Cyber Security for Medical Devices and Life Science Companies

By | July 3, 2014

Many medical devices and life science companies contain configurable embedded computer systems that can be vulnerable to cyber-security breaches. In addition, as medical devices are increasingly interconnected via the Internet, hospital networks, other medical devices or smartphones, there is an increased risk of cyber-security breaches, which could affect how a medical device operates.

The Food and Drug Administration (FDA) has recently become aware of cyber-security vulnerabilities and incidents that could directly impact medical devices and Life Science Companies, 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, manufactured products 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 has been working closely with other federal agencies and manufacturers to identify, communicate and mitigate vulnerabilities and incidents as they are identified.

FDA Recommendations/Actions

For all device manufacturers:

Manufacturers are responsible for remaining vigilant about identifying risks and hazards associated with their products, including risks related to cyber security, and are responsible for putting appropriate mitigations in place to address patient safety and ensure proper device performance.

The FDA expects medical device manufacturers and Life Science to take appropriate steps to limit the opportunities for unauthorized access to medical devices. Specifically, it is recommended that manufacturers review their cyber-security practices and policies to ensure that appropriate safeguards are in place to prevent unauthorized access or modification to their medical devices and life science companies. The extent to which security controls are needed will depend on the company, its environment of use, the type and probability of the risks to which it is exposed and the probable risks to patients from a security breach.

In evaluating your device or product, consider doing the following:

  • Take steps to limit unauthorized device or product access to trusted users only, particularly for those devices that are life sustaining or could be directly connected to hospital networks.
  • Appropriate security controls may include user authentication, such as user ID and password, smartcard or biometrics; strengthening password protection by avoiding hard-coded passwords and limiting public access to passwords used for technical device access; physical locks; card readers; and guards.
  • Protect individual components from exploitation and develop strategies for active security protection appropriate for the device’s use environment. Such strategies should include timely deployment of routine, validated security patches and methods to restrict software or firmware updates to authenticated code. Note: The FDA typically does not need to review or approve product software changes made solely to strengthen cyber security.
  • Use design approaches that maintain a device or product critical functionality, even when security has been compromised, known as “fail-safe modes.”
  • Provide methods for retention and recovery after an incident where security has been compromised.
  • Cyber-security incidents are increasingly likely and manufacturers should consider incident response plans that address the possibility of degraded operation and efficient restoration and recovery.

Reporting Problems to the FDA

Prompt reporting of adverse events can help the FDA identify and better understand the risks associated with medical devices. If you suspect that a cyber-security event has impacted the performance of a medical device or has impacted a hospital network system, file a voluntary report through MedWatch, the FDA Safety Information and Adverse Event Reporting program.

Health care personnel employed by facilities that are subject to the FDA’s user facility reporting requirements should follow the reporting procedures established by their facilities.

Device manufacturers must comply with the Medical Device Reporting (MDR) regulations.

Contact the cyber security professionals at The Buckner Company today to discuss how to keep your health care facility safe and secure from cyber threats.

 

Source: FDA

 

Information provided by :

Josh Creer

Life Science Risk Manager

801-937-6757

jcreer@buckner.com

 

Cyber Security for Medical Device and Life Science Companies

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