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Telemedicine
and E-Health Law
Lynn D. Fleisher
and James C. Dechene
Detailed
Table of Contents
CHAPTER 1
Telemedicine: Legal and Regulatory Issues
§ 1.01 Introduction
§ 1.02 Regulation of Telemedicine [1] Defining
the “Practice of Telemedicine”
[2] Licensure Requirements
[3] Credentialing
§ 1.03 Corporate
Practice of Medicine Prohibitions
§ 1.04 Telemedical Malpractice Liability
[1] Procedural
Issues
[2] Providing Health Law Information v. Practicing
Medicine
[3] The Practice of Telemedicine
[4] Telemedicine Equipment
[5] Risk Reduction
CHAPTER 2
Establishing an E-Health Web Site
§ 2.01 Introduction
§ 2.02 Contracting For Web Site Design and Development
[1] Basic
Terms of a Web Development Agreement
[2] Other Contract Considerations
§ 2.03 Terms
of Use/Disclaimers
[1] Sources
of Potential Liability
[2] Terms and Conditions of Use
[3] Disclaimers Regarding Use of Site, Medical Advice
and Health Information
[4] Privacy Policy
§ 2.04 Indemnification
in Agreements to Provide Content
§ 2.05 Insurance
CHAPTER 3
Regulation of the Promotion and Sale of Drugs, Medical Devices,
and Dietary Supplements on the Internet
§ 3.01 Introduction
§ 3.02 Online Advertising and Promotion of Health-Related
Prod-ucts
[1] Prescription
Drugs and Restricted Medical Devices
[2] Over-the-Counter (OTC) Drugs and Unrestricted Medical
De-vices
[3] Dietary Supplements
§ 3.03 Online
Sale of Health-Related Products
[1] Online
Non-Pharmacy Sales of Drugs and Medical De-vices
[2] Online Pharmacy Sales of Prescription Drugs/Devices
[3] Cooperative Enforcement Against Online Sellers
§ 3.04 Conclusion
CHAPTER 4
Intellectual Property and E-Health Sites
§ 4.01 Introduction
§ 4.02 Copyright
[1] Copyright
Protection in the United States
[2] Overview of United States Copyright Law
[3] International Copyright Protection
[4] Licensing Content on the Internet
§ 4.03 Rights
of Privacy and Publicity
[1] Common-Law
Right of Privacy
[2] Right of Publicity
§ 4.04 Trademarks
and Service Marks
[1] Trademark
Protection in the United States
[2] International Trademark Protection
[3] Trademark Licensing
§ 4.05 Trade
Secrets
[1] The
Uniform Trade Secrets Act
[2] Common Law Trade Secret Protection
[3] Overlap with Other Forms of Protection
[4] Methods, Practices and Policies for Trade Secret
Protection for E-Health Activities
§ 4.06 Patents
[1] Utility
Patent Protection in the United States
[2] Design Patents
[3] Design Patents May Be Applicable to E-Commerce,
Including Icons and Other Subject Matter
[4] Emerging Issues Unique or Related to E-Health
[5] Patent Protection Outside the United States
§ 4.07 Importance
to E-Health
CHAPTER 5
Legal Issues Relating to Electronic Medical Records
§ 5.01 Introduction
[1] What
is an Electronic Medical Record?
[2] What is Wrong With Paper Records?
[3] Why are Paper Records Still Used if They Are So
Ineffi-cient
[4] Why EMRs?
§ 5.02 Compliance
with Requirements for Maintenance, Completion and Retention of Medical
Records
[1] State
Laws and Guidelines
[2] Federal Laws and Guidelines
§ 5.03 Legal
Recognition of Electronic Signatures and Re-cords
[1] State
[2] Federal: Electronic Signatures in Global and National
Commerce Act
§ 5.04 Ownership
of Electronic Medical Records
[1]
In General
[2] Special Issues Related to Ownership of Electronic
Re-cords
§ 5.05 Standardization
of Electronic Medical Records
[1] State
Initiatives for Standardization of Electronic Medical Re-cords
[2] Private Initiatives
[3] Federal Initiatives
§ 5.06 Issues Raised
By Electronic Medical Records: Security/Integrity of Elec-tronic
Medical Records
[1] Issues
Related to Security/Integrity of Electronic Medical Re-cords
[2] Laws Addressing Security/Integrity Concerns
CHAPTER 6
Privacy of Electronic Health Information
§ 6.01 Basic Concepts of Privacy, Confidentiality
and Security
[1] Privacy
as an Individual's Right “To Be Left Alone”
[2] Privacy of Personal Health Information
[3] Protections for Personal Health Information in
an Electronic Age
[4] Striking a Balance: Protecting the Privacy of Electronic
Health Information Without Hindering the Advancement of Medical
Research and Other Activities for the Public Good
§ 6.02 Self-Regulation
for Health Internet Websites
[1] The
American Accreditation Health Care Commission (“URAC”)
Accreditation Program
[2] Health Internet Ethics (“Hi-Ethics”)
Principles for Offering Internet Health Services to Customers
[3] TRUSTe Privacy Seal of Approval
[4] Health of the Net (HON) Foundation HONcode Seal
of Ap-proval
[5] Internet Health Coalition eHealth Code of Ethics
§ 6.03 Health
Insurance Portability and Accountability Act of 1996
[1] HIPAA
Administrative Simplification Regulations
[2] HIPAA Privacy Regulations
[3] Information Covered Under the Privacy Regulations
[4] Entities Covered Under the Privacy Regulations
[5] General Rule: Use or Disclosure of Protected Health
Information is Prohibited Unless it is Permitted or Required
[6] Acknowledgement of Notice, Authorization, and Consent
Re-quirements for Uses and Disclosures
[7] Uses and Disclosures Permitted for Treatment, Payment,
or Health Care Operations with Acknowledgment
[8] Additional Uses and Disclosures Permitted with
Authoriza-tion
[9] Uses and Disclosures Permitted If the Individual
Has the Oppor-tunity to Object Prior to the Use or Disclosure
[10] Uses and Disclosures Permitted If the Individual
Has the Op-portunity to Object Prior to the Second Use or Disclosure—Uses
and Disclosures for Fundraising
[11] Uses and Disclosures Permitted or Required Without
Any Permission
[12] General Rules for Uses and Disclosures
[13] Patients' Rights Under the Privacy Regulations
[14] Rules for Special Types of Covered Entities
[15] Administrative Requirements for Covered Entities
[16] Preemption of State Laws
[17] Compliance and Enforcement
§ 6.04 Other
Federal Restrictions
[1] Federal
Privacy Act of 1974
[2] Gramm-Leach-Bliley Act
[3] Children's Online Privacy Protection Act
[4] Federal Substance Abuse Record Confidentiality
Rules
[5] Electronic Communications Privacy Act
[6] Other Federal Privacy Laws
§ 6.05 State
Law: Health Information Privacy
[1] Examples
of State Statutes
[2] Additional State Privacy Protections
[3] Mandatory Disclosures Under State Law
§ 6.06 International
Restrictions—The European Union Directive on Data Protection
[1] Prohibitions
on Transfer of Personal Data
[2] Transfers of Health-Related Information
[3] Data Protection Authorities and Tribunals
[4] Principles for Protecting Personal Data
[5] Protection of Data Outside of the EU Community
[6] The EU-U.S. Safe Harbor
CHAPTER 7
E-Health and Antitrust
§ 7.01 Introduction
§ 7.02 The Antitrust Laws
[1] Governing
Principles
[2] Types of Conduct Prohibited
[3] Exemptions and Immunities
[4] Remedies and Enforcement
§ 7.03 Potential
Antitrust Issues in the E-Health Context
[1] Competition
Among the Venture Participants
[2] Competition at the Network Level
§ 7.04 Case
Studies
[1] Scenario
One: A Cooperatively-Formed Claims Processing Network
[2] Scenario Two: An Independent Medical Products Procurement
Exchange
§ 7.05 Conclusion
CHAPTER 8
Reimbursement for Telemedicine Services
§ 8.01 Introduction
[1] Overview
[2] Reimbursement Coverage Considerations
[3] Service Definition and Payment Amount
[4] Obtaining Coverage
§ 8.02 Medicare
[1] Background
[2] Medicare Coverage of Telemedicine
§ 8.03 Medicaid
[1] Background
[2] Federal Statute and State Determinations
[3] Medicaid Managed Care Programs
[4] Current State Medicaid Telemedicine Programs
[5] Future Developments
§ 8.04 Veterans
Administration
§ 8.05 State Regulated Insurance Companies
[1] Mandatory
Coverage Laws
[2] Discretion of Payers
[3] Required State Insurance Department Filings
[4] Providers' Obligation to Check Policy and Coverage
Before Submitting Claims
[5] Case Management Coverage Opportunities
[6] Preferred Provider Organizations
[7] Summary
§ 8.06 Health
Maintenance Organizations
§ 8.07 ERISA Plans
[1] State
Regulation of ERISA Plans That Purchase Coverage From Commercial
Insurers
[2] Discretion of Self-Insured Plans
[3] ERISA Plans Driven Both by Economic Concerns and
Paternal-ism for Employees
[4] Case Management and Exceptions
[5] Summary
§ 8.08 Conclusion
CHAPTER 9
Fraud and Abuse
§ 9.01 Introduction
[1] Overview
of Federal Fraud and Abuse Laws
[2] Issues in Application to E-Health
§ 9.02 False
Claims or False Statements
[1] False
Claims Against the Government
[2] False Claims Against Private Entities
§ 9.03 Kickbacks
and Financial Inducements for Referrals
[1] Prohibition
on Kickbacks
[2] Regulatory Safe Harbors to the Anti-Kickback Statute
[3] Penalties Under the Anti-Kickback Statute
[4] Scope and Breadth of Anti-Kickback Statute
§ 9.04 Exclusion
Remedies
§ 9.05 Stark Bill
[1] Violation
and Penalties
[2] Designated Health Care Services
[3] Principal Exceptions
§ 9.06 Special
Fraud Alerts
[1] Joint
Venture Arrangements
[2] Routine Waiver of Part B Copayments and Deductibles
[3] Hospital Incentives to Physicians
[4] Prescription Drug Marketing Schemes
[5] Clinical Laboratory Arrangements
§ 9.07 OIG
Advisory Opinions
[1] Ophthalmologist/Optometrist
Arrangement
[2] Rural Telemedicine Network
[3] Telemedicine School Screening Program
§ 9.08 Potential
E-Health Fraud and Abuse Issues
[1] Integrated
Delivery System/Joint Venture Issues
[2] Provision of Transcription Services in Connection
with E-Records
[3] Provision of Equipment or Software to Facilitate
E-Health Con-nections
[4] Responsibility for Costs of E-Health Networks
[5] Manufacturer Sponsored Web-Based Referral Services
[6] False Claim Issues with Telemedicine
[7] Fee Splitting/Inducements
[8] GPOs and B2B Arrangements
§ 9.09 Conclusion
CHAPTER 10
Taxes and Web Activities
§ 10.01 Introduction
§ 10.02 Unrelated Business Income Tax Basics
[1] Purpose
of Tax
[2] Basic Tests For Taxability
[3] Exclusions
§ 10.03 Sales/Merchandising
Activities
§ 10.04 Web Site Activities
[1] Corporate
Sponsorship Rules
[2] Specific Issues
§ 10.05 Exemption
Issues
[1] Lobbying
Restrictions
[2] Political Campaign Activity Restrictions
[3] Joint Ventures
§ 10.06 State
Charitable Solicitation Statutes
§ 10.07 Conclusion
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