Content by Marianne Kolbasuk McGee

Unforeseen Risks to Medical Devices in Ransomware Attacks

Marianne Kolbasuk McGee  •  October 24, 2024

While ransomware attacks against medical devices don't happen often, disruptive cyber incidents that affect the availability of the IT systems that medical devices rely on are a big concern that needs the industry's critical attention, said Jessica Wilkerson of the FDA.

Helping Medical Device Makers Meet Latest Cyber Expectations

Marianne Kolbasuk McGee  •  October 22, 2024

Medical device makers have become more proactive in trying to meet higher cybersecurity expectations of regulators, but many still need to better understand the importance of life cycle security risk management and related issues, said Axel Wirth of Medcrypt and Christopher Gates of Velentium.

Securing Lives: FDA's Latest Push for Safer Medical Devices

Marianne Kolbasuk McGee  •  August 9, 2024

Aftin Ross, deputy director of the Office of Readiness and Response at FDA's Center for Devices and Radiological Health, discusses the latest medical device cybersecurity regulations, industry collaboration and manufacturers' efforts to address vulnerabilities and ensure patient safety.

Top 'Privacy by Design' Considerations for Medical Devices

Marianne Kolbasuk McGee  •  July 18, 2024

The interconnectedness of medical devices, which generate data that can be distributed to multiple systems that are often managed by different policies, presents privacy concerns that device manufacturers must address, said Adam Hesse, CEO of Full Spectrum.

Gaining Better Visibility Into Medical Devices, IoT, OT

Marianne Kolbasuk McGee  •  July 12, 2024

The deployment of an asset management platform is helping Main Line Health gain deeper visibility and better security over the 100,000-plus medical devices and IoT gear used throughout the group's multiple hospitals and medical facilities, said CISO Aaron Weismann, who discusses the implementation.

Feds Issue Alerts for Flaws in 2 Baxter Medical Devices

Marianne Kolbasuk McGee  •  June 5, 2024

U.S. federal authorities are alerting healthcare entities about critical vulnerabilities in two medical device products from manufacturer Baxter. Both flaws can be exploited remotely, potentially jeopardizing patient care. Some experts say such disclosures in general need more attention.

Report: 11 Vulnerabilities Found in GE Ultrasound Devices

Marianne Kolbasuk McGee  •  May 15, 2024

Security researchers have found 11 vulnerabilities in certain GE HealthCare ultrasound products that could allow malicious actors to physically implant ransomware or manipulate patient data stored on the affected devices. GE said the risks can be mitigated through best security practices.

The Challenges in Keeping Medical Device Software Updated

Marianne Kolbasuk McGee  •  May 6, 2024

Updating software as new vulnerabilities are discovered persistently remains a top medical device cybersecurity challenge, said David Brumley, a cybersecurity professor at Carnegie Mellon University and CEO of security firm ForAllSecure. Solving this requires a major mindset shift, he said.

Major Areas of Cybersecurity Focus for Medical Device Makers

Marianne Kolbasuk McGee  •  April 24, 2024

Medical device makers submitting products for premarket approval by the Food and Drug Administration often struggle the most with cybersecurity in three major areas - design controls, providing a software bill of materials and testing, according to Nastassia Tamari of the FDA.

Evolving Threats Facing Robotic and Other Medical Gear

Marianne Kolbasuk McGee  •  April 9, 2024

Robotic medical devices, such as surgical gear, offer great potential to improve patient care, but the cyber risks associated with these products must be carefully addressed, said Kevin Fu, director of the Archimedes Center for Health Care and Medical Device Cybersecurity at Northeastern University.

Medical Device Cyberthreat Modeling: Top Considerations

Marianne Kolbasuk McGee  •  April 5, 2024

Besides not doing cyberthreat modeling at all, some the biggest mistakes medical device manufacturers can make are starting the modeling process too late in the development phase or using it simply as a "paper weight exercise," said threat modeling expert Adam Shostack of Shostack & Associates.

Safeguarding Critical OT and IoT Gear Used in Healthcare

Marianne Kolbasuk McGee  •  March 18, 2024

The many kinds of OT and IoT gear that are not regulated medical devices but are critical to run hospitals and other care facilities present a variety of cybersecurity and patient safety concerns, said Dr. Benoit Desjardins, professor of radiology at the University of Pennsylvania Medicine.

Protecting Medical Devices Against Future Cyberthreats

Marianne Kolbasuk McGee  •  March 15, 2024

Healthcare organizations and makers of medical devices need to think about how to safeguard their critical medical gear against future cyberthreats, including the looming dangers posed by quantum computing, said Mike Nelson, global vice president of digital trust at security firm DigiCert.

Critical Considerations for AI Developments in Healthcare

Marianne Kolbasuk McGee  •  March 11, 2024

AI has enormous potential for transforming and reimagining all aspects of healthcare but mitigating the risks requires a collaborative, comprehensive approach that prioritizes data security, regulatory compliance and ethical considerations, said Sunil Dadlani, CIO and CISO at Atlantic Health System.

Why Legacy Medical Imaging Devices Are Leaking Data on Web

Marianne Kolbasuk McGee  •  March 1, 2024

Tens of millions of patient records are exposed on the internet as many healthcare providers and hospitals have moved their medical imaging system storage infrastructures to the cloud without putting adequate security measures in place, warns security researcher Sina Yazdanmehr of Aplite.