November 9th, 2023
9:00 AM - 12:30 PM PST
Kimpton Shorebreak, Huntington Beach Resort
500 Pacific Coast Hwy
Huntington Beach, CA 92648
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
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)
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
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
11:45 – 12:30 PM Session 4 - Panel Discussion
- Q&A with general counsel from industry on various regulatory topics
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.