Start a Three-Tier Regulatory Strategy Advisory for Mental Health Products

1. 1

   Codify the three-tier model

   Define the structure clearly: a free or low-cost AI self-help tier with the lightest regulatory burden, a paid human-coach tier positioned as non-clinical support, and a fully clinical program tier on the medical and reimbursement pathway. Show how one product can hold all three. This framework, exemplified by products that separate self-help, coaching, and clinical states, is your core IP.

2. 2

   Map the pathways for each tier

   Each tier faces a different regulatory and reimbursement reality, from unregulated wellness to FDA and DiGA or NICE clinical pathways, so map where each tier sits and how to keep the boundaries clean. The value is in spreading risk and revenue across pathways deliberately. Clarity about where clinical begins is both a legal and a commercial necessity.

3. 3

   Build the advisory engagements

   Offer product-structure design, regulatory-pathway mapping, and positioning that keeps the tiers legally distinct, as projects or retainers for digital mental health companies. Help them avoid presenting a wellness tier as clinical care. Concrete tiering blueprints are what clients pay for.

4. 4

   Reach digital-health builders

   Find clients among founders and product teams building mental health apps, and investors who want portfolio companies to de-risk their regulatory strategy, through content and networks. Demonstrating the tiering model is your pitch. The rarity of combined regulatory-and-product expertise is your moat.

5. 5

   Know what this is not

   This advises on structuring one product's regulatory tiers. A funnel model that routes a free app's users to a separate paid human program is a related but distinct adjacency card. International reimbursement arbitrage is a separate card. This card is specifically about designing the three-tier structure within a single product.

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