Digitized Respiratory Inhaler: Will Patient Data be Safe?

Earlier this year I wrote about the potential of “hacking” personal data with a new FDA-approved digitized respiratory inhaler ProAir® Digihaler ^TM (albuteral 117 mcg). Recently, the FDA approved another digitized respiratory inhaler for the treatment of asthma in patients 12 years of age or older—AirDuo Digihaler, a combination of fluticasone propionate and salmeterol.

The product contains a built-in electronic module that detects, records and stores data on inhaler events. The inhaler can be paired with Bluetooth Wireless Technology in the form of a app. This app allows the healthcare provider to track patient data including inspiratory flowrate, maintenance use and frequency of use. Use of the app is not required for administration of the digitized inhaler. ¹

Although this technology does seem to provide benefits in tracking a few major metrics of inhaler use including compliance and inspiratory flow, there are major concerns regarding what happens to the stored electronic data:

• Will third party payers have access to it?
• Will patients be penalized for not using the medication as prescribed?
• Will co-pays be increased for noncompliance?

An example of how patients have been penalized for noncompliance include home CPAP systems. These electronic systems are used for treatment of sleep apnea; however, they also track device compliance. Many patients are denied coverage based upon not meeting compliance goals which are tracked electronically. Will this be the next step for these digitized respiratory devices?

Since the AirDuo Digihaler will not be available until 2020 our answers to these questions are unknown. As more devices containing our personal data become “trackable” by third party payers, how will this affect us all in the future? Until then, we all must consider if this technology will also be used to track our personal data that may have punitive effects on our future health care needs.

Michael J. Cawley, PharmD, RRT, CPFT, FCCM, is a professor of clinical pharmacy at the Philadelphia College of Pharmacy, University of the Sciences. He has more than 25 years of experience practicing in the areas of medical, surgical, trauma, and burn intensive care as both a critical care clinical pharmacist and registered respiratory therapist.

Reference

1. Monthly Prescribing Reference. MPR. AirDuo Digihaler a Digital Maintenance Asthma Inhaler Therapy. Gets FDA Approval.   https://www.empr.com/home/news/airduo-digihaler-a-digital-maintenance-asthma-inhaler-therapy-gets-fda-approval/. Accessed July 21,2019.