Cybersecurity threats to medical devices are a growing concern. In an effort to make new devices more secure, the FDA will begin refusing medical device submissions on the basis of cybersecurity starting Oct. 1st, 2023. This pivotal change is likely to have far-reaching impact on the entire healthcare industry.

Join expert hosts, Samantha Jacques, Vice President, Clinical Engineering at McLaren Health Care, and Kate Pierce, Senior Virtual Information Security Officer at Fortified Health Security, as they discuss:

  • This new legislation and why it’s happening now
  • The impact on the FDA, medical device manufacturers, providers, health systems, and legacy devices
  • How to prepare your healthcare organization as an IT leader

About the presenters

Samantha Jacques
Vice President, Clinical Engineering

Samantha Jacques, PhD, FACHE, AAMIF, manages Services throughout the McLaren system, including 13 hospitals, ambulatory surgery centers, imaging centers, and Michigan’s largest network of cancer centers. Prior to McLaren, she was Director of Clinical Engineering at Penn State Health and Texas Children’s Hospital. She is a Fellow in the American College of Healthcare Executives and AAMI. She sits on the AAMI board and is an executive committee member of the Health Sector Coordinating Council – Cybersecurity. In 2020, she published a book titled “Introduction to Clinical Engineering”. She has a BS in Biomedical Engineering from Milwaukee School of Engineering and a PhD in Biomedical Engineering from Louisiana Tech University.

Kate Pierce
Senior vCISO
Fortified Health Security

With over 30 years of experience in healthcare information technology, and over 13 years in healthcare cybersecurity, Kate Pierce has deep insight into the persistent challenge of improving security with increasingly limited resources. During her tenure as the CIO and CISO at a Critical Access Hospital, Kate spearheaded the creation of the organization’s security program, encompassing governance, strategic planning, and the selection and rollout of security controls. To further the cause of cybersecurity in healthcare, Kate actively collaborates with the HSCC CWG and the 405(d) program, and consistently advocates at the federal and state levels to fortify cybersecurity within healthcare organizations.