What applicants must show about device-based data
For cardiometabolic tracks under the CMS ACCESS Model, device data plays a direct role in outcome measurement.
This is not a general remote monitoring scenario. CMS expects source-verifiable vital sign data.
Are devices required under ACCESS?
For tracks involving hypertension and cardiometabolic conditions, blood pressure measurement is central.
Applicants must demonstrate that:
- Blood pressure is collected using validated, FDA-cleared upper-arm devices
- Readings are not manually entered
- Data includes timestamp, device source, and patient attribution
- Transmission is reliable for Medicare populations
Manual transcription does not meet expectations.
Why data provenance matters
CMS requires confidence that device readings are:
- Authentic
- Attributable
- Time-specific
- Clinically relevant
Without device source and timestamp, data cannot support outcome reporting.
What applicants must describe
Organizations should outline:
- Their device strategy
- How devices connect and transmit data
- How device identity is preserved
- How patient attribution is handled
- How device data integrates with outcome reporting
Device infrastructure becomes part of the reporting architecture, not a separate add-on.