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