Cybersecurity: Page 6
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Vulnerability in medication dispensing system flagged again by DHS cyber team
An alert Tuesday from the Department of Homeland Security is the third issued in relation to BD's Pyxis products in as many years.
By Nick Paul Taylor • April 1, 2020 -
Some pacemakers, EKGs, diabetes devices may face newly flagged Bluetooth cyber risk
FDA and the Department of Homeland Security said microchips from seven manufacturers and a range of consumer wearables and connected medical devices may be affected.
By Susan Kelly • March 4, 2020 -
California's new cybersecurity law sidesteps most medical devices, lawyers say
How the state enforces its "internet of things" or connected devices law "may end up becoming a source of persuasive authority for the FDA in its decision making" on cybersecurity guidance, said White and Williams' Joshua Mooney.
By Fred Donovan • Feb. 28, 2020 -
DHS warns of WannaCry-like vulnerability in Spacelabs Healthcare systems
The homeland security agency revealed certain telemetry devices suffer from the weakness, scoring 9.8 out of 10 on a cybersecurity vulnerability scale.
By Nick Paul Taylor • Feb. 19, 2020 -
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Hospitals, clinics most likely to be hit with ransomware attack
But medical testing and supplies companies weren't spared among the 172 individual attacks from 2016 to 2019 that affected 6.6 million patients.
By Shannon Muchmore • Feb. 11, 2020 -
Jacob Bell
GE cybersecurity flaw gets maximum risk score, triggering rare FDA notice
"An attacker could potentially silence an alarm that is intended to communicate vital information about a patient to health care staff, such as a patient's cardiac status," the agency wrote of an issue with certain tech platforms.
By Nick Paul Taylor • Jan. 24, 2020 -
EU group offers guidance on meeting MDR's cybersecurity standards
The document says it's important to reference the International Medical Device Regulators Forum's cybersecurity guidance, and policies like the General Data Protection Regulation and the EU Cybersecurity Act "might apply in parallel."
By Susan Kelly • Jan. 7, 2020 -
Roundup 2019: Breast implants, mesh, paclitaxel-coated devices among hot topics at FDA expert panels
The public meetings in some cases instigated voluntary recalls and led to required market removals. Nearly all called for further research or more robust medical device monitoring.
By Maria Rachal • Dec. 23, 2019 -
Dexcom server outage rocks Type 1 diabetes community
The company announced late Monday it has restored services for its Dexcom Follow app to "near normal performance." Dexcom said it will work to improve communication methods with its customers.
By David Lim • Updated Dec. 3, 2019 -
Medtronic reveals high-risk cyber vulnerability in electrosurgical generators
The Department of Homeland Security rated the vulnerability, which could be exploited remotely by a low-skilled hacker, a 9.8 on a 10-point risk scale.
By Nick Paul Taylor • Nov. 8, 2019 -
FDA expands MDIC quality pilot to non-compliant manufacturers
A $2.8 million funding award from the agency aims to extend a program used by big players like Medtronic, Abbott and Boston Scientific to those not yet up to snuff on regulatory compliance.
By Susan Kelly • Oct. 22, 2019 -
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Hospitals, manufacturers could donate cybersecurity software under proposed regs
With the cost of protecting systems from malicious hackers increasing, the idea to tweak the anti-kickback laws recognizes some physician practices don't have the resources or expertise to keep pace, one lawyer told MedTech Dive.
By David Lim • Oct. 14, 2019 -
Amazon Textract now HIPAA-eligible as tech giant expands AI portfolio
Of Amazon's $3.1 billion in operating income last quarter, more than half came from its cloud services business.
By Rebecca Pifer • Oct. 11, 2019 -
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From robots to staplers, a top 10 list of medtech safety hazards
The nonprofit ECRI identified increased use of certain devices outside of acute care settings and adoption of some technologies before safety is fully assessed as common themes in its annual ranking.
By Susan Kelly • Oct. 8, 2019 -
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Third-party software vulnerability could endanger medical devices, FDA and DHS warn
The alerts expand the list of vendors whose operating systems could be exploited due to vulnerabilities known as URGENT/11. Medical devices affected include an infusion pump and an anesthesia machine, FDA said Tuesday.
By Susan Kelly • Oct. 2, 2019 -
FDA creates agencywide tech modernization roadmap
The agency plans to spend the next one to two years upgrading its infrastructure to meet emerging data handling needs.
By Nick Paul Taylor • Sept. 19, 2019 -
Moody's: Hospitals highly vulnerable to cyberattacks
Although email phishing, EHR breaches and ransomware schemes are most common, the new report also calls attention to vulnerabilities in medical technologies like insulin pumps and cardiac devices.
By Ron Shinkman • Sept. 16, 2019 -
US needs cyber-savvy doctors as connected device use rises, FDA panel says
Patients deserve cybersecurity training as part of the informed consent process, but healthcare providers aren't well-equipped to offer it, an FDA advisory committee said Tuesday.
By Maria Rachal • Sept. 11, 2019 -
FDA looks to define 'triggers' for medical device cybersecurity warnings
When do the benefits of notifying patients of potential risks outweigh possible harms? The agency's Patient Engagement Advisory Committee is weighing in Tuesday.
By Maria Rachal • Sept. 10, 2019 -
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McKesson, Philips devices flagged by DHS for cyber vulnerabilities
Certain cardiovascular IT systems and ultrasound devices could be exploited by hackers, the Department of Homeland Security wrote in separate notices.
By Nick Paul Taylor • Aug. 30, 2019 -
VA software workarounds put patient data at risk: OIG
The watchdog made several recommendations after determining fixes intended to allow medical devices to interface with the Veterans Health Administration's EHR system compromised patients’ personal information.
By Susan Kelly • Aug. 5, 2019 -
Data breaches in 2019 already double all of last year
The single largest data breach stemmed from a hack of a major medical collections agency working for companies including Quest and LabCorp, the report from Protenus found. Twenty million patient records were affected.
By Rebecca Pifer • Aug. 2, 2019 -
Philips, DHS flag cyber vulnerability in EKG analysis software
Highly skilled, unauthorized users may be able to enable system options not purchased in Philips' Holter 2010 Plus software, but the company said the issue shouldn't compromise patient data or overall system operations.
By Maria Rachal • July 15, 2019 -
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Feds warn of cyber vulnerability in hospital anesthesia machines
The issue, found in GE's Aestiva and Aespire devices, could allow an attacker to impair respirator functionality by silencing alarms, altering time and date records, and changing the composition of aspirated gases.
By Susan Kelly • July 9, 2019 -
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FDA patient advisory meeting set to tackle cybersecurity in devices
The September meeting will partly focus on how healthcare providers should best communicate cybersecurity risks to medical device users.
By Susan Kelly • July 3, 2019
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