Cybersecurity: Page 2
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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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TrendlineTop 5 stories from MedTech Dive
From haphazard layoffs at the Food and Drug Administration to the industry’s current IPO environment and tracking FDA-authorized AI devices, here is a collection of top stories from MedTech Dive.
By MedTech Dive staff -
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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 -
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Henry Schein expects cyber incident costs to continue in 2024
The company reported a $350 million to $400 million reduction in Q4 sales due to the incident, which forced it to take some systems offline.
By Elise Reuter • Feb. 27, 2024 -
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FDA creates ‘super office’ to oversee device cybersecurity, digital health and supply chain
The reorganization establishes new divisions at the Office of Strategic Partnerships and Technology Innovation to account for its growth since 2019.
By Nick Paul Taylor • Jan. 25, 2024 -
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Patient records exposed in data breaches doubled in 2023
Though the number of data breaches declined slightly from 2022, more than 116 million records were exposed last year, according to a new report from a cybersecurity firm.
By Emily Olsen • Jan. 22, 2024 -
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Roundup: Cyber incidents, vulnerabilities hit the medtech sector in 2023
From vulnerable medical devices to a breach that took some of Henry Schein’s systems offline, cybersecurity was a key topic for the industry this year.
By Ricky Zipp • Dec. 21, 2023 -
Courtesy of Billington CyberSecurity Summit
White House wants to set minimum cyber standards for hospitals, healthcare
The sector has faced a wave of ransomware linked to the critical CitrixBleed vulnerability, which has led to major attacks from LockBit and other threat groups.
By David Jones • Dec. 12, 2023 -
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Henry Schein says 29K people affected in September cyber incident
The ransomware group AlphV/BlackCat has claimed responsibility for the data breach and a second incident involving the company.
By Susan Kelly • Dec. 8, 2023 -
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LivaNova warns cybersecurity incident disrupts systems, takes steps to limit impact
The medical device maker warned that the incident is expected to continue to disrupt its business operations.
By Nick Paul Taylor • Nov. 27, 2023 -
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FDA-ordered report tackles how to manage cybersecurity risks of legacy devices
The report from MITRE proposes multiple actions for protecting older medical devices, including research into more modular devices and collecting data on cyber risks.
By Nick Paul Taylor • Nov. 16, 2023 -
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Henry Schein says customer data breached in cyber incident
The company lowered its 2023 sales and earnings forecasts in response to the incident, which took some of its distribution systems offline.
By Elise Reuter • Nov. 13, 2023 -
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White House orders HHS to start collecting reports on the safety of AI in healthcare
President Joe Biden outlined the planned program as part of an executive order on “safe, secure, and trustworthy” artificial intelligence.
By Nick Paul Taylor • Nov. 1, 2023 -
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Cybersecurity incident prompts Henry Schein to take systems offline, disrupting operations
The incident affected a portion of the company’s manufacturing and distribution businesses.
By Nick Paul Taylor • Oct. 18, 2023 -
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FDA prioritizes guidance on AI, cybersecurity, pulse oximeters in stacked schedule for 2024
The administration is ramping up production of medtech guidance, adding 18 draft documents to the list of priorities for the upcoming financial year.
By Nick Paul Taylor • Oct. 13, 2023 -
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FDA finalizes guidance on cybersecurity for medical devices
Congress granted the agency authority to deny premarket submissions that lack cybersecurity information, starting in October.
By Nick Paul Taylor • Sept. 27, 2023 -
Courtesy of U.S. Food and Drug Administration
FDA proposes 3 guidances to improve 510(k) clearance process
The agency has made recommendations for selecting predicate devices, using clinical data and conducting performance testing for implants.
By Nick Paul Taylor • Sept. 7, 2023 -
Permission granted by Becton Dickinson
Becton Dickinson flags cybersecurity vulnerabilities in Alaris system
The company identified eight security issues affecting its infusion pump system, including one high-risk concern.
By Elise Reuter • July 13, 2023 -
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Medtronic identifies cybersecurity vulnerability in cardiac data system
Cyber attackers could exploit the vulnerability if healthcare organizations have enabled its optional messaging service, the device maker said.
By Susan Kelly • July 5, 2023 -
Permission granted by Taylor Wessing
OpinionThe importance of trust in AI as a medical device
Building trust with patients, as well as regulators, will be key to the adoption of AI in medical devices and diagnostics, argues Alison Dennis, a London-based partner with law firm Taylor Wessing.
By Alison Dennis • June 15, 2023 -
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MedTech Europe sets out position on cybersecurity, making case for reliance on MDR
As the number of connected medical devices grows, the industry group argues that Europe’s new medtech regulations should remain “the primary avenue” for medical device cybersecurity.
By Nick Paul Taylor • Updated June 12, 2023 -
Carol Highsmith. (2005). "The Apex Building" [Photo]. Retrieved from Wikimedia Commons.
FTC moves to strengthen Health Breach Notification Rule’s applicability to digital health apps
Regulators are increasingly leaning on the HBNR to crack down on the sharing of sensitive medical data, and the FTC is looking to strengthen its case.
By Rebecca Pifer • May 18, 2023 -
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Report names connected medical devices with the biggest cybersecurity risks
The findings come as medical device makers face upcoming FDA requirements for providing cybersecurity information as part of their pre-market submissions.
By Nick Paul Taylor • April 21, 2023 -
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FDA says it won’t issue ‘refuse to accept’ letters on cyber devices before Oct. 1
Until October 1, the FDA will work with device makers to ensure pre-market submissions have adequate cybersecurity information.
By Elise Reuter • Updated March 30, 2023 -
Permission granted by MedCrypt
Q&AFriday Q&A: MedCrypt’s Naomi Schwartz on designing cybersecurity for diabetes devices
Schwartz, who helped review the first automated insulin dosing system, talks about balancing patient access and device security.
By Elise Reuter • March 3, 2023
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