Understanding the Regulatory Landscape for Healthcare Startups

As a healthcare startup, you've likely started your company to "do well by doing good" - but the barriers of being in regulated industry are daunting and present significant risk. Wouldn't it be easier just to build a photo sharing app? 
 
We will assuage your concerns through detailed review of the FDA and HIPAA requirements and their impact on healthcare companies. We will use real-world case studies from startups and established companies to demonstrate successes and failures in regulatory compliance. Finally, we  will review existing case law and upcoming legislation to explore best practices, craft positions and test outcomes. 
 
At the end of this course, entrepreneurs will be more comfortable with many of the regulations applying to healthcare startups including the FDA 510k process, and the HIPAA privacy and security standards, and will be able to craft a strategy that best fits their company. 
 

Geoffrey Clapp

Geoffrey Clapp is a serial entreprenuer focused on health technology. As COO/CTO of Health Hero Network, Geoffrey helped build the largest remote patient monitoring company in the world, serving over 130 different disease states and generating hundreds of millions of dollars in cost savings to the healthcare system.  He has gone through more than seven FDA 510k submissions, several FDA audits, and several implementations of HIPAA and VA complaint systems and process.

Geoffrey is currently a mentor at Rock Health, an accelerator for healthcare startups, an advisor to many health and technology startups, and frequent speaker on Health Technologies. 

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