Tag Archive for: medical

FDA Collaborates with MITRE to update Medical Device Cybersecurity Playbook | Nexsen Pruet, PLLC

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On November 14, 2022, under contract with the United States Food and Drug Administration (FDA), the MITRE Corporation (MITRE), an organization that administers the National Cybersecurity Center of Excellence, a federally funded research and development center dedicated to cybersecurity, published an update to the Medical Device Cybersecurity Regional Incident Preparedness and Response Playbook (the “Playbook”). MITRE also published a Quick Start Companion Guide to the Playbook, which is shorter than the Playbook and consists of tables that align with the structure of the Playbook. MITRE, under contract with the FDA, had prepared and published the first version of the Playbook in October 2018, which followed the 2017 WannaCry ransomware attack (the first known ransomware attack to affect networked medical devices). Since the publication of the first version of the Playbook, the healthcare and public health sector has experienced an increasing number of cyber incidents. For instance, from mid-2020 through 2021, 82% of healthcare systems reported a cyberattack, 34% of which reportedly involved ransomware. Moreover, 133 healthcare entities in the United States appeared on a ransomware extortion blog in 2021.

The Playbook is a resource designed primarily for healthcare delivery organizations (HDOs), such as hospitals and large physician practices, and can be incorporated into an HDOs’ existing medical device cybersecurity response plan or serve as a starting point for HDOs that have no response plan. The Playbook outlines a framework to assist HDOs, their staff involved in medical device cybersecurity incident preparedness and response, and other stakeholders, such as device manufacturers and other entities that support HDOs’ response efforts, prepare for and respond to medical device-related cybersecurity incidents helping ensure effectiveness of medical devices and patient care and safety. The framework outlined in the Playbook is designed to provide baseline medical device cybersecurity information for emergency preparedness and response; define roles and responsibilities for internal and external responders; describe a standardized approach to response efforts that…

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Armis Named Clear Leader in SPARK Matrix for Connected Medical Device Security Solutions

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Company recognized for comprehensive and robust asset intelligence platform; ranked highest among competitors for technology excellence and customer impact

SAN FRANCISCO, Dec. 1, 2022 /PRNewswire/ — Armis, the leading asset visibility and security company, today announced that it has been named a clear leader for technology excellence and customer impact by Quadrant Knowledge Solutions in its recent report, SPARK Matrix: Connected Medical Device Security Solutions, Q4 2022. The advisory and consulting firm recognized Armis for its comprehensive and robust asset intelligence platform, which applies the collective intelligence from more than 3 billion tracked Internet of Medical Things (IoMT), Internet of Things (IoT), operational technology (OT), and information technology (IT) assets to secure the integrated technology requirements of modern connected care delivery.

Armis has been named a clear leader for technology excellence and customer impact by Quadrant Knowledge Solutions in its recent report, SPARK Matrix: Connected Medical Device Security Solutions, Q4 2022.
Armis has been named a clear leader for technology excellence and customer impact by Quadrant Knowledge Solutions in its recent report, SPARK Matrix: Connected Medical Device Security Solutions, Q4 2022.

The report provides a detailed analysis of global connected medical device security solutions; market dynamics, major trends, vendor landscape, and competitive positioning analysis, ranking the leading connected medical device security solution vendors in the form of a SPARK Matrix. This research provides strategic information for healthcare delivery organizations (HDOs) to evaluate different vendor capabilities and competitive differentiation.

“The key differentiators for the Armis platform include strong risk and vulnerability management capabilities,” said Rohan Paul, Analyst at Quadrant Knowledge Solutions. “Further, the company’s extensive Collective Asset Intelligence Engine, the agentless security approach, passive, real-time monitoring with no latency or disruption of operations, its querying capabilities, and the intelligent reporting and analytic tools that can help HDOs optimize usage/performance of their assets are a few components that set Armis apart from its competitors. Based on our analysis of the company’s capabilities compared to the market, Armis is a clear leader for its…

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Singapore extends cyber security labelling scheme to medical devices

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The Cyber Security Agency of Singapore (CSA) is extending the Cybersecurity Labelling Scheme (CLS) to medical devices used by hospitals in a bid to shore up the security of internet of things (IoT) devices used in healthcare settings.

Noting that devices are now increasingly connected to hospital and home networks, providing benefits such as real-time monitoring of health status, the CSA said the growing connectivity could increase security risks and compromise patients’ personal information, clinical data or treatment protocols, ultimately affecting patient health outcomes.

Under the CLS for medical devices (CLS MD), which was developed together with the Ministry of Health, Health Sciences Authority (HSA) and Integrated Health Information Systems, medical devices are rated based on four levels of cyber security provisions.

Each level corresponds to the level of testing and assessment that the product has undergone. For a start, all HSA-registered medical devices in Singapore are deemed to be compliant with CLS (MD) Level 1, as the registration requirements by the HSA have already incorporated the baseline cyber security requirements defined in Level 1.

For the higher levels in the scheme, a formal consultation with the medical device industry and associations will be held in the coming month to seek feedback on their proposed requirements, including the timeline for implementation. More details on the industry consultation and CLS (MD) registration will be announced later.

Through the new scheme, CSA hopes to incentivise manufacturers to adopt a security-by-design approach to develop more secure products for the medical device industry. The scheme will also enable consumers and healthcare providers to make informed decisions about the use of devices, as they can identify products according to their cyber security provisions.

The CLS was first launched in 2020 to provide different levels of cyber security ratings to help users make informed choices about the security features of the smart devices they purchase. As of October 2022, more than 200 products – ranging from routers to smart lighting to smart cameras – have been awarded the CLS label.

Separately, Singapore…

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Ransomware gang threatens to expose one million sensitive medical records online

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Ransomware operators Daixin Team are claiming to have stolen “more than a million records” from a U.S. healthcare organization, and are threatening to leak it all to the public. 

It’s unclear whether this means a million affected patients, or a million pieces of sensitive information belonging to fewer patients, but whatever the case, the threat actors stole sensitive data from OakBend Medical Center, which operates three hospitals in the state of Texas, and shut down its communications and IT systems in the process. 

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