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Timeline: Medical Device Security

  • Experts warn of pacemaker hacking threat

    Experts warn of pacemaker hacking threat
    Before device hacking became a hot topic, security experts worried that hackers might one day go after the medical devices designed to deliver medicine or help heart conditions, calling for the FDA to regulate and work with medical device manufacturers to stop potential security breaches in a variety of wireless, implantable devices. (Image: Medtronic)
    [Read more](http://www.fiercemedicaldevices.com/story/experts-warn-pacemaker-hacking-threat/2010-04-01)
  • Wireless devices risky, says group

    Wireless devices risky, says group
    The Medical Device Security Center hacks medical devices in tests, bringing attention to security vulnerabilities in pacemakers and insulin pumps relying on wireless communication between physicians and the implant. (Image: Medical Device Security Center)
    [Read more](http://www.fiercemedicaldevices.com/story/group-highlights-risk-medical-device-security/2010-07-07)
  • MIT, UMass deter hackers

    MIT, UMass deter hackers
    In light of the growing threat of device hacking, researchers proposed a system that uses a jamming transmitter to halt unauthorized signals in an implant's operating frequency, permitting only authorized users, such as doctors, to communicate with it. They proposed the transmitter to be small enough to wear as a necklace or watch. (Image: MIT)
    [Read more](http://www.fiercemedicaldevices.com/story/mit-umass-look-protect-implantable-devices-attack/2011-06-13)
  • FDA issues guidance on mobile apps

    FDA issues guidance on mobile apps
    The FDA issues [draft guidance](http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM263366.pdf) (.pdf) seeking to regulate "high-risk" medical applications that control an existing medical device's use, function or energy source. (Image: Apple, FDA)
    [Read more](http://www.fiercegovernmentit.com/story/fda-releases-draft-guidance-mobile-medical-apps/2011-07-19)
  • Insulin pump hacked

    Insulin pump hacked
    A Medtronic insulin pump is hacked. After [initially denying the hack](http://bit.ly/p3hDc8) (which [the hacker](http://bit.ly/qwfjhk) stands by) Medtronic [seeks security help from Symantec](http://bit.ly/NJUU1R). (Image: Medtronic)
  • FDA urged to vet device software

    FDA urged to vet device software
    The Information Security and Privacy Advisory Board asked the FDA to evaluate how secure wireless devices such as insulin pumps and defibrillators are against hacking before approving them for use. The board also wanted to involve the U.S. Computer Emergency Readiness Team, through which device security problems could be reported, tracked and fixed. (Image: FDA)
    [Read more](http://www.fiercemedicaldevices.com/story/board-urges-evaluation-device-hacking-risks/2012-04-11)
  • DHS warns of hacking, malware

    DHS warns of hacking, malware
    The Department of Homeland Security issued a warning to regulators about the susceptibility of medical devices to malware and hackers, also noting that devices that transmit data over wireless networks may imperil patients' privacy. (Image: DHS)
    [Read more](http://www.fiercemedicaldevices.com/story/department-homeland-security-issues-device-hacking-warning/2012-05-17)
  • NIST issues Bluetooth guidance

    NIST issues Bluetooth guidance
    The National Institute of Standards and Technology issues final guidance on securing Bluetooth technology and updates vulnerability mitigation information for protecting low-energy devices like heart rate monitors and medical sensors. (Image: NIST)
    [Read more](http://www.nist.gov/itl/csd/20120612_bluetooth.cfm)
  • FDA: Software flaws drive recalls

    FDA: Software flaws drive recalls
    FDA's Office of Science and Engineering Laboratories releases a report finding 24 percent of device recalls in 2011 were due to software failures. The agency vows to ramp up review of software-based medical instruments and equipment. (Image: ©iStockPhoto/Andrey Prokhorov)
    [Read more](http://bit.ly/MFPgjw)
  • CareFusion’s ventilator hacked

    CareFusion’s ventilator hacked
    The website CareFusion uses to update the software on its respiratory devices was infected with viruses and malware that may have been streamed to patients' ventilators. Twenty pages on CareFusion's site were host to Trojan viruses and malicious programs when Google flagged the site, and the company is investigating how it happened. (Image: CareFusion)
    [Read more](http://www.fiercemedicaldevices.com/story/carefusions-ventilator-software-may-have-been-hacked/2012-06-20)