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The U.S. mHealth Regulatory and
Investment Landscape
mHealth Israel Conference & Business Contest
Susan W. Berson, Esq.
Me...
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,...
•

ACA and Health IT
ACA and Health IT
• IT systems needed to implement healthcare exchanges
–Ability to track and report quality of care measu...
Health Care Delivery System Reform
• Move from volume-based payment (fee-for-service) to
value-based payment
• Center for ...
Funding & Partnership Opportunities
• CMMI and Medicaid Waiver authority allow for the
creation of new demonstrations/pilo...
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., Su...
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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

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Transcript of "Mintz Levin_mHealth Israel_October 7 2013_Susan Berson"

  1. 1. 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
  2. 2. Overview • Patient Protection and Affordable Care Act ("ACA") • FDA developments • Planning for a post-ACA world
  3. 3. U.S. Food and Drug Administration • ACA has little impact on FDA. Approval process remains unpredictable.
  4. 4. Medical Apps for Mobile Devices • By 2015, 500 million smartphone users worldwide • New FDA guidance issued September 25, 2013
  5. 5. • ACA and Health IT
  6. 6. 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
  7. 7. 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
  8. 8. Funding & Partnership Opportunities • CMMI and Medicaid Waiver authority allow for the creation of new demonstrations/pilot programs
  9. 9. Demonstrating Value • Health IT companies need to demonstrate value to providers, health systems, and insurers
  10. 10. Is Your Company Ready? • Need more than FDA approval • How are you addressing value in R&D, trials, and marketing?
  11. 11. 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
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