FDA

GAO Urges FDA, CISA to Revamp Medical Device Cybersecurity Agreement

December 28, 2023 - The US Government Accountability Office (GAO) released a report on medical device cybersecurity to address limitations in federal agencies’ authority, explore challenges in accessing federal support, and provide recommendations to the government on improving coordination in this space. As a result of its research, GAO recommended that the...

Read More


More Articles

FDA: Critical Illumina Cybersecurity Vulnerability May Allow Threat Actors to Control Devices Remotely

by Jill McKeon

The US Food and Drug Administration (FDA) alerted healthcare providers and laboratory personnel of a cybersecurity vulnerability that impacts the Universal Copy Service (UCS) software in select...

FDA to Refuse Medical Device Submissions For Cybersecurity Reasons Beginning in October

by Jill McKeon

Effective immediately, the US Food and Drug Administration (FDA) will require medical device manufacturers to provide cybersecurity information in their premarket device submissions. Additionally,...

FDA, MITRE Publish Updated Medical Device Security Incident Response Playbook

by Jill McKeon

The US Food and Drug Administration (FDA) and MITRE released an updated version of their “Medical Device Cybersecurity Regional Incident Preparedness and Response Playbook.” The playbook...

Experts Weigh in on Medical Device Security Exit from FDA User Fee Bill

by Jill McKeon

An appropriations bill that will reauthorize US Food and Drug Administration (FDA) user fees is advancing without key medical device security provisions included in the House bill, which passed with overwhelming support in June.  The...

Certain Medtronic Insulin Pumps Pose Healthcare Cybersecurity Risks, FDA Says

by Jill McKeon

The US Food and Drug Administration (FDA) warned the sector of healthcare cybersecurity risks associated with the Medtronic MiniMed 600 Series Insulin Pump System that could jeopardize patient...

Bill Calls on FDA to Regularly Update Medical Device Security Guidelines

by Jill McKeon

The recently introduced Strengthening Cybersecurity for Medical Devices Act called on the US Food and Drug Administration (FDA) to review and update its medical device security guidelines more...

FDA Urges Healthcare to Patch Severe Illumina Cybersecurity Vulnerabilities

by Jill McKeon

The US Food and Drug Administration (FDA) urged healthcare organizations to immediately patch severe cybersecurity vulnerabilities impacting certain Illumina medical devices. The vulnerabilities impact...

FDA Bill Includes Medical Device Security Requirements For Manufacturers

by Jill McKeon

Recently introduced Food and Drug Administration (FDA) user fee legislation contains medical device security provisions that aim to quell cybersecurity concerns at the premarket stage. The bipartisan...

FDA Seeks Feedback on Medical Device Security Guidance

by Jill McKeon

The US Food and Drug Administration (FDA) is seeking feedback on its medical device security guidance surrounding premarket submission cybersecurity considerations. Stakeholders have until July 7,...

Senators Introduce PATCH Act to Ensure Medical Device Security

by Jill McKeon

US Senators Bill Cassidy (R-LA) and Tammy Baldwin (D-WI) introduced the Protecting and Transforming Cyber Health Care (PATCH) Act with the intention of ensuring medical device security at the premarket...

FDA, OIG Request Cybersecurity Investments in FY 2023 Budget

by Jill McKeon

The Biden Administration announced its FY 2023 budget proposal, which contains increased investments in cybersecurity across critical infrastructure. “The Budget invests in cybersecurity...

Medical Device Security Requires Standards, Shared Responsibility

by Jill McKeon

Medical device security is arguably one of the biggest security challenges healthcare organizations face today. With thousands of connected devices moving around a hospital at once, organizations have historically struggled to keep a...

Healthcare Sector Spearheads SBOM Adoption to Support Cybersecurity

by Jill McKeon

The healthcare sector is spearheading rapid software bill of materials (SBOM) adoption to mitigate growing cybersecurity concerns and support the Food and Drug Administration’s (FDA) push toward...

FDA, MITRE, MDIC Create Medical Device Threat Modeling Playbook

by Jill McKeon

MITRE and the Medical Device Innovation Consortium (MDIC) teamed up to release a playbook for medical device threat monitoring to help organizations strengthen the cybersecurity of medical...

FDA Recalls Medtronic Insulin Pump Controller, Cites Cybersecurity Risks

by Jill McKeon

The US Food and Drug Administration (FDA) issued a Class I recall on all Medtronic MiniMed remote controllers used with the Medtronic MiniMed 508 insulin pump or the MinMed Paradigm family of insulin...

FDA’s Best Practices on Communicating Medical Device Vulnerabilities

by Jill McKeon

The US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health recently released best practices for communicating medical device vulnerabilities to patients and caregivers...

Data Management, Cybersecurity Top Priorities for New FDA Office

by Jill McKeon

The US Food and Drug Administration (FDA) announced the formation of the Office of Digital Transformation (ODT), which will report directly to the FDA commissioner. The office is a reorganization of...

FDA Outlines Medical Device Cybersecurity Goals

by Jill McKeon

In response to the National Institute of Standards and Technology’s (NIST) workshop and call for position papers to aid them in delivering on President Biden’s cybersecurity executive...

FDA Names First Acting Director of Medical Device Cybersecurity

by Jessica Davis

The Food and Drug Administration recently named Kevin Fu as the agency’s first Acting Director of Medical Device Cybersecurity in its Center for Devices and Radiological Health. Fu is an...

Recent Articles