Medical Device Cybersecurity

Groups Ask FDA to Rethink Some Medical Device Cyber Proposals

Some of the associations submitting comments on FDA’s draft guidance suggested modifications to the agency’s call for a “cybersecurity bill of materials,” or CBOM, that medical device makers would need to submit to the FDA for premarket review. Some also critiqued FDA’s proposal to define two tiers of medical devices based on their cybersecurity risk

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3 Ways to Manage the Cyber Risk Posed by Connected Medical Devices

Its not just computers or smartphones that can make your healthcare organization vulnerable to security breaches. Pacemakers, insulin pumps, wearable devices that track patient activity levels and pills containing ingestible sensors that track medication adherence are among the innovations that allow physicians to monitor patients remotely, promising more cost-effective care and improved outcomes.But connected medical

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Bolstering the Cybersecurity of Medical Devices

As cybersecurity threats in the healthcare sector evolve, medical device manufacturer ICU Medical is taking a number of steps to help safeguard its products. As cybersecurity threats in the healthcare sector evolve, medical device manufacturer ICU Medical is taking a number of steps to help safeguard its products. Marshall Fryman and Chaitanya Srinivasamurthy of the

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Japan to Hack 200 Million IoT Devices

In mid-February, the Japanese government plans to start openly hacking more than 200 million IoT devices already installed at home and elsewhere in Japan.The governments plan announced a week ago is likely to expose the uncomfortable truth known to many experts but unknown to most consumers: Many IoT devices in use are vulnerable to cyberattacks.Insecurity

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New Medical Device Cybersecurity Framework Unveiled

The framework recommends, for example, that in the product concept development phase, manufacturers should establish how cybersecurity will be managed throughout the device’s lifecycle. It also recommends that these companies provide a bill of materials listing third-party software contained in their products, plus provide a mechanism for obtaining feedback about devices – including reports about

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Medical Device Vulnerabilities Continue to Plague the Industry

Its no secret that medical devices pose security risks to healthcare organizations as networks, tools and devices themselves become ever more connected. Common and pervasive cyberthreats, such as ransomware and malware, are also finding their way onto machines. In fact, 18 percent of provider organizations in a recent survey by the College of Healthcare Information

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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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