Mastering Tomorrow's Healthcare Tech: A Cutting-Edge Approach to Regulatory, Compliance, and Privacy Demands

November 09, 2023

In a recent program, FDA law firm Gardner Law and EU-based Fieldfisher discussed regulatory, compliance, and privacy matters relevant to high-tech healthcare products.

Watch the replay to learn about:

  • 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
  • An EU Compliance and Regulatory Update

And stay tuned until the end for a Q&A with general counsel from industry on related topics.

* Detailed program agenda below.



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

Panel Members:

  • Jeff Dennis, Global Privacy & Cybersecurity Attorney; Chief Privacy Officer, Edwards Lifesciences
  • Sara Kerrane, VP Intellectual Property, Litigation and Regulatory Counsel, Glaukos
  • Sushana Vijayakumar, Principal Legal Counsel at Medtronic
  • Mark Gardner (moderator), Directing Attorney, Gardner Law

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.