer Kent
Soapbox

Empowering Patients Through RPM

By Jennifer Kent, Ph.D.
Jennifer Kent

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.

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