| Title:
FDA Items for Patients, Providers, and Medical Companies to Appreciate
Presenter: Rachel V. Rose, JD, MBA – Attorney at Law Time: 45.14 minutes
Description:
Education is critical for FDA pre- and post-approval processes. Rachel Rose, Attorney at Law, outlines these processes, discusses cybersecurity and AI risks, and considers potential implications to FDA law
Objectives: -
Review the FDA and its history.
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Appreciate the approval process for medical devices, including the role of institutional review boards (IRBs).
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Learn how to mitigate cybersecurity and GenAI risk for providers and patients.
- Understand how the Loper opinion may impact certain aspects of FDA law.
Key Topics:
- FDA Overview
- The Approval Process for Medical Devices
- How to Mitigate Cybersecurity and GenAI Risk
- Potential Impacts on FDA Law
Presenter:
Rachel V. Rose, JD, MBA - Principal
Ms. Rose has a unique background. Throughout her career, she has accumulated knowledge in a multitude of fields, with an emphasis on various facets of healthcare. Her experience includes: - Working on Wall Street and at one of the "Big Four" consulting firms
- Producing for the Chairman of the Reform and Oversight Committee on Capitol Hill
- Interning at the Department of Health and Human Services
- Compiling policy papers at the Royal College of Nursing in London
- Consultative work as a top performing representative for the pharmaceutical and medical device industry
- Clerking for the Honorable Linda R. Allan (6th Judicial Circuit, FL)
Prior to opening her law firm, Ms. Rose was Director of Business Development and Assistant General Counsel for a healthcare advisory company.
Ms. Rose is extensively published and presents on a variety of healthcare, False Claims Act, and securities law topics, including: cybersecurity, qui tam, physician reimbursement, ICD-10, access to care, anti-kickback and Stark laws, U.S. Supreme Court cases impacting the medical device industry, international comparative healthcare laws, and the HIPAA/the HITECH Act.
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