Intended use & attestation
What HepBuddy is, and what it is not.
Last updated: July 22, 2026
Intended-use statement
HepBuddy is intended to monitor a patient’s adherence to a clinician-prescribed musculoskeletal home-exercise program by recording completed therapy sessions and self-reported status. It supports, and does not replace, the physical therapist’s clinical judgment.
HepBuddy meets the FDA definition of a medical device and operates under FDA enforcement discretion. It is not FDA-cleared, approved, or registered.
What HepBuddy does
- Records each completed home-exercise session as a timestamped data day.
- Counts those data days across the monitoring period and tallies the management minutes the treating clinician logs.
- Captures the patient’s documented consent to remote monitoring.
- Assembles the resulting record so the treating clinician can review, attest, and bill what their own documentation supports.
What HepBuddy does not do
- It does not diagnose, and it is not a diagnostic device.
- It does not interpret a patient’s data or make clinical decisions.
- It does not educate or treat the patient on the clinician’s behalf.
- It does not determine medical necessity or decide what is billable. The treating clinician does.
The clinician’s role
The treating physical therapist prescribes the home-exercise program, explains it to the patient, reviews the monitored data, exercises clinical judgment, conducts any live interactive check-in, and attests to each billed cycle. HepBuddy records that this work happened; it does not perform it.
Reimbursement
Any reimbursement figures shown on this site are 2026 Medicare national averages and vary by region and payer. Coverage of remote therapeutic monitoring differs by plan. You are responsible for billing only what your own documentation supports.