Araceli López-Arenas
I would like to submit a study for review that examines mental health/behavioral health by using mHealth technologies to conduct real time mood assessments (e.g., Patient Health Questionnaire-PHQ-9) and other mood assessments and provide psycho-education based on their reported symptoms. Are there any samples of IRB approved language that ensures that we meet HIPAA standards?
Anonymous
There is approved language for Ecological Momentary Assessment used in mental health studies. When we open the Forum to the larger network, I expect you will receive a reply.
Rubi Linares-Orozco
Hi Aracely,
I think it is important to distinguish between Research acquired Health Information from Information that is obtained directly from the medical record, or information that will be directly entered into the medical record.
HIPAA only applies to data that is being entered, copied, or extracted from the subjects medical record.
If the medical record will not be accessed or used to obtain data, the device or platform does not need to be HIPAA compliant.
The device will still need to meet other security demands for the protection of private information.