Contocracy, a form of rule proposed in 2026, gives one chosen leader permanent authority in an organization and allows a declared AI stand-in to act on urgent matters after the leader’s death. Contocracy’s rule allows that only if the new model matches the leader’s record at least as well.
The Tessaly Medication Safety Network illustrates the concept. This nonprofit links 60 hospital pharmacies to share reports of infusion pump errors and mislabeled vials. For two decades, founder Dr. Ingrid Vollmer decided which safety alerts went out. The network operates as a contocracy with Vollmer as its contocrat. After her death, an AI stand-in trained on her record handles the urgent matters, such as whether a dosing library error in a widely used pump justifies an alert that night. Five years later, the operators want to rebuild the stand-in on a newer model.
The Regulatory Framework
Section 515C of the Federal Food, Drug, and Cosmetic Act lets FDA authorize a predetermined change control plan (PCCP) as part of a device’s marketing authorization. A change consistent with the authorized plan needs no new premarket approval supplement or 510(k). FDA may attach labeling, notification, and performance requirements to changes made under the plan. The guidance asks for three parts: a description of modifications, a modification protocol covering data management, retraining, performance evaluation, and update procedures, and an impact assessment. Changes to a device’s intended use do not belong in a PCCP.
Applying the Principles
In October 2023, the agencies issued five guiding principles for PCCPs. These include being focused and bounded, risk-based, evidence-based, transparent, and taking a total product lifecycle perspective. Applying these to the rebuild rule turns a single sentence into a procedure. Tessaly’s plan would name what may change, namely the underlying model and the way it is trained on Vollmer’s record, and what may not: the stand-in’s declared role, its reach limited to matters the operators judge urgent, the labels on its rulings and the precedence of her religion over the mission.
Risk-based principles suggest that testing scales with the stakes. An overnight ruling on a pump alert carries more risk than the date of a members’ meeting, so the plan can demand more evidence for the categories of ruling that matter most, and it can track the cumulative effect of successive rebuilds, not only the latest one.
Evidence-based requirements force a specific metric to define “at least as well.” The plan could hold back part of Vollmer’s record, decisions the candidate never sees during training, and score both the current model and the candidate on how often they match her decisions. Contocracy’s canon does not fix the metric for “at least as well,” nor does it name who reviews the operators’ urgency calls or the stand-in’s rulings.
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Consent and Oversight
Hospitals that join Tessaly after Vollmer’s death never chose her. Patients affected by its alerts never chose anyone. Device users do not consent to each change under a PCCP either; FDA’s authorization stands between them and the manufacturer. Contocracy puts no regulator in that seat, and whether a published plan gives later members enough notice to make joining a real choice is open.
FDA reviews a plan before authorizing it and can act after changes reach the market. Contocracy’s canon names the operators and the stand-in, but it does not say who reviews the operators’ urgency calls or the stand-in’s rulings, or how a member contests one. A network could add an internal panel or an outside auditor, but that would be its own addition rather than part of the form.
New Circumstances and Verifiable Return
A model can reproduce Vollmer’s past decisions closely and still diverge on a device class that did not exist in her lifetime. A device plan handles this with its bounds: a change beyond the intended use needs a new submission. The rebuild rule has no equivalent step, because no one can supply new decisions by Vollmer. Whether matching the record is enough for decisions in new circumstances is open.
If a return never becomes verifiable, the stand-in acts on urgent matters indefinitely. The rebuild rule governs every model change for as long as the network lasts. The benchmark for every future rebuild is fixed. The canon does not say whether the plan itself may be revised. The canon does not say when the plan may be revised. The open question remains.
A Regulatory Exercise
Regulatory professionals write and review PCCPs as routine work. This puts them in a strong position to test contocracy’s rebuild rule. The exercise asks no one to endorse the form. They can propose which metric defines “at least as well.” They can define which bounds belong in the plan. They can name who should see the results. They can draft a plan or find the gap. The term contocracy is new enough. The first careful analyses will shape how it is understood. The author invites professionals to publish their drafts.
