{
  "signal_id": "SIG-2026-001",
  "observed_date": "2026-07-22",
  "category": "Regulation + Payment + Digital Health",
  "title": "FDA TEMPO selects Dexcom as first participant linked to CMS ACCESS",
  "what_changed": "FDA selected Dexcom's Glucose Health Program for the TEMPO pilot. The intended use is tied to ACCESS clinical use areas and will be evaluated using real-world data while the program is offered through ACCESS participants.",
  "why_it_matters": "This creates an unusually direct bridge among regulatory flexibility, real-world evidence generation, Medicare payment, chronic-disease care, and digital-health adoption.",
  "affected_actors": [
    "FDA",
    "CMS Innovation Center",
    "Dexcom",
    "ACCESS participants",
    "clinicians",
    "Medicare beneficiaries"
  ],
  "decision_implication": "Digital-health companies should evaluate whether product evidence, use case, outcome measures, and care model can align with ACCESS/TEMPO-style pathways.",
  "status": "Live / active",
  "evidence_class": "E5 — official federal source",
  "impact": 5,
  "immediacy": 5,
  "relevance": 5,
  "novelty": 5,
  "adoption_leverage": 5,
  "priority_score": 100,
  "sources": [
    "https://www.fda.gov/news-events/press-announcements/fda-announces-first-participant-selected-tempo-digital-health-devices-pilot"
  ],
  "public_slug": "/signal/2026-07-22-tempo-dexcom-access/",
  "watch_conditions": [
    "Additional TEMPO participants",
    "RWD requirements",
    "implementation experience",
    "ACCESS outcomes."
  ],
  "last_verified": "2026-08-08",
  "version": "1.0"
}