Blank Rome partner Thomas M. Sundlof joined host Jill Malandrino on Nasdaq TradeTalks for a wide‑ranging discussion on “Balancing Healthtech Innovation with Regulatory Integrity.”
During the episode, Tom participated in a roundtable with Dr. Severence MacLaughlin, CEO and Founder of DeLorean AI; Matthew Richardson, Partner in the Cybersecurity & Data Privacy and Digital Commerce practice at Brown Rudnick; and Matt Maher, CEO of M7 Innovations and Member of the MIT Media Lab Consortium. The panel explored the growing privacy paradox facing health technology companies, as consumers increasingly exchange highly sensitive biometric data for personalized insights and AI‑driven health coaching.
The conversation examined what consumers can realistically expect from wearable technology, where regulatory oversight begins and ends, and the data‑privacy and cybersecurity risks associated with collecting hundreds of thousands of biometric data points per user each day. Panelists also addressed emerging risks posed by generative AI and large‑language‑model health assistants, including transparency, informed consent, and the potential for real‑world harm. The discussion concluded with insights on how wearable technology companies can strategically leverage the FDA’s real‑world evidence and regulatory frameworks, not only to manage risk, but to build consumer trust and create a competitive advantage.
To watch the episode, please click here.