Under which condition can PHI be disclosed for research purposes?

The disclosure of protected health information (PHI) for research purposes is permitted when there is valid authorization from the individual whose information is being disclosed. A valid authorization must contain specific elements, including a description of the information to be disclosed, the purpose of the disclosure, and the signature of the individual or their representative, among other requirements. This authorization is a key component in ensuring that individuals have control over their personal health information, aligning with the principles of the Health Insurance Portability and Accountability Act (HIPAA) and protecting the privacy of individuals involved in research.

While informed consent and minimum necessary guidelines are important principles in research ethics and compliance, they do not serve as standalone conditions for disclosing PHI. Informed consent typically relates to the individual's agreement to participate in the research study and may encompass broader ethical considerations beyond just the disclosure of PHI. Minimum necessary guidelines require that only the minimum amount of PHI needed to accomplish the research purpose should be shared, but this does not replace the need for valid authorization. The sponsor’s request alone does not suffice, as authorization must come from the individual whose PHI is being disclosed. Thus, a valid authorization is the key to allowing PHI to be disclosed for research.