Your SlideShare is downloading. ×
Mintz Levin_mHealth Israel_October 7 2013_Susan Berson
Upcoming SlideShare
Loading in...5
×

Thanks for flagging this SlideShare!

Oops! An error has occurred.

×

Saving this for later?

Get the SlideShare app to save on your phone or tablet. Read anywhere, anytime - even offline.

Text the download link to your phone

Standard text messaging rates apply

Mintz Levin_mHealth Israel_October 7 2013_Susan Berson

205
views

Published on

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


0 Comments
0 Likes
Statistics
Notes
  • Be the first to comment

  • Be the first to like this

No Downloads
Views
Total Views
205
On Slideshare
0
From Embeds
0
Number of Embeds
0
Actions
Shares
0
Downloads
7
Comments
0
Likes
0
Embeds 0
No embeds

Report content
Flagged as inappropriate Flag as inappropriate
Flag as inappropriate

Select your reason for flagging this presentation as inappropriate.

Cancel
No notes for slide

Transcript

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