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.

Transcript of The Connected Health Regulatory Environment USCIPP 2014

  • Boston Bruxelles Chicago Dsseldorf Francfort Houston Londres Los Angeles Miami Milan Munich New York Orange County Paris Rome Soul Silicon Valley Washington, D.C. Alliance stratgique avec MWE China Law Offices (Shanghai) 2013 McDermott Will & Emery. Les entits suivantes sont collectivement dsignes "McDermott Will & Emery", "McDermott" ou "la Firme": McDermott Will & Emery LLP, McDermott Will & Emery AARPI, McDermott Will & Emery Belgium LLP, McDermott Will & Emery Rechtsanwlte Steuerberater LLP, McDermott Will & Emery Studio Legale Associato et McDermott Will & Emery UK LLP. Ces entits coordonnent leurs activits via des contrats de prestations de services. McDermott bnficie d'une alliance stratgique 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 Environment: Some Basic Categories Telemedicine EHR and Diagnostic Tools Apps and mHealth Remote Monitoring Online Services and Information Email, Text and Social Media 2
  • 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 3
  • The Connected Health Environment: Industry Infrastructure Developing Trade Associations Accreditation and Standards Professional Training Insurance Products Specialty Products 4
  • The Connected Health Environment: Evolution of Models ? ? ? ? Evolution of an Accepting Infrastructure Multiplicity of Catalysts for Change Multiplicity of Connected Health Models 5
  • The Connected Health Environment: Evolution of Models 6
  • The Connected Health Environment: Evolution of Models 7
  • The Connected Health Environment: Evolution of Models 8
  • The Connected Health Environment: Legal and Regulatory Focus Safety Efficacy Reimbursement Privacy Public Policy Goals 9
  • The Connected Health Environment: Hitting the Target? 10 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
  • The Basic Regulatory Approach 12 Regulation Is it a Medical Device? Does it Constitute the Practice of Medicine? Does it Transmit PHI? Should it be Reimbursed? Does it Do What it Says it Will? Who is Responsible?
  • Is it a Medical Device? 13 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
  • Mobile Medical Applications: Current Status of FDAs Regulatory Oversight (by Application Functionality) Focus of FDAs 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 14
  • Does it Constitute Practicing Medicine? The Realm of Telemedicine 15 Remote Interactive or Not Special Technology or Not Intrastate Cross Border Intermediated, in some way Monitoring Face-to-Face Data transmission VOIP Services Specialty Devices Apps Cameras
  • Does it Constitute Practicing Medicine? Licensure / Practice of Medicine Defined by State Law Practice of Telemedicine Sometimes Defined Location of Patient E Prescription Restrictions 16
  • Does it Transmit PHI or Other Private Information? 17 HIPAA State Privacy Rules Other Privacy Rules Risk
  • Should it Be Reimbursed? Medicare Medicaid Programs Other Federal Programs State Programs (Non-Medicaid) Private Payors Individuals 18
  • Does it Do What it Says it Will? 19 Risk FDA Approval? No Rigorous Accreditation Standards Do Technology Companies Get It Insurance (Malpractice or Product Liability?)
  • Who is Responsible? You . . . . maybe 20
  • Dale C. Van Demark [email protected] +1 (202) 756-8177 Questions? 21