Tackling Medical Device Cybersecurity

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1 Tackling Medical Device Cybersecurity Anthony J. Coronado Methodist Hospital of Southern California Biomedical Engineering Manager

2 Overview of Initiative With the advancement of technology in the design of medical devices, in regards to electronic patient information (ephi) and network integration, Methodist Hospital of Southern California s Biomedical Engineering team recognized the need to manage medical devices by defining the vulnerabilities associated by each device and developing an Integrated Systems Management program. This advancement in technology has improved workflow and information management activities, but has also introduced new vulnerabilities to patient safety, information availability, and cybersecurity. In a recent published market research, it is estimated that as many as 61 % of the electronic medical devices in a typical healthcare organization today are networked in some way [1].

3 Overview of Initiative Who is responsible for the technical support of the new medical device technology, Biomed or IT? For years now, hospital IT departments have been implementing physical, technical, and administrative controls to protect their enterprise information systems (safeguards). The main challenge for IT department to integrate medical devices are the varied configurations of hardware and software present in each kind of system. As technology has advanced, so must healthcare organizations and Methodist Hospital realized that in order to address the risks associated, we had to implement an Integrated Systems Management (ISM) Program.

4 Integrated System

5 Integrated Systems Management The new framework incorporates the best practices of management engineering to shift the focus from managing individual components to supporting the system.

6 Incoming and Risk Assessment Does the equipment store/transmit electronic patient health information? Conduct an initial risk assessment that includes 57 questions during an incoming inspection and on existing systems through out the facility. Part of the 57 question assessment is an interview with the end user to determine how the medical device is used, what information is being stored, and how is the information is being transmitted. Obtain Medical Device Security (MSD2) forms from corresponding vendors. Based on the assessment, conduct an Integrated Systems management Security Assessment Review your healthcare organization s policy and procedures that effect information security. Provide a quantified risk score for: Confidentiality, Integrity, and Availability Identify the mitigation needs for each system, which identifies all vulnerabilities. Review medical device s software agreements to identify the customers responsibilities.

7 Sample Risk Assessment

8 Mitigation Phase Can the system be included on the hospital organization's IT domain to take advantage of their safeguards? What are the IT domain requirements and how can the system be upgraded to meet them? OS requirements Contact the manufacturer to verify if systems can be updated. Develop a Project Management Plan to incorporate the IT department. Develop mitigation plans for each system Communicate the plan and obtain IT approval before conducting the mitigation based on their policy and procedures for security. Communicate with related department personnel on the security changes and educate about cybersecurity awareness. Provide change management on all mitigation events and document all changes under the service history of the corresponding equipment. The new technology requires the redefying of medical equipment management and a collaborative relationship between CE and IT needs to be established, but most importantly a mutual cultural change is needed in both departments.

9 Medical Devices

10 Medical Devices

11 Reinventing Preventive Maintenance Incorporating ISM activities to the current PM procedure after mitigation is achieved. Verifying virus protection Providing vendor approved patch management Hardware management (i.e. Servers, workstations) Disaster recovery (i.e. Backups, hard drive ghosting) Data security Policies and procedures enforcement Manual Safe Guard Management Password management per hospital policy Login monitoring and auditing Windows maintenance Software updates Manual lock ups

12 Outcomes Advisor - Support Clinicians & IT throughout system selection, installation and support phases of system implementations Manager - Coordinate migration of patient care devices to network platforms Maintainer - Apply & enforce IT system management policies to mitigate risks introduced by network exposure in coordination with vendor FDA medical device classification

13 Outcomes

14 Outcomes Making a Cybersecurity Aware Facility requires a change in the culture at your facility. Materials Management must ask vendors if their technology matches their facility s security requirements and make sure the hospital purchases network compatible devices that have a well documented security features and which can be configured safely to the hospital network. Ongoing mitigation activity reports must be presented to EOC/Safety Committees for trends identification and security measure implementation. Continual training for the Biomedical Engineering on Cybersecurity, focusing on a proper risk assessment, mitigation activities, and continual management. Continual training with the end user to make them aware of the safeguards established at their facility and making them aware of the risks. With the combination of Hospital's IT Security Policies and Procedures with an Integrated Systems Management Program, a well rounded cybersecurity program can be established which ensures patient safety and continual success.

15 References [1] Ness, D., and Lambie, B. Raising the Performance Bar: Gauging Asset Management Improvement in a Government. Proceeding from Clients Driving Innovation International Conference, (2004)

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