The Food and Drug Administration's decision to incorporate "quality systems regulations" into its new draft guidance for premarket medical device cybersecurity is an important development in the scope of the agency's expectations for manufacturers, says Dr. Suzanne Schwartz of the FDA.
New guidance provides healthcare entities and medical device makers a jump-start for negotiating critical cybersecurity issues pertaining to procurement contracts, says Jim Jacobson of device manufacturer Siemens Healthineers, co-chair of an industry group that developed the contract template.
Researchers say five critical vulnerabilities in certain mobile hospital robots - if exploited - could allow hackers to interfere with delivery of medication and supplies, elevator operation and patient privacy. Some experts say the situation is a reminder of commonly overlooked IoT device risks.
The Food and Drug Administration on Thursday issued revamped draft guidance providing updated and detailed recommendations for how medical device makers should address cybersecurity risk in the premarket of their products, especially as the threat landscape continues to evolve.
The Justice Department has announced that it has successfully disrupted "Cyclops Blink," a botnet controlled by the Russia-linked threat actor Sandworm, aka Voodoo Bear. The court-authorized operation was conducted in March and removed the botnet from thousands of infected devices worldwide.
German wind turbine manufacturer Nordex, which develops, manufactures and distributes wind power systems across the world, has switched off its IT systems in multiple locations after a reported cybersecurity incident. It says the shutdown may affect customers, employees and other stakeholders.
The White House is seeking fiscal 2023 budget increases for the Department of Health and Human Services, including a boost in funding for cybersecurity initiatives including medical device security and regulatory and enforcement efforts related to secure health data exchange.
Eighty percent of survey respondents say they either are well on the way or getting started toward becoming a "smart manufacturing company." Cloud migration, business resiliency and securing OT environments are among their priorities. Del Rodillas of Palo Alto Networks analyzes the survey results.
If Russia uses hack attacks to support its invasion, would Western governments want to immediately attribute those attacks or disruptions? Enter a Thursday alert from the U.S. government warning that it is "aware of possible threats to U.S. and international satellite communication networks."
It is critical for medical device manufacturers to take a threat modeling approach early in a product's design stage, say MITRE medical device cybersecurity experts Margie Zuk and Penny Chase, co-authors of the recently released Playbook for Threat Modeling Medical Devices commissioned by the FDA.
Federal authorities are warning about seven vulnerabilities affecting a software agent used to remotely manage an array of medical devices and other connected gear. If exploited, the vulnerabilities could enable hackers to gain full control of the affected devices or alter their configurations.
Guidance from the Healthcare Sector Coordinating Council provides healthcare delivery organizations and vendors with recommendations for including cybersecurity in contracts pertaining to the procurement of medical device products and related services.
Critical cybersecurity gaps in smart infusion pumps have put the data and care of hundreds of patients at risk, according to researchers at Unit 42 of cybersecurity firm Palo Alto Networks. They say that 75% of the 200,000 smart infusion pump networks they scanned contained known security gaps.
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