HIPAA - The Privacy Rule

Research subject to the Health Insurance Portability and Accountability Act (HIPAA) must comply with Case Western Reserve University’s policies and procedures for HIPAA.

What is HIPAA?

The Health Insurance Portability and Accountability Act (HIPAA) went into effect on April 14, 2003, to:

• Promote the portability of insurance coverage as employees moved from job to job;
• Increase accountability and decrease fraud and abuse in healthcare; and
• Improve the efficiency of the healthcare payment process, while protecting a patient's privacy.

HIPAA applies to "Covered Entities," defined by the Privacy Rule as:

• A healthcare provider that conducts certain transactions in electronic form,
• A healthcare clearinghouse,
• A health plan, or
• A business associate (person or organization) performing a function on behalf of the Covered Entity for which access to protected health information is needed.

Because CWRU has at least one department that provides healthcare services and electronically transmits health information, it is considered a Covered Entity.

CWRU As A "Hybrid Entity"

Since the primary function of CWRU is not to provide healthcare, CWRU is permitted to designate itself as a "hybrid entity," which allows it to apply the Privacy Rule only to those parts of CWRU that, if standing alone, would be a Covered Entity. As a hybrid entity, CWRU must designate its "healthcare components," which includes departments that provide support for healthcare components.

Healthcare components at CWRU are:

• CWRU School of Dental Medicine
• CWRU School of Dental Medicine Faculty Practice
• CWRU Student Self-Insured Health Plan and Optional Dependent Medical Plan
• CWRU Employee Health Plan
• CWRU Postdoctoral Benefits Program
• Prion Disease Pathology Surveillance Center
• CWRU Frances Payne Bolton (FPB) School of Nursing Clinical Practice

CWRU Policies and Procedures for HIPAA

Learn more about HIPAA at Case Western Reserve University. 

HIPAA and Research

A researcher who obtains Protected Health Information (PHI) from a Covered Entity (whether at CWRU, University Hospitals of Cleveland, the MetroHealth System, the Louis Stokes Cleveland Veterans Affairs Medical Center, Cleveland Clinic or from some other Covered Entity) or creates new PHI through the Covered Entity will need to comply with the Privacy Rule. CWRU and its affiliated hospitals empower their Institutional Review Boards (IRBs) to act as Privacy Boards on behalf of each Covered Entity. For example, the MetroHealth IRB also acts as MetroHealth's Privacy Board for research purposes.

For more information on how to meet each institution's HIPAA requirements, please click on the link for the appropriate IRB below:

• CWRU IRB 
• MetroHealth Medical System IRB
• University Hospitals Cleveland Medical Center IRB
• Louis Stokes Cleveland VA Medical Center IRB
• Cleveland Clinic

Other Resources on HIPAA

• Definition of PHI and the 18 identifiers considered to be PHI under HIPAA
• The National Institutes of Health (NIH) Privacy Rule and Research
• Government HIPAA Office: U.S. Department of Health and Human Services Office for Civil Rights

CWRU HIPAA Contacts