The FDA recommends that medical device manufacturers and health care facilities take steps to evaluate their network security and to assure that appropriate safeguards are in place to reduce the risk of failure due to cyber attack, which could be initiated by the introduction of malware into the medical equipment or unauthorized access to configuration settings in medical devices and hospital networks. 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 smart phones, 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, smart phones 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.

The FDA is not aware of any patient injuries or deaths associated with these incidents nor does it have any indication that any specific devices or systems in clinical use have been purposely targeted at this time. The FDA has been working closely with other federal agencies and manufacturers to identify, communicate, and mitigate vulnerabilities and incidents as they are identified.

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