BLOOMBERG BNA WEBINAR EVENT: Mobile Health: Update from the Regulatory Front
Tuesday, July 30, 2013
1:00 PM - 2:30 PM ET
This program will address recent developments on regulations and policies from the Food and Drug Administration (FDA) and the Federal Communication Commission (FCC) that affect the development of mobile health technology. Mobile health and health IT regulatory issues have become increasingly critical to a successful product lifecycle.
The faculty will address the FDA’s regulation of mHealth technology in terms of understanding the current regulatory landscape and expected changes. They will provide an overview of product types currently or expected to be regulated by the FDA.
Additionally, the FCC spectrum considerations for the health community will be discussed, including commercial spectrum considerations and special-use frequencies such as MedRadio Service at 400 MHz; Medical Body Area Networks at 2360-2400 MHz; and Wireless Medical Telemetry Service in the 608-614 MHz, 1395-1400 MHz, and 1427-1432 MHz bands.
The new rules for experimental radiofrequency licenses will be addressed as well as the recent joint request for comment from the FDA, the ONC, and the FCC that seeks to develop a comprehensive regulatory framework to stimulate health IT.
- Gain a greater understanding of the current FDA and FCC regulatory issues affecting mHealth product development.
- Learn whether your product is already regulated as an accessory.
- Understand what it takes to get FDA clearance/approval for mobile apps and other mHealth products.
- Discover other implications for your business when your product is regulated.
Who would benefit from attending?
In-house attorneys and regulatory personnel at mHealth companies; health care practitioners; intellectual property attorneys; medical device developers; those involved with government regulation.
Program Level: Intermediate
Credit Available: This program’s CLE-credit eligibility varies by state.