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Overview of the connected health regulatory environment. Co-presenter with Dr. Michael S. Weiner of IBM who offered a great presentation on IBM's Watson.
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The Connected Health Regulatory Environment
Dale C. Van Demark, Washington, DC
DM_US 51043871_1
2
The “Connected Health” Environment: Some Basic Categories
Telemedicine
EHR and Diagnostic
Tools
Apps and mHealth
Remote Monitoring
Online Services and Information
Email, Text and Social
Media
3
The “Connected Health” Environment: Multiple Accelerators for Innovation
Consumerism
Consumers are active and engaged
Provider Interest
Some providers are creative and technologically oriented
New and Innovative Players
Entrepreneurs are in the market, moving quickly and attracting money
Cost Savings
Push for more efficiency and access is greater than ever before (ACA)
Business
Service line and market expansion – domestic and abroad
4
The “Connected Health” Environment: Industry Infrastructure Developing
Trade Associations
Accreditation and Standards
Professional Training
Insurance Products
Specialty Products
5
The “Connected Health” Environment: Evolution of Models
? ? ? ?
Evolution of an
Accepting Infrastructur
e
Multiplicity of Catalysts for Change
Multiplicity of
Connected Health Models
6
The “Connected Health” Environment: Evolution of Models
7
The “Connected Health” Environment: Evolution of Models
8
The “Connected Health” Environment: Evolution of Models
9
The “Connected Health” Environment: Legal and Regulatory Focus
Safety
Efficacy
Reimbursement
Privacy
Public Policy Goals
10
The “Connected Health” Environment: Hitting the Target?
Law and Regulation Connected Health Efforts
The “Connected Health” Environment: The Fundamental Conundrum
The law is slow to develop, moderately inflexible, and concerned with much more than speed, consumerism, business development and innovation
Connected health is diverse, experimental, evolving and disrupting traditional notions of health care delivery
12
The Basic Regulatory Approach
Regulation
13
Is it a Medical Device?
“An instrument, apparatus,
contrivance. . . including a component part or accessory. . .”
“intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation,
treatment, or prevention of disease”
is a medical device
14
Mobile Medical Applications: Current Status of FDA’s Regulatory Oversight (by Application Functionality)
Focus of FDA’s oversight (to be regulated as medical devices): •Functions as an accessory to a medical device•Transforms a mobile platform into a medical device
Regulatory status TBD: •Performs patient-specific analysis•Supports clinical decision-making
Enforcement discretion:•Coaches/prompts patients to manage their health in their daily environment•Provides simple tools to organize/track patient health information•Provides easy access to information related to patient health conditions/treatments•Helps patients document, show, or communicate potential medical issues to providers•Performs simple calculations routinely used in clinical practice•Interacts with PHR or EHR systems
15
Does it Constitute Practicing Medicine?The Realm of “Telemedicine”
Remote
Interactive or Not
• Monitoring• Face-to-Face• Data transmission
Special Technology or Not
• VOIP Services• Specialty Devices• Apps• Cameras
16
Does it Constitute Practicing Medicine?Licensure / Practice of Medicine
“Defined” by State Law
Practice of Telemedicine Sometimes Defined
Location of Patient
“E” Prescription Restrictions
17
Does it Transmit PHI or Other Private Information?
HIPAA
State
Privacy Rules
Other
Privacy Rules
Risk
18
Should it Be Reimbursed?
MedicareMedicaid Programs
Other Federal Programs
State Programs (Non-Medicaid)
Private Payors
Individuals
19
Does it Do What it Says it Will?
RiskFDA
Approval?
No Rigorous Accreditation
Standards
Do Technology Companies
“Get It”
Insurance (Malpractice or Product Liability?)
20
Who is Responsible?
You
. . . . maybe
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