Literally seeing
the future
before it arrives

Armstrong and Kleidermacher immediately conferenced in two other renowned specialists: David C. Klonoff, Clinical Professor of Medicine at UCSF, founder of the Diabetes Technology Society, and editor-in-chief of the Journal of Diabetes Science and Technology; and Marvin J. Slepian, Regents Professor of Medicine, Medical Imaging, and Biomedical Engineering at the University of Arizona, co-founder of SynCardia Systems — maker of the world's first and only FDA-approved Total Artificial Heart — and a named inventor on over 160 patents.

Together, the four wrote the first paper in the peer-reviewed medical literature on medjacking — the malicious hacking of medical devices — bridging a cybersecurity industry concept into clinical medicine and proposing a regulatory framework based on international Common Criteria.

That paper helped spark a much larger effort. Klonoff established the Cybersecurity Standard for Connected Diabetes Devices (DTSec) Steering Committee, and Kleidermacher co-led the technical work over several years — but the standard was built by a broad coalition of dedicated contributors from across industry, government, and academia. The committee brought together the FDA, the Department of Homeland Security, the National Security Council, NIST, NASA, the NSA, Booz Allen Hamilton, the Bluetooth Special Interest Group, leading device manufacturers, and many others who gave their expertise to the cause.

DTSec became the world's first consensus cybersecurity standard for connected medical devices, later adopted by IEEE and Underwriters Laboratories as the foundation for IEEE 2621 — a milestone that belongs to the entire community that built it. In 2018, the Insulet Omnipod DASH became the first insulin pump certified under the standard. In 2019, the first-ever recall of a diabetes device for cybersecurity vulnerabilities validated what the original authors had warned about.

A decade later, the threat landscape has exploded. AI-powered diagnostics, remote patient monitoring, connected insulin pumps, smart wound care — the attack surface is no longer theoretical. It's on every patient's body.

BFAM exists to think about what happens next.