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

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