Cybersecurity: Page 3

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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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    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
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    Trendline

    Top 5 stories from MedTech Dive

    From the top medtech trends to watch in 2026 to haphazard layoffs at the Food and Drug Administration and the evolving use of AI in the medtech sector, here is a collection of top stories from MedTech Dive.

    By MedTech Dive staff
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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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    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
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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
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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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    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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    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
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    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 • 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 • July 5, 2023
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    Opinion

    The 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 • Updated June 12, 2023
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    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 Parduhn • 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 • 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 • Updated March 30, 2023
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    Q&A

    Friday 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 • March 3, 2023
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    Courtesy of Flex
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    Opinion

    Why medical device designers need to become more agile — and how they can do it

    To stay competitive, medtech firms must center manufacturing in business optimization plans, while embracing a design-to-value approach, says Jennifer Samproni, Flex’s chief technology officer for its Health Solutions division.

    By Jennifer Samproni • Jan. 26, 2023
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    Medtech trends in 2023

    Medtech regulation outlook in 2023: Faster approvals among priorities as AI moves to fore

    Leaders in the medtech field weigh in on the prospects and challenges for product regulation in 2023.

    By Peter Green • Updated Jan. 26, 2023
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    Cybersecurity ‘more critical than ever’ in era of connected care: BD

    The device maker’s annual report on the state of healthcare cybersecurity calls for better transparency and coordination across the industry.

    By • Jan. 25, 2023
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    FDA outlines benefits and risks of emerging augmented and virtual reality medical devices

    AR/VR may increase access to healthcare and make procedures less invasive, but could potentially cause cybersickness and head and neck strain.

    By • Dec. 8, 2022
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    Vulnerability in BD’s infusion pump flagged to US cybersecurity agency

    An attacker with physical access to the device could exploit the vulnerability to change the configuration settings or disable the pump.

    By • Updated Dec. 6, 2022
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    The 10 biggest medtech stories of 2022

    MedTech Dive reporting this year has explored how companies maintained momentum even amid supply shortages and rising inflation rates.

    By MedTech Dive staff • Dec. 3, 2022
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    HHS cybersecurity center warns of new ransomware threat

    Venus ransomware has attacked targets worldwide, including at least one U.S. health group, since it was first identified in mid-August.

    By • Nov. 14, 2022
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    FDA seeks feedback on plans to draft and finalize medical device guidance in 2023

    The agency’s review includes guidance on transitioning away from emergency use authorizations, while abandoning plans for guidance on software as a medical device.

    By • Oct. 19, 2022
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    GE advances healthcare spinoff plan, providing close look at workings of the unit

    Localization requirements, third-party servicers, and more sophisticated data security threats are cited as risks to the healthcare unit.

    By • Oct. 13, 2022