Privacy Notice Guidance - HIPAA|
Under the HIPAA Privacy Rule, a
"Notice of Privacy Practices" must be given to each individual receiving
medical services delivered by LSUHSC-NO. Generally, this notice will be
provided to each patient the first time they are seen in a LSUHCSD hospital
or LSUHSC-NO clinic. At times, however, the first contact may be with a
LSUHSC-NO investigator conducting a research study that comes under the
HIPAA Privacy Rule. Because of this, the LSUHSC-NO Office of Compliance
Programs now requires that a “LSUHSC-NO Notice of
Privacy Practices” be given to subjects enrolled into all studies
requiring a HIPAA Authorization document. This includes studies conducted
at LSUHSC-NO facilities as-well-as affiliated public and private hospitals.
It must be provided to the subject despite the fact that private facilities
have their own “Notice of Privacy Practices”.
must be kept of either providing this document to the subject or that an
attempt was made to provide it to them. Even though they should be asked to
do so, the subject does not have to acknowledge receipt. A "Privacy Notice
Acknowledgement" form for this purpose is available in the forms section of
the ORS “HIPAA and Research” webpage. An “Acknowledgement” form signed by
the subject or signed by a study team member if the subject does not want to
sign must be kept by the investigator for each subject.
random compliance audits are conducted by the Office of Compliance Programs
and the IRB. In addition to the informed consent and Authorization
documents, Privacy Notice “Acknowledgements” will is a subject of these
audits. Investigators will also be monitored for use of the “Notice of
Privacy Practices” and maintenance of “Acknowledgement” records at the time
of application to the IRB for re-approval of their study.