Predicting whether the activities of a mobile health application 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 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.”