FDA law firm Gardner Law and EU-based Fieldfisher discuss regulatory, compliance, and privacy matters relevant to high-tech healthcare products.

• Harnessing AI and Connected Devices in Medical Innovation in an FDA-Compliant Manner
• OIG and CMS fraud and Abuse Considerations for Compliance in High-Tech Healthcare
• Managing Privacy and Cybersecurity Risks in Connected Devices
• EU Compliance and Regulatory Update
• Panel Discussion: Q&A with general counsel from industry on related topics

Live and virtual attendance options:

• In person - Kimpton Shorebreak, Huntington Beach Resort
• Remote – Attendees will be sent a link during the registration process

Presenters

FULL EVENT AGENDA

9:00 – 9:05 AM Program Introduction

Speaker: Mark Gardner

9:05 – 10:00 AM Session 1- Compliance Considerations in High-Tech Healthcare

Join us for an informative session that addresses key healthcare compliance challenges linked to connected devices and AI technology. In this session, we will discuss:

• Recent developments in DME technology and associated compliance considerations
• Relevance of the Anti-Kickback Statute in AI technology partnerships and strategies for compliance
• Avoiding the practice of medicine in the provision of AI/ML technology
• False Claims Act implications related to cybersecurity in healthcare and strategies for mitigation
• EU compliance including country-specific updates (Germany, Italy, and The Netherlands)

Speakers: Amanda Johnston and Cord Willhöeft

10:00 – 10:45 AM Session 2 - Preparation and Opportunity: Managing Privacy and Cybersecurity Risks in Connected Devices

Designing your medical technology with privacy and cybersecurity in mind is critical to success in today’s market. We will discuss how:

• Business models, data security, and device design decisions can impact not only privacy risk but product sales
• Data collection and use are impacted by current laws and regulations
• To use contracts and consent to leverage data

Speakers: Paul Rothermel and Oliver Süme

10:45 – 11:00 AM - BREAK

11:00 – 11:45 AM Session 3 - FDA Engagement Strategies: Harnessing AI and Connected Devices in Medical Innovation

To bring cutting-edge medical technologies to market, companies must understand how to engage with the FDA effectively. In this session, we will discuss:

• FDA's evolving regulatory framework for AI-powered medical devices and connected devices, including recent updates and future trends
• How to effectively engage and interact with the FDA, including successful approaches and potential pitfalls to avoid
• Unique regulatory considerations for AI/ML and connected devices
• Regulatory Update for the EU, Switzerland and UK

Speakers: Nathan Downing and Cord Willhöeft

11:45 – 12:30 PM Session 4 - Panel Discussion

• Q&A with general counsel from industry on various regulatory topics

Moderator: Mark Gardner

12:30 PM - Luncheon (heavy apps and beverages on the Terrace)

Complimentary event: Approved for 3 MN CLE credits. A Uniform Certificate of Attendance is available for other jurisdictions.

Attendees include in-house general counsel, corporate attorneys, compliance officers, regulatory lawyers, executives, and allied non-lawyer professionals that work in the medical technology, pharmaceutical, biotechnology, and diagnostics industries.