Tag Archives: medical devices

Rep. Jim Langevin Backs FDA Strategy to Secure Medical Devices

Rep. Jim Langevin (D-R.I.) has voiced support for the Food and Drug Administration‘s draft guidance for manufacturers to protect medical technology products against cybersecurity threats. Langevin, co-chair of the Congressional Cybersecurity Caucus, said Thursday he believes the guidance FDA issued in January can serve as a tool for the safe implementation of networked medical devices. “It is critical that medical device manufacturers …

Read More »

Doug Maughan: DHS, Industry to Present Agency-Funded Cybersecurity Tech Projects

The U.S. Department of Homeland Security will hold an event on Tuesday to showcase agency-backed research and development work on information technology security tools, Federal News Radio reported Wednesday. Jason Miller writes DHS’ science and technology organization chose 11 industry partners to demonstrate their cybersecurity technologies and commercialization strategies at …

Read More »

FDA to Host Medtech Cybersecurity Workshop

The Food and Drug Administration has scheduled a two-day public workshop in October to gather insight from healthcare experts on how to address cyber threats tied to medical technology. FDA said Tuesday in the Federal Register it will hold the event on Oct. 21 and 22 at the National Intellectual …

Read More »

Report: Health IT Products Not Subject to FDA Regulations

The Food and Drug Administration‘s new framework on medical device regulations deems health information technology products as different from medical devices and not subject to regulatory compliance, Federal Times reported Thursday. Adam Stone writes the move was intended to help clear up the agency’s stance on medical technology and encourage further innovation from health IT developers. “The FDA …

Read More »

FDA, Industry Groups Partner to Form Medical Tech Cyber Standards

The Food and Drug Administration has partnered with industry groups to develop standards meant to help medical device firms protect their technology offerings from cybersecurity threats, MassDevice reported Thursday. Arezu Sarvestani writes the FDA released formal guidance last year recommending that manufacturers document their cyber risk management measures in premarket …

Read More »

Lawmakers Want FDA to Address Medical Device Hacking Concerns

While medical devices have yet to be a main subject of hackers’ attacks, a group of U.S. lawmakers want to address the concern before the problem arises. The interest in medical device hacking stemmed from security researcher Jeremy Radcliffe’s demonstration where he hacked his own insulin pump. Medical Device Security …

Read More »