Search Results for Cybersecurity

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FDA, DHS Find Cybersecurity Vulnerabilities in St. Jude Heart Devices By Michael Mezher - Published 11 January 2017

The US Food and Drug Administration (FDA) and the Department of Homeland Security (DHS) Industrial Control Systems Cyber Emergency Response Team (ICS-CERT) issued an advisory on Monday warning of cybersecurity vulnerabilities found in St. Jude Medical's Merlin@home wireless transmitter that could affect the company's line of implantable cardiac devices (ICDs).

Categories: News, US, FDA, Medical Devices, Postmarket surveillance

Tags: Cybersecurity, Medical Device Cybersecurity, St. Jude Medical, MedSec, Muddy Waters Research, Merlin@home Transmitter

FDA Finalizes Postmarket Cybersecurity Guidance By Michael Mezher - Published 03 January 2017

Just before the close of 2016, the US Food and Drug Administration (FDA) finalized its guidance for managing postmarket cybersecurity for connected medical devices.

Categories: News, US, CDRH, Communication, Medical Devices

Tags: Cybersecurity, Medical Device Cybersecurity

Cybersecurity Researcher: Recent Device Vulnerabilities Should Be a Wake-Up Call for FDA By Michael Mezher - Published 05 April 2016

A prominent cybersecurity researcher says the US Food and Drug Administration (FDA) needs to "buckle down" and regulate medical device cybersecurity more firmly.

Categories: News, FDA, Communication, Medical Devices, Postmarket surveillance

Tags: Cybersecurity, ICS-CERT, Pyxis SupplyStation, Mike Ahmadi, Billy Rios

NIST Kicks Off Wireless Infusion Pump Cybersecurity Project By Michael Mezher - Published 25 January 2016

The National Institute of Standards and Technology (NIST) is launching a project to improve the cybersecurity of wireless infusion pumps.

Categories: News, US, CDRH, Medical Devices, Postmarket surveillance

Tags: Cybersecurity, NIST, National Cybersecurity Center of Excellence, NCCoE, Infusion Pumps, Hospira

Questions Remain on How Device Cybersecurity Data Sharing Will Work By Michael Mezher - Published 21 January 2016

A key component in the US Food and Drug Administration's (FDA) postmarket guidance for medical device cybersecurity is participation in Information sharing analysis organizations (ISAOs), though questions remain about how these organizations will function and be governed.

Categories: News, US, CDRH, Government affairs, Medical Devices, Postmarket surveillance

Tags: Cybersecurity, Information Sharing and Analysis Organizations, ISAO, NH-ISAC

FDA Emphasizes Sharing, Collaboration in Medical Device Cybersecurity By Michael Mezher - Published 20 January 2016

The US Food and Drug Administration (FDA) is looking to advance awareness of cybersecurity for medical devices by encouraging sharing and collaboration between manufacturers, healthcare providers and cybersecurity researchers.

Categories: News, US, CDRH, Communication, Medical Devices, Postmarket surveillance

Tags: Cybersecurity, ISOA, ISEC

FDA Calls on Device Manufacturers to Monitor, Report Some Postmarket Cybersecurity Vulnerabilities By Zachary Brennan - Published 15 January 2016

The prospect of a hacker or software vulnerability in a medical device causing serious harm to patients is pushing the US Food and Drug Administration (FDA) to require manufacturers to report a small subset of cybersecurity vulnerabilities that could compromise the clinical performance of a device, according to draft guidance released Friday.

Categories: News, US, FDA, Crisis management, Government affairs, Manufacturing, Medical Devices, Postmarket surveillance, Product withdrawl and retirement

Tags: cybersecurity, hacking medical devices, device software hacks, medical device malware

FDA to Hold Workshop on Medical Device Cybersecurity By Zachary Brennan - Published 03 December 2015

The US Food and Drug Administration (FDA) will convene a two-day public workshop in January to discuss ways that the agency can address what’s becoming a more imminent threat: the cybersecurity of medical devices.

Categories: News, US, FDA, Crisis management, Due Diligence, Ethics, Government affairs, Medical Devices, Postmarket surveillance, Quality

Tags: device cybersecurity, medical device hacking, device hackers, FDA and cybersecurity

CDRH Unveils Top Regulatory Science Priorities for 2016 By Zachary Brennan - Published 20 October 2015

The US Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH) will look to better leverage big data and advance the use of patient-reported outcomes in regulatory decision making, according to a top 10 list of regulatory science priorities released on Tuesday.

Categories: News, US, CDRH, Government affairs, In vitro diagnostics, Manufacturing, Medical Devices, Regulatory intelligence, Regulatory strategy

Tags: CDRH, FDA, regulatory science, device cybersecurity, device safety

Security Researcher Says Additional Hospira Infusion Pumps Vulnerable to Hacking By Alexander Gaffney, RAC - Published 09 June 2015

A prominent security researcher is warning that additional infusion pump models manufactured by Hospira are vulnerable to intrusion by hackers, just weeks after a similar warning prompted action by the US Food and Drug Administration (FDA) and the US Department of Homeland Security (DHS).

Categories: News, US, CDRH, Medical Devices, Postmarket surveillance

Tags: Cybersecurity, Billy Rios, Hacking, Vulnerabilities, Hospira

Government Cybersecurity Officials Warn Hospira Device Vulnerable to Hackers By Alexander Gaffney, RAC - Published 06 May 2015

US cybersecurity officials have issued a warning regarding a medical device manufactured by Hospira, saying the device was identified as having several vulnerabilities which have since been patched.

Categories: News, US, Medical Devices

Tags: Cybersecurity, Hacking, ICS-CERT

Pacemakers Get Hacked On TV, But Could It Happen In Real Life? By Daniela Hernandez and Julie Appleby, Kaiser Health News - Published 20 November 2014

Jay Radcliffe breaks into medical devices for a living, testing for vulnerabilities as a security researcher.

Categories: News, US, CDRH, Medical Devices

Tags: Medical Device Hacking, Medical Device Cybersecurity, Cybersecurity

Money or Your Life: Report Predicts Ransomware Affecting Medical Devices in Near Future By Alexander Gaffney, RAC - Published 09 October 2014

European law enforcement authorities are predicting a dark, nefarious future for the cybersecurity of products, including medical devices, which could eventually lead to patients being held hostage from afar.

Categories: News, Medical Devices, Postmarket surveillance

Tags: Cybersecurity, Ransomware, Medical Device Security, Medical Device Cybersecurity, Europol