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

Explore the Trendline➔

Top 5 stories from MedTech Dive

From haphazard layoffs at the Food and Drug Administration to the industry’s current IPO environment and tracking FDA-authorized AI devices, here is a collection of top stories from MedTech Dive.

By MedTech Dive staff

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

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

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

Quest, LabCorp breach stirs questions of cybersecurity risk from outside vendors

The breach could result in new regulations and rules governing how U.S. companies select and assess their vendors, according to Moody's.

By Rebecca Pifer • Updated June 11, 2019

Inside Quest Diagnostics, LabCorp's supply chain breach

The intrusion happened inside the American Medical Collection Agency, but responsibility is shared through its partner ecosystem.

By Samantha Schwartz • June 6, 2019

LabCorp says 7.7M patients exposed in same data breach as Quest Diagnostics

The company Wednesday also announced Adam Schechter, current lead independent director of LabCorp's board and longtime Merck executive, will replace David King as CEO Nov. 1.

By David Lim • June 5, 2019

11.9M Quest Diagnostics patients potentially exposed to data breach

Financial, medical and other personal information, such as Social Security numbers, may have been exposed, the company reported Monday morning.

By David Lim • June 3, 2019

WannaCry malware still hitting healthcare organizations

About 40% of healthcare delivery organizations have experienced at least one WannaCry attack in the past six months, largely because of older, unmanaged devices that are difficult to patch, according to cybersecurity firm Armis.

By Shannon Muchmore • May 30, 2019

Touchstone Medical Imaging pays $3M to settle HIPAA breach case

HHS found Touchstone failed to properly investigate the security incident until months after it learned of the breach.

By Nick Paul Taylor • May 7, 2019

DHS highlights cybersecurity weakness in Philips EMR

Hackers could exploit a vulnerability in the company's electronic medical record system to access sensitive information or execute arbitrary code, the Cybersecurity and Infrastructure Security Agency said.

By Nick Paul Taylor • May 1, 2019

Legacy systems, employee error leave hospitals, devices vulnerable to cyberattacks

The challenge of guarding health systems is compounded by connected medical devices not being vetted for cybersecurity controls before joining networks, according to new research from threat detection firm Vectra.

By Meg Bryant • April 26, 2019

Australia strategizes to tighten medical device oversight

Regulators are considering mandating greater clinical evidence for certain high-risk devices, including spinal implants, diabetes management devices, medical devices used for IVF and companion diagnostics.

By David Lim • April 5, 2019

Hackers manipulate lung cancer scans, fool radiologists and AI software in study

Using an artificial intelligence technique called deep learning, hackers can dupe radiologists and AI software 98% of the time in the case of lung cancer, according to a Ben-Gurion University of the Negev study.

By Rebecca Pifer • April 4, 2019

Industry groups seek safe harbor in comments to senator's cybersecurity query

A think tank's analysis of several organizations' recommendations highlights the need for a national strategy and greater collaboration among various stakeholders.

By Meg Bryant • April 3, 2019

Most health apps share data with third, fourth parties, BMJ analysis warns

"Clinicians should be conscious of privacy risks in their own use of apps and, when recommending apps, explain the potential for loss of privacy as part of informed consent," the study authors wrote.

By Meg Bryant • March 21, 2019

Moody's warns medtech is highly vulnerable to cyberattacks

The credit rating agency said impact of an attack would still not rival the severity of one on the broader healthcare industry.

By Nick Paul Taylor • March 1, 2019