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2025-07-24 13:00:00

2 Credits

Medical device cybersecurity regulatory landscape: FDA guidance, HIPAA compliance, risk management frameworks, and liability mitigation strategies for legal professionals.

2025-07-24 13:00:00

Medical device cybersecurity regulatory landscape: FDA guidance, HIPAA compliance, risk management frameworks, and liability mitigation strategies for legal professionals.

2025-07-24 13:00:00

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1000+

Live stream programs

24/7

Access to live webinars & recordings

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Trusted by Legal Professionals

1000+

Live stream programs

24/7

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70,000+

Trusted by Legal Professionals

Key topics that will be covered

What will you learn

Attorneys will learn the evolving legal and regulatory framework surrounding cybersecurity risks in medical devices, including liability exposure, regulatory requirements, and risk mitigation strategies.

What will you gain

Attorneys will gain expertise in defending cybersecurity practices during inspections, audits, and submissions while understanding enforcement actions from DOJ, FTC, HHS OCR, and SEC.

Regulatory Framework
FDA, HIPAA, state laws, and international regulations governing medical device cybersecurity.
AI Compliance
EU AI Act implementation and state-level AI legislation affecting medical devices.
Enforcement Agencies
DOJ, FTC, HHS OCR, and SEC authority over medical device cybersecurity enforcement.
Risk Management
Threat modeling, vulnerability assessments, and software bill of materials requirements.
Design Controls
Incorporating cybersecurity into device design, verification, and validation processes.
Defense Strategies
Mapping cybersecurity activities to design controls and consensus standards during inspections.

What will you learn

Attorneys will learn the evolving legal and regulatory framework surrounding cybersecurity risks in medical devices, including liability exposure, regulatory requirements, and risk mitigation strategies.

What will you gain

Attorneys will gain expertise in defending cybersecurity practices during inspections, audits, and submissions while understanding enforcement actions from DOJ, FTC, HHS OCR, and SEC.

Agenda

Session 1

Noteworthy News in AI and Privacy Legislation

Session 2

Common Cybersecurity and AI Terminology Essentials

Session 3

Navigating the Current Medical Device Regulatory Landscape

Session 4

Break

Session 5

Healthcare Cybersecurity Issues and Risk Management Overview

Session 6

Medical Device Cybersecurity Design Controls Deep Dive

Session 7

Strategies for Defending Your Cybersecurity Practices

Session 8

Comprehensive Risk Mitigation and Compliance Programs

clock 1:00 pm - 1:05 pm EST

Noteworthy News in AI and Privacy Legislation

Rachel V. Rose

Rachel V. Rose – Attorney at Law, PLLC

Eric Henry

Brooke & Associates

This 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

Rachel V. Rose – Attorney at Law, PLLC

Eric Henry

Brooke & Associates

clock 1:05 pm - 1:30 pm EST

Common Cybersecurity and AI Terminology Essentials

Rachel V. Rose

Rachel V. Rose – Attorney at Law, PLLC

Eric Henry

Brooke & Associates

Participants 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

Rachel V. Rose – Attorney at Law, PLLC

Eric Henry

Brooke & Associates

clock 1:30 pm - 2:00 pm EST

Navigating the Current Medical Device Regulatory Landscape

Rachel V. Rose

Rachel V. Rose – Attorney at Law, PLLC

Eric Henry

Brooke & Associates

This 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

Rachel V. Rose – Attorney at Law, PLLC

Eric Henry

Brooke & Associates

clock 2:00 pm - 2:10 pm EST

Break

Rachel V. Rose

Rachel V. Rose – Attorney at Law, PLLC

Eric Henry

Brooke & Associates

A 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

Rachel V. Rose – Attorney at Law, PLLC

Eric Henry

Brooke & Associates

clock 2:10 pm - 2:25 pm EST

Healthcare Cybersecurity Issues and Risk Management Overview

Rachel V. Rose

Rachel V. Rose – Attorney at Law, PLLC

Eric Henry

Brooke & Associates

This 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

Rachel V. Rose – Attorney at Law, PLLC

Eric Henry

Brooke & Associates

clock 2:25 pm - 2:50 pm EST

Medical Device Cybersecurity Design Controls Deep Dive

Rachel V. Rose

Rachel V. Rose – Attorney at Law, PLLC

Eric Henry

Brooke & Associates

Participants 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

Rachel V. Rose – Attorney at Law, PLLC

Eric Henry

Brooke & Associates

clock 2:50 pm - 3:00 pm EST

Strategies for Defending Your Cybersecurity Practices

Rachel V. Rose

Rachel V. Rose – Attorney at Law, PLLC

Eric Henry

Brooke & Associates

This 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

Rachel V. Rose – Attorney at Law, PLLC

Eric Henry

Brooke & Associates

clock 3:00 pm - 3:10 pm EST

Comprehensive Risk Mitigation and Compliance Programs

Rachel V. Rose

Rachel V. Rose – Attorney at Law, PLLC

Eric Henry

Brooke & Associates

The 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

Rachel V. Rose – Attorney at Law, PLLC

Eric Henry

Brooke & Associates

01 08
Prev
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speakers

Joe Ervin

The Law Firm for Truck Safety, LLP
A Partner at The Law Firm for Truck Safety. He focuses exclusively on cases involving commercial motor vehicle crashes and wrongful death. Joe also holds a valid class “A” commercial driver’s license with endorsements for double/triple trailers and tankers.

Education & Credentials

A 2013 graduate of the Gerry Spence Trial Lawyers College in Dubois, Wyoming, Joe is rated AV Preeminent™ by Martindale-Hubbell — the highest peer rating for exceptional legal ability and ethics. He is among the first nine attorneys nationwide to earn board certification in Truck Accident Law from the National Board of Trial Advocacy.

Recognition & Leadership

Joe received the Roadway Safety Award from the American Association for Justice (AAJ) for his commitment to improving highway safety.
 He currently serves as Co-Chair of the Academy of Truck Accident Attorneys (ATAA) Safety Committee, advocating for higher safety standards across the trucking industry.

Professional Involvement

Joe serves on the faculty of the AAJ Advanced Trial Advocacy College: Litigating Truck Collision Cases (2015 & 2024).
 He is an active member of AAJ’s Trucking Litigation Group and sits on the Board of Regents for the Academy of Truck Accident Attorneys.

Experience

Joe frequently consults and co-counsels on complex commercial truck cases. His proven track record includes numerous successful trials against motor carriers and truck leasing companies — delivering justice for victims of commercial vehicle accidents.

Kevin Foley

Reminger Co
A Partner at The Law Firm for Truck Safety. He focuses exclusively on cases involving commercial motor vehicle crashes and wrongful death. Joe also holds a valid class “A” commercial driver’s license with endorsements for double/triple trailers and tankers.

Education & Credentials

A 2013 graduate of the Gerry Spence Trial Lawyers College in Dubois, Wyoming, Joe is rated AV Preeminent™ by Martindale-Hubbell — the highest peer rating for exceptional legal ability and ethics. He is among the first nine attorneys nationwide to earn board certification in Truck Accident Law from the National Board of Trial Advocacy.

Recognition & Leadership

Joe received the Roadway Safety Award from the American Association for Justice (AAJ) for his commitment to improving highway safety.
 He currently serves as Co-Chair of the Academy of Truck Accident Attorneys (ATAA) Safety Committee, advocating for higher safety standards across the trucking industry.

Professional Involvement

Joe serves on the faculty of the AAJ Advanced Trial Advocacy College: Litigating Truck Collision Cases (2015 & 2024).
 He is an active member of AAJ’s Trucking Litigation Group and sits on the Board of Regents for the Academy of Truck Accident Attorneys.

Experience

Joe frequently consults and co-counsels on complex commercial truck cases. His proven track record includes numerous successful trials against motor carriers and truck leasing companies — delivering justice for victims of commercial vehicle accidents.

Grant H. Lawson

The Law Firm for Truck Safety, LLP
A Partner at The Law Firm for Truck Safety. He focuses exclusively on cases involving commercial motor vehicle crashes and wrongful death. Joe also holds a valid class “A” commercial driver’s license with endorsements for double/triple trailers and tankers.

Education & Credentials

A 2013 graduate of the Gerry Spence Trial Lawyers College in Dubois, Wyoming, Joe is rated AV Preeminent™ by Martindale-Hubbell — the highest peer rating for exceptional legal ability and ethics. He is among the first nine attorneys nationwide to earn board certification in Truck Accident Law from the National Board of Trial Advocacy.

Recognition & Leadership

Joe received the Roadway Safety Award from the American Association for Justice (AAJ) for his commitment to improving highway safety.
 He currently serves as Co-Chair of the Academy of Truck Accident Attorneys (ATAA) Safety Committee, advocating for higher safety standards across the trucking industry.

Professional Involvement

Joe serves on the faculty of the AAJ Advanced Trial Advocacy College: Litigating Truck Collision Cases (2015 & 2024).
 He is an active member of AAJ’s Trucking Litigation Group and sits on the Board of Regents for the Academy of Truck Accident Attorneys.

Experience

Joe frequently consults and co-counsels on complex commercial truck cases. His proven track record includes numerous successful trials against motor carriers and truck leasing companies — delivering justice for victims of commercial vehicle accidents.

Rachel V. Rose

Rachel V. Rose – Attorney at Law, PLLC

Eric Henry

Brooke & Associates

Rachel V. Rose

Rachel V. Rose – Attorney at Law, PLLC

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.

Education & Credentials

MBA with minors in healthcare and entrepreneurship from Vanderbilt University, law degree from Stetson University College of Law, and an Executive Certification in Leadership and Negotiation from Harvard Law School.

Recognition & Leadership

Named consecutively to the Texas Bar College, National Women Trial Lawyers Association's Top 25, Houstonia Magazine's Top Lawyers (healthcare), National Trial Lawyers Association's Top 100, SuperLawyers (healthcare), and 1st Healthcare Compliance's 2019 and 2022 Top Presenter. Extensively published, sought-after presenter, and quoted expert. Co-editor of the American Health Lawyers Association's Enterprise Risk Management Handbook for Healthcare Entities (2nd Edition), 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.

Professional Involvement

Affiliated Member with Baylor College of Medicine's Center for Medical Ethics and Health Policy, where she teaches bioethics.

Experience

Worked on Capitol Hill when HIPAA passed in 1996 and at HHS in 2009 when the HITECH Act was being implemented. Has conducted HIPAA Risk Analyses for domestic and international organizations and represented persons related to government enforcement inquiries and responses on cybersecurity and healthcare related matters.

Rachel V. Rose

Rachel V. Rose – Attorney at Law, PLLC

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.

Education & Credentials

MBA with minors in healthcare and entrepreneurship from Vanderbilt University, law degree from Stetson University College of Law, and an Executive Certification in Leadership and Negotiation from Harvard Law School.

Recognition & Leadership

Named consecutively to the Texas Bar College, National Women Trial Lawyers Association's Top 25, Houstonia Magazine's Top Lawyers (healthcare), National Trial Lawyers Association's Top 100, SuperLawyers (healthcare), and 1st Healthcare Compliance's 2019 and 2022 Top Presenter. Extensively published, sought-after presenter, and quoted expert. Co-editor of the American Health Lawyers Association's Enterprise Risk Management Handbook for Healthcare Entities (2nd Edition), 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.

Professional Involvement

Affiliated Member with Baylor College of Medicine's Center for Medical Ethics and Health Policy, where she teaches bioethics.

Experience

Worked on Capitol Hill when HIPAA passed in 1996 and at HHS in 2009 when the HITECH Act was being implemented. Has conducted HIPAA Risk Analyses for domestic and international organizations and represented persons related to government enforcement inquiries and responses on cybersecurity and healthcare related matters.

Eric Henry

Brooke & Associates

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.

Professional Involvement

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

Experience

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, worked at law firms King & Spalding and Brooke & Associates advising on medical device regulatory compliance.

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Special credits (Ethics, Elimination
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Why Attend

Why this 
program matters

Understanding medical device cybersecurity regulations is essential for legal practitioners to advise clients on navigating complex FDA requirements, HIPAA compliance, and multi-agency enforcement risks that carry multi-million dollar liability exposure.
$10M+
Average cost of a U.S. healthcare data breach in 2025, according to the IBM Cost of a Data Breach Report.
846M+
Total individuals affected by healthcare data breaches reported to HHS OCR between 2009 and 2024, per HIPAA Journal.
1.2k+
AI-enabled medical devices authorized by the FDA as of mid-2025, reflecting rapid growth in regulated health technologies.
80%+
Stolen protected health information records taken from third-party vendors rather than hospitals, according to American Hospital Association.

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