Program Details
2025-07-24 13:00:00
Over 1,000+ webinars
Course Overview
2025-07-24 13:00:00
2h CLE Credits
Intermediate
2
1:00 pm - 1:05 pm ESTThis session covers recent developments in the EU AI Act implementation and its impact on medical device classification. State-level AI legislation from Colorado and Texas is also examined, including neural data protections and responsible AI governance requirements.
Rachel V. Rose.
Eric Henry 1:05 pm - 1:30 pm ESTParticipants will learn fundamental cybersecurity definitions including the CIA triad (Confidentiality, Integrity, Availability) and key regulatory bodies like CISA and NIST. The session also explores AI categories—predictive, generative, and agentic—along with the five principles for AI compliance in healthcare settings.
Rachel V. Rose.Eric Henry 1:30 pm - 2:00 pm ESTThis comprehensive session examines enforcement authority across DOJ, FTC, HHS OCR, and SEC regarding medical device cybersecurity. Key topics include HIPAA Security Requirements, the H.R. 7898 safe harbor provisions, and international considerations such as GDPR compliance for global organizations.
Rachel V. Rose.Eric Henry 2:00 pm - 2:10 pm ESTA short break allowing participants to refresh before diving into detailed cybersecurity risk management topics. Use this time to review notes and prepare questions for the remaining sessions.
Rachel V. Rose.Eric Henry 2:10 pm - 2:25 pm ESTThis session reviews the June 2025 FDA guidance and comprehensive cybersecurity literature for medical devices across U.S. and international frameworks. Key industry standards from AAMI, IMDRF, and IEC are examined alongside Health Sector Coordination Council resources.
Rachel V. Rose.Eric Henry 2:25 pm - 2:50 pm ESTParticipants explore ten common themes in regulatory literature including threat modeling, SBOMs, design controls, and incident response programs. The session covers the complete software lifecycle from planning through validation, with special attention to cloud considerations and common device deficiencies found during audits.
Rachel V. Rose.Eric Henry 2:50 pm - 3:00 pm ESTThis session presents five key strategies for successfully navigating inspections, audits, and regulatory submissions. Learn how to map cybersecurity activities to design controls, leverage consensus standards, and prepare for remote FDA inspections authorized under the December 2022 omnibus bill.
Rachel V. Rose.Eric Henry 3:00 pm - 3:10 pm ESTThe final session covers the seven fundamental compliance program elements evaluated by HHS OIG and DOJ, from written policies to risk assessments. AI-specific risk mitigation strategies are addressed, including algorithm integrity concerns and the current FDA limitations on adaptive algorithms.
Rachel V. Rose.Eric HenryRachel V. Rose, JD, MBA has a unique background in healthcare, securities, cybersecurity, and international law. 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.
Eric Henry is a 35-year veteran of the high-tech and medical device industries, now focusing 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.
Rachel V. Rose, JD, MBA has a unique background in healthcare, securities, cybersecurity, and international law. 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.
Eric Henry is a 35-year veteran of the high-tech and medical device industries, now focusing 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.
Requirements
The Alabama State Bar MCLE Commission requires attorneys to complete 12 credits, including 1 ethics, by December 31 of each year. All credits must be reported by February 15 of the following year. A maximum of 12 credits, including 1 ethics credit, may be carried over for 1 year only.
Formats
