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www.mwe.com Boston Bruxelles Chicago Düsseldorf Francfort Houston Londres Los Angeles Miami Milan Munich New York Orange County Paris Rome Séoul Silicon Valley Washington, D.C. Alliance stratégique avec MWE China Law Offices (Shanghai) © 2013 McDermott Will & Emery. Les entités suivantes sont collectivement désignées "McDermott Will & Emery", "McDermott" ou "la Firme": McDermott Will & Emery LLP, McDermott Will & Emery AARPI, McDermott Will & Emery Belgium LLP, McDermott Will & Emery Rechtsanwälte Steuerberater LLP, McDermott Will & Emery Studio Legale Associato et McDermott Will & Emery UK LLP. Ces entités coordonnent leurs activités via des contrats de prestations de services. McDermott bénéficie d'une alliance stratégique avec MWE China Law Offices, cabinet d'avocats distinct. The Connected Health Regulatory Environment Dale C. Van Demark, Washington, DC DM_US 51043871_1

The Connected Health Regulatory Environment USCIPP 2014

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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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Page 1: The Connected Health Regulatory Environment USCIPP 2014

www.mwe.com

Boston Bruxelles Chicago Düsseldorf Francfort Houston Londres Los Angeles Miami Milan Munich New York Orange County Paris Rome Séoul Silicon Valley

Washington, D.C.

Alliance stratégique avec MWE China Law Offices (Shanghai) © 2013 McDermott Will & Emery. Les entités suivantes sont collectivement désignées "McDermott Will & Emery", "McDermott" ou "la Firme":  McDermott Will & Emery LLP, McDermott Will & Emery AARPI, McDermott Will & Emery Belgium LLP, McDermott Will & Emery Rechtsanwälte Steuerberater LLP, McDermott Will & Emery Studio Legale Associato et McDermott Will & Emery UK LLP.  Ces entités coordonnent leurs activités via des contrats de prestations de services.  McDermott bénéficie d'une alliance stratégique avec MWE China Law Offices, cabinet d'avocats distinct.

The Connected Health Regulatory Environment

Dale C. Van Demark, Washington, DC

DM_US 51043871_1

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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

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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

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The “Connected Health” Environment: Industry Infrastructure Developing

Trade Associations

Accreditation and Standards

Professional Training

Insurance Products

Specialty Products

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The “Connected Health” Environment: Evolution of Models

? ? ? ?

Evolution of an

Accepting Infrastructur

e

Multiplicity of Catalysts for Change

Multiplicity of

Connected Health Models

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The “Connected Health” Environment: Evolution of Models

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The “Connected Health” Environment: Evolution of Models

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The “Connected Health” Environment: Evolution of Models

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The “Connected Health” Environment: Legal and Regulatory Focus

Safety

Efficacy

Reimbursement

Privacy

Public Policy Goals

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The “Connected Health” Environment: Hitting the Target?

Law and Regulation Connected Health Efforts

Page 11: The Connected Health Regulatory Environment USCIPP 2014

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

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The Basic Regulatory Approach

Regulation

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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

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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

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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

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Does it Constitute Practicing Medicine?Licensure / Practice of Medicine

“Defined” by State Law

Practice of Telemedicine Sometimes Defined

Location of Patient

“E” Prescription Restrictions

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Does it Transmit PHI or Other Private Information?

HIPAA

State

Privacy Rules

Other

Privacy Rules

Risk

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Should it Be Reimbursed?

MedicareMedicaid Programs

Other Federal Programs

State Programs (Non-Medicaid)

Private Payors

Individuals

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Does it Do What it Says it Will?

RiskFDA

Approval?

No Rigorous Accreditation

Standards

Do Technology Companies

“Get It”

Insurance (Malpractice or Product Liability?)

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Who is Responsible?

You

. . . . maybe

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Dale C. Van [email protected]+1 (202) 756-8177

Questions?