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FDA s Kevin Fu on Threat Modeling for Medical Devices

FDA s Kevin Fu on Threat Modeling for Medical Devices HealthInfoSec) • April 9, 2021 13 Minutes Twitter Kevin Fu, acting director of medical device cybersecurity, U.S. Food and Drug Administration More precise and pervasive cybersecurity threat modeling during manufacturers development of medical devices - and also during the regulatory product review process - is critical for risk mitigation, says Kevin Fu, new acting director of medical device cybersecurity at the Food and Drug Administration. Cybersecurity is a foreseeable risk, so it shouldn t be a surprise that we see vulnerabilities in software and hardware that are components to medical devices, he says in an interview with Information Security Media Group. The big challenge is how to become less reactive and more proactive.

United statesKevin fuDigital health centerArchimedes centerRadiological healthInformation security media groupDrug administrationDevice innovation consortiumUniversity of michiganInformation security mediaMedical device innovation consortiumஒன்றுபட்டது மாநிலங்களில்கெவின் ஃபூடிஜிட்டல் ஆரோக்கியம் மையம்ஆர்க்கிமிடீஸ் மையம்கதிரியக்கவியல் ஆரோக்கியம்

A Look Ahead: US FDA And Medical Device Regulations In 2021 | Lowenstein Sandler LLP

Med Device Online - March 10, 2021 The pandemic year of 2020 presented FDA with many enormous challenges, including how to use emergency authorizations to approve diagnostic tests, personal protective equipment, and therapies, how to conduct remote inspections, and what accommodations should be made for clinical trials disrupted by COVID-19. On top of that, FDA found itself facing an enormous and unprecedented amount of political pressure, with its actions, or lack thereof, potentially altering the presidential election. Yet through it all, the agency continued to largely fulfill its core responsibilities of ensuring compliance and helping to bring new products to market, including, for example, approving by its own reckoning 132 novel medical devices, a significant increase over 2019. Now that we are in 2021, what big developments can we expect from FDA in general and regarding medical devices in particular? This article explores some of the FDA initiatives and activities worth fol

United statesKevin fuStephen hahnJanet woodcockJoshua sharfsteinPatty murraySoftware and digital healthUniversity of michiganDigital health centerProduct developmentArchimedes centerDigital healthPublic health emergency preparednessSenate committee on healthJohns hopkins bloomberg school of public healthSafer technologies program ste

A Look Ahead US FDA And Medical Device Regulations In 2021

Now that we are in 2021, what big developments can we expect from FDA in general and with regard to medical devices in particular? This article.

United statesKevin fuStephen hahnJanet woodcockJoshua sharfsteinLowenstein sandlerPatty murrayJim shehanSoftware and digital healthUniversity of michiganDigital health centerProduct developmentArchimedes centerDigital healthPublic health emergency preparednessSenate committee on health

FDA Appoints Acting Director of Medical Device Security, Signaling Increased Commitment to Medical Device Cybersecurity | Akin Gump Strauss Hauer & Feld LLP

FDA Appoints Acting Director of Medical Device Security, Signaling Increased Commitment to Medical Device Cybersecurity The U.S. Food and Drug Administration (FDA) announced that the newly-created post of Acting Director of Medical Device Security has been filled by Kevin Fu, a University of Michigan associate professor and founder of the Archimedes Center for Medical Device Security. Fu, who was appointed for a one-year term, is expected to “work to bridge the gap between medicine and computer science and help manufacturers protect medical devices from digital security threats.” 1 The creation of the position reflects the FDA’s ongoing efforts to ensure the safety and effectiveness of Internet of Things and medical devices such as insulin pumps, pacemakers, and hospital imaging machines. These devices, which increasingly rely on software and the cloud to operate, are particularly vulnerable to threat actors targeting hospitals and other medical providers with ransomware

United statesKevin fuAkin gump strauss hauer feldDepartment of defenseNational science foundationUniversity of michiganNational institute of standardsRadiological healthDepartment of healthInformation administrationNational telecommunicationsHuman servicesUs department of healthDrug administrationArchimedes centerInfrastructure security agency

FDA Appoints Acting Director Of Medical Device Security, Signaling Increased Commitment To Medical Device Cybersecurity - Food, Drugs, Healthcare, Life Sciences

FDA Appoints Acting Director Of Medical Device Security, Signaling Increased Commitment To Medical Device Cybersecurity - Food, Drugs, Healthcare, Life Sciences
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United statesKevin fuHuman servicesDepartment of defenseVeterans affairsScience foundationDrug administrationUniversity of michiganNational institute of standardsArchimedes centerInfrastructure security agencyRadiological healthDepartment of healthInformation administrationNational security agencyActing director