mintz levin_mhealth israel_october 7 2013_susan berson
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2014 US mHealth and eHealth Regulatory and Investment Landscape from Mintz Levin LLPTRANSCRIPT
The U.S. mHealth Regulatory and Investment Landscape
mHealth Israel Conference & Business Contest
Susan W. Berson, Esq.MemberMintz, Levin, Cohn, Ferris, Glovsky & Popeo, P.C.Washington, DC, USA
October 7, 2013
• Patient Protection and Affordable Care Act ("ACA")
• FDA developments
• Planning for a post-ACA world
Overview
• ACA has little impact on FDA. Approval process remains
unpredictable.
U.S. Food and Drug Administration
• By 2015, 500 million smartphone users worldwide
• New FDA guidance issued September 25, 2013
Medical Apps for Mobile Devices
•
ACA and Health IT
• IT systems needed to implement healthcare exchanges
–Ability to track and report quality of care measures
–Connect patients to their providers
ACA and Health IT
• Move from volume-based payment (fee-for-service) to value-based payment
• Center for Medicare & Medicaid Innovation (“CMMI”) to scale programs that improved or maintained quality while reducing total costs
Health Care Delivery System Reform
• CMMI and Medicaid Waiver authority allow for the creation of new demonstrations/pilot programs
Funding & Partnership Opportunities
• Health IT companies need to demonstrate value to providers, health systems, and insurers
Demonstrating Value
• Need more than FDA approval
• How are you addressing value in R&D, trials, and marketing?
Is Your Company Ready?
Questions?
Susan W. Berson, Esq.Member
Mintz, Levin, Cohn, Ferris, Glovsky & Popeo, P.C.701 Pennsylvania Avenue N.W., Suite 900
Washington, DC, USA