This document summarizes US regulatory trends for mHealth opportunities from 2015 and beyond. Key points include: 1) The Affordable Care Act promotes new patient care models using mHealth technologies like remote patient monitoring and digital tools to engage patients, and has appropriated $10 billion for innovative payment models. 2) Both private markets and government agencies like CMS provide funding and collaboration opportunities for mHealth. Medicare is also reimbursing for some telemedicine services. 3) Regulators like HHS, FDA, FCC, and FTC provide guidance on issues like data privacy, security and regulation of medical devices and apps, but debate continues on reducing burdens to promote innovation while ensuring patient safety. 4

1. Mintz Levin. Not your standard practice.
US Regulatory Trends:
2015 and Beyond
Ellen L. Janos, Esq
December 15, 2014

2. mHealth: US Opportunities
Affordable Care Act
• New Patient Care Models
– Wellness Initiatives and Incentives
– Patient Engagement
• Congress Appropriated $10B (2011-2019)
• Innovative Payment Models
– ACOs to promote the use of enabling technologies
for improving care coordination
• remote patient monitoring
• electronic tools to engage patients in their care
• telehealth

3. mHealth: US Opportunities
• Funding/Collaboration Opportunities
– Private markets
– CMS, ONC and other funding opportunities
– Provider Collaborations/Affiliations
• Medicare Reimbursement
for Telemedicine
• Private Health Insurance
Telehealth Parity Laws

4. mHealth: What to Expect from HHS
HIPAA and HITECH Act
Data Privacy
Required Policies
and Procedures
Data Security
Data Breach
Enforcement
Doing Business with
a Covered Entity
Who is a Business
Associate?
What does it mean
to be a Business
Associate?

5. mHealth: What to Expect from the FDA
• Current FDA Regulation of Devices
– Is it a Device?
• Equipment/software intended for use in
the diagnosis/treatment of a disease/condition
– If so-
• Must register and list, premarket notification
and/or approval, good manufacturing
practices, and post-market surveillance

6. mHealth: What to Expect from the FDA
Reducing Regulatory Burdens: Risk Based Framework
FDA
Guidance
for Mobile
Medical
Apps
(Sept 2013)
FDASIA
Health IT
Report
(April 2014)
FDA
Guidance
on Medical
Device Data
Systems
(June 2014)

7. mHealth: What to Expect from the FDA
Will Congress take away FDA's discretion??
• Software Act (House) & Protect Act (Senate)
Clinical software and health software
would not be subject to regulation by the FDA
as "devices". Goal is to:
• Remove uncertainty
• Reduce regulatory burdens
• Promote patient safety
• Foster innovation

8. mHealth: What to Expect from the FCC
• CONNECT2HEALTHFCC Task Force
– to accelerate adoption of health
care technologies
– Serve as umbrella for FCC health-
oriented activities
• Proposed Net Neutrality Rules
– delay until 2015
• Consideration of Medical Body
Area Network (MBAN) devices

9. mHealth: What to Expect from the FTC
Continued
Regulation of
Personal Health
Records (PHRs)
Data Breach
Concerns
Focus on Consumer
Generated Health
Information (CHI)
FTC Data Broker
Study
FTC concerns
about sale of
data to market
products

10. Where Are We Headed?
Medicare and
Medicaid
Reimbursement
Risk Based
Approach by FDA
to Regulation of
Devices
Focus on
Privacy and
Security
Increased
Collaborations
More Coordination
Among Regulatory
Bodies
Public and
Private Funding

11. Ellen L. Janos, Esq.
Mintz Levin Cohn Ferris Glovsky and Popeo, PC
One Financial Center
Boston, MA 02113
617.348.1662
ejanos@mintz.com
Thank You!