Start a Value-Assessment Service for Radiology AI

1. 1

   Understand value assessment versus clearance

   FDA clearance is safety-and-performance focused; it does not assess whether a tool delivers clinical and economic value worth its cost. European-style health technology assessment (HTA) evaluates exactly that, and the 2025 JAMA Network Open review recommended post-approval clinical and economic value assessment as a complement to clearance. Your business fills the gap between cleared and worth-buying.

2. 2

   Build the health-economics methodology

   Develop rigorous methods to assess a radiology AI tool's real-world clinical impact (outcomes, workflow, error reduction) and economic value (cost, reimbursement, downstream savings). This HTA-style methodology, grounded in health-economics and outcomes research, is your product. Credibility rests on defensible, transparent analysis.

3. 3

   Assemble clinical and economics expertise

   You need clinical understanding of radiology workflows and health-economics and outcomes-research capability together. This blended expertise lets you translate clinical effects into economic value credibly. It is the core hire and the moat.

4. 4

   Sell to systems, payers, and vendors

   Health systems and payers want to know which AI is worth paying for and covering; vendors want independent value evidence to sell with. All three are buyers of credible value assessment. Position as the independent evaluator whose assessment carries weight because you are not the seller.

5. 5

   Establish the category in the US market

   Because formal HTA is not yet provided at scale in the US for medical AI, part of the work is establishing the category and its credibility, which is both a challenge and a first-mover opportunity. Build a reputation for rigor and independence. Early credible assessments define the market.

6. 6

   Position within the adjacency suite

   This complements the validation-audit service (does it work) and the performance-heterogeneity consultancy (who benefits) by answering is it worth it. Together they form an independent evidence-and-value practice for radiology AI. You can specialize in value assessment or offer the full suite.

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