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Regulations + Reimbursement Roundup

Paid course

Video/Text

Video/Text

Startup

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About the Teacher

Kyle Rolfing

Kyle is a serial healthcare entrepreneur with particular experience in next-generation tools for employers to manage health benefits. Kyle was a founder at Definity Health (acquired by United Health for $300m in 2004), Redbrick Health (acquired by Marlin Equity Partners in 2018), and Bright Health (IPO 2021, NYSE:BHG).

By the end of this module you'll be able to:

  • Identify FDA regulatory pathways (510k, De Novo, PMA) and key questions to determine the right pathway.
  • Explain the reimbursement process for health technologies, including coding, coverage, and payment.
  • Distinguish between Medicare, Medicaid, and commercial payers and their impact on reimbursement.
  • Explore regulatory and reimbursement resources.
  • Connect with Medical Alley experts for guidance and support.
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Text lesson

As a health tech entrepreneur, it pays to understand what the Food and Drug Administration (FDA) is, how it operates, and how it may impact your business. Take this simple self-assessment to test your FDA smarts.

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Video lesson
Video lesson
Text lesson

Read this article to review the top 5 takeaways from this module.

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A Step in the Right Direction

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