Cybersecurity Failures and Legal Fallout in Medical Device Technology

Rachel V. Rose | Rachel V. Rose – Attorney at Law, PLLC

Rachel V. Rose, JD, MBA (Houston, Texas) has a unique background, having worked in many different facets of healthcare, securities, cybersecurity, as well as international law and business throughout her career. For over a decade, her practice has focused on transactional, compliance, and litigation matters related to cybersecurity, health care, securities, and Dodd-Frank/False Claims Act whistleblower claims. She has conducted HIPAA Risk Analyses for a variety of domestic and international organizations and represented persons related to government enforcement inquiries and responses on cybersecurity and healthcare related matters. Ms. Rose worked on Capitol Hill when HIPAA passed in 1996 and worked at HHS in 2009 when the HITECH Act was being implemented.

In addition to being extensively published, a sought-after presenter, and quoted expert, Ms. Rose holds an MBA with minors in healthcare and entrepreneurship from Vanderbilt University, a law degree from Stetson University College of Law, and an Executive Certification in Leadership and Negotiation from Harvard Law School. She is also the co-editor of the American Health Lawyers Association’s Enterprise Risk Management Handbook for Healthcare Entities (2nd Edition), as well as a co-author of the ABA’s books The ABCs of ACOs and What Are International HIPAA Considerations, as well as various chapters in legal and medical books alike.

She has been named consecutively to the Texas Bar College, the National Women Trial Lawyers Association’s Top 25, Houstonia Magazine’s Top Lawyers (healthcare), the National Trial Lawyers Association’s Top 100, SuperLawyers (healthcare), as well as 1st Healthcare Compliance’s 2019 and 2022 Top Presenter. Ms. Rose is also an Affiliated Member with the Baylor College of Medicine’s Center for Medical Ethics and Health Policy, where she teaches bioethics.

Eric Henry | Brooke & Associates

Eric Henry is a 35-year veteran of the high-tech and medical device industries having led global quality and technical organizations at firms such as the Nasdaq Stock Market, Boston Scientific, GE Healthcare, Medtronic, and Philips. After leaving industry in 2018, Eric’s work at the law firms King & Spalding and Brooke & Associates has focused on advising medical device company boards, management, and staff on medical device regulatory compliance, quality management systems, and strategic risk management, with a specific emphasis on software-enabled devices and digital health.

Eric is an adjunct faculty member at Pathway for Patient Health, a member of the AFDO/RAPS MedCon strategic committee, and an advisor to the Coalition for Health AI (CHAI) on the intersection of healthcare delivery and medical device manufacturing.

I. Noteworthy news | 1:00pm – 1:05pm

II. Common cybersecurity & artificial intelligence vernacular | 1:05pm – 1:30pm

III. The current regulatory landscape (Government contracts, HIPAA, FDA guidance, international laws & securities laws) | 1:30pm – 2:00pm

Break | 2:00pm – 2:10pm

IV. Common cybersecurity issues and risk management in healthcare | 2:10pm – 2:25pm

V. Cybersecurity design controls and risk management associated with medical devices | 2:25pm – 2:50pm

VI. Defending cybersecurity practices | 2:50pm – 3:00pm

VII. Overall risk mitigation | 3:00pm – 3:10pm