HIPAA Privacy Rule

In compliance with the HIPAA Privacy Rule, Schulman will review Authorizations to Use or Disclose Protected Health Information that are incorporated into informed consent documents. The Board will review, upon request, stand-alone Authorizations.

The Board has approved standard  Authorization language for research involving the use and/or disclosure of Protected Health Information by a "Covered Entity" according to the HIPAA Privacy Rule. Each site must make its own decision as to whether or not it is a Covered Entity. The site should consult its legal counsel and review the decision tree, "Am I a Covered Entity?" on the HIPAA web site. Even if a site is not technically a "Covered Entity," the study protocol may require compliance with the HIPAA Privacy Rule.

According to the HIPAA Privacy Rule, Authorization language must be study specific. The Board recommends that the Authorization language be attached to and incorporated into the informed consent document.