Medical Device Cybersecurity

FDA’s Reworked Premarket Medical Device Guidance

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.

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FDA Reacts to Critique of Medical Device Security Strategy

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

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Medical device security gets a boost

Suzanne Schwartz, Associate Director for Science and Strategic Partnerships at the FDA, shared insights and advice on medical device security, including cybersecurity attack response and best practices for CIOs and CTOs.

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Medical Device Security Best Practices From Mayo Clinic

Kevin McDonald, director of clinical information security at Mayo Clinic, says ensuring the security of medical devices requires several specific steps, stressing that there’s no “silver bullet” that can do the job.”Because of the way that some of these devices are built so well, from a physical standpoint, you can use some of these machines

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How to Use FDA’s Medical Device Cybersecurity ‘Playbook’

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

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FDA proposes updated cybersecurity recommendations to help ensure device manufacturers are adequately addressing evolving cybersecurity threats

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

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FDA updates medical device premarket guidance to include cybersecurity recommendations

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,

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