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Event Details

Medical Device Risk Management and Assessment Methods

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Dates: May 2, 2017 - 2:30 p.m. to 4 p.m. (eastern)

Location: Webinar (in conjunction with the Nebraska Hospital Association)

Registration Deadline: April 26, 2017

Online registration for this program has closed. Please contact HAP Education Services at (717) 561-5270, if you would like to register for this event.

Medical device risk management and assessment activities support hospitals’ and health systems’ efforts to create secure medical device networks for patient safety and privacy. This webinar will explain methods for risk management and assessment across the device life cycle. It will explain how the medical device risk assessment platform (MDRAP) facilitates assessments, education of staff, and assessment sharing.

Program Objectives

  • Describe risk management and assessment methodologies across the life cycle of medical devices, from design to retirement
  • Explain risk management and assessment methodologies to support hospital and health system medical device network design
  • Discuss trends in the medical device procurement process and understand challenges and risks in common procurement processes and discuss strategies to mitigate the risks

 

Faculty

Phillip M. Englert
National Director of Technology Operations – Physical Asset Services
Catholic Health Initiatives

A recognized thought leader responsible for developing and delivering support initiatives for health care technology, Phil Englert leads medical device cybersecurity initiatives, a medical device self-insurance extended warranty program, and the business resilience team for Catholic Health Initiatives. He also operationalized medical device security risk assessment and a multi-disciplinary standard configuration team to reduce vulnerability footprint on clinical equipment. He has activity collaborated with DHS, FDA, NH-ISAC, and several manufacturers and health care providers to advance the cyber information sharing in the health care community. Mr. Englert leads collaborative efforts with emergency management and information technology infrastructure leaders to support business continuity planning at CHI care delivery facilities and supporting services. His specific areas of interest include comprehensive benchmarking of health care technology maintenance activities for over 100 acute care centers to optimize and amplify business unit strengths through data drive decision support.  Mr. Englert, a Thomas More College graduate, has worked for Catholic Health Initiatives since 1994 and has over 31 years of experience in technical service and management of health care and scientific technologies.  He expanded his skills and expertise through affiliates with COHR Masterplan, Labtronics, Inc., Fisher Scientific, Instrumentation Laboratories, Langham-Mathis Instruments, and the United States Air Force.

Ken Hoyme
Distinguished Scientist
Adventium Labs

Ken Hoyme has over 30 years experience in the design and development of safety-critical, real-time, fault-tolerant, and secure systems in a variety of regulated domains, including medical systems, commercial and military avionics, industrial automation, and space systems.  He is a recognized expert in the field of systems engineering.  Mr. Hoyme is the co-chair of the AAMI Device Security working group, which is developing guidance for the application of medical safety risk standard ISO 14971 to security risk management and serves on AAMI’s Systems Engineering Advisory Board.  At Adventium Labs, Mr. Hoyme’s research focus was on safety and security-critical architectures and risk management methods for cyberphysical systems in a variety of domains, including medical devices.  Prior to joining Adventium Labs, Mr. Hoyme was a Senior Fellow at Boston Scientific where he was the systems lead for the development of the LATITUDE Remote Patient Management system.  He was also the technical focal for developing standards for interconnecting implantable cardiac device data to electronic medical records systems. Prior to joining Boston Scientific, he spent 18 years at Honeywell’s Corporate Research lab, where he was a senior fellow in their real-time computer systems group. He was awarded the H.W. Sweatt Award, Honeywell’s highest technical recognition for his work on the Boeing 777. He has been granted 27 US patents. He is a member of IEEE and INCOSE.  He received Bachelors and Master’s degrees in Electrical Engineering from the University of Minnesota.

Steve Abrahamson
Senior Director of Product Security
GE Healthcare
Waukesha, Wisconsin

Steve Abrahamson is senior director of Product Security at GE Healthcare, based in his hometown of Waukesha, Wisconsin. He leads the GE Healthcare Product Cyber Security organization in development and implementation of the GE Healthcare Design Engineering Privacy and Security process across all global product lines, as well as development of security systems and tools, integration of security within strategic software programs, and development of collaborative approaches with customers, regulators, and industry groups. He has promoted systemic risk-based approaches for health care security through frequent speaking engagements including the FDA Workshop on Collaborative Approaches for Healthcare Cyber Security, US Information Security and Privacy Advisory Board, National Academy of Sciences Innovation Forum, HHS/NIST HIPAA Security Conference, HIMSS, mHealth, Advmed, AAMI, and the SANS Healthcare Cybersecurity Summit, and recently served as chairperson for the Medical Device Cybersecurity Risk Mitigation Conference. Prior to joining GE, Mr. Abrahamson worked at Texas Instruments in various technical management roles supporting precision-guided weapons programs within their Defense Electronics Group.  He is a certified Six Sigma Black Belt and Master Black Belt, and has a Bachelor’s Degree in Mechanical Engineering from Marquette University and a MBA from the University of Dallas.

Who Should Attend

This webinar will be of particular interest to all stakeholders with interest in, or responsibility for, the cyber security and data protection in the health care environment. This includes executive leadership, clinical leadership, IT security and governance leaders, biomedical staff

Pricing and Registration Information

Fee

$199 HAP Member Rate (includes 1 phone line/web connection per site. Additional phone lines will be billed at $199)

$299 Non-Member Rate (includes 1 phone line/web connection per site. Additional phone lines will be billed at $299)

Fee includes handout materials forwarded via email prior to the session.

Registration Cancellation Policy

No refunds will be issued for cancellations received after April 27. There is a $25 administrative fee on all cancellations. Cancellations must be received in writing.

The registration deadline is April 26.

Certificate of Attendance

A general certificate of attendance will be emailed to all participants. Some national, state, and local licensing boards and professional organizations will grant continuing education credits for attendance when you submit the course outline (save the brochure) and your certificate of attendance. It is recommended you contact your own board or organization to find out what is required.

How the Webinar Will Work

There is no limit to the number of staff from your office per connection who can tune in to the seminar via speakerphone and computer. Additional connections dialing/logging in will be billed. Enjoy the benefits of attending a live conference without having to leave the office.

Upon receipt of registration, confirmation will be emailed to the registrant. Dial-in instructions will be emailed to each registrant’s email address approximately 48 hours prior to the program, including information on how to obtain handout materials for the conference. If you do not receive an email by this date, please email HAP_Education_Services@HAPonline.org.

Please register only one name per connection.

Questions

For registration information, or if you need special accommodations, please contact HAP Education Services at (717) 561-5270.

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