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This article originally appeared in MedTech Strategist on November 28, 2025.

By Colin Miller

The human body’s built-in security, the immune system, can recognize threats, send alerts in the form of symptoms, and neutralize foreign agents like viruses and bacteria. The security of the electronic devices used in the course of healthcare should be expected to have a similar level of robustness, yet regulatory requirements in that area are murky at best. To get a handle on an increasingly digital, and thus increasingly vulnerable, healthcare industry, Daniel Bardenstein, co-founder and CEO of Manifest, has proposed that the FDA obligate medical device manufacturers (MDMs) to adhere to certain baseline standards, from password complexity and minimized exposure to software updates and validation.