Flo Health, Inc., which marketed an app used by more than 100 million women interested in tracking their personal menstruation and fertility information, seems to be getting off easily as compared with HIPAA-covered entities who misuse individual health information. The FTC’s January 13, 2021 press release announcing its proposed settlement with Flo Health sidesteps mention
health app
New OCR Resource Adds Guidance on HIPAA and Direct-to-Consumer Health Apps
By Elizabeth G. Litten on
A tricky issue for mobile health app developers since the Office for Civil Rights (OCR) released its first “Health App Use Scenarios & HIPAA” guidance back in 2016 has been deciphering whether the developer is a business associate if it offers its app on a consumer-facing basis as well as through covered entities (or their…
“I Have an App for That”: ONC’s Information Blocking Rule and HIPAA Access Rights
By Elizabeth G. Litten on
A patient asks her doctor to send her test results to an app the patient has downloaded on her phone. The doctor worries that the app is not secure and that the patient might not understand the security risks. What should the doctor do?
Covered entity health care providers and their business associates likely need…
New Apple Watch May Mark Time To Rethink HIPAA
By Elizabeth Litten on
The new Apple Watch Series 4® is one of the more recent and sophisticated consumer health engagement tools. It includes a sensor that lets wearers take an electrocardiogram (ECG) reading and detect irregular heart rhythms. The U.S. Food & Drug Administration (FDA) recently approved these functions as Class II medical devices, which generally…
There’s An App For That Health Information – But is it HIPAA-Covered?
By Elizabeth Litten on
“Maybe” is the take-away from recent guidance posted on OCR’s mHealth Developer Portal, making me wonder whether the typical health app user will know when her health information is or is not subject to HIPAA protection.
The guidance is clear and straightforward and contains no real surprises to those of us familiar with HIPAA,…
Basic HIPAA Question for Mobile Health Application Developers: What Are You?
By Elizabeth Litten on
Health-related technology has developed light-years faster than health information privacy and security protection laws and policies, and consumers can find new mobile health applications for a wide range of purposes ranging from diabetes management to mole or rash evaluation to fitness tracking. Smart mobile app developers wondering when and how HIPAA privacy and security requirements…