May 4, 2017
OCR settles HIPAA complaint with CardioNet. CardioNet, one of the oldest companies in the mobile cardiac arrhythmia monitoring space, has agreed to pay the Office of Civil Rights $2.5 million and enter into a corrective action plan in the end result of a HIPAA breach investigation that's been going on since 2012. The judgment is significant, writes law firm Morgan Lewis in a blog post, because it...
April 6, 2016
The Federal Trade Commission (FTC) has released a new interactive tool on its website, with help from the Office of National Coordinator for Health Information Technology (ONC), Office for Civil Rights (OCR) and the Food and Drug Administration (FDA), to help health app developers to determine whether certain regulations apply to their app.
“Mobile app developers need clear information about the...
March 7, 2016
The ONC and OCR are tired of providers using HIPAA as an excuse not to share data with patients — the opposite of its intended purpose. That was the strongest message delivered by ONC Chief Privacy Officer Lucia Savage, who said during an educational session at HIMSS16 in Las Vegas that her office is working on an educational campaign, including blog posts, fact sheets, and new guidance documents...
February 12, 2016
The HHS Office for Civil Rights has published additional guidance on its mHealth Developer Portal that provides developers with different scenarios in which HIPAA might apply to the data their app collects.
“We hope these new scenarios will help developers determine how federal regulations might apply to products they are building; we also hope they will reduce some of the uncertainty that can be...
September 15, 2014
This morning ACT -- The App Association and a number of its mobile health company members sent a letter to Rep. Tom Marino (R-PA) to encourage Congress to push HHS to make HIPAA regulations clearer for mobile app developers.
"We see a huge chunk of our membership engaged on both fitness and the more health-specific side," ACT's Executive Director Morgan Reed told MobiHealthNews in an interview. "...
December 8, 2013
AcneApp, one of the mobile medical apps the FTC removed in 2011.
Correction: A previous version of this article said the ONC, not the OCR, released the HIPAA omnibus rule.
This year has been a big year for health app regulation: FDA released its final guidance on regulation of mobile medical apps earlier this year, and the Office of Civil Rights released its final HIPAA omnibus rule in January...