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  • Regulatory NewsRegulatory News

    FDA, DHS Alert to Cybersecurity Flaws Affecting Medtronic Cardiac Devices, Programmers, Monitors

    Hundreds of thousands of units of Medtronic implantable cardiac devices, programmers and home monitors are vulnerable to cybersecurity incidents, according to two US federal government notices. On Thursday, the US Food and Drug Administration (FDA) issued an FDA safety communication, while the US Department of Homeland Security's (DHS) Industrial Control Systems Cyber Emergency Response Team (ICS-CERT) issued an advisory to flag cybersecurity vulnerabilities detected in...
  • Regulatory NewsRegulatory News

    ICD and Pacemaker Ecosystems Vulnerable to Hacks: Report

    Cybersecurity firm WhiteScope says it has identified cybersecurity vulnerabilities in the device ecosystems for pacemakers and implantable cardioverter-defibrillators (ICDs) across four major vendors. Background In recent years, the US Food and Drug Administration (FDA) has advanced efforts to improve medical device cybersecurity, and has held three public workshops and issued two final guidances detailing device makers' pre- and postmarket cybersecurity responsibilitie...
  • Report Finds that Pharmaceutical Counterfeiting Busts Fell in 2012

    An annual report just issued by the US Customs and Border Patrol (CBP) shows that counterfeit and pirated goods experienced "explosive growth" in 2012, causing problems for healthcare product regulators who continue to struggle with ways to prevent counterfeit products from entering the supply chain. The Scale of the Problem: Big, but less so for Pharmaceuticals Purveyors of counterfeiters often use a tried-and-true tactic to get counterfeit products into the country:...
  • Security Agency Warns About Medical Device Vulnerabilities

    The US Department of Homeland Security (DHS) issued a warning on 4 May regarding the potential for medical devices to be compromised by hackers, saying "health care entities need to take [the threat] very seriously." The report, " Attack Surface: healthcare and Public Health Sector ," put out by DHS's National Cybersecurity and Communications Integration Center (NCCIC), says the US Food and Drug Administration (FDA) currently "cannot regulate medical device use or users,...