Mightier as a Medical Device
Mightier is considered a Class I software medical device under the classification of the United States Food and Drug Administration (FDA). Mightier provides mitigation to symptoms of mental health disorders. Mightier does not pose a risk to patients when improperly used, meaning that the FDA has elected not to apply regulatory oversight to Mightier or similar software-based medical devices.
Mightier and HIPAA
Mightier maintains protected health information (PHI) in a HIPAA compliant manner. Mightier maintains a HIPAA compliance certification from the Compliancy Group, a third-party agency that attests to Mightier’s efforts and policies to fulfill obligations around data safety and security set forward through relevant laws and regulations.