FDA Safety Communication: Cybersecurity for Medical Devices and Hospital Networks

by Sabrina I. Pacifici on June 13, 2013

News release: “Many medical devices contain configurable embedded computer systems that can be vulnerable to cybersecurity breaches. In addition, as medical devices are increasingly interconnected, via the Internet, hospital networks, other medical device, and smartphones, there is an increased risk of cybersecurity breaches, which could affect how a medical device operates. Recently, the FDA has become aware of cybersecurity vulnerabilities and incidents that could directly impact medical devices or hospital network operations, including:

  • Network-connected/configured medical devices infected or disabled by malware;
  • The presence of malware on hospital computers, smartphones and tablets, targeting mobile devices using wireless technology to access patient data, monitoring systems, and implanted patient devices;
  • Uncontrolled distribution of passwords, disabled passwords, hard-coded passwords for software intended for privileged device access (e.g., to administrative, technical, and maintenance personnel);
  • Failure to provide timely security software updates and patches to medical devices and networks and to address related vulnerabilities in older medical device models (legacy devices);
  • Security vulnerabilities in off-the-shelf software designed to prevent unauthorized device or network access, such as plain-text or no authentication, hard-coded passwords, documented service accounts in service manuals, and poor coding/SQL injection.”

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