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Telemedicine and E-Health Law
Incisive Media, Pages: 600

  Description  

  Table of Contents  
    
    
    
   
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Chapter 1.

Telemedicine: Legal and Regulatory Issues
- 1.01 Introduction
- 1.02 Regulation of Telemedicine

[1] Defining the 'Practice of Telemedicine'
[2] Licensure Requirements
[2] 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 Products

[1] Prescription Drugs and Restricted Medical Devices
[2] Over-the-Counter (OTC) Drugs and Unrestricted Medical Devices
[3] Dietary Supplements
- 3.03 Online Sale of Health-Related Products

[1] Online Non-Pharmacy Sales of Drugs and Medical Devices
[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 Inefficient
[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 Records

[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 Records
- 5.05 Standardization of Electronic Medical Records

[1] State Initiatives for Standardization of Electronic Medical Records
[2] Private Initiatives
[3] Federal Initiatives
- 5.06 Issues Raised By Electronic Medical Records: Security/Integrity of Electronic Medical Records

[1] Issues Related to Security/Integrity of Electronic Medical Records
[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 Individuals 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 Approval
[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 Prohib-ited Unless it is Permitted or Required
[6] Acknowledgement of Notice, Authorization, and Consent Requirements 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 Authorization
[9] Uses and Disclosures Permitted If the Individual Has the Opportunity to Object Prior to the Use or Disclosure
[10] Uses and Disclosures Permitted If the Individual Has the Opportunity 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] Childrens 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 Paternalism 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 Govern-ment
[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 Connections
[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

Index


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