Cybersecurity

  • A brick building with a sign that says "Henry Schein Inc."
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    Bruce Bennett via Getty Images
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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 • Aug. 7, 2024
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    Sarah Silbiger via Getty Images
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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 • July 30, 2024
  • CrowdStrike booth at RSA Conference in San Francisco.
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    Matt Kapko/MedTech Dive
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    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
  • A view of Baxter International's production facility in the state of North-Rhine Wetsphalia on January 15, 2021 in Halle, Germany.
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    Sascha Schuermann via Getty Images
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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 • Updated June 10, 2024
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    JuSun via Getty Images
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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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    Stringer via Getty Images
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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 • May 15, 2024
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    jariyawat thinsandee via Getty Images
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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 • April 26, 2024
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    iStock/Getty Images Plus via Getty Images
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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 • April 17, 2024
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    Techa Tungateja via Getty Images
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    Deep Dive

    As 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 • April 3, 2024
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    Just_Super via Getty Images
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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 • March 13, 2024
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    zhuweiyi49 via Getty Images
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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 • March 12, 2024
  • A brick building with a sign that says "Henry Schein Inc."
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    Bruce Bennett via Getty Images
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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 • Feb. 27, 2024
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    Sara Silbiger via Getty Images
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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 • Jan. 25, 2024
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    JuSun via Getty Images
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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
  • A brick building with a sign that says "Henry Schein Inc."
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    Bruce Bennett via Getty Images
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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 • Dec. 21, 2023
  • Anne Neuberger deputy national security advisor for cyber and emerging technologies, speaks at the Billington Cybersecurity Summit with Brad Medairy, EVP, Booz Allen.
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    Courtesy of Billington CyberSecurity Summit
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    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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    Bruce Bennett via Getty Images
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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 • Dec. 8, 2023
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    jariyawat thinsandee via Getty Images
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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 • Nov. 27, 2023
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    solarseven via Getty Images
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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 • Nov. 16, 2023
  • A brick building with a sign that says "Henry Schein Inc."
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    Bruce Bennett via Getty Images
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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 • Nov. 13, 2023
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    Chip Somodevilla via Getty Images
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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 • Nov. 1, 2023
  • A brick building with a sign that says "Henry Schein Inc."
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    Bruce Bennett via Getty Images
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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 • Oct. 18, 2023
  • Artificial intelligence in healthcare
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    ArtemisDiana via Getty Images
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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 • Oct. 13, 2023
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    jariyawat thinsandee via Getty Images
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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 • Sept. 27, 2023
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    Courtesy of U.S. Food and Drug Administration
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    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 • Sept. 7, 2023