Cybersecurity: Page 2

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    Permission granted by ECRI

    ECRI CEO: FDA, industry must revisit COVID-19 medical device EUAs as shortages ebb

    Marcus Schabacker spoke to MedTech Dive about patient safety, cyberattacks in healthcare and risks from the rise of at-home care.

    By Sept. 3, 2021
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    Outpatient facilities targeted for cyberattacks nearly as often as hospitals, data shows

    The number of breaches at healthcare organizations in the first half of this year was up significantly from the first half of last year, and higher than any six-month period since 2018, according to the Critical Insight report.

    By Hailey Mensik • Aug. 30, 2021
  • FDA warns of BlackBerry cyber vulnerability in medical devices

    The operating system is often deployed in devices such as cardiac and patient monitors, drug infusion pumps, imaging and surgical robots, according to Nick Yuran, CEO of security consultancy Harbor Labs.

    By Aug. 18, 2021
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    Deep Dive

    Predicting the future of healthcare: 10 takeaways from HIMSS21

    Along with "guarded optimism" on the current state of the pandemic, some 19,000 on-site attendees in Las Vegas mulled what's next for AI, telehealth, cybersecurity, mental health and more.

    By Rebecca Pifer , Hailey Mensik • Aug. 17, 2021
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    Sarah Silbiger via Getty Images

    FDA seeks more power for medical device cybersecurity mandates

    CDRH wants to require medtechs to have a Software Bill of Materials ready upfront as part of a premarket submission, as well as the capability to update and patch device security into a product's design.

    By Aug. 17, 2021
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    Medtechs need to up their cybersecurity threat modeling game, FDA says

    The agency "will be looking for much more detailed and comprehensive" cyber threat models as part of premarket review, said Suzanne Schwartz, director of CDRH's Office of Strategic Partnerships and Technology Innovation.  

    By Aug. 13, 2021
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    Rebecca Pifer/MedTech Dive

    Should healthcare organizations pay to settle a ransomware attack? Experts weigh in at HIMSS21

    "I don't think there's a single yes or no," said Michael Coates, former chief information security officer for Twitter.

    By Rebecca Pifer • Aug. 11, 2021
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    Yujin Kim/MedTech Dive

    Growing cyberattacks on hospitals may soon hit bottom lines, patient care: Fitch

    The increased use of smart monitoring devices, telehealth and other virtual care capabilities are putting patient data at risk, the report said. CT scanners and MRI machines were not necessarily designed with "cyber risk in mind."

    By Ron Shinkman • July 26, 2021
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    FDA wants to require timely updates, patches for legacy devices: cyber chief

    Kevin Fu, acting director of device cybersecurity, spelled out the agency's plans to protect aging devices from hackers. There's no current statutory requirement compelling manufacturers to address the problem.

    By June 30, 2021
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    More than 1/3 of health organizations hit by ransomware last year, report finds

    Of those attacked, 65% said the criminals were successful in encrypting their data, according to the report from cybersecurity company Sophos.

    By Rebecca Pifer • June 24, 2021
  • Medicare lacks cyber oversight of hospitals' networked medical devices: OIG

    Without proper cybersecurity controls, these devices can be compromised with the potential for patient harm, according to the HHS watchdog. OIG wants CMS to do more to address hospital vulnerabilities.

    By June 24, 2021
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    Legacy medical devices, growing hacker threats create perfect storm of cybersecurity risks

    Aging medtech and increasingly sophisticated criminals are leaving hospitals highly vulnerable to attacks.

    By June 22, 2021
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    Jacob Bell

    FDA seeks feedback on distinction between device remanufacturing and servicing

    The long-awaited draft guidance is meant to clarify a blurry line between the two processes. The Medical Imaging and Technology Alliance contends remanufacturing is being done by unregulated third-party device servicers.

    By June 18, 2021
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    Jacob Bell / BioPharma Dive

    FDA lays out device cybersecurity efforts as feds look to implement Biden executive order

    The president signed an order last month seeking to bolster the nation's cyber posture amid growing threats from hackers. 

    By June 9, 2021
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    Joe Raedle via Getty Images

    Rising hospital ransomware attacks could endanger patients, hit bottom lines hard, Moody's says

    Systems have been rendered more vulnerable due to COVID-19 as more non-clinical employees work from home. The warning echos comments made recently by the FDA's cyber chief for medical devices. 

    By Ron Shinkman • May 27, 2021
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    Leon Neal via Getty Images

    Ransomware, other cyber threats mount as medtech industry tries to adapt

    "Everything is hackable," said Kevin Fu, the FDA's medical device cybersecurity chief, who noted that ransomware in particular can render a device useless. 

    By May 25, 2021
  • Biden orders Software Bill of Materials to boost cybersecurity. AdvaMed wants uniform standards.

    An executive order calls for an electronically readable way to provide an inventory of third-party components in devices. The medtech lobby backs the idea but says standardization is critical.  

    By May 21, 2021
  • Deep Dive

    5 things medtech can expect from FDA in 2021

    "What you saw under the prior administration was this concept of a kinder, softer FDA to industry," said Dennis Gucciardo, partner at Morgan Lewis. Experts now expect a shift, including more enforcement activity.

    By March 15, 2021
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    COVID-19 leads to explosion in cyberattacks, data breaches

    A survey from CI Security found successful hacks involving healthcare organizations or their business associates soared in the second half of last year, leading to a jump in the number of breached patient records.

    By Ron Shinkman • Feb. 12, 2021
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    Jacob Bell / BioPharma Dive

    FDA appoints first medical device cybersecurity chief

    University of Michigan professor Kevin Fu will serve a one-year term as acting cyber director at the Center for Devices and Radiological Health. Experts fear the chaos of the pandemic creates the perfect storm for hackers to exploit.

    By Feb. 3, 2021
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    Deep Dive

    3 big predictions for digital health in 2021

    As tech and data sharing become more pervasive, healthcare will likely pivot to being more predictive and telehealth will evolve, giving rise to new modalities of care. This will force companies to invest more in cybersecurity.

    By Rebecca Pifer • Jan. 29, 2021
  • Healthcare funding shatters records in 2020, helped by COVID-19

    Medical device startups raised roughly $6 billion in the fourth quarter, a high point over the last three years, according to a CB Insights report.

    By Rebecca Pifer • Jan. 22, 2021
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    Samantha Liss, Healthcare Dive

    Healthcare cyberattacks spiked 45% since November, report finds

    While most ransomware attacks a broad sector, Check Point found Ryuk is tailored toward targets in the healthcare industry.

    By Samantha Schwartz • Jan. 5, 2021
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    Deposit Photor

    BD calls for 'Zero Trust' to combat rising healthcare hacking amid pandemic

    The medtech warns threats are plaguing the industry as providers increasingly rely on telehealth and remote monitoring to deliver care to patients.

    By Dec. 14, 2020
  • GE medical imaging devices impacted by critical cyber vulnerability

    Dozens of products like CT scanners and MRI machines are susceptible to hackers getting access to sensitive health data and disrupting their operation, according to firm CyberMDX. GE says there is no risk to patient safety.

    By Dec. 8, 2020