The role of HIPAA when you join a medical research team

Clinical trials and medical studies are fundamental to the advancement of medicine and if you join a research team, you may be asked to sign certain important forms. One of these may be an authorization form which will authorize the research team to use or share your personal health information with others for the research study such as:

* Your name and address
* Your health background
* Your health care provider’s name
* Your birthday Your medical records
* Your ethnic origin
* Your lab test results and X-rays
* Notes taken by a doctor or nurse
* Your medical diagnosis

The good news is that “patients and health plan members should be more willing to authorize disclosures of their information for research and to participate in research when they know their information is protected…The Privacy Rule both permits important research and, at the same time, encourages patients to participate in research by providing much needed assurances about the privacy of their health information.”

HIPAA Privacy Rule here regulates the documentation needed (i.e. the waiver that patients sign to release their information for the study).

The other entities who can see the information include “The Office for Human Research Protections (OHRP) is a public health authority under the HIPAA Privacy Rule. Therefore, covered entities can continue to disclose protected health information to report adverse events to the OHRP either with patient authorization as provided at 45 CFR 164.508, or without patient authorization for public health activities…”