FDA official: Draft cybersecurity guidance has 'teeth'

Not following the guidance in premarket submissions means potential delays for device makers, said Suzanne Schwartz, director of CDRH's Office of Strategic Partnerships and Technology Innovation.

By Greg Slabodkin • April 11, 2022

Going beyond HIPAA compliance is worthwhile

Just because HIPAA doesn't require the use of data governance technology doesn't mean you can do without it.

April 11, 2022

FDA clarifies cybersecurity recommendations for device makers in new guidance

The draft guidance, which replaces a 2018 document, sets recommendations for how medical device companies should approach cybersecurity in premarket submissions and maintaining products throughout their lifecycle.

By Elise Reuter • April 7, 2022

Senators drill down on rising user fees, cybersecurity and clinical trial diversity in MDUFA hearing

While Tuesday's Senate hearing did not include FDA officials, lawmakers questioned industry groups as they consider the MDUFA V agreement that would increase the amount the agency can collect in fees from device makers.

By Elise Reuter • April 6, 2022

CISA warns about cyber flaw in Philips MRI monitoring software

Philips' e-Alert has a vulnerability that could allow an unauthorized user to remotely shut down the system, the U.S. Cybersecurity and Infrastructure Security Agency said in an advisory.

By Greg Slabodkin • March 30, 2022

FDA asks Congress for 14% bump in device budget for supply chain, cybersecurity programs

For the devices program, the FDA is asking for roughly $698 million, with approximately $466 million from the budget authority and $232 million from user fees.

By Nick Paul Taylor • March 29, 2022

'On high alert': Hospitals wary of cyber threats from Russia-Ukraine war

Cybersecurity has always been chronically underfunded in hospitals, even before COVID-19 swallowed up more resources. Now, this major international threat is creating a "perfect storm," one cybersecurity expert said.

By Rebecca Pifer • March 21, 2022

FDA warns of cyber vulnerabilities in medical device software components

An agency alert warned that flaws in PTC's Axeda agent and desktop server, used in devices from several manufacturers, could allow an unauthorized attacker to take full control of the host operating system.

By Greg Slabodkin • March 9, 2022

75% of infusion pumps have cyber flaws, putting them at risk from hackers: study

An analysis of more than 200,000 infusion pumps, using crowd-sourced data supplied by healthcare organizations, found about half were susceptible to "critical" and "high" severity cybersecurity vulnerabilities.   

By Greg Slabodkin • March 3, 2022

Medtech, hospitals on alert for cyberattacks after Russia's invasion of Ukraine

While cybersecurity threats to healthcare and medical devices have grown during the pandemic, the Russia-Ukraine conflict has raised the threat level, putting patient safety at risk.

By Greg Slabodkin • Feb. 28, 2022

Cybersecurity leads ECRI's list of top medtech hazards for 2022

Cyber incidents can compromise patient care and attacks against hospitals have become more prevalent in recent years. However, ECRI said the worst consequences are preventable.

By Elise Reuter • Jan. 18, 2022

FDA warns about Log4j cybersecurity vulnerabilities in medical devices

The bugs in Apache's Java-based open source logging library could potentially allow unauthorized users to remotely impact the safety and effectiveness of device functionality, according to the agency.

By Greg Slabodkin • Dec. 20, 2021

Medical device security continues to be casualty of hospital-medtech divide

FDA says manufacturers and hospitals are both responsible for protecting devices from growing cybersecurity threats. However, experts say healthcare providers carry a much heavier load.

By Greg Slabodkin • Dec. 1, 2021

Cyber playbook sets out strategies for modeling threats to medical devices

The FDA-funded guide arrives against a backdrop of calls from the agency for the medtech industry to step up its threat modeling throughout the device lifecycle in order to strengthen cybersecurity and patient safety.

By Nick Paul Taylor • Dec. 1, 2021

Siemens software vulnerabilities potentially put millions of medical devices at risk

A U.S. cybersecurity agency issued an alert about the vulnerabilities which could allow hackers to disrupt the operation of anesthesia machines and bedside monitors from multiple manufacturers.

By Nick Paul Taylor • Nov. 11, 2021

Will a software bill of materials help or hurt medical device cybersecurity?

President Joe Biden's executive order calls for SBOMs, and the FDA wants to require premarket submissions to have an inventory of third-party device components. AdvaMed is concerned the data could be exploited by hackers.

By Greg Slabodkin • Oct. 7, 2021

Medtronic expands 2 MiniMed insulin pump recalls on ring flaw, cyber risks

The recalls have hit the medtech giant at a time when competitors Insulet and Tandem are ramping up in the insulin pump market and amid flagging sales in its diabetes unit.

By Susan Kelly • Oct. 5, 2021

MCIT, cyber, RWE and 3 more takeaways from AdvaMed's 2021 conference

The medtech industry gathered virtually and in person for the lobby's annual conference, with topics ranging from the kill-off of the breakthrough device payment pathway to the pandemic upending CDRH's 2021 reset.

Oct. 4, 2021

Ransomware attacks put availability of medical devices at risk: FDA cyber chief

Industry reached a "watershed moment" earlier this year when a device outage caused by malware endangered patient lives, Kevin Fu, acting director of cybersecurity at CDRH said. "That was something we haven't seen before."

By Greg Slabodkin • Oct. 1, 2021

Quarter of providers saw mortality rates rise after ransomware attacks, survey finds

Only 36% of healthcare organizations said they are effective in knowing where all their medical devices are, while just 35% indicated they know when a device's operating system is at end of life or out of date.

By Rebecca Pifer • Sept. 24, 2021

FTC warns app makers fall under breach notification rule

The agency noted that developers of health apps and connected devices are considered healthcare providers. Any unauthorized access, including sharing information without consent, would trigger the Health Breach Notification Rule.

By Shannon Muchmore • Sept. 16, 2021

FDA creates new office to drive forward digital transformation strategy

Vid Desai, who will help lead the new Office of Digital Transformation, was also named as the agency's chief information officer. FDA is seeking an extra $75.9 million in the 2022 budget to support the modernization plan.

By Nick Paul Taylor • Sept. 16, 2021

ECRI CEO: FDA, industry must revisit COVID-19 medical device EUAs as shortages ebb

Marcus Schabacker spoke to MedTech Dive about patient safety, cyberattacks in healthcare and risks from the rise of at-home care.

By Ricky Zipp • Sept. 3, 2021

Outpatient facilities targeted for cyberattacks nearly as often as hospitals, data shows

The number of breaches at healthcare organizations in the first half of this year was up significantly from the first half of last year, and higher than any six-month period since 2018, according to the Critical Insight report.

By Hailey Mensik • Aug. 30, 2021

FDA warns of BlackBerry cyber vulnerability in medical devices

The operating system is often deployed in devices such as cardiac and patient monitors, drug infusion pumps, imaging and surgical robots, according to Nick Yuran, CEO of security consultancy Harbor Labs.

By Greg Slabodkin • Aug. 18, 2021