Your brand on the cover. Our bench behind it.
Two things the Institute does for other companies: governance work delivered under your name, and a licence to the regulatory dataset we already maintain. Both are ordinary commercial agreements between two firms.
Delivered under your brand
You have the client relationship, the brand and the sales motion. What you may not have on the bench is someone who can sit in a governance committee, read a 510(k) summary, write a validation protocol a clinical audience will accept, and say plainly when a model should be switched off.
The Institute takes that work as a subcontractor. The deliverable carries your letterhead, your engagement letter governs, and your client deals with you throughout. We are not introduced, not credited, and not in the room unless you want us there.
What we take on. Readiness assessments against the RUAIH focus areas; governance committee charters, intake and risk-tiering methods; local validation protocols and monitoring plans with defined escalation; vendor and procurement diligence, including the technical questions behind an AI purchase; and the evidence file that has to survive an external examination.
How it runs. Fixed scope, fixed fee, fixed dates, agreed before anything starts. Mutual NDA as a matter of course. Rates on request and set per engagement, because a two-week assessment and a fourteen-week programme build are not the same animal. No exclusivity is asked of you and none is offered.
What we will not do. Contact your client directly, market to them afterwards, or claim the work publicly. Nor will we write a recommendation we do not hold: if an assessment concludes that a tool is not ready, the deliverable will say so, and that has to be acceptable to you before we start.
The registry is free. Take it.
The Institute maintains a structured record of FDA clearances under AI-associated product codes — currently 568 entries across nine codes, refreshed weekly from openFDA, with a citable DOI. It is published under CC BY 4.0, which means you may already use it commercially, including inside a product you sell, provided you attribute it. There is no licence to negotiate and nothing to pay.
We say so plainly because the alternative is selling you something you can download for nothing. The underlying records come from openFDA, which is free, and our set is a deliberate slice rather than a complete census of every AI-enabled device the FDA has cleared. What we add is structure, a predictable refresh and stable identifiers.
Where firms do engage us around it is the work the data does not do by itself: a cut shaped to a specific question, fields we do not currently publish, or an analysis someone has to stand behind. That is an engagement, priced like any other, not a data licence.
Independence still applies
The Institute accepts no vendor sponsorship, holds no vendor equity and takes no referral fees, and a partner arrangement does not change that. We will not take work whose purpose is to produce a favourable conclusion about a named product, and we will not license the registry on terms that let a licensee present altered records as ours.
Starting a conversation
Write to hello@healthcareaiops.com with the shape of the engagement or the dataset question. A reply comes from the Institute, usually within one working day, and the first response will tell you honestly whether this is something we should take.