Date/Time: Monday, May 13, 4:00 – 6:15 p.m.
Location: Wiley Rein LLP, 1776 K Street, NW

AGENDA

4:00 ­– 4:05 p.m.         Welcome and Introductions

4:05 – 5:05 p.m.         FCC Issues in MedTech and Telehealth
Wireless medical technologies, and telehealth networks and services, implicate a variety of practical issues at the FCC, particularly for those launching new business ventures or looking to bring new wireless medical devices to market.  For example, what services and frequency bands are available for medical devices and telehealth services, and what are the advantages and disadvantages of each?   What are the key elements of the process for approving wireless medical devices, and what are the respective roles of the FCC and the FDA?  What other “nuts and bolts” FCC-related issues need to be considered?  What compliance issues come into play and what are the penalties?  Panelists will offer perspectives from the practitioner’s and the regulator’s point of view.

Moderator:
Bob Primosch, Partner, Wilkinson Barker Knauer, LLP

Speakers:
Axel Rodriguez, Equipment Authorization & Compliance Branch Chief, Office of Engineering and Technology, Federal Communications Commission
Bruce A. Romano, Consulting Counsel, Wiley Rein LLP
David R. Siddall, Managing Partner, DS Law, PLLC

5:05 – 5:15 p.m.         Break

5:15 – 6:15 p.m.         Effective Business Planning: Additional Regulatory and Policy Challenges
Bringing MedTech and telehealth devices and services to market implicates a host of other legal, regulatory, and legislative issues at the state and federal levels.  Panelists will offer their insight on critical issues such as FDA regulation and approvals, reimbursement and Medicare payment policies, foreign practitioner authorization, HIPPA, and health data interoperability and cybersecurity.

Moderator:
Trey Hanbury, Partner, Hogan Lovells US LLP

Speakers:
Zach Rothstein, Vice President for Technology & Regulatory Affairs, Advanced Medical Technology Association (AvaMed)
Ellen Janos, Member, Mintz
Other speakers TBD

 

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