547,427 active members*
1,712 visitors online*
Register for free
Login Register

Perfection in Protection, Licensing, and Security

Protecting Medical Device Endpoints

January 2017
Author: Wibu-Systems
Protecting Medical Device Endpoints

The US FDA recently published new recommendations for both manufacturers and regulators to address medical device cybersecurity. The final document, Postmarket Management of Cybersecurity in Medical Devices: Guidance for Industry and Food and Drug Administration Staff, was issued on December 28, 2016.

In its guidance, the FDA said it "recognizes that medical device cybersecurity is a shared responsibility among stakeholders including health care facilities, patients, providers, and manufacturers of medical devices. Failure to maintain cybersecurity can result in compromised device functionality, loss of data (medical or personal) availability or integrity, or exposure of other connected devices or networks to security threats. This in turn may have the potential to result in patient illness, injury or death."

The report further noted that "A growing number of medical devices are designed to be networked to facilitate patient care. Networked medical devices, like other networked computer systems, incorporate software that may be vulnerable to cybersecurity threats . . . . manufacturers are encouraged to address cybersecurity throughout the product lifecycle, including during the design, development, production, distribution, deployment and maintenance of the device."

In the wake of the ongoing security concerns surrounding the IoT, security by design is a concept that manufacturers of all types of connected devices, including medical equipment, are taking into consideration.

The best way to combat cyberthreats is for manufacturers to consider #cybersecurity throughout the total product lifecycle of a device.

Suzanne B. Schwartz, Associate director for Science and Strategic Partnerships, at the Center for Devices and Radiological Health, commented in the FDA Voice, that “The best way to combat these threats is for manufacturers to consider cybersecurity throughout the total product lifecycle of a device. In other words, manufacturers should build in cybersecurity controls when they design and develop the device to assure proper device performance in the face of cyber threats, and then they should continuously monitor and address cybersecurity concerns once the device is on the market and being used by patients.”

The endpoint security approach addresses several vulnerability areas:

  • physical security to prevent uncontrolled changes to or the removal of the endpoint
  • root of trust to provide confidence on the endpoint identity
  • integrity protection to ensure that the endpoint is in the configuration that enables it to perform its functions predictably
  • access control to ensure that proper identification, authentication and authorization protocols are performed
  • secure configuration and management control updates of security policies and configurations
  • monitoring and analysis including integrity checking, detecting malicious usage patterns or denial of service activities, and enforcing security policies and analytics
  • data protection to control data integrity, confidentiality and availability
  • security models and policies governing the implementation of security functions.

At Wibu-Systems, one of our major areas of focus is on the protection of medical device endpoints, where vulnerabilities may permit the unauthorized access, modification, or misuse. Our approach is to build multi-layered security measures directly into the design of sensors, PLCs, embedded devices, virtual systems or other connected endpoints.

For more details, Oliver Winzenried, President and CEO of WIBU-SYSTEMS AG, further explains the risks and rewards of endpoint security in his article, Protecting endpoint security of medical systems, published in Medical Device Developments magazine.


Blog Archiv

September 2021
August 2021
July 2021
June 2021
May 2021
April 2021
March 2021
February 2021
January 2021
November 2020
October 2020
September 2020
August 2020
July 2020
June 2020
May 2020
April 2020
March 2020
February 2020
January 2020
November 2019
October 2019
September 2019
August 2019
July 2019
June 2019
May 2019
April 2019
March 2019
February 2019
January 2019
December 2018
November 2018
October 2018
September 2018
August 2018
July 2018
June 2018
May 2018
April 2018
March 2018
February 2018
January 2018
December 2017
November 2017
October 2017
September 2017
August 2017
July 2017
June 2017
May 2017
April 2017
March 2017
February 2017
January 2017
December 2016
October 2016
September 2016
July 2016
June 2016
May 2016
April 2016
March 2016
February 2016
January 2016