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Mobile Health: Update from the Regulatory Front


Mobile Health: Update from the Regulatory Front
$224
Webinar
Product Code - LGA168
Speaker(s): Yarmela Pavlovic, Hogan Lovells US LLP; Trey Hanbury, Hogan Lovells US LLP
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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.

Educational Objectives

• 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: CLE  (For more information, please click on the "CLE Credit" tab.)

Yarmela Pavlovic, Hogan Lovells US LLP; Trey Hanbury, Hogan Lovells US LLP

Yarmela Pavlovic, Hogan Lovells US LLP
Yarmela Pavlovic is a partner with the law firm of Hogan Lovells. Ms. Pavlovic’s practice focuses primarily on the U.S. Food and Drug Administration’s (FDA’s) regulation of medical devices. She has particular experience in the area of FDA regulation of medical software. Specifically, Ms. Pavlovic assists clients in assessing FDA requirements for a variety of software products, as well as developing premarket strategies where necessary. She regularly counsels clients regarding strategic plans that not only comply with government regulations, but also achieve their business objectives.

Ms. Pavlovic also frequently advises traditional medical device manufacturers regarding development of regulatory strategies for obtaining FDA marketing approval for their devices. Yarmela has extensive experience in assisting companies in matters pertaining to product development and product submissions (510(k)s, IDEs, and PMAs), as well as providing advice on a variety of other device-related regulatory issues.

Ms. Pavlovic earned a J.D. from the University of Michigan Law School and a B.S., magna cum laude, from Linfield College.

Trey Hanbury, Hogan Lovells US LLP
Trey Hanbury is a partner in Hogan Lovells' Washington, D.C. office and a member of the Technology, Media and Telecoms practice. He has extensive experience working for the private and public sectors on a variety of communications policy issues, including wireless, spectrum, satellite and international telecom matters.
Mr. Hanbury came to Hogan Lovells from Sprint Nextel, where he served as Director of Government Affairs. In this position, Mr. Hanbury acted as regulatory counsel in major rulemaking proceedings, mergers and acquisitions, and cases before the Federal Communications Commission (FCC), the National Telecommunications and Information Administration of the Department of Commerce, the Departments of Justice and Homeland Security, Congress, and federal courts.

Prior to working for Sprint Nextel, Mr. Hanbury held various policy-making positions at the FCC, including working on numerous satellite and international telecom matters in the International Bureau. He also served as Special Counsel in the Office of General Counsel, where he was responsible for providing policy and legal advice to the Office of Chairman on wireless issues.

Mr. Hanbury is a Co-Chair of the Federal Communications Bar Association’s FCC Wireless Practice Committee. He also frequently lectures on complex communications policy issues and industry trends.

Mr. Hanbury earned a J.D. from the University of Virginia School of Law, and a B.A., with high distinction, from the University of Virginia. 

This program’s CLE-credit eligibility varies by state. Bloomberg BNA is an accredited provider in the states of New York*, California, Pennsylvania, Texas and Virginia, and most other jurisdictions grant CLE credit on a per-program basis. At this time, Bloomberg BNA does not apply directly to the states of Florida, Rhode Island, Montana and Hawaii although credit is usually available for attorneys who wish to apply individually. Additionally, the following states currently do not grant credit for Bloomberg BNA OnDemand programming: Arkansas, Ohio, Nebraska, and Delaware. All requests are subject to approval once the live webinar has taken place or the customer has viewed the OnDemand version. Please contact the Bloomberg BNA accreditations desk if you have specific questions that have not been addressed.

If you have further questions regarding a specific state or how to file for CLE credit, please contact Bloomberg BNA customer service at 800-372-1033 and ask to speak to the CLE Accreditation Coordinator.

Hardship Policy
Bloomberg BNA offers a hardship policy for attorneys earning less than $50,000 per year. If an attorney wishes to take advantage of this option, he or she must contact Bloomberg BNA directly. For attorneys who are unemployed or earning less than $35,000 per year, a full discount off the price of the program will be awarded upon written proof of hardship. Attorneys earning between $35,000 and $50,000 per year will receive a 50% discount off the price of the program. Any attorney working in the public service sector also qualifies for a special price. If you have further questions regarding the hardship policy or seek additional information, please contact Bloomberg BNA customer service at 800-372-1033 and ask to speak to the CLE Accreditations Coordinator, or email us at accreditations@bna.com.

Questions
For more information about Mandatory or Minimum Continuing Legal Education (MCLE) requirements, visit the American Bar Association website at http://www.abanet.org/cle/mandatory.html.

*Bloomberg BNA is an accredited provider in New York for experienced attorneys only.