Manager   •   about 4 years ago

Q: How important is it to integrate informed consent form into our app to communicate to the patient? Is an informed consent needed to communicate nonsensitive information?

A: "Informed consent" specifically refers to ensuring that patients have been given appropriate information by a medical professional to help them determine whether or not they would like to accept or refuse a particular medical treatment or procedure. If this aligns with the type of product you are developing, check out this link for more information about what informed consents should cover, what information should be obtained, etc.: http://www.templehealth.org/ICTOOLKIT/html/ictoolkitpage5.html.

Under a separate law called HIPAA (the Health insurance Portability and Accountability Act), providers, payers, or other systems must obtain an individual's consent before sharing his or her health information with others. HIPAA mandates that patient health information is kept confidential and secure, so tools designed to promote communication between patients and third parties about their health should ensure that they are HIPAA-compliant. If your digital health tool has any information-sharing features, you should familiarize yourself with HIPAA and build in consent features as needed. For more information about HIPAA as it relates to digital health, visit this website: http://www.entrepreneurship.org/emed/is-your-digital-health-startup-subject-to-hipaa.aspx.

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