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Polsinelli - Health Care
         

  

February 2014

  

HHS Extends Patient Access to Laboratories

  

 
 

  

     

  

 
 

For more information about this e-Alert, please contact:

  

Kristen B. Rosati

602.650.2003

krosati@polsinelli.com

  

Kathleen D. Kenney

312.463.6380

kdkenney@polsinelli.com

  

Lauren Z. Groebe

816.572.4588

lgroebe@polsinelli.com

  

Health Care Practice Leaders:

  

Matthew J. Murer

Practice Area Chair

312.873.3603

mmurer@polsinelli.com

  

Jane E. Arnold

Practice Area Vice Chair

312.622.6687

jarnold@polsinelli.com

  

Colleen M. Faddick

Practice Area Vice Chair

303.583.8201

jarnold@polsinelli.com

  

  

To learn more about our Health Care practice, or to contact one of our Health Care attorneys, click here.

  


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On February 6, 2014, the Department of Health and Human Services (HHS) published a Final Rule amending regulations implementing the Clinical Laboratory Improvement Amendments of 1988 (CLIA) and the Health Insurance Portability and Accountability Act of 1996 (HIPAA). The Final Rule takes effect on April 7, 2014. HIPAA covered entities must comply by October 6, 2014.

The Final Rule was jointly issued by the Office for Civil Rights (OCR), the Centers for Medicare and Medicaid Services (CMS), and the Centers for Disease Control and Prevention (CDC), and extends to laboratories a patient's right to access records. The Final Rule removes the HIPAA access exception for CLIA or CLIA-exempt laboratories and requires laboratories that meet the definition of a HIPAA covered entity to provide a patient with direct access to test results.

HHS indicates that the policy behind the extended patient right of access is "part of an ongoing effort to empower patients to be informed partners with their health care providers." The Final Rule does not require laboratories to review test results with patients, but HHS encourages laboratories to refer patients to their health care providers to discuss those results.

Key action items for HIPAA-covered laboratories include:

  • Update the entity's Notice of Privacy Practices to include the new right of access.
  • Modify policies and procedures to ensure an authentication process is in place for verifying the identity of the individual requesting PHI directly from the lab.
  • Ensure that access policies address an individual's right to obtain access and to designate access to a third party, and the obligation to provide the individual (or individual's designee) the PHI in the form requested (including in electronic format if it is readily producible).
  • Train workforce members on the new access rights and the new policies and procedures for providing an individual access and verifying identity.
  • Review applicable state law to determine whether there are conflicts with HIPAA (and if so, determine whether HIPAA preempts that state law).

For More Information

The Final Rule is available in its entirety here. For more information about the contents of this eAlert please contact:

 
 

  

     

  

 
         

 

 

 

  

     

  

 
 

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