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Practice Area
Regulatory & Compliance
Healthcare and data regulation handled by counsel who knows the structures cold.
The situation
Your model touches patient data, physician practices, or referrals, and the rules carry real penalties. Generic counsel sends you a memo. You need someone who has built compliant structures in healthcare and SaaS and can tell you what actually works.
What this covers
- HIPAA and PHI handling for digital health and SaaS
- Corporate Practice of Medicine (CPOM) and friendly-PC structures
- Anti-Kickback (AKS) and Stark analysis
- Data privacy programs and vendor data terms
- Regulatory review of new products and go-to-market plans
- A top-down plan that tackles the most urgent and sensitive issues first, then builds out a compliance program on a timeline that works for the company
Who it's for
Healthtech founders, physician practice groups, and SaaS companies handling regulated data.
You ship the product knowing where the lines are and that you're inside them.
Common questions
Regulatory & Compliance, answered.
- Do you actually know healthcare regulation, or just contracts?
- Healthcare regulation is a core part of the practice. We work on HIPAA, the Corporate Practice of Medicine, and AKS/Stark analysis for digital health and physician practice structures.
- Can you review a new product before we launch?
- Yes. We review the model and the go-to-market plan, flag the regulatory lines, and tell you what to change before it ships.
- We handle patient data. Where do we start?
- Usually with your data flows and vendor agreements. We help build a HIPAA program and the BAAs and data terms your contracts need.
This page provides a general overview of regulatory & compliance matters. Every situation is different. Contact Mond Law to discuss the specifics of your matter.