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OCR Releases HIPAA Guidance for mHealth App Use

February 19, 2016
by Rajiv Leventhal
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The Department of Health and Human Services’ (HHS) Office of Civil Rights (OCR) has released further guidelines to help healthcare professionals fully understand Health Insurance Portability and Accountability Act (HIPAA) laws.

Last month, OCR released well-received guidelines to help ensure that individuals understand and can exercise their right to access their health information. Although HIPAA laws have always provided individuals with the right to access their health data, consumers haven’t gotten much guidance from the feds on how to exercise that right—until recently.

Now, OCR has released new guidance related to mobile health (mHealth) apps. It specifically focuses on two questions:

1. How does HIPAA apply to health information that a patient creates, manages or organizes through the use of a health app?

2. When might an app developer need to comply with the HIPAA Rules?

The answers to these questions are fact and circumstance specific, OCR stresses. The guidelines provide six scenarios based on a specific set of facts. Change in a scenario may of course change the analysis and, as a result, change the determination of whether the app developer is required to comply with HIPAA. 

OCR goes on to say that even if you are not a covered entity, you may be a business associate if you are creating or offering the app on behalf of a covered entity (or one of the covered entity’s contractors), and in that case you are required to comply with certain provisions of the HIPAA Rules. In general, a business associate is a person [or entity] who creates, receives, maintains or transmits protected health information (PHI) on behalf of a covered entity or another business associate. So, most vendors or contractors (including subcontractors) that provide services to or perform functions for covered entities that involve access to PHI are business associates, OCR says.

To read more about key HIPAA questions related to health app use, and to see the scenarios outlined by OCR, click here for the guidance.



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