Clinical trials and medical studies are fundamental to the advancement of medicine. But how does HIPAA impact the research and what personal health information can be shared? The National Institutes of Health has put together a 38-question FAQ addressing this: HIPAA Privacy Rule for Researchers.
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.”
What does the Privacy Rule cover when it comes to research? In short, it regulates the documentation needed (i.e. the waiver that patients sign to release their information for the study).
Who else might see your information? “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…”
Are you a patient involved in a clinical research study? Learn more about the protections for your personal health information by clicking here to read the lowdown at the National Institues of Health.