Signal/docs/compliance
Kisa 77395a1112 docs: reactivation plan + FDA CDS exemption memo draft
- docs/build-plans/00-signal-reactivation-plan.md: umbrella re-activation plan
  (two-currency logic, critical path, Week1/Week2/backlog sequence with
  owners+gates, labABLE-vs-Gaboro call, compliance guardrail, 2026-07-06 findings).
- docs/compliance/fda-cds-exemption-memo-DRAFT.md: attorney-review draft (Fable).
  Primary position = Signal is administrative/billing software outside the FD&C
  201(h) device definition; CDS-exemption kept as the secondary argument. Citations
  grounded against current FDA sources (CDS guidance updated 2026-01-29).
  Flags: internal 2026-06-04 whitepaper overstates the CDS claim; attorney of
  record unconfirmed (Bittinger/Nixon vs Clyde Mathes).

Co-Authored-By: Claude Opus 4.8 (1M context) <noreply@anthropic.com>
2026-07-06 12:12:06 -04:00
..
data-handling.md coverage calculator and UI refinements; add demo MVP gap analysis and quality review docs 2026-06-12 13:04:23 -04:00
fda-cds-exemption-memo-DRAFT.md docs: reactivation plan + FDA CDS exemption memo draft 2026-07-06 12:12:06 -04:00
incident-response.md feat: demo MVP — 90/60/45 priority tiers, doc state machine, confirm visit workflow 2026-06-07 11:29:33 -04:00
privacy-policy.md fix(compliance): trust fixes — audit retention 7yr→6yr (45 CFR §164.530(j)), false BAA claim corrected to live posture 2026-06-22 08:06:01 -04:00