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ETHICS AND GOVERNANCE

Governance is not an afterthought.

Behavioral simulation of patient populations carries real ethical stakes. We have built governance into the system from the start, not added it after. This page documents what we built, how it works, and what it does not cover.


THE FRAMEWORK

Five commitments. Each with operational controls.

Soft concentric rings in a pastel field

Patient Dignity First

Synthetic patients are models, not replacements. We do not use them to substitute for actual patient input. This technology exists to reduce preventable burden and improve patient-centered design. Every simulation is evaluated against whether it serves that goal.

Abstract galaxy-like field representing privacy

Privacy by Architecture

Intera never requires, receives, or stores personally identifiable health information. All data flows are anonymized and aggregate. Partners retain full ownership of any data they provide. If a proposed data exchange creates privacy risk, we decline the engagement.

Warm flow of light between two regions

Mutual Value, not Extraction

Every partnership delivers concrete value back to the organization whose patient community is being modeled. Your organization elevates patient voice. We operationalize that voice in design-stage forecasting. The shared objective is fewer preventable dropouts and more representative care systems.

Networked globe suggesting transparency

Transparency about Limitations

We do not claim perfect prediction or equivalence to real patients. We explicitly acknowledge rare disease coverage gaps, age skew in training data, domain shift between data sources, instruction-following bias in language models, and simulation artifacts. We surface limitations per simulation rather than obscure them in aggregate accuracy claims.

Human figure emerging from light and particles

Health Equity as a Requirement

The populations most underserved by current approaches are the populations where better conditioning data matters most. We actively seek partnerships with organizations serving diverse communities because improving coverage for underrepresented groups is not optional to the mission. Partnerships that improve our coverage of older adults, non-English-speaking populations, and low-income segments are prioritized over partnerships that deepen coverage of already-well-represented groups.

OPERATIONAL CONTROLS

What the governance looks like in practice.

De-Identification Standard

Synthetic personas are generated from de-identified datasets meeting HIPAA Expert Determination or Safe Harbor standard as applicable. We do not ingest or store direct identifiers including name, email, phone, address, or medical record number. Contractual and technical controls prevent re-identification at every data transfer point.

No individual patient is represented in any Intera output.

Transparent Conditioning

Every persona's demographic, clinical, and psychosocial conditioning is visible and auditable. Clients can inspect the conditioning inputs for any simulation. There are no hidden assumptions in how synthetic patients are built. The conditioning methodology is documented and versioned.

You can audit what the model assumed about your patient population.

Versioned and Reproducible

Every simulation is versioned with traceable inputs and reproducible runs. The same inputs produce the same outputs. A full audit trail is maintained for regulatory and compliance review. Simulation versions are retained for the duration of the partnership.

Any output we provide can be reconstructed and examined after the fact.

Disclosed Limitations Per Simulation

We do not report aggregate accuracy and allow clients to infer it applies to their use case. Every simulation delivery includes a limitations section specific to that simulation: which segments have lower confidence, where data coverage is thin, and what the outputs should not be used to decide. Limitations are documented before results are presented, not appended afterward.

You know what the model cannot tell you before you act on what it can.

SCOPE AND LIMITS

What Intera outputs should not be used for.

Regulatory Substitution

Intera outputs are directional signals for design-stage decision-making. They are not validated clinical evidence and must not be submitted as supporting data for regulatory filings, IND applications, or claims of clinical efficacy. All regulatory submissions require real-world evidence.

Simulation informs design. It does not replace evidence.

High-Stakes Decisions Without Human Review

No Intera output should be the sole basis for a high-stakes irreversible decision. Protocol lock, site selection, patient exclusion criteria, and commercial launch strategy should use Intera outputs as one input among several, reviewed by qualified human experts before commitment.

Augmentation layer. Not autonomous decision-maker.

Questions about our governance framework?

We are happy to walk through our data governance, conditioning methodology, and limitations documentation with any prospective partner before engagement begins.

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