A Kaplan EduNeering course

The Health Insurance Portability and Accountability Act of 1996 (HIPAA) evolved from the rapid development of health information technology systems as a response to the challenges posed for maintaining the confidentiality of health information.  This course addresses how to best implement the challenges presented by HIPAA requirements in the process of new drug, biologic, and device development.  Learners will become aware of the impact that HIPAA could have on the use of information emanating from clinical trials in the United States.

After completing this course, learners will be able to recognize the definitions of covered and non-covered entities, and protected health information (PHI), as well as identify what is included in limited data sets and de-identified information.  Learners will also be able to identify how to properly gain authorization from subjects for release of PHI, how and when authorization may be revoked, the criteria for waiving PHI authorization, and exceptions for using PHI without authorization.  Finally, the course addressed how HIPAA relates to informed consent requirements, IRBs, and Privacy Boards, as well as the penalties for failing to comply with HIPAA regulations.

Topics include:
      ·          Compliance
      ·          PHI
      ·          Enforcements
      ·          ICs, IRBs, and PBs
      ·          Waivers
      ·          Limited data sets
      ·          Exceptions
      ·          HIPAA affect on future clinical research