Cybersecurity: Page 7
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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 -
Explore the Trendline➔
Courtesy of Intuitive Surgical
TrendlineTop 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 -
Yujin Kim / MedTech Dive, original photo courtesy of U.S. Food and Drug Administration
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 -
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 Parduhn • Oct. 11, 2019 -
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 -
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
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 -
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 Parduhn • 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 -
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 -
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 -
Interagency workshop to focus on device interoperability
The Health Information Technology Research and Development Interagency Working Group is seeking feedback from industry, academia and government experts on potential solutions for creating interoperable systems.
By Susan Kelly • June 28, 2019 -
Medtronic insulin pump recall lands in FDA's top risk category after cybersecurity warning
The Class I determination follows an FDA warning in June that a hacker could dangerously tamper with insulin dosing. As of Tuesday, the agency is unaware of any cases of patient harm stemming from the vulnerability.
By Nick Paul Taylor • Updated Nov. 5, 2019 -
SaMD will increase device innovation: Fitch
FDA’s proposed regulatory framework will allow medical technology manufacturers to incorporate AI and machine learning while improving software monitoring.
By Susan Kelly • June 17, 2019 -
Kendall Davis/MedTech Dive
DHS warns of severe security flaw with BD infusion pumps
The department gave the BD Alaris Gateway Workstation vulnerability the maximum score on a standard grading scale.
By Nick Paul Taylor • June 14, 2019 -
China leads world in digital health adoption, Philips survey finds
Healthcare professionals in China are more likely to recommend patients use digital health technologies than their peers in the West.
By Nick Paul Taylor • June 12, 2019
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