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Regulatory Risk Assessments

Asking the Right Questions Is the First Step

We help healthcare organizations and investors spot and solve regulatory risks — using standards-based tools, not guesswork.

Whether you're preparing for growth, evaluating internal gaps or launching something new, we help you get clarity.

Scope of Focus

  • Privacy & Data Protection – HIPAA, 42 Part 2, FTC, FERPA, State, etc.

  • Fraud, Waste & Abuse – FCA, AKS, Stark, Billing

  • Marketing & Advertising – Website, testimonials, promotions

  • AI & Automation – Bias, opacity, unfair practices

  • Telehealth – CPOM, scope of practice, modality

  • Government Programs – Medicare, Medicaid, FAR

  • Emerging Rules – Info blocking, identity verification

Specific Area or Global Review

Depth of Review

  • Focused Checkups. Quick reviews of high-impact items like new websites, AI tools, operational workflow or marketing campaigns. A second set of eyes before launch.

  • Business Model Reviews. Deep dives into new products, services, or workflows. We evaluate structural and legal soundness.

  • Full Risk Scan. A top-to-bottom review of your operations to pinpoint key risks, prioritize fixes, and guide smart next steps.

Isolated Workflows or Entire Business

Tailored to Your Trajectory

  • Internal Assurance – You want confidence that you’re on solid ground, and clear next steps to improve.

  • Investor-Ready – You’re preparing for diligence and want to show a clean bill of health.

  • Audit-Proof – You need a review strong enough to stand up to regulators, board scrutiny, or enterprise partners.

Calibrated to Your Business

Strike the right balance of speed, depth, and audit strength—get what you need, without overbuilding.
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Transform Uncertainty into Strategy

Risk assessments aren’t about finding flaws — they’re about seeing clearly. We help you identify key exposures, align your next steps, and strengthen trust with regulators, investors, and enterprise partners.

Who We Work With

We conduct regulatory risk assessments for healthcare organizations that want a clear, structured view of their exposure—so they can move forward with confidence.

  • Health tech startups preparing to scale, raise capital, or formalize compliance
  • ​Digital health and SaaS vendors serving payers, providers, or regulated partners
  • PE-backed provider groups or MSOs seeking visibility into internal risk
  • Clinics or multi-site practices expanding telehealth, automation, or new services
  • Companies launching new models or marketing campaigns involving healthcare data
  • Investors or acquirers evaluating risk exposure as part of diligence

Not Sure What You Need?  
Let's Talk

Not exactly sure what you're looking for? That’s okay.
We can help define the right questions and build a custom plan.
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