mhealth israel_ellen janos_healthcare partner_mintz levin_ us regulatory environment
TRANSCRIPT
Mintz Levin. Not your standard practice.
US Regulatory Trends:
2015 and Beyond
Ellen L. Janos, Esq
December 15, 2014
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
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
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?
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
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)
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
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
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
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
Ellen L. Janos, Esq.
Mintz Levin Cohn Ferris Glovsky and Popeo, PC
One Financial Center
Boston, MA 02113
617.348.1662
Thank You!