This is our third installment in our series about the legal issues involved in launching a health app, which the U.S. Food and Drug Administration (“FDA”) refers to as “mobile apps.” The goal of this post is to provide you with a basic understanding of FDA’s evolving approach to mobile apps so that you can make informed decisions about the legal consequences of your app’s functionality. Continue Reading Building a Health App? Part 3: What You Need to Know About FDA’s Regulation of Mobile Apps

The HHS Office for Civil Rights (OCR) has released a new platform to provide mobile health developers (and any other interested stakeholders) a sounding board to ask questions, voice concerns, and “spitball” ideas about HIPAA and its interplay in the Health IT space. Users can submit questions and comments on the site, on which other viewers can comment and vote (similar to “liking” a timeline post on Facebook). All comments remain anonymous and OCR has stated specifically that they will not be used as the basis of enforcement actions. Although OCR will not normally respond to these comments, it has said that feedback provided through the platform will be used to inform the development of future guidance. Continue Reading OCR Launches Platform for Developer HIPAA Questions

Written by: Kimberly Gold and Stephanie Willis

As health information technology (HIT) advancements proliferate, so too must governing regulations.  Three agencies – the Food and Drug Administration (FDA), the Office of the National Coordinator for Health Information Technology (ONC), and the Federal Communication Commission (FCC) – are following a specific mandate under Section 618(a) of the Food and Drug Administration Safety and Innovation Act (FDASIA) to pursue a collaborative approach in regulating HIT. Continue Reading Agencies Seek Comments to Inform Future Health IT Regulation