Mintz Levin_mHealth Israel_October 7 2013_Susan Berson
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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 LLP

2014 US mHealth and eHealth Regulatory and Investment Landscape from Mintz Levin LLP

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    Mintz Levin_mHealth Israel_October 7 2013_Susan Berson Mintz Levin_mHealth Israel_October 7 2013_Susan Berson Presentation Transcript

    • The U.S. mHealth Regulatory and Investment Landscape mHealth Israel Conference & Business Contest Susan W. Berson, Esq. Member Mintz, Levin, Cohn, Ferris, Glovsky & Popeo, P.C. Washington, DC, USA October 7, 2013
    • Overview • Patient Protection and Affordable Care Act ("ACA") • FDA developments • Planning for a post-ACA world
    • U.S. Food and Drug Administration • ACA has little impact on FDA. Approval process remains unpredictable.
    • Medical Apps for Mobile Devices • By 2015, 500 million smartphone users worldwide • New FDA guidance issued September 25, 2013
    • • ACA and Health IT
    • 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
    • Health Care Delivery System Reform • 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
    • Funding & Partnership Opportunities • CMMI and Medicaid Waiver authority allow for the creation of new demonstrations/pilot programs
    • Demonstrating Value • Health IT companies need to demonstrate value to providers, health systems, and insurers
    • Is Your Company Ready? • Need more than FDA approval • How are you addressing value in R&D, trials, and marketing?
    • Questions? Susan W. Berson, Esq. Member Mintz, Levin, Cohn, Ferris, Glovsky & Popeo, P.C. 701 Pennsylvania Avenue N.W., Suite 900 Washington, DC, USA +1-202-661-8715 SBerson@mintz.com