As a healthcare startup, you've likely started your company to "do well by doing good" - but the barriers of being in a 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 a 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.