The below piece is based on the resource: How FDA and the Omnibus Bill Will Reshape Pre & Post Market Product Security ——- The December 2022 Omnibus bill, a large spending bill passed by the US government, continues the Biden administration’s rhetoric of securing America’s infrastructure. Buried within this bill are new powers granted to […]
Phil Englert was ahead of the curve in introducing cybersecurity into the medical device industry, building medical device cybersecurity programs from scratch several times during his career. Today he is the Director of Medical Device Security at the Health Information Sharing and Analysis Center H-ISAC, helping establish connections within the medical device community, and well-versed […]
With an early eye on pediatrics and a specialty in burn-victim surgery, the Food & Drug Administration’s (FDA) Dr. Suzanne Schwartz, Director of Strategic Partnerships & Technology Innovation at the Center for Diseases and Radiological Health (CDRH) didn’t foresee that she’d be such an important champion for medical device cybersecurity. Toward the beginning of Dr. […]
In a highly-regulated sector like medical device manufacturing, time-to-market needs to be carefully balanced with security and compliance. In addition to the aggressive timeframes development and product teams are tasked with to get new innovation to the market, medical device manufacturers (MDMs) are also responsible for the security of connected systems and processes that have […]
Recent years have shown an alarming increase in cyber attacks geared towards the healthcare sector. Just last year alone, the FBI reported that 148 ransomware attacks successfully penetrated healthcare organizations– more than any other industry. While there are many steps that can be taken, from securing the IT infrastructure to implementing better credential security practices, […]
Better understand how to meet the below regulations with Guy Gilam’s webinar: Supercharging Product Security in 6 1/2 Steps ———— Over the past few years, cybersecurity has become a major concern for medical device manufacturers (MDMs), for a number of reasons. First and foremost, medical devices are becoming connected like never before with multiple communication […]
Originally published on BeepingComputer, May 25, 2022 As medical devices become more connected and reliant on software, their codebase grows both in size and complexity, and they are increasingly reliant on third-party and open source software components. This forces security pros to address today’s rapidly evolving threat landscape. In the hopes of helping security professionals […]
Medical device manufacturers (MDMs) are increasingly turning their attention towards cybersecurity, according to a recent survey of 150 senior decision-makers in the medical device industry, the Cybellum 2022 Medical Device Security Survey Report. As medical devices become exponentially more connected and reliant on software, regulators and government agencies are stepping up the pace in encouraging […]
There are very few professionals that influenced Medical Device cybersecurity more than Chris Gates. Recently we had a chance to sit and talk with him on our podcast “Left to Our Own Devices”. Currently Director of Product Security at Velentium, a professional engineering firm specializing in the design and manufacturing of therapeutic and diagnostic active […]