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

Cybersecurity priorities laid out by key House panel

The House Energy and Commerce Committee issued a report outlining six strategies for strengthening the nation's defenses against cybersecurity vulnerabilities with a focus on medical devices in healthcare.

By Susan Kelly • Dec. 10, 2018

Cybersecurity, telehealth, tech disruptors top health system concerns for 2019

Nearly 90% of health systems expect to increase spending on cybersecurity in the coming year, many by more than 5%, according to the Center for Connected Medicine.

By Meg Bryant • Nov. 26, 2018

Abbott seeks clearer security standards as feds increase cyber risk focus

President Trump is expected to sign legislation Friday creating a new cyber agency within the Department of Homeland Security. 

By Maria Rachal • Nov. 16, 2018

With technology foundation solidified, Johnson & Johnson's attention turns to what's next

Though advanced in its technical capabilities, J&J has weighed the merits of build versus buy when it comes technologies like AI.

By Naomi Eide • Nov. 16, 2018

Grassley questions FDA about 'troubling' cybersecurity audit

"Medical devices could be exploited by those same foreign actors to not only interfere with normal device operation, which could cause harm to patients, but also to steal personal medical information," the senator wrote.

By Nick Paul Taylor • Nov. 13, 2018

Gap between perception, reality of connected medical device security, survey finds

Nearly two-thirds of health IT professionals trust traditional security measures like firewalls to protect connected medical devices from cyber attack, according to a new Zingbox survey, but that trust may be misplaced.

By Meg Bryant • Nov. 2, 2018

HHS opens cybersecurity coordination center after troubled year

It comes five months after a bipartisan group of lawmakers took HHS to task over stuttering attempts to coordinate cybersecurity information sharing.

By Nick Paul Taylor • Oct. 31, 2018

FDA floats changes to cybersecurity guidance to strengthen safeguards

Proposals include creation of lists of all hardware and software components used in a device that could be vulnerable to attack.

By Nick Paul Taylor • Oct. 18, 2018

FDA warns of Medtronic device cybersecurity risk

The alert follows discovery that hackers could adjust the settings of cardiac devices. While the FDA has not received reports of patient harm, Medtronic has disabled the online software update.

By Nick Paul Taylor • Oct. 12, 2018