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

HIMSS19: Medical device cybersecurity still top concern

The WannaCry attack highlighted the need for hospitals to have a better understanding of medical devices in their inventory in order to better be equipped to respond to cyberattacks.

By David Lim • Feb. 15, 2019

Hospitals call on medtech to ease interoperability by boosting security

"Medical device manufacturers must do more to confront the privacy challenges that unsecurable devices may pose to hospitals and health systems," the American Hospital Association and six other groups said in a report.

By Meg Bryant • Jan. 23, 2019

5 medtech trends to watch in 2019

FDA regulatory changes, diagnostics legislation, a sustained focus on cybersecurity, looming European Union regulations and China trade headwinds are likely to take center stage.

By David Lim • Jan. 11, 2019

What's in a connected medical device? Cybersecurity regulators want to know

FDA could require device makers to publicize a software bill of materials as early as the premarket application process to more quickly identify vulnerabilities in the event of a cyberattack.

By Meg Bryant • Jan. 3, 2019

HHS issues voluntary guidelines amid rise of cyberattacks

The department, together with an industry-led task force, compiled best practices on how to protect patients and health systems from growing cyberthreats.

By Samantha Liss • Jan. 2, 2019

Regulatory makeovers and international game changers: MedTech Dive's top stories of 2018

Hard looks at cybersecurity and digital health's hot streak also left their mark on the year.

By Maria Rachal • Dec. 22, 2018

Repeat cyberattacks a reality for 1 in 3 healthcare employees, survey shows

More than a quarter of those surveyed said their organization experienced a ransomware attack in the past year, according to a Kaspersky Lab report.

By Meg Bryant • Dec. 18, 2018