• Regulatory NewsRegulatory News

    FDA to Hold Workshop on Medical Device Cybersecurity

    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. The workshop comes five months since FDA issued its first safety communication on a device’s cybersecurity, raising concerns about the vulnerabilities of Hospira’s Symbiq infusion system, a computerized pump. Suzanne Schwartz, who coordinates cybersecurit...
  • Regulatory NewsRegulatory News

    Hacking Group Targets Regulatory Professionals, Seeking Insider Information

    Regulatory professionals, watch out: A group of hackers is targeting pharmaceutical and medical device companies, and eyeing regulatory professionals as a way past corporate firewalls. The New York Times is reporting that a group of investment-oriented hackers has been targeting more than 100 companies—"the vast majority publicly traded healthcare or pharmaceutical companies"—in a bid to gain a "market edge." The attacks are remarkable, The Times noted, in that the ...
  • Researchers Say They Can Stop Medical Device Hackers From Gaining Unauthorized Access

    After reports were issued by a government body warning government regulators of the susceptibility of life-sustaining medical devices to rogue hackers, researchers at the Universities of Purdue and Princeton have announced the creation of a prototype firewall that could prevent such attacks from occurring. The previous report, issued by the National Institute of Standards and Technology, warned the US Food and Drug Administration (FDA) about the lack of security standard...