external-review-required
Legal Readiness
Establish the contracts, ownership, regulatory classification, and external review needed to sell and operate SCRIMED responsibly.
Current posture
The product boundary and prohibited clinical claims are explicit. Final legal documents and regulatory determinations require qualified counsel.
Public commitments
- Use written scope, boundaries, and acceptance criteria for each engagement.
- Preserve human review and synthetic-only boundaries until approved controls exist.
- Do not present readiness artifacts as legal opinions or certifications.
Control register
Evidence, required actions, and launch gates stay linked.
external-review-required
Entity, ownership, and intellectual-property register
SCRIMED SOLUTIONS, founder identity, product names, slogan, repositories, and operating context are documented.
Verify entity records, invention assignment, contractor agreements, copyright registration candidates, trademark strategy, domains, and repository ownership.
- Owner: Founder and counsel
- Launch gate: Required before institutional financing, material partnerships, or enterprise contracting.
external-review-required
Copyright, license, and provenance control
Trust Safety Ops defines a Copyright And IP Sentinel for source, generated asset, logo, dataset, code, and publication provenance.
Create an IP inventory, asset-source register, copyright registration queue, third-party license review, generated-content provenance process, and takedown/escalation workflow.
- Owner: Founder, product, engineering, brand, and qualified IP counsel
- Launch gate: Required before publishing external decks, training materials, datasets, customer artifacts, or broad marketing campaigns.
external-review-required
Enterprise contract stack
Offers, buyer path, pilot boundaries, deliverables, and production exclusions are structured in the product.
Approve NDA, evaluation agreement, MSA, SOW, DPA, BAA when applicable, acceptable-use terms, and order form.
- Owner: Counsel and sales operations
- Launch gate: Executed agreement required before receiving confidential buyer data or beginning a paid engagement.
external-review-required
Product and regulatory classification
Current product is framed as synthetic operational intelligence with human review and no autonomous diagnosis.
Document intended use, user, workflow, claims, decision-support role, and device/non-device assessment for every promoted capability.
- Owner: Regulatory counsel and product governance
- Launch gate: Classification review required before changing intended use or entering live clinical workflows.
decision-required
Enterprise insurance posture
No insurance attestation is made in the current product.
Select appropriate general liability, cyber, technology E&O, and other coverage with qualified advisors.
- Owner: Executive leadership
- Launch gate: Coverage decision required before protected pilots and enterprise contract commitments.
Prohibited actions
These actions remain blocked.
- Claiming HIPAA compliance, FDA clearance, certification, or regulatory approval without documented basis.
- Accepting PHI or confidential buyer data without an approved agreement and data-handling path.
- Changing intended use through marketing copy without regulatory and governance review.
Authoritative references