Navigating the Digital Health Legal Landscape with Dr. Stephanie D. Barnes

Brilliant digital health ideas die every day, not because of technology, but because founders ignore the legal and regulatory realities of healthcare.

In this episode, Dr. Stephanie D. Barnes, Senior Counsel at Nixon Law Group, discusses how digital health entrepreneurs can navigate the complex intersection of law, regulation, and innovation without jeopardizing their company's growth before it scales. She shares her journey from traditional health law to innovation and explains why every startup must first understand who pays for their solution, as reimbursement drives everything from design to go-to-market strategy.

Dr. Barnes breaks down the implications of software becoming a regulated medical device, how FDA scrutiny increases as products move closer to clinical decision-making, and why MSO/PC structures and corporate practice of medicine laws are critical for anyone deploying virtual care or owning clinics across state lines.

She clarifies the risks of Anti-Kickback, Stark, and False Claims for RPM, telehealth, and SaaS models, and demonstrates how poor contracting, governance, and entity structure can compromise limited liability or deter investors.

Finally, Dr. Barnes highlights her passion for supporting women and Black founders who receive a tiny fraction of venture capital.

Tune it and learn how to build legally sound, scalable digital health solutions that can actually stay in the market long enough to save lives!

Resources

• Connect with Stephanie Barnes on LinkedIn here.
• Follow Nixon Law Group on LinkedIn here and visit their website here.
• Subscribe to Nixon Law Group’s newsletter here.

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