Cybersecurity
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DaVita hit by ransomware attack
The kidney dialysis firm doesn’t have an estimate for how long disruption from the attack will last, though DaVita stressed it’s continuing to provide patient care.
By Emily Olsen • April 17, 2025 -
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HHS overhaulHHS layoffs could imperil medical device cybersecurity, Democrats say
The FDA has 3,500 jobs on the chopping block, which could hinder cybersecurity oversight, Democrats said during a House subcommittee hearing.
By Emily Olsen • April 2, 2025 -
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ECRI warns insufficient AI governance threatens patient safety
ECRI included other medtech-related threats on its list of patient safety concerns, noting that cybersecurity breaches can delay care and diagnostic errors can lead to improper treatment.
By Nick Paul Taylor • March 11, 2025 -
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FDA warns about patient monitor cybersecurity vulnerabilities
Vulnerabilities in certain Contec and Epsimed patient monitors can allow people to gain access and potentially manipulate the devices, the FDA warned.
By Nick Paul Taylor • Jan. 31, 2025 -
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Deep DiveTop healthcare technology trends in 2025
How the incoming Trump administration will regulate AI this year remains unclear. Meanwhile, experts say healthcare companies will continue bolstering cyber defenses to withstand increasing attacks.
By Emily Olsen • Jan. 17, 2025 -
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HHS proposes HIPAA update to boost healthcare cybersecurity
The update, which would be the first since 2013, aims to clarify and provide more instruction on securing health data as cyberattacks and breaches in the sector skyrocket.
By Emily Olsen • Jan. 6, 2025 -
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Robots, AI and PFA: The top medtech Q&As of 2024
From challenging market leaders to the growing influence of artificial intelligence, medical device executives had a lot to discuss this year. Check out MedTech Dive’s top Q&As of 2024.
By Ricky Zipp • Dec. 20, 2024 -
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BD receives FDA warning letter over quality system violations
Inspectors found 111 open tickets for software defects categorized as catastrophic or severe patient harm. Several safety complaints were also listed that BD didn’t report within the required timeframe.
By Nick Paul Taylor • Dec. 20, 2024 -
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Q&ACDRH cyber official on compliance with new rules, ongoing security threats
Nastassia Tamari discussed compliance with new device cybersecurity requirements, the risks of legacy devices and frequent cyberattacks in healthcare.
By Ricky Zipp • Updated Dec. 17, 2024 -
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Artivion says cybersecurity incident has disrupted order, shipping processes
The heart device manufacturer has taken certain systems offline in response to the incident, which involved the acquisition and encryption of files.
By Nick Paul Taylor • Dec. 11, 2024 -
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AI-enabled apps top ECRI’s list of health tech hazards in 2025
Other health tech hazards on ECRI’s annual list include the unmet technology support needs of home care patients, cybersecurity threats and substandard or fraudulent medical devices.
By Nick Paul Taylor • Dec. 9, 2024 -
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FDA prioritizes guidance on lab developed tests in 2025 plan
The Center for Devices and Radiological Health intends to develop final guidance on its enforcement discretion policy regarding special controls for LDTs, among other topics.
By Nick Paul Taylor • Oct. 18, 2024 -
Elise Reuter/MedTech Dive
The Medtech ConferenceLegacy medical devices keep regulators up at night
The FDA’s Suzanne Schwartz said at The Medtech Conference that addressing legacy devices is a “work in progress” and a problem regulators and industry need to work on together.
By Elise Reuter • Oct. 17, 2024 -
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Deep Dive4 steps to minimize the threat of legacy medical devices
Older medical devices with unsupported software pose cybersecurity threats that regulators and industry are struggling to solve. Here are four steps experts say can help mitigate risks.
By Ricky Zipp • Sept. 23, 2024 -
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Henry Schein’s slow recovery from cyber incident hits Q2 results
William Blair analysts said the “lingering impacts from the cyberattack are somewhat surprising.”
By Nick Paul Taylor • Aug. 7, 2024 -
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FDA officials outline benefits of AI lifecycle management
The digital health leaders detailed a seven-stage diagram for how the healthcare industry could monitor artificial intelligence software development.
By Nick Paul Taylor • July 30, 2024 -
Matt Kapko/MedTech Dive
CrowdStrike outage hits US hospitals
The cybersecurity firm released what was meant to be a routine software update, but now health systems, including CommonSpirit Health and Cleveland Clinic, are locked out of Windows systems.
By Susanna Vogel • July 19, 2024 -
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CISA warns of cybersecurity risks in Baxter products
The cybersecurity notices covered vulnerabilities identified in a Baxter Welch Allyn patient monitor and a Baxter Welch Allyn configuration tool.
By Ricky Zipp • Updated June 10, 2024 -
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More than a third of healthcare organizations aren’t prepared for cyberattacks: report
Thirty-seven percent of healthcare organizations did not have a cyberattack contingency plan in place, despite half having experienced an attack, according to a new survey from Software Advice.
By Sydney Halleman • May 28, 2024 -
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GE Healthcare warns of cybersecurity risks in ultrasound devices, software
Cybersecurity group Nozomi Networks Labs identified 11 vulnerabilities across several systems and software in an investigation of imaging machines.
By Nick Paul Taylor • May 15, 2024 -
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Livanova says patient data obtained in 2023 cyberattack
Livanova learned that an unauthorized party obtained patient data, including Social Security numbers and health conditions, during last year’s attack.
By Ricky Zipp • April 26, 2024 -
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Files taken from Orasure systems in cybersecurity incident
Orasure believes it has contained the incident and “preserved the integrity of its core financial and operational systems.”
By Nick Paul Taylor • April 17, 2024 -
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Deep DiveAs cyberattacks on healthcare persist, can the FDA’s new device regs hold up?
Revamped regulations to thwart hackers are a big step forward, but issues such as legacy devices and reliance on software patches pose lingering challenges.
By Ricky Zipp • April 3, 2024 -
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FDA seeks feedback on expansion of premarket cybersecurity guidance
The agency is providing information on cybersecurity requirements for companies seeking authorization of new devices.
By Nick Paul Taylor • March 13, 2024 -
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AI to expand medtech portfolios, revenue streams: Moody’s
The rating agency predicts AI will start to have a positive impact on medical device companies in the next two years.
By Nick Paul Taylor • March 12, 2024
