• Regulatory NewsRegulatory News

    CDRH Unveils Top Regulatory Science Priorities for 2016

    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. The release of the list coincides with the overarching goal of CDRH regulatory science, which is to help develop and apply tools, standards and methodologies to study the safety, eff...
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    Security Researcher Says Additional Hospira Infusion Pumps Vulnerable to Hacking

    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). Background In May 2015, DHS' Industrial Control Systems Cyber Emergency Response Team (ICS-CERT) released a warning regarding potential security vulnerabilities within Hospira's LifeCa...
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    Government Cybersecurity Officials Warn Hospira Device Vulnerable to Hackers

    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. The warning, issued on 5 May 2014 by the Department of Homeland Security's Industrial Control Systems Cyber Emergency Response Team (ICS-CERT) focuses on Hospira's LifeCare PCA Infusion System, an intravenous pump used to deliver medication to patients. ICS-CERT said that a ...
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    Pacemakers Get Hacked On TV, But Could It Happen In Real Life?

    Jay Radcliffe breaks into medical devices for a living, testing for vulnerabilities as a security researcher. He’s also a diabetic, and gives himself insulin injections instead of relying on an automated insulin pump, which he says could be hacked. “I’d rather stab myself six times a day with a needle and syringe,” Radcliffe recently told security experts meeting near Washington, D.C. “At this point, those devices are not up to standard.” Concern about the vulnerabilit...
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    Money or Your Life: Report Predicts Ransomware Affecting Medical Devices in Near Future

    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. The prediction, made in Europol's 2014 Internet Organized Crime Threat Assessment (iOCTA) , comes amid growing concern about the cybersecurity of devices. In the US, in particular, regulators and researchers have sounded the alarm over the lack of inherent security...