Understanding FDA Guidance on Mobile Medical Applications
Overview:On September 23, 2013, the U.S. Food and Drug Administration (FDA) issued the final guidance for mobile medical applications, confirming that the federal agency views such products to be within its regulatory authority. The guidance clarifies the focus of the regulatory activity as it pertains to a specific set of apps. All Companies should have a complete and thorough understanding of the particulars of the final rule to avoid costly errors and penalties.
The Knowledge Group has assembled a panel of key thought leaders and practitioners to provide the audience with an in-depth analysis of the final guidance on mobile medical applications.
In a two-hour live webcast, speakers will discuss:
• Mobile Medical Applications: An Overview
• How will the FDA regulate mobile medical apps?
• Mobile medical apps that the FDA will regulate
• Mobile apps for which the FDA intends to exercise enforcement discretion
• Does the FDA regulate mobile devices and mobile app stores?
• Does the guidance apply to electronic health records?
• Impact of the Final Rule
• Penalties and Exemptions
• Enforcement and Best Practices in Compliance
• Latest Regulatory Updates
Greenberg Traurig, LLP
Locke Lord LLP
The types of mobile apps the FDA intends to focus its enforcement power on. (if not already discussed by another panelist).
How the intended use of a mobile app, as demonstrated by labeling claims, advertising and marketing directly impact whether it must go through the FDA approval process.
Discuss enforcement actions, if any, that have been taken after the guidance was issued.
Who Should Attend:
- General Counsel for All Healthcare and Related Companies
- Senior Corporate Management at Healthcare and related companies
- FDA/ Life Sciences/ Health Care Law Attorneys
- Chief Technology Officer
- IP Attorneys
- Health Care Advisory Services Consultants
- Health Policy Directors
- Risk Officers
- IT Professionals
- Quality Improvement Director
- And Other Related/Interested Professionals
Eric D. Hargan is a Shareholder in Greenberg Traurig, LLP, based in its Chicago office. He focuses his practice on transactions, health care regulations and government relations. For health industry companies and investors, his experience as a senior official at the U.S. Department of Health and Human Services, combined with over two decades of experience as a transactional attorney, allow him to provide unique and advantageous insights to his clients.
Previously, Eric served in the position of Deputy Secretary of the U.S. Department of Health and Human Services. He also served as Regulatory Policy Officer of the Department, overseeing the development and approval of all HHS, FDA and CMS regulations and significant guidances. He also served as Deputy General Counsel of HHS.
Eric D. Hargan is a Shareholder in Greenberg Traurig, LLP, based in its Chicago office. He focuses his practice on transactions, …
Ginger Appleberry is an International Partner with Locke Lord LLP. She is a member of the Business Litigation and Health Care practice groups. Ms. Appleberry has experience defending pharmaceutical companies and device manufactures in False Claims Act and qui tam lawsuits including government investigations regarding pharmaceutical pricing, marketing, promotion and regulatory issues. She regularly advises clients in connection with the development, registration, protection, and enforcement of trademarks and copyrights. Ms. Appleberry also has significant experience with trust and estate litigation, fiduciary litigation, products liability, and complex commercial litigation. She can be reached at email@example.com.
Ginger Appleberry is an International Partner with Locke Lord LLP. She is a member of the Business Litigation and Health …
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Method of Presentation:
NASBA Field of Study:
Specialized Knowledge and Applications
NY Category of CLE credit:
Areas of Professional Practice
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About Greenberg Traurig, LLP
Greenberg Traurig, LLP is an international, multi-practice law firm with approximately 1750 attorneys serving clients from 36 offices in the United States, Latin America, Europe, the Middle East and Asia. Greenberg Traurig is among the Top 10 law firms on The National Law Journal’s 2013 NLJ 350, an annual ranking of the largest firms in the U.S.
GT provides integrated legal services for clients worldwide. The firm offers a multidisciplinary team, including senior lawyers who have been the chief legal officers at major multinational companies and have spent years solving real-world problems in the business, political and legal environments of major commercial centers. GT’s experience in more than 100 practice areas and their network of contacts throughout the world positions them to help clients achieve their objectives both domestically and in the global marketplace.
About Locke Lord LLP
Locke Lord is well-known nationally for its skill in the health care industry. Our health care practice litigation team includes trial lawyers who routinely represent the interests of multi-national pharmaceutical companies, medical device companies, managed care, health plan and health care insurers, hospitals, multi-hospital health systems, physicians and physician groups, academic medical centers, skilled nursing centers, and home health, hospice, and long term care facilities in a range of litigation, investigations, civil investigative demand (CID) proceedings, and threatened litigation, including high-profile matters involving billion dollar claims and cutting-edge issues. They work in tandem with the Firm's more than 650 lawyers in 11 U.S. offices, Hong Kong and London.