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• Preface(p. xiii)
• Acknowledgments(p. xv)
• About the Authors(p. xvii)
• Chapter 1 Introduction to the American Legal System(p. 1)
• Chapter Objectives(p. 1)
• Introduction(p. 1)
• The Nature of Law(p. 2)
• Sources of Law(p. 3)
• The Constitution(p. 3)
• Statutes(p. 6)
• Decisions and Rules of Administrative Agencies(p. 8)
• Court Decisions(p. 9)
• Governmental Organization and Function(p. 11)
• Organization of the Court System(p. 13)
• State Court System(p. 14)
• Federal Court System(p. 15)
• Chapter 2 Medical Records and Managed Care(p. 19)
• Chapter Objectives(p. 19)
• Introduction(p. 19)
• Utilization Review(p. 20)
• Managed Care(p. 20)
• Managed Care Organizations and Related Entities(p. 21)
• Health Maintenance Organizations(p. 21)
• Preferred Provider Organizations(p. 22)
• Independent Practice Associations(p. 23)
• Group Practice Without Walls(p. 23)
• Consolidated Medical Group(p. 23)
• Physician/Hospital Organizations(p. 24)
• Management Services Organizations(p. 24)
• Foundation Model Integrated Delivery System(p. 24)
• Physician Ownership Model Integrated Delivery System(p. 25)
• Other Managed Care Organizations(p. 25)
• The Impact of Managed Care on Health Information Management(p. 26)
• HIPAA and State Privacy Rules(p. 28)
• Changes in Medical Records Standards(p. 30)
• Chapter 3 Medical Records Requirements(p. 31)
• Chapter Objectives(p. 31)
• Records That Must Be Kept(p. 31)
• The Legal Health Record(p. 33)
• Content Requirements(p. 35)
• Record Retention Requirements(p. 40)
• Statutory and Regulatory Concerns(p. 41)
• Statutes of Limitations(p. 43)
• Medical Research and Storage Space Considerations(p. 44)
• Association and Accreditation Agency Guidelines(p. 46)
• Developing a Record Retention Policy(p. 47)
• Destruction of the Record(p. 48)
• Chapter 4 Medical Records Entries(p. 51)
• Chapter Objectives(p. 51)
• Introduction(p. 52)
• Legible and Complete Medical Records Entries(p. 53)
• Timely Medical Records Entries(p. 58)
• Authorship and Countersignatures(p. 59)
• Authentication of Records(p. 62)
• Auto-Authentication(p. 66)
• Verbal Orders(p. 68)
• Corrections and Alterations(p. 69)
• Chapter 5 Document Consent to Treatment(p. 73)
• Chapter Objectives(p. 73)
• Introduction(p. 74)
• Legal Theories of Consent(p. 76)
• Express and Implied Consent(p. 76)
• Informed Consent(p. 78)
• Exceptions to the Informed Consent Requirement(p. 82)
• Distinguishing Informed Consent and HIPAA Authorization(p. 85)
• Who Can Give Consent(p. 86)
• Competent Adults(p. 86)
• Incompetent Adults(p. 87)
• Minors(p. 89)
• Responsibility for Obtaining Consent(p. 91)
• Documentation(p. 94)
• Types of Consent Forms(p. 95)
• Short Consent Forms(p. 96)
• Long Consent Forms(p. 96)
• Challenges to Consent Forms(p. 97)
• Withdrawal of Consent(p. 98)
• Impact of State Statutes(p. 98)
• Impact of the Medicare Conditions of Participation(p. 99)
• HIPAA Preemption(p. 100)
• Chapter 6 Access to Health Information(p. 103)
• Chapter Objectives(p. 103)
• Introduction(p. 104)
• Types of Health Information(p. 105)
• Protected Health Information(p. 105)
• De-Identification of Health Information(p. 106)
• Limited Data Set(p. 109)
• Designated Record Set(p. 111)
• Ownership of the Medical Record(p. 111)
• Summary of Confidentiality Requirements(p. 114)
• Federal Law(p. 114)
• State Law(p. 129)
• International Privacy Standards(p. 139)
• Accreditation Organizations(p. 140)
• HIPAA Covered Entities(p. 141)
• Healthcare Providers(p. 141)
• Healthcare Clearinghouses(p. 142)
• Health Plans(p. 143)
• Exercise of Professional Judgment(p. 145)
• Minimum Necessary Rule(p. 146)
• Hybrid Entities, Affiliated Covered Entities, and Organized Healthcare Arrangements(p. 149)
• Hybrid Entities(p. 149)
• Affiliated Covered Entities(p. 151)
• Documentation of Designations(p. 153)
• Organized Healthcare Arrangement(p. 153)
• Uses and Disclosures of Medical Records Information(p. 156)
• Access by or on Behalf of the Patient(p. 157)
• Access, Uses, and Disclosures with the Patient's Authorization(p. 164)
• Access by Family and Friends(p. 170)
• Facility Directories(p. 172)
• Records of Minors(p. 173)
• Access for Treatment, Payment, or Healthcare Operations(p. 177)
• Access by Employers(p. 182)
• Mental Health Records(p. 183)
• Alcohol and Drug Abuse Patient Records(p. 187)
• Genetic Information(p. 194)
• Record Duplication and Fees(p. 196)
• QIO Record Keeping(p. 199)
• QIO Access to Individual Patient Records(p. 200)
• Third Party Access to Information Collected by a QIO(p. 201)
• Patient Access to QIO Information(p. 204)
• Utilization Review and Quality Assurance(p. 205)
• Business Associates(p. 208)
• Qualifying as a Business Associate(p. 208)
• Requirements for Business Associate Agreements(p. 213)
• Non-HIPAA Required Provisions for Business Associate Agreements(p. 214)
• Liability for Acts or Omissions of Business Associates(p. 217)
• Additional Patient Rights Under HIPAA(p. 218)
• Right to Notice of How a Covered Entity Will Use and Disclose PHI(p. 218)
• Right to Have Access to, Inspect, and Copy PHI(p. 227)
• Right to Request Restrictions on the Uses and Disclosures of PHI for Treatment, Payment, and Healthcare Operations(p. 227)
• Right to Request to Receive Confidential Communications(p. 230)
• Right to Request Restrictions on the Uses and Disclosures for Which an Authorization Is Not Required(p. 231)
• Right to Request an Amendment to PHI(p. 231)
• Right to Receive an Accounting of Disclosures of PHI(p. 235)
• Right to Report Violations of the Regulations to the Secretary of DHHS(p. 238)
• Verifying Identity and Representations(p. 239)
• HIPAA Administrative Requirements(p. 242)
• Policies and Procedures(p. 242)
• Documentation(p. 242)
• Personnel(p. 243)
• Training(p. 243)
• Sanctions Imposed on Workforce(p. 244)
• Duty to Mitigate(p. 245)
• Safeguards(p. 245)
• Chapter 7 Reporting and Disclosure Requirements(p. 247)
• Chapter Objectives(p. 247)
• Introduction(p. 247)
• Disclosures Required by Law(p. 248)
• Child Abuse and Neglect(p. 249)
• Abuse of Adults and Injuries to Disabled Persons(p. 253)
• Controlled Drug Prescriptions and Abuse(p. 255)
• Occupational Diseases(p. 255)
• Abortion(p. 256)
• Birth Defects and Other Conditions in Children(p. 257)
• Cancer and Other Registries(p. 258)
• Death or Injury from Use of a Medical Device(p. 258)
• Communicable Diseases(p. 259)
• Misadministration of Radioactive Materials(p. 261)
• Death(p. 261)
• Gunshot and Knife Wounds(p. 262)
• Other Health Related Reporting Requirements(p. 263)
• Required Disclosure by Managed Care Organizations(p. 264)
• Health Oversight(p. 265)
• Chapter 8 Documentation and Disclosure: Special Areas of Concern(p. 267)
• Chapter Objectives(p. 267)
• Introduction(p. 268)
• Special Documentation Concerns(p. 269)
• Emergency Department Records(p. 269)
• Celebrity Patients(p. 275)
• Hostile Patients(p. 277)
• Recording Indicators of Child or Elder Abuse or Domestic Violence(p. 278)
• Patients Reusing Treatment and/or Near Death(p. 278)
• Deceased Patients and Autopsy Authorizations(p. 290)
• Recording Disagreements Among Professional Staff(p. 291)
• Special Disclosure Concerns(p. 292)
• Use and Disclosures for Marketing Purposes(p. 292)
• Use and Disclosures for Fund-Raising(p. 295)
• Records Sought by Managed Care Organizations(p. 297)
• Records Sought by Parties to Adoption(p. 300)
• Records Indicating Child or Elder Abuse(p. 305)
• Health Information Sought by Law Enforcement Agencies(p. 308)
• Warrants and Searches(p. 313)
• Responding to Subpoenas and Court Orders(p. 317)
• Fraud and Abuse Investigations(p. 325)
• Oversight for HIPAA Compliance(p. 327)
• Use of Outside Test Reports in Hospital Patients' Records(p. 329)
• Licensure and Accreditation(p. 329)
• Antitrust Issues(p. 331)
• Change of Ownership or Closure: Disposition of Records(p. 332)
• Chapter 9 HIV/AIDS: Mandatory Reporting and Confidentiality(p. 343)
• Chapter Objectives(p. 343)
• Introduction(p. 344)
• Duty to Report(p. 345)
• Protecting Confidentiality of HIV-Related Information(p. 348)
• The Privacy Rule and the Security Rule(p. 348)
• State Law(p. 349)
• Statutory Provisions Regarding Disclosure(p. 351)
• Disclosures Permitted by the Privacy Rule(p. 351)
• Disclosure to Third Parties with Patient Authorization(p. 352)
• Disclosure to Healthcare Workers(p. 352)
• Disclosure Without Consent to Emergency Medical Personnel(p. 357)
• Disclosure Without Consent to Spouse or Needle-Sharing Partner(p. 358)
• Other Permissible Disclosures Without Patient Authorization(p. 362)
• Disclosure of Healthcare Provider's Status to Patients(p. 363)
• Disclosure by Court Order(p. 364)
• Liability for Unauthorized Disclosure of HIV-Related Information(p. 367)
• Recommended Policies and Procedures(p. 369)
• Chapter 10 Discovery and Admissibility of Medical Records(p. 373)
• Chapter Objectives(p. 373)
• Introduction(p. 373)
• Discoverability of Medical Records(p. 374)
• Physician-Patient Privilege(p. 376)
• Admissibility of Medical Records(p. 383)
• Medical Records as Hearsay(p. 383)
• Other Healthcare Documentation(p. 386)
• Peer Review Records(p. 387)
• Incident Reports(p. 390)
• Chapter 11 Legal Theories in Improper Disclosure Cases(p. 395)
• Chapter Objectives(p. 395)
• Introduction(p. 395)
• HIPAA Liability(p. 396)
• Violations(p. 396)
• Other Statutory Bases for Liability(p. 399)
• Theories of Liability(p. 400)
• Defamation(p. 400)
• Invasion of Privacy(p. 406)
• Breach of Confidentiality(p. 415)
• Chapter 12 Risk Management and Quality Management(p. 421)
• Chapter Objectives(p. 421)
• Introduction(p. 422)
• Increased Scrutiny of Medical Errors and Demand for Improving Quality Care(p. 422)
• Relationship Between Risk Management and Quality Management(p. 423)
• Risk Management(p. 424)
• Quality Management(p. 427)
• HIPAA and Risk Management/Quality Management(p. 430)
• Compliance Programs(p. 432)
• Medical Records in Risk Management, Quality Review, Compliance Activities, and Pay for Performance Initiatives(p. 436)
• Chapter 13 Electronic Health Records(p. 439)
• Chapter Objectives(p. 439)
• The Movement to Electronic Health Records(p. 440)
• Electronic Health Records Systems(p. 446)
• HIPAA Privacy Rule(p. 450)
• Privacy Rule Issues for Interoperable Electronic Health Records(p. 450)
• Other Privacy Issues(p. 455)
• HIPAA Security Rule(p. 456)
• General Security Requirements(p. 458)
• Administrative Safeguards(p. 461)
• Physical Security Standards(p. 466)
• Technical Security Standards(p. 469)
• Organizational Security Safeguards(p. 471)
• Security Requirements in Health Data Networks(p. 473)
• State Data Security Laws(p. 474)
• Electronic Health Records Contracting Issues(p. 475)
• Considerations for Contracting(p. 475)
• Health Data Network Agreements(p. 476)
• Vendor Agreements(p. 477)
• Participation Agreements(p. 478)
• Regulatory Issues(p. 479)
• Antikickback Laws(p. 479)
• Stark Law(p. 481)
• Tax Laws Affecting Tax-Exempt Organizations(p. 482)
• Antitrust(p. 484)
• Electronic Health Records as Evidence(p. 485)
• The Rule Against Hearsay(p. 485)
• Best Evidence Rule(p. 487)
• The Difficulties of E-Discovery(p. 488)
• Professional Liability(p. 490)
• Specific Electronic Health Records Security Issues(p. 492)
• Facsimile Transmission of Health Information(p. 492)
• Electronic Claims Processing: The Transactions Code Set Rule(p. 495)
• Telemedical Records(p. 498)
• Electronic Mail(p. 499)
• Transmission of Health Information Through the Internet(p. 506)
• Chapter 14 Health Information in Medical Research(p. 515)
• Chapter Objectives(p. 515)
• Introduction(p. 515)
• U.S. Federal Laws Relating to Acquisition and Use of Health Information in Connection with Medical Research(p. 517)
• The Common Rule(p. 517)
• HIPAA Privacy Rule(p. 521)
• Information Protected Under the Family Educational Rights and Privacy Act(p. 527)
• Transitional Rule(p. 527)
• Use of De-Identified Information and Limited Data Sets(p. 528)
• Other Accommodations for Research in the HIPAA Privacy Rule(p. 529)
• Certificates of Confidentiality(p. 529)
• State Laws Relating to Acquisition and Use of Health Information in Connection with Medical Research(p. 531)
• State HIPAA Statutes(p. 531)
• State Common Law(p. 532)
• International Laws Relating to Medical Records and Clinical Trials(p. 533)
• European Union (EU)(p. 533)
• United Kingdom(p. 536)
• Canada(p. 537)
• Japan(p. 538)
• Other Guidance(p. 539)
• International Conference on Harmonisation(p. 539)
• Conclusion(p. 541)
• Appendix A Glossary: Acronyms and Definitions(p. 543)
• Index(p. 561)