Using the Public Health Law Map Public Health Topics General Medical Law Topics General Legal Topics Introduction to Public Health Law The History of Public Health Authority Legal Standards for Public Health Authority Expert Decision Makers Reviewing Public Health Orders Due Process and Privacy Organization of the Legal System Federalism Checks and Balances The Legislative Branch The Executive Branch The Judicial Branch State Versus Federal Powers Regulation of Commerce The Police Power Federal Preemption Limits to Federal Power The State Court System The Common Law The Importance of Precedent Weaknesses in the Common Law Process The Litigation Bias Administrative Adjudications versus Trials Private Alternatives to the Courts—Alternative Dispute Resolution (ADR) ADR Techniques Implementing ADR References - ADR Tort Claims against Private Parties Types of Claims Personal Injury Torts Negligence Res Ipsa Loquitur Negligence Per Se Intentional Torts Sexual Assault Contract and Property Claims Divorce, Custody, and Incompetence Statutory Causes of Action Nonmonetary Remedies - Injunctions Medical Malpractice Claims Duty Standard of Care The Expert’s Role Schools of Practice The Locality Rule The Importance of Setting Objective Standards Malpractice Considerations in Pediatrics Acute Medical Care Long Statutes of Limitation Causation Defensive Medicine Technology-Oriented Medicine Diagnosis and Testing Specialty Blinders Medical Malpractice Litigation References The Measure of Damages Direct Economic Damages Lost Earnings Medical Expenses Preexisting Illness Future Medical Costs Rehabilitation and Accommodation The Strategic Value of Medical Expenses Indirect Economic Damages Pain and Emotional Distress Consortium Punitive Damages The Collateral Source Rule Strategies for Paying Damages Lump Sum Payments Structured Settlements Products Liability The Legal Risks of Safety Devices* Filtering Data Fetal Monitors Pulse Oximeters Lessons for Technology Assessment References - Civil Claims Claims against the Government Sovereign Immunity The Court of Claims The Tucker Act The Little Tucker Act Mixed Cases Current Status of Federal Sovereign Immunity Federal Tort Liability Federal Tort Claims Acts (FTCA) Process for Filing a Demand and Lawsuit Damages Exceptions to the FTCA Discretionary Acts Ministerial Tasks Intentional Torts under FTCA Assault and Battery Defamation Quarantine Military Law Enforcement Exception Medical Malpractice under the FTCA The Discretionary Function Defense in FTCA Medical Malpractice Cases Community Health Centers Constitutional Torts - Bivens Actions Bivens and Alternative Remedies Public Health Bivens Claims Tort Claims against Federal Contractors FTCA Liability The Government Contractor Defense Bivens Actions against Private Actors Liability of a Federal Officer under State Law Liability for Intentional Actions: 42 U.S.C. § 1983 (1871) State Immunity: The Eleventh Amendment Exceptions to Eleventh Amendment Immunity Abrogating State Immunity Personal Liability for Constitutional Torts Limits of Claims Brought under § 1983 § 1983 Liability for Defamation Failure to Perform a Governmental Service Liability for Violating the State Constitutions Liability for Violating State Statutes and Regulations Liability of State Contractors State Tort Claims Acts Discretionary Acts Governmental v. Proprietary Functions Tort Liability for State Contractors Construction Liability for Damages of State or Agency in Operating Hospitals Personal Liability of State Health Officials Public Health Examples Immunity Defenses Absolute Immunity Qualified Immunity The Policy Rationale for Qualified Immunity The Clearly Established Rights Test The Role of Precedent in Establishing Immunity Federal Review of State Court Proceedings Criminal Law Commonalties in Criminal and Administrative Law The Constitutional Basis for Criminal Law Punishment versus Prevention The Constitutional Provisions The Special Stigma of Criminal Prosecution Applying the Constitutional Protections Specificity Requirements Right to Counsel Privilege against Self-Incrimination Searches and Seizures Standard of Proof Double Jeopardy Investigation of the Criminal Case The Citizen’s Duty Protecting Your Rights Criminal Law in Health Care Federal Fraud Prosecutions The Prohibited Transactions The History of Enforcement The Constitutionality of the Laws The Everyone-Does-It Defense False Claims Act Risk Management Issues Waiving Deductibles and Copays as Fraud Waiving Copays Discounts “No Charge” “Kickbacks” and Inducements To Refer Patients Penalties Antitrust Laws Market Share State Action Immunity The Federal Trade Commission Technical Fraud: Rico Violations Understanding RICO Mail and Wire Fraud Incentives and Commercial Bribery The Pattern of Racketeering Prosecuting a RICO Claim The Federal Sentencing Guidelines and Compliance Sentencing Implications for Health Care Practitioners Abuse of Position of Trust or Use of Special Skill Compliance Plans Sentencing Guideline Standards for Compliance Special Characteristics of the Organization Considerations for Physicians Implications for Health Care Practitioners Responding to Government Investigations References - Criminal Law in Health Care The Litigation Process Prefiling Investigating the Criminal Case Witness Statements Search Warrants Investigating the Private Civil Case Preclaim Discovery Statute of Limitations Pretrial Settlements Criminal Settlements Civil Settlements Pretrial Pleadings Service of Process The Plaintiff’s Complaint The Defendant’s Answer Civil Discovery Interrogatories Requests for Admissions Depositions by Written Questions Oral Depositions Requests for Production Subpoenas Subpoena Duces Tecum Objecting to Civil Discovery Criminal Discovery Which Cases Go To Trial? Why Settle before Trial? Incentives against Settlement Delays in Getting to Trial Admitting Evidence Protecting the Jury Invoking the “Rule” Cross-Examination The Hearsay Rule Business Records Exception to Hearsay Entry in the Regular Course of Business Personal Knowledge Timely Entry in the Usual Course of Business Standard Recordkeeping Procedure Fact Witnesses Expert Witnesses Evaluating Expert Witnesses The Frye Rule The Daubert Case The Daubert Test Kumho Tire: Applying Daubert to Experts Qualifying a Medical Standards Expert Witness Guidelines for Expert Witness Testimony in Medical Liability Cases Expert Witness References Posttrial The Cost of Litigation Contingent Fees Problems with Contingent Fees Costs in Other Countries Emotional Risks of a Trial Attacking the Defendant Surviving a Trial Administrative Law Primer Establishing Agencies The Delegation Problem Enabling Legislation Political Control over Agencies Executive Branch Supervision Congressional Supervision State and Local Control Agency Procedure Agency Expertise Inquisitorial versus Adversarial Formal Agency Action The Goldberg Rights The ALJ’s Decision Informal Agency Action Rule Making Notice-and-Comment Rule Making Informal Rule Making Enforcement Permits, Licenses, and Registrations Administrative Orders and Civil Penalties Injunctions and Seizures Administrative Searches Under the Constitution Judicial Review of Agency Actions Exhaustion of Remedies Standard of Review Agency Interpretation of Law Scientific or Technical Expertise References - Administrative Law Working With Lawyers Legal Relationships The State Patients Other Practitioners Physician-Owned Businesses Corporate Employers and Institutions Clash Of Cultures Paternalism in Medicine Attorneys and Autonomy Legal Education The Limitations of Legal Education Pitfalls in On-the-Job Legal Education Choosing an Attorney How to Approach the Law and Lawyers Preventive Law The Hazards of Ignoring Legal Risks Conflicts of Interest Doing Business with Your Clients Conflicts with Other Clients Medical Malpractice Defense In-House Counsel Paying for Legal Services Legal Bills Chronological Billing May June July August September October November Legal Practice Styles Being an Effective Client Preventive Law and Compliance Undetected Legal Problems Legally Risky Situations Potential Future Risks Remedying Problems Confidentiality and Legal Privilege Attorney Independence Attorney–Client Privilege Attorney Work Product Doctrine Attorney as Witness Protecting Investigations Preserving Physical Evidence Conclusions References - Lawyering The Physician–Patient Relationship Managed Care and the Professional Relationship Establishing the Relationship Explicitly Accepting the Patient Exercising Independent Medical Judgment Telephone Calls Private Office Walk-In Patients Informal Consultations Financial Considerations Assisting at Accidents Good Samaritan Laws Emergency Care in the Office Referral and Consultation Obtaining a Consultation Requesting a Consultation Patient Choice Using Consultants Properly Documenting a Consultation Referral Duty To Refer Duty To Refer to a Nonphysician Referring to Institutions The Duty To Find Care Continuing Care Liability for Improperly Managed Referrals Being a Consultant The Consultant–Patient Relationship Tests and Procedures Informing the Patient Recordkeeping Public Duties Institutional Consultants Radiology Pathologists Cardiology Limited Duty Relationships Specialty Care The Treating Specialist Occupational Physician–Patient Relationship Contractual and Statutory Duties to Treat Emergency Medical Treatment and Active Labor Act Americans with Disabilities Act MCOs Expectation of Continued Treatment Terminating the Relationship Abandoning Patients Patient-Initiated Terminations Physician-Initiated Termination of Care Documenting the Termination Telemedicine and Internet Medicine Traditional Electronic Physician–Patient Relationships Licensure Issues Interstate Enforcement Issues Trade Regulation Issues Practicing Telemedicine The Telemedicine Physician–Patient Relationship Being the Local Contact Being the Remote Consultant Emergency Care and EMTALA Examination and Treatment for Emergency Medical Conditions and Women in Labor Special Responsibilities of Medicare Hospitals in Emergency Cases References - Physician Patient Relationship General Telemedicine Consent to Medical Treatment Battery—No Consent Exceptions to the Requirement for Consent The Emergency Exception When Does the Emergency Exception Apply? Children in the Emergency Room Refusal of Care Legally Mandated Treatment The Therapeutic Exception Informed Consent Social Trends behind Informed Consent Technology-Oriented Medicine The Demise of Paternalism Changing Values Legal Standards for Informed Consent Who Must Get Consent? The Community Standard Fraud in Consent The Uncertainty of the Community Standard Reasonable-Person Standard Alternative Treatments Statutory Disclosure Standards Fraud The Commonsense Approach Knowable Risks Unknowable Risks Voluntariness Public Policy Medically Unnecessary Procedures Duty to Inform of HIV Professional Standard Reasonable-Patient Standard The Medical Value of Informed Consent The Patient’s Expectations Conflicts of Interest and Informed Consent Financial Conflicts of Interest Treating Family Members Hospitals Laboratories Sexual Relationships with Patients Consent for Minors Documenting Who Can Consent for Your Patients Special Circumstances Guardians Conflict between Parents Conflicts between Parents and Children Statutory Right To Treat Minors Emancipated Minors Interests of the Child versus the Parents Religious Objections to Medical Care Specific Types of Care Consent for Medical Research International Codes The Nuremberg Code World Medical Association Consent under the International Codes HHS Regulations on Protecting Human Subjects General Requirements for Informed Consent [45 C.F.R. § 46.116 (1998).] Documenting Consent The Form of the Documentation Blanket Consent Forms Treatment-Specific Consent Forms Patient-Specific Consent Forms Non-English Speakers Illiterate Patients Documenting the Oral Consent Proxy Consent Power of Attorney To Consent to Medical Care Conflicts of Interest Limitations Guardianships Establishing the Authority of a Guardian Emergency Guardianships Minors Adults The Interim until the Judge Rules Refusal of Care and Termination of Life Support Who Are the Stakeholders? Patients’ Interests Physicians’ Interests Hospitals Families Society’s Interests The Cruzan Case The Missouri Supreme Court Ruling The U.S. Supreme Court’s Ruling The Persistent Vegetative State Living with Cruzan Formalizing the Patient’s Wishes The Duty To Counsel Complying with a Patient’s Refusal of Care The Role of Courts Following the Patient’s Wishes Judicial Intervention The Simple Cases Living Wills in the Emergency Room The Impact of Cruzan The Drawbacks of Substituted Consent The Problem of Relatives Assisted Suicide History of Suicide Law Physician-Assisted Suicide as a Constitutional Right Right to Pain Relief References - Consent General Consent Issues Impaired or Mentally Ill Patients Research Exhibit 9–1 World Medical Association Recommendations For Clinical Research I. Basic Principles II. Clinical Research Combined with Professional Care III. Nontherapeutic Clinical Research Medical Privacy Why are People Worried about Medical Privacy? A Historical Perspective Why Have Medical Records Changed? What is in the Medical Record? Why are People Worried about Medical Privacy? Controlling Access to Your Medical Records HIPAA Regulations for Medical Care What is a Covered Entity? What is PHI? Authorization to Release PHI HIPAA Release Form Subsequent Use of PHI Preventing Unauthorized Release When Can PHI Be Released without Authorization? Limits on What Information is Released Patient Access to their own PHI Privacy Issues in Medical Research Access to Databases for Research HIPAA Data Use Agreement Access to Patient Records without Authorization Standards for Access without Autorization Issues Raised by Unauthorized Access Designing Research Studies Conclusions Medical Records Legal Uses of Medical Records Medical Malpractice Litigation Medical Records as a Plaintiff’s Weapon Defensible Records Administrative Review of Records Criminal Discovery Quality Assurance and Accreditation Review of Records Medical Office and Clinic Records Basic Patient Information Team and Managed Care Maintaining the Records Readability Altered Records Protecting Records Retention of Records Statutory Requirements on Recordkeeping Destroying Records Telephone Encounters Off-Chart Records Selling Medical Records Pediatric Records Acute Illness Observation Scale Recording Physical Growth and Development Recording Neuromuscular Development Hospital Medical Records Electronic Medical Records References - Medical Records Exhibit 7–1 P.L. Mccarthy’s Technique For Evaluating Pediatric Patients Team Care and Managed Care The Changing Nature Of Physicians’ Practices Corporate Practice of Medicine The Rise of MCOs The Structure of MCOs The Controlling Entity Relationships with Physicians Additional Contractual Terms How Do They Reduce Costs? Fiduciary Duty Physicians as Fiduciaries Training and Licensure Market Factors Duties of a Fiduciary Legal Risks ERISA Health Plans ERISA Preemption Hidden Incentives Preemption of Claims The Shea Case Team Care Issues Vicarious Liability Method of Payment Control Scope of Employment Intentional Acts Hospital Employees Delegation of Authority Explicit Delegation of Authority Implicit Delegation of Authority Triage Evaluation of Medical Tests Supervising NPPS Scope of Practice Documentation Quality Assurance Drug Laws Protocols Physician Protocols Teaching Protocols Physician’s Orders NPP Protocols: Strict Protocols Sample Protocol Diagnostic Criteria Examination/Laboratory Treatment Follow-Up Referral Epidemiology Notes Supervising Medical Students and Residents Patients’ Rights Faculty Physicians Fraud Medical Students, Residents, and Fellows Residents and Fellows Medical Students Nursing and Other Students The Reality of Teaching Programs Importance of the Law Working with a Teaching Program Maintaining Supervision The Physician–Student Relationship Fraud Medical Director’s Liability Dual Capacity Doctrine Medical Licensing Issues Business Risks in Dealing with MCOS Deselection from the MCO Shifting Insurance Risks Capitation Agreements Indemnification Agreements Malpractice Insurance Considerations Antitrust Issues in Managed Care References - Team Care Managed Care Teaching And Supervision Peer Review and Deselection Peer Review Medical Staff Committees The Legal Status of Medical Staff Committees Legal Climate for Peer Review State Law Violations Federal Law Violations Due Process Violations The Federal Peer Review Law Provisions of the Act Protection from Liability Standards for Professional Review Actions Definition of Acceptable “Professional Review Action” Limitations of the Act Adequate Notice and Hearing Notice of a Right to a Hearing Notice of the Nature of the Hearing Economic Competition Rights in the Hearing Rights at the Completion of the Hearing Emergency Procedures Duty of Hospitals To Obtain Information Access to Information Disclosure and Correction of Information Confidentiality of Information National Practitioner Data Bank Reporting by Boards of Medical Examiners Reporting by Health Care Entities Form of Reporting Protection for Persons Providing Information Definitions and Reports (Sec. 11151) Attorney’s Fees Good Faith or Objective Standard? Potential Adverse Impacts The Problem of Bias Conducting the Review Documenting the Peer Review Process Deselection MCO Physician Market Strategy Due Process and HCQIA Public Policy Claims References - Peer Review Public Health and Communicable Disease Control Disease Control Disease Control and the Individual Epidemics and Plagues Carrier State Disease Control and the Physician–Patient Relationship Reportable Diseases Complying with Reporting Duties Warning Third Parties Coercive Measures Involuntary Testing Contact Tracing Mandated Treatment Quarantine and Isolation Using Isolation and Quarantine HIV/AIDS History Hepatitis B in the Bathhouses How Infectious Diseases Emerge Initial Concentration in the Gay Community Parallels with Other Diseases Disease Control for HIV Immunizations Herd Immunity and Community Health Compulsory Immunization Consent for Immunizations Medical Exemptions The Vaccine Compensation Act Recording Duties Reporting Duties Attorney’s Duty Vital Statistics Birth Certificates Naming the Child Stillbirths Death Certificates Declaration of Death Coroner Cases and Autopsies Disease Registries Law Enforcement Reporting Child Abuse Child Neglect Defending the Child Dangerousness Due to Mental Illness Elder and Spousal Abuse Violent Injuries Intoxications Dealing with Peace Officers The Role of Community Physicians in Public Health References - Public Health Disease Control Law Enforcement Reporting Environmental Health Federal Environmental Law Fluoridation of Water The Fluoridation Controversy Model Brief Supporting the Fluoridation of Water Fluoridation is a Proper Use of the Police Power Fluoridation is Rationally Related to Protecting the Public's Health The Fluoridation Plan The State May Act to Prevent Chronic Diseases Fluoridation is not Compelled Medication Fluoridation Benefits all Members of the Community Fluoridation does not Harm Individual Health Other Arguments Against Fluoridation Conclusion Table of Authorities Support by Professional Organizations Food Sanitation Family Planning, Adoption, and Surrogacy Ethical Dilemmas in Family Planning Balancing the Health Care Practitioner’s and the Patient’s Rights Contractual Limitations on Refusing To Provide Care Consent for Reproductive Care Taking a Sexual History Contraception Balancing the Risk of Pregnancy Legally Mandated Warnings for Oral Contraceptives Implantable Contraceptives Natural Family Planning HIV Infection and AIDS Minors’ Access to Contraception Medical Issues in Contraception for Minors Sterilization Determining Which Partner To Sterilize The Childless Patient Sterilizing Minors and Incompetents Federal Law Requirements Informed Consent Required Consent Form Required Signatures Required Certifications Abortion The Politics of Abortion The Problem of Privacy Protecting Personal Beliefs Limiting Governmental Support Consent to Abortion Informing the Patient Adoption Alternatives Time Constraints The Changing Nature of Abortion Adoption And Parental Rights Parental Rights The Presumption of Legitimacy Biological Fathers and Legitimization Termination of Parental Rights Adoption Risks to Health Care Practitioners Matchmaking Evaluating Potential Adoptive Children Access to Adoption-Related Records Surrogate Parenthood Davis v. Davis—The Tennessee Appeals Court Decision Davis v. Davis—The Tennessee Supreme Court Decision Conclusion In the Matter of Baby M Facts Invalidity and Unenforceability of Surrogacy Contract A. Conflict with Statutory Provisions B. Public Policy Considerations References - Family Planning Adoption Family Planning and Abortion Surrogacy Obstetrics Genetic Counseling Medical Risks Screening for Neural Tube Defects as a Model MSAFP and Down Syndrome The Genetic History Information about Specific Diseases Patient Characteristics Risks of the Diagnostic Procedures Reliability of Testing Time Limitations Social Considerations Am I the Baby’s Father? Can I Have a Healthy Baby with Someone Else? Should We Get Married? Should We Get Divorced? What Should I Tell My Family? Recordkeeping for Genetic Counseling Fertility Treatment Patient Privacy Fitness Medical Fitness Psychiatric Problems Prospects for Successful Treatment Dealing with Multiple Gestation Artificial Insemination Consent Choosing a Donor The Husband as Donor Related Donors Unrelated Donors Genetic Disease Infection Control Unmarried Couples A Structured Approach to Obstetric Care Zero-Defects Management Legal and Ethical Benefits of Structured Care Thinking Like a Plaintiff’s Attorney The Birth Plan Purpose of a Birth Plan Contraindications Authority To Consent Participation of Others Risk-Benefit Analysis The Patient’s Interests Risks to the Baby Emergencies Availability of Facilities and Personnel Custom versus Fashion Evaluating The Mother’s Medical Condition Maternal Disease Legally Mandated Testing Medical Interventions Past-Term Pregnancies Cesarean Sections Home Deliveries The Politics of Home Deliveries Participating in Home Deliveries Working with Midwives Classes of Midwives Referrals and Consultations Behavioral Risks in Pregnancy The American Medical Association Policy Statement Implications of the AMA Policy Consent in High-Risk Pregnancies The Self-Destructive Pregnant Woman Obstetrics Risk Management Preconception versus Postconception Remedies Patients’ Views about Abortion Creating Unreasonable Expectations The Birth-Injured Infant References - Obstetrics Fertility Treatment Genetic Counseling General Obstetrics Occupational Medicine and Disability Law Legal And Ethical Problems in Occupational Medicine Return to Work Certifications Release from Work Certifications Workers’ Compensation The Payment System Work Relatedness Emergency Treatment Reporting Records Dealing With OSHA Employee Medical Information Defining OSHA-Regulated Occupational Medicine Employee Medical Records Authorization To Release Covered Records Physical Access to Records Limitations on Access to Medical Records Preservation of Records OSHA 200 Log Recordable Injuries Material Safety Data Sheets Trade Secrets Drug Testing Occupational Medicine for Health Care Organizations The Americans With Disabilities Act Findings and Purpose (a) Findings (b) Purpose Predecessor Legislation ADA-Defined Disability Exemptions What Is a Major Life Activity? The Majority Opinion The Dissent on Major Life Activity Unanswered Questions Preemployment Medical Examinations Allowable Examinations Preemployment Examination Records New Duties for Occupational Medicine Physicians Persons with Known Disabilities Collective Bargaining and the ADA Direct Threats to Health and Safety The Legal Risks of the Ada Drug and Alcohol Testing under the ADA Pregnant Workers under the ADA Disability Insurance Evaluations Social Security Disability SSA Disability or SSI How To Qualify Listing of Impairments Residual Functional Capacity Other Program Requirements Social Factors Medicare and Medicaid Private Disability Insurance Determining Disability: Workers’ Compensation Versus ADA Communicable Diseases In The Workplace The Increase of Communicable Diseases in the Workplace Immunizations and Antibiotic Misuse Immunosuppression The Legal Risks of Communicable Diseases Third-Party Liability Productivity Communicable Diseases as a Handicap or Disability Additional Requirements of the ADA The Elements of a Communicable Disease Policy Nature of the Risk Methods of Transmission Airborne Fomites Foodborne Insect Vectors Sexually Transmitted Diseases Bloodborne Direct Contact Duration of the Risk Severity Probability of Transmission and Complications Federal and State Requirements Identifying Employees at Risk or Who Pose Risks The Special Problems of Immunosuppression Bloodborne Pathogens Health Care Organizations The Reach of the Regulations Tuberculosis Control References - Occupational Medicine Health Care Organizations Americans with Disabilities Act General Occupational Medicine Institutional Medicine The Prison Doctor Prison Medical Care Physician–Prisoner Relationship Right To Refuse Medical Care Emergency Medical Care Experimentation Public Health and Safety in Prisons Disease Control in Prisons The Physician’s Obligations to the Jailers The Team Doctor The Physician–Player Relationship Team versus Player The Child Athlete Supervision of Nonphysician Personnel Performance Enhancement Engineering People Screening for Participation The School Doctor Supervisory Responsibilities School Clinics Consent to Care Medicines at School Athletics Medical and Public Health Responsibilities Screening Handicapped Children College Health Programs Comprehensive Care References - Institutional Medicine Schools Teams Prisons Glossary