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INTERNATIONAL TELEHEALTH –
WHAT’S HAPPENING & KEY LEGAL CONSIDERATIONS
Telehealth Secrets Conference
October 3, 2019
OVERVIEW
• What’s Happening?
• Focus on Cross-Border Activities (although note intra-jurisdictional
telehealth activities outside US appear to be increasing)
• General overview of Categories of Offerings
• Key Legal Considerations & Approach
• A Few Reminders
This presentation should not be construed as legal advice on any specific facts or circumstances. The contents are intended for general information
purposes only and may not be quoted or referred to in any other publication or proceeding without the prior written consent of Jones Day, to be given or
withheld at our discretion. The views set forth herein are the personal views of the authors and do not necessarily reflect those of Jones Day.
© 2019 Jones Day. All rights reserved. 51 Louisiana Avenue, N.W., Washington D.C. 20001-2113
Incorporating Cross-Border Support Services
Provider-to-Provider
& Direct to Consumer
Digital Capabilities in Trials & Virtual Trials
Direct to Consumer
KEY LEGAL CONSIDERATIONS
• Health Regulatory (increasing telemedicine-specific regulations)
• Are you practicing medicine? Where?
• Does the payer limit the location of the provider (e.g. Medicare)?
• Data Privacy (many jurisdictions are more restrictive than US)
• Device Registration & IP Considerations
• Business Licenses & Taxes
• FCPA (Foreign Corrupt Practices Act)
APPROACH & EVOLVING RISK PROFILE
• Educational – Informational Only Services
• Contractual Provider to Provider Arrangements
• Increasing Risk for “Lack of Regulatory Enforcement & Fly Under
the Radar” Approaches
• Significant Need for Streamlined Policy
NOTABLE REMINDERS
• Documentation, Marketing & Training should be consistent with legal
compliance approach
• Medicare, Medicare Advantage & Medicaid can require notifications
or limit utilization of vendors located outside the US
QUESTIONS
Alexis Slagle Gilroy
Washington, DC
agilroy@jonesday.com
202.879.5552
Tw - EHealthLaw

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Telehealth Secrets 2019: Key Legal Considerations for International Telehealth - Alexis Gilroy, Jones Day

  • 1.
  • 2. INTERNATIONAL TELEHEALTH – WHAT’S HAPPENING & KEY LEGAL CONSIDERATIONS Telehealth Secrets Conference October 3, 2019
  • 3. OVERVIEW • What’s Happening? • Focus on Cross-Border Activities (although note intra-jurisdictional telehealth activities outside US appear to be increasing) • General overview of Categories of Offerings • Key Legal Considerations & Approach • A Few Reminders This presentation should not be construed as legal advice on any specific facts or circumstances. The contents are intended for general information purposes only and may not be quoted or referred to in any other publication or proceeding without the prior written consent of Jones Day, to be given or withheld at our discretion. The views set forth herein are the personal views of the authors and do not necessarily reflect those of Jones Day. © 2019 Jones Day. All rights reserved. 51 Louisiana Avenue, N.W., Washington D.C. 20001-2113
  • 4.
  • 7. Digital Capabilities in Trials & Virtual Trials
  • 9. KEY LEGAL CONSIDERATIONS • Health Regulatory (increasing telemedicine-specific regulations) • Are you practicing medicine? Where? • Does the payer limit the location of the provider (e.g. Medicare)? • Data Privacy (many jurisdictions are more restrictive than US) • Device Registration & IP Considerations • Business Licenses & Taxes • FCPA (Foreign Corrupt Practices Act)
  • 10. APPROACH & EVOLVING RISK PROFILE • Educational – Informational Only Services • Contractual Provider to Provider Arrangements • Increasing Risk for “Lack of Regulatory Enforcement & Fly Under the Radar” Approaches • Significant Need for Streamlined Policy
  • 11. NOTABLE REMINDERS • Documentation, Marketing & Training should be consistent with legal compliance approach • Medicare, Medicare Advantage & Medicaid can require notifications or limit utilization of vendors located outside the US
  • 12. QUESTIONS Alexis Slagle Gilroy Washington, DC agilroy@jonesday.com 202.879.5552 Tw - EHealthLaw