Table 3 Study Inclusion and Exclusion Criteria
Inclusion Criteria | Exclusion Criteria |
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[1] the study included a device on or touching the human body that [2] sensed a biometric measure related to the body itself; [3] the study contained a relevant control group; [4] the device automatically transmitted data to a web portal or app that could be accessed by the patient and/or care provider; [5] if a care provider had access to patient device data, they communicated back to the patient in regards to those data; and [6] the study measured a meaningful, clinically relevant health outcome. | [1] Studies in languages other than English, [2] studies not concerned with human subjects, [3] studies conducted with regards to implantable or invasive or ingestible or injectable devices, [4] studies on the cellular, biochemical or microscale and [5] studies primarily focused on the theory, design or proof of concept of the device. |