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.
Decision implication
Digital-health companies should evaluate whether product evidence, use case, outcome measures, and care model can align with ACCESS/TEMPO-style pathways.
Who or what is affected
- FDA
- CMS Innovation Center
- Dexcom
- ACCESS participants
- clinicians
- Medicare beneficiaries
Evidence and sources
Decision priority: Historical
Source authority: Primary/authoritative · official federal source
Evidence design: Program record
Applicability: Direct
Confidence for the stated claim: High
Freshness: Historical
P4L distinguishes the sourced record from interpretation. Program inclusion, participation, funding, proposal status, or a public listing does not by itself establish clinical effectiveness, endorsement, coverage, or scaled adoption unless the cited source specifically establishes it.
For this decision
Health-system leaders · Payers/employers · Clinicians · Policymakers · Researchers
What P4L is watching next
- Additional TEMPO participants
- RWD requirements
- implementation experience
- ACCESS outcomes.
Related proof records
- CLM-0003 — FDA's maintained TEMPO participant table currently lists four participants: SonderMind, Inc. / SonderMind Adjunctive Care Application (SACA); Limbic Inc. / Unpacked; Cadence Solutions, Inc. / HypertensionOS; and Dexcom, Inc. / Dexcom Glucose Health Program.
- CLM-0004 — ACCESS + TEMPO creates a practical bridge among payment, regulatory oversight, real-world evidence, and technology-supported chronic care.
Record provenance
- Last verified
- 2026-08-25
- Revision state
- Version 1.2 adds FDA's exact effectiveness limitation to this historical launch record.
- Status
- Historical launch record
- Freshness
- Historical
- Version
- 1.2
- Stable ID
- SIG-2026-001