The Medical Device Cybersecurity Gap Hiding in Plain Sight
In healthcare, a cyber vulnerability is not just an IT problem. It can quickly become a patient-care problem.
Tag Archives: cybersecurity
Cybersecurity Tactics for Medical IoT Devices
Protect patient data with medical IoT security. Learn how AI, Zero Trust, and encryption can prevent cyber threats and secure healthcare IoT devices.
The FDA Raised the Bar on MedTech Cybersecurity: Are Companies Ready?
In the current Cyber Threat environment, companies must have strong cyber liability insurance. Policies must specifically account for cyber-physical risks and the substantial costs of post-market remediation, including mandatory software patches and patient notifications. Insurers are well aware of the 524B mandate and are increasingly requiring proof of compliance before issuing coverage or offering favorable rates. How do you assure your cyber risk plan insurable?
What’s getting R&D attention: how will MedTech evolve in 2025?
What’s getting R&D attention? The impact of upcoming regulations, A.I., new cybersecurity risks, developments in battery power and innovation, collaborative efforts, and other impacts on the industry in the year ahead.
The Role of EPSS in Prioritizing IoMT Security Threats
The Exploit Prediction Scoring System (EPSS) can help healthcare organizations prioritize security vulnerabilities, but it has limitations in IoMT environments. While EPSS provides valuable data-driven prioritization, it should be combined with other risk assessments, cybersecurity frameworks, and strategies to more comprehensively secure healthcare systems’ IoMT devices.
Information Sharing: A Valuable Tool in Preventing Cyber Attacks
Information Sharing and Analysis Centers (ISACs), developed to help critical infrastructure industries prevent and become more resilient to cyber and physical security attacks, are expanding their strategies to meet ever-evolving threats. Errol Weiss, Chief Security Officer of the Health-ISAC, discusses how these groups work to protect industry, emerging threats and how device developers and healthcare organizations are working together to protect patients.
Utilizing CSF to Manage Cyber Risks
Dave Bailey, VP of Consulting Services at Clearwater Security, highlights the need for top-down support in managing healthcare-related cyber risks and how the new NIST Cybersecurity Framework can help enhance cybersecurity in healthcare and MedTech organizations.
FDA Issues New Draft Guidance on Premarket Cybersecurity Considerations
The new draft guidance proposes select updates to the FDA guidance document “Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions” and focuses on information FDA considers necessary to support obligations under section 524B of the FD&C Act, “Ensuring Cybersecurity of Devices.”
NIST Releases Updated Cybersecurity Framework
The National Institute of Standards and Technology (NIST) has updated its Cybersecurity Framework (CSF) guidance document for reducing cybersecurity risk. The new 2.0 edition is designed for all audiences, industry sectors and organization types. This is the framework’s first major update since its creation in 2014.
Medcrypt Appoints Former FDA Officer to Vice President of Services
“We’re excited to have Naomi in this role. With her FDA experience, her visionary approach will pave the way for success, ensuring that businesses not only meet the FDA’s stringent requirements but also thrive in an environment where cybersecurity is a fundamental business value.”