Observation is not diagnosis
Displaying information differs from interpreting it. An observation differs from a diagnosis. Helping someone understand history differs from recommending clinical action.
Health technology needs a proportionate safety bar.
EverRhythm can help people organise information, understand context, notice changes and prepare for conversations. That does not make every health-related capability equivalent.
Higher risk means a higher bar.Controls should match consequence
As potential consequences increase, expectations around evidence, testing, validation, safety controls, limitations, governance and appropriate human involvement should increase too.
Uncertainty matters
Incomplete information, measurement error and missing context matter. A Signal should not become a diagnosis because an AI can produce a plausible explanation. Sometimes “We don't know” is the safer answer.
Professional judgement matters
Technical operation is not automatically clinical effectiveness or safety. EverRhythm should help people understand and communicate, not quietly replace clinical judgement.
Evidence and limitations
Safety evidence and its limits
A safety principle is not itself a validated clinical outcome.
Clinical effectiveness
No clinical effectiveness or diagnostic validation outcome is asserted here.
Source: No independent clinical outcome evidence supplied for publication
Risk-based review
The level of review must be determined for each capability and intended use; internal implementation does not establish regulatory clearance.
Source: Product governance principle; capability-specific assessment remains necessary
Working technically does not establish clinical validation.
Internal testing and external clinical evidence remain distinct, and unsupported clinical claims cannot be created by release approval alone.