The Food and Drug Administration’s recently issued draft document updating its premarket medical device cybersecurity guidance originally issued in 2014 contains several important provisions, says regulatory attorney Yarmela Pavlovic.”The 2014 guidance that FDA issued about premarket cybersecurity considerations was fairly sparse; it wasn’t particularly detailed,” Pavlovic notes in an interview with Information Security Media Group.
The Department of Health and Human Services’ Office of Inspector General’s report says the agency found FDA’s policies and procedures insufficient for handling postmarket medical device cybersecurity events.In addition, the watchdog agency notes that FDA had not adequately tested its ability to respond to emergencies resulting from cybersecurity events in medical devices. It also notes
A new “playbook” co-developed by the Food and Drug Administration and Mitre Corp. aims to assist healthcare delivery organizations in responding to cybersecurity incidents involving medical devices, says Julie Connolly, who helped develop the guide.”One thing we tried to do with the playbook was not recreate the wheel,” Connolly says in an interview with Information
In addition to releasing the proposed guidance this week, the FDA announced a formalized agreement with the Department of Homeland Security to implement a new framework for greater collaboration between the two agencies for addressing cybersecurity in medical devices.”From my vantage point, it looks like everyone in the medical device security community is happy to
Cybersecurity threats and vulnerabilities in todays modern medical devices are evolving to become more apparent and more sophisticated, posing new potential risks to patients and clinical operations, said FDA Commissioner Scott Gottlieb, M.D. The FDA has been working to stay a step ahead of these changing cybersecurity vulnerabilities, including engaging with external stakeholders. In this
Updated guidance issued by the Food and Drug Administration on Wednesday includes several new cybersecurity recommendations for medical devices.Among those changes, the FDA is asking manufacturers to include a list of hardware and software components within each deviceknown as a bill of materialsthat could be susceptible to a cyberattack.Earlier this month, FDA Commissioner Scott Gottlieb,
At today’s Healthcare Security Forum in Boston, FDA’s Dr. Suzanne Schwartz revealed that patchability forensic data capture will be key components of the agency’s soon-to-be-released premarket guidance for medical device cybersecurity.
The FDA issued a cybersecurity safety warning for Medtronic cardiac devices. Plus, Apple partners with a large orthopedic device firm to track outcomes for joint replacements. In a safety communication issued last week, the Food and Drug Administration (FDA) said cardiac device maker Medtronic was issuing a software update to resolve cybersecurity vulnerabilities that posed
The Food and Drug Administration issued a cybersecurity alert on two Medtronic devices that could allow a hacker to hijack the software update process to change the devices function. Medtronic disabled the online software update to eliminate the flaw. Following a review of potential security vulnerabilities around the internet connection, the FDA found 34,000 CareLink
FDA Commissioner Dr. Scott Gottlieb released a statement today unveiling the Medical Device Cybersecurity Regional Incident Preparedness and Response Playbook a document co-authored with the non-profit Mitre Corporation describing how healthcare delivery organizations can best prepare their medical devices and staff for a device security breach. The agency also announced the development of its own
