Share this e-Alert:

Polsinelli - Health Care Polsinelli - Health Care Technology
         

  

March 2016

  

OCR New Guidance Aims to Help Medical Mobile App Developers Predict when HIPAA Obligations Might Apply

  

 
 

  

     

  

 
 
Best Lawyers - Law Firm of the Year - U.S. News and World Report - Health Care Law - 2015

  

Modern Healthcare - by the numbers 2015 - No. 1 Polsinelli - Largest healthcare law firms

  

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

  

Jean Marie R. Pechette

312.873.3690

Email | Bio

  

Lindsay R. Kessler

312.873.2984

Email | Bio

  

  

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

  


View Polsinelli documents on JD Supra  

SUBSCRIBE

LinkedIn Twitter Facebook Polsinelli Podcast Connect with us on LinkedIn. Connection with us on Twitter. Connect with us on Facebook.
   

Predicting whether the activities of a mobile health application (app) developer trigger legal obligations under the Health Insurance Portability and Accountability Act of 1996 (HIPAA) presents some new challenges – not surprising when 20th century law is extrapolated to apply to 21st century technology.

In recognition of the complexity introduced by rapidly evolving and innovative digital health technology, the Office for Civil Rights (OCR) on Feb. 11, 2016, issued new guidance on its mHealth Developer Portal (here) titled “Health App Use Scenarios & HIPAA.” OCR released the guidance in hopes that it “will help developers determine how federal regulations might apply to products they are building” and “will reduce some of the uncertainty that can be a barrier to innovation.”

The new guidance describes six scenarios involving a mobile health app, accompanied by OCR’s analysis and determination under each scenario as to whether the app software developer would be considered a business associate under HIPAA. In each scenario, the app collects, stores, maintains, or transmits health information from the consumer and/or the consumer’s provider.

The apps in these various scenarios range in function from tracking the user’s diet, exercise, and weight; enabling the user to enter certain health metrics collected by other devices (e.g., blood glucose levels and blood pressure readings obtained using home health equipment); helping users manage chronic conditions; to providing users with a mobile version of their Personal Health Records (PHRs), as offered by the users’ health plan.

The new guidance provides insight into OCR’s approach that attempts to strike a balance between protecting consumer health information and minimizing uncertainty that can stifle innovation. While app developers may be able to navigate HIPAA more clearly, they will still have to navigate other potentially applicable federal laws and state privacy laws.

To view the full PDF, click here.

For More Information

For questions regarding the content of this alert, please contact the authors.

  

 
 

  

     

  

 
         

 

 

 

  

     

  

 
 

Atlanta  Boston  Chattanooga  Chicago  Dallas  Denver  Houston  Kansas City  Los Angeles  Nashville  New York
Overland Park  Phoenix  Raleigh  St. Joseph  St. Louis  San Francisco  Washington, D.C.  Wilmington
polsinelli.com

 
 

  

     

  

 
 

  

ABOUT POLSINELLI

real challenges. real answers.SM  
Polsinelli is an Am Law 100 firm with more than 775 attorneys in 19 offices, serving corporations, institutions, entrepreneurs and individuals nationally. Ranked in the top five percent of law firms for client service*, the firm has risen more than 100 spots in Am Law's annual firm ranking over the past six years. Polsinelli attorneys provide practical legal counsel infused with business insight, and focus on health care and life sciences, financial services, real estate, technology and biotech, mid-market corporate, and business litigation. Polsinelli attorneys have depth of experience in 100 service areas and 70 industries. The firm can be found online at www.polsinelli.com. Polsinelli PC. In California, Polsinelli LLP.

* 2016 BTI Client Service A-Team Report

  

 
 

  

     

  

 
 

Polsinelli provides this material for informational purposes only. The material provided herein is general and is not intended to be legal advice. Polsinelli is very proud of the results we obtain for our clients, but you should know that past results do not guarantee future results; that every case is different and must be judged on its own merits; and that the choice of a lawyer is an important decision and should not be based solely upon advertisements.

Copyright © 2016 Polsinelli PC.

 
             
Connect with us on LinkedIn. Connection with us on Twitter. Connect with us on Facebook. Polsinelli Health Care Technology Health Care