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MHealth: Regulation and How to Avoid Practicing Medicine on the Web

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Mobile healthcare or “mHealth” has gained significant traction and investment from many participants, as pilots and trials evolve to substantively funded business ventures aimed at reaching broad consumer segments. Early results suggest that mHealth products and services can help meet two important goals: improving quality outcomes while reducing costs, particularly in managing chronic diseases.During this session panelists will discuss strategies for navigating the potential legal risks associated with the practice of telemedicine and the rules governing the commercialization of mobile medical devices. This session will introduce FDA’s regulation of mobile medical devices, mHealth applications (“apps”) for use on smartphones and other portable devices, and accessories to such devices. Panelists will also discuss the status of FDA’s 2011 Draft Guidance document focused on the regulation and commercialization of mobile medical apps. Attendees will learn various the various factors to consider when evaluating data security and data privacy. Issues related to medical practice licensure, corporate practice restrictions and reimbursement will also be considered.

PLEASE NOTE DATE & LOCATION CHANGE

In collaboration with
AccentureSquire Sanders

Second in a two-part series
looking into the
commercial and regulatory
aspects of mHealth

September 12: Commercial Model

November 15: Regulation

Speakers

Scott A. Edelstein
Partner
Squire Sanders
Paul Nerger
CTO
Happtique, Inc.
Karl M. Nobert
Of Counsel
Squire Sanders
What: Life Science Series:
mHealth: Regulation and How to Avoid
Practicing Medicine on the Web
When: Thursday, November 15, 2012Registration: 8:00AM – 9:00AM

Breakfast, Networking: 8:00AM – 8:30AM

Program: 8:30AM – 10:00AM

Networking: 10:00AM – 10:30AM

Where: Squire Sanders
275 Battery Street
San Francisco, CA 94111
Directions
Cost: Pre-registration through November 13
$20 members
$40 non-members
On-site registration on November 15
$40 members
$80 non-members
Attire: Business attire suggested
  • Pre-registered attendees will receive an immediate receipt/confirmation after submission.
  • Please print this receipt/confirmation and bring it with you to receive your conference credentials.
  • Photo ID (driver’s license or passport) will be required at check-in.
  • All sales are final – BayBio offers no refunds

Please mail your event-related questions to: registration@baybio.org or you can contact us via phone: 650-871-3257.

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