Protect vs Disclose — The Trade-Secret Seam

The disclose side: what has to be written down

ISO 13485:2016 §4.2.3 requires a medical device file for each device type or device family — one file containing or referencing the documents that demonstrate conformity, including the description of the device and its intended use, the labelling, and the specifications and procedures for manufacture, measurement, installation and servicing where those apply. The clause is short and its effect is wide: it makes the file, not the team’s memory, the place where the product is defined.

In the European Union, Annex II of Regulation (EU) 2017/745 sets out the technical documentation a manufacturer must draw up and keep up to date: the device description and specification, the information supplied by the manufacturer, design and manufacturing information, the general safety and performance requirements with the solutions adopted to meet them, the benefit-risk analysis and risk management, and product verification and validation.

For a learned system, the material these clauses reach is precisely the part a technical team is most likely to treat as internal: how the training data were obtained and curated, who drew the labels and against what definition, what stood as the reference standard, and how performance was measured and on which population. None of that is optional documentation. It is the argument that the thing does what it is claimed to do.

The protect side: what a trade secret is, and what keeps it one

The definitions are not folklore; the FDA writes them down in its own public-information rules. 21 CFR 20.61, "Trade secrets and commercial or financial information which is privileged or confidential", describes a trade secret as a commercially valuable plan, formula, process or device used in making or processing trade commodities, being the end product of innovation or substantial effort, with a direct relationship to the productive process. It describes confidential commercial or financial information as valuable data used in one’s business, of a type customarily held in strict confidence or regarded as privileged, and not disclosed to any member of the public by the person to whom it belongs. Data and information submitted to the agency that fall within those definitions are not available for public disclosure.

The conditional clause is the load-bearing one, and it is a fact about conduct rather than a stamp: material the company itself circulates without restriction is not of a type it customarily holds in confidence. The rule also contemplates that a submitter designates records as exempt from disclosure in writing, either when they are submitted or within a reasonable time afterwards — which means the protection has a procedure attached to it and is not automatic on value alone.

SPEQ synthesis, labelled as such: the practical consequence for a small team is that the protect side is mostly lost by ordinary conduct rather than by regulatory action — a slide deck shown without restriction, a preprint with the method in full, a demo with the corpus attached. The documentation obligation is the visible half of this seam and the easier half to satisfy correctly.

The fork: disclosure to a reviewer, and disclosure to the public

Treating disclosure as one act is what makes this seam feel unresolvable. It is two acts with different clauses. What goes to a reviewer inside a submission is assessed under confidentiality; what is published after a decision is a separate, shorter document written for a different audience, and it is the one worth reading early.

In the United States the published document is the 510(k) summary. 21 CFR 807.92, "Content and format of a 510(k) summary", requires it to be in sufficient detail to provide an understanding of the basis for the determination of substantial equivalence: the device description and its intended use, a comparison of the technological characteristics with the predicate device, and, where non-clinical or clinical testing was submitted, a summary of it including the subjects tested and the safety or effectiveness results. FDA makes the summary publicly available once the substantial-equivalence decision has issued.

The alternative under 21 CFR 807.93 is not privacy. A 510(k) statement is a certification that the submitter will make the safety and effectiveness information supporting the finding of substantial equivalence available to any person within 30 days of a written request. A team that chooses the statement to avoid publishing a summary has chosen to answer requests instead.

In the European Union the equivalent is Article 32 of Regulation (EU) 2017/745: for implantable devices and class III devices other than custom-made or investigational ones, the manufacturer draws up a summary of safety and clinical performance, written to be clear to the intended user and, where relevant, the patient. The draft forms part of the documentation submitted to the notified body, is validated by that body, and is uploaded to Eudamed, where it is available to the public.

That is why the sharpest point of the collision is the public summary rather than the confidential submission. The submission is protected by rules with a name; the summary is written to be read by anyone, and its content is specified rather than chosen.

What the seam looks like for a learned system

Applied to a model, the disclose side reaches the corpus and how it was assembled, the labelling protocol and its reference standard, the performance figures and how they break down across the population the device is claimed for, and the policy governing what happens when the model is retrained. The protect side reaches the same corpus, the same procedure, and often the specific engineering that made the results reproducible.

The change-control instrument sits inside this seam rather than outside it. A predetermined change control plan — the FDA final guidance of 4 December 2024 — describes in advance which modifications a manufacturer may make to an AI-enabled device without a new submission, together with the methods and the acceptance criteria for making them. A plan of that kind is itself a disclosure: it states what you intend to do to the model and how you will show that the result still holds.

SPEQ synthesis, labelled as such: the useful order for a team is to write the disclose side first. It is specified, it is largely predictable from the clauses above, and drafting it is what reveals which parts of the method genuinely carry commercial value and which parts a team merely assumed were secret.

Where SPEQ stops

SPEQ names the clauses that create the collision and shows where they meet. It does not advise what to keep and what to file, how to mark a submission, whether to seek a patent — whose own bargain is publication in exchange for a right — or how any of this interacts with a contract, a licence or an employment agreement. Those are questions for counsel, and the boundary is marked rather than disclaimed in passing.

Nothing on this page is legal advice, and nothing on it determines the regulatory status of a product. The instruments cited are current published sources; the framing of the seam and the ordering advice above are SPEQ interpretation and are labelled where they appear.