What Types of Organizations are Subject to HIPAA?
In determining whether your research project may be subject to HIPAA, the first question is whether a collaborating individual or organization is subject to HIPAA. These individuals and organizations are collectively known as covered entities. HIPAA covered entities include health care providers, health plans, and health care clearinghouses that transmit health information in electronic form.
If your research will not require the involvement of HIPAA covered entities or their employees, the Privacy Rule and Security Rule will not apply to your project. If a HIPAA covered entity will be involved in your project, the next step is to determine whether your project will require them to disclose Protected Health Information to you.