Towards cybersecure medical devices

The senate passage of the omnibus appropriations bill funding the federal government is an unprecedented step toward empowering the FDA for the cyber safety of connected medical devices.

‍The bill requires FDA to ask for a plan to address postmarket vulnerabilities and exploits with a justifiable regularity and have a process in place for critical vulnerabilities.

‍In a significant nod to Executive Order 14028 — Improving the Nation’s Cybersecurity — the bill also asks FDA to collect a software bill of materials (SBOM) for such devices.

‍At Interlynk, we believe that an easy, obvious, and automated software disclosure is the foundational block of software security and welcome these requirements in the Senate bill.