Medical Records And the Law, 4th edition

Contents......Page 4
Preface......Page 14
Acknowledgments......Page 16
About the Authors......Page 18
Introduction......Page 22
The Nature of Law......Page 23
The Constitution......Page 24
Due Process of Law......Page 25
Right of Privacy......Page 26
Statutes......Page 27
Decisions and Rules of Administrative Agencies......Page 29
Court Decisions......Page 30
Governmental Organization and Function......Page 32
Organization of the Court System......Page 34
State Court System......Page 35
Federal Court System......Page 36
Stare Decisis......Page 37
Introduction......Page 40
Managed Care......Page 41
Health Maintenance Organizations......Page 42
Preferred Provider Organizations......Page 43
Consolidated Medical Group......Page 44
Foundation Model Integrated Delivery System......Page 45
Pharmacy Benefits Managers......Page 46
The Impact of Managed Care on Health Information Management......Page 47
HIPAA and State Privacy Rules......Page 49
Changes in Medical Records Standards......Page 51
Records That Must Be Kept......Page 52
The Legal Health Record......Page 54
Content Requirements......Page 56
Record Retention Requirements......Page 61
Statutory and Regulatory Concerns......Page 62
Statutes of Limitations......Page 64
Medical Research and Storage Space Considerations......Page 65
Association and Accreditation Agency Guidelines......Page 67
Developing a Record Retention Policy......Page 68
Destruction of the Record......Page 69
CHAPTER 4: Medical Records Entries......Page 72
Introduction......Page 73
Legible and Complete Medical Records Entries......Page 74
Timely Medical Records Entries......Page 79
Authorship and Countersignatures......Page 80
Authentication of Records......Page 83
Auto-Authentication......Page 87
Verbal Orders......Page 89
Corrections and Alterations......Page 90
CHAPTER 5: Document Consent to Treatment......Page 94
Introduction......Page 95
Express and Implied Consent......Page 97
When Is Consent Implied?......Page 98
Informed Consent......Page 99
What Information Must Be Disclosed?......Page 100
Proving Causation......Page 102
Exceptions to the Informed Consent Requirement......Page 103
Therapeutic Privilege......Page 104
Treatment of Criminal Suspects and Prisoners......Page 105
Distinguishing Informed Consent and HIPAA Authorization......Page 106
Competent Adults......Page 107
Incompetent Adults......Page 108
Emancipated Minors......Page 110
Mature Minors......Page 111
Responsibility for Obtaining Consent......Page 112
Documentation......Page 115
Types of Consent Forms......Page 116
Long Consent Forms......Page 117
Challenges to Consent Forms......Page 118
Impact of State Statutes......Page 119
Impact of the Medicare Conditions of Participation......Page 120
HIPAA Preemption......Page 121
CHAPTER 6: Access to Health Information......Page 124
Introduction......Page 125
Protected Health Information......Page 126
De-Identification of Health Information......Page 127
Limited Data Set......Page 130
Ownership of the Medical Record......Page 132
Federal Law......Page 135
Constitution......Page 136
Privacy Act......Page 141
USA Patriot Act......Page 143
Freedom of Information Act......Page 144
Medicare Conditions of Participation......Page 148
Other Federal Confidentiality Laws......Page 149
State Law......Page 150
State Medical Records Statutes and Regulations......Page 151
State Open Records Laws......Page 154
Relationship of HIPAA to State Laws: HIPAA Preemption of State Laws......Page 156
International Privacy Standards......Page 160
Accreditation Organizations......Page 161
Healthcare Providers......Page 162
Healthcare Clearinghouses......Page 163
Health Plans......Page 164
Exercise of Professional Judgment......Page 166
Minimum Necessary Rule......Page 167
Hybrid Entities......Page 170
Affiliated Covered Entities......Page 172
Organized Healthcare Arrangement......Page 174
Uses and Disclosures of Medical Records Information......Page 177
Access by or on Behalf of the Patient......Page 178
Privacy Rule Requirements for Authorizations......Page 185
State Law Requirements for Authorizations......Page 187
Revocation of Authorizations......Page 190
Access by Family and Friends......Page 191
Facility Directories......Page 193
Unemancipated Minors......Page 194
Access for Treatment, Payment, or Healthcare Operations......Page 198
Access by Employers......Page 203
Mental Health Records......Page 204
Alcohol and Drug Abuse Patient Records......Page 208
Genetic Information......Page 215
Record Duplication and Fees......Page 217
QIO Record Keeping......Page 220
QIO Access to Individual Patient Records......Page 221
Third Party Access to Information Collected by a QIO......Page 222
Patient Access to QIO Information......Page 225
Utilization Review and Quality Assurance......Page 226
Qualifying as a Business Associate......Page 229
Requirements for Business Associate Agreements......Page 234
Non-HIPAA Required Provisions for Business Associate Agreements......Page 235
Minimum necessary representations......Page 236
Security policies and procedures......Page 237
Liability for Acts or Omissions of Business Associates......Page 238
Right to Notice of How a Covered Entity Will Use and Disclose PHI......Page 239
Who Must Receive Notice and Give Acknowledgment......Page 240
Content of the Notice......Page 241
Changes to the Notice......Page 244
Time and Manner of Giving Notice......Page 245
Requirements for Electronic Notice......Page 246
Joint Notices......Page 247
Right to Request Restrictions on the Uses and Disclosures of PHI for Treatment, Payment, and Healthcare Operations......Page 248
Right to Request to Receive Confidential Communications......Page 251
Nature of the Right to Amend......Page 252
Accepting an Amendment......Page 253
Denying an Amendment......Page 254
Future Disclosures of Amended Records......Page 255
Right to Receive an Accounting of Disclosures of PHI......Page 256
Right to Report Violations of the Regulations to theSecretary of DHHS......Page 259
Verifying Identity and Representations......Page 260
Documentation......Page 263
Training......Page 264
Sanctions Imposed on Workforce......Page 265
Safeguards......Page 266
Introduction......Page 268
Disclosures Required by Law......Page 269
Child Abuse and Neglect......Page 270
Abuse of Adults and Injuries to Disabled Persons......Page 274
Occupational Diseases......Page 276
Abortion......Page 277
Birth Defects and Other Conditions in Children......Page 278
Death or Injury from Use of a Medical Device......Page 279
Communicable Diseases......Page 280
Death......Page 282
Gunshot and Knife Wounds......Page 283
Other Health Related Reporting Requirements......Page 284
Required Disclosure by Managed Care Organizations......Page 285
Health Oversight......Page 286
CHAPTER 8: Documentation and Disclosure- Special Areas of Concern......Page 288
Introduction......Page 289
Emergency Department Records......Page 290
Celebrity Patients......Page 296
Hostile Patients......Page 298
Patients Refusing Treatment and/or Near Death......Page 299
Background......Page 300
Patient Self-Determination Act......Page 302
Living Will Legislation......Page 304
Durable Power of Attorney......Page 306
Do-Not-Resuscitate Orders......Page 308
Deceased Patients and Autopsy Authorizations......Page 311
Recording Disagreements Among Professional Staff......Page 312
Use and Disclosures for Marketing Purposes......Page 313
Use and Disclosures for Fund-Raising......Page 316
Records Sought by Managed Care Organizations......Page 318
Records Sought by Parties to Adoption......Page 321
“Good Cause” to Obtain Adoption Records Information......Page 324
Responding to Records Requests......Page 325
Records Indicating Child or Elder Abuse......Page 326
Health Information Sought by Law Enforcement Agencies......Page 329
HIPAA Privacy Rule Provisions......Page 330
State Law Provisions......Page 332
Practical Considerations......Page 333
Warrants and Searches......Page 334
Subpoenas......Page 338
Court Orders......Page 340
HIPAA and State Compliance Requirements......Page 341
Fraud and Abuse Investigations......Page 346
DHHS Investigations......Page 348
Disclosures by Whistle-blowers or Crime Victims......Page 349
Licensure and Accreditation......Page 350
Antitrust Issues......Page 352
Change of Ownership or Closure: Disposition of Records......Page 353
Change of Ownership......Page 355
Closure......Page 357
CHAPTER 9: HIV/AIDS: Mandatory Reporting and Confidentiality......Page 364
Introduction......Page 365
Duty to Report......Page 366
The Privacy Rule and the Security Rule......Page 369
State Law......Page 370
Disclosures Permitted by the Privacy Rule......Page 372
Disclosure to Healthcare Workers......Page 373
Disclosure Without Consent to Emergency Medical Personnel......Page 378
Disclosure Without Consent to Spouse or Needle-Sharing Partner......Page 379
Other Permissible Disclosures Without Patient Authorization......Page 383
Disclosure of Healthcare Provider’s Status to Patients......Page 384
Disclosure by Court Order......Page 385
Court Orders and Disclosure in Blood Donor Cases......Page 386
Liability for Unauthorized Disclosure of HIV-Related Information......Page 388
Recommended Policies and Procedures......Page 390
Introduction......Page 394
Discoverability of Medical Records......Page 395
Physician-Patient Privilege......Page 397
Waiver of the Physician-Patient Privilege......Page 399
Physician-Patient Privilege vs. the Public Interest......Page 400
HIPAA’s Treatment of the Physician-Patient Privilege......Page 402
Medical Records as Hearsay......Page 404
Business Records Exception to the Bar on Hearsay......Page 405
Other Exceptions to the Bar on Hearsay......Page 406
Other Healthcare Documentation......Page 407
Peer Review Records......Page 408
Admissibility of Peer Review Records......Page 410
Incident Reports......Page 411
Practical Tips......Page 414
Introduction......Page 416
Violations......Page 417
Other Statutory Bases for Liability......Page 420
Defamation......Page 421
Privileges Against Defamation......Page 423
Consent as a Defense......Page 426
Invasion of Privacy......Page 427
Photographs......Page 429
Payment-Related Disclosures......Page 431
Disclosure to the News Media......Page 432
Breach of Confidentiality......Page 436
Defenses Against Breach of Confidentiality......Page 438
CHAPTER 12: Risk Management and Quality Management......Page 442
Increased Scrutiny of Medical Errors and Demand forImproving Quality Care......Page 443
Relationship Between Risk Management and Quality Management......Page 444
Risk Management......Page 445
Quality Management......Page 448
HIPAA and Risk Management/Quality Management......Page 451
Compliance Programs......Page 453
Medical Records in Risk Management, Quality Review, Compliance Activities, and Pay for Performance Initiatives......Page 457
CHAPTER 13: Electronic Health Records......Page 460
The Movement to Electronic Health Records......Page 461
Electronic Health Records Systems......Page 467
Privacy Rule Issues for Interoperable Electronic Health Records......Page 471
Other Privacy Issues......Page 476
HIPAA Security Rule......Page 477
General Security Requirements......Page 479
Administrative Safeguards......Page 482
Workforce Security......Page 484
Security Awareness and Training......Page 485
Contingency Planning......Page 486
Facility Access Controls......Page 487
Workstation Use and Security......Page 488
Device and Media Controls......Page 489
Access Control......Page 490
Transmission Security......Page 491
Business Associates......Page 492
Hybrid and Affiliated Entities and Group Health Plans......Page 493
Security Requirements in Health Data Networks......Page 494
State Data Security Laws......Page 495
Considerations for Contracting......Page 496
Health Data Network Agreements......Page 497
Vendor Agreements......Page 498
Participation Agreements......Page 499
Antikickback Laws......Page 500
Stark Law......Page 502
Tax Laws Affecting Tax-Exempt Organizations......Page 503
Tax Pitfalls for Tax-Exempt Health Data Networks......Page 504
Antitrust......Page 505
The Rule Against Hearsay......Page 506
Best Evidence Rule......Page 508
The Difficulties of E-Discovery......Page 509
Professional Liability......Page 511
Facsimile Transmission of Health Information......Page 513
Electronic Claims Processing:The Transactions Code Set Rule......Page 516
Telemedical Records......Page 519
Electronic Mail......Page 520
Transmission of Health Information Through the Internet......Page 527
Introduction......Page 536
Generally......Page 538
The Informed Consent Requirement......Page 539
FDA Protection of Human Subject Regulations......Page 541
HIPAA Generally......Page 542
Applicability to Medical Research......Page 543
Valid Authorization......Page 545
Valid Waiver......Page 546
Research Exceptions to Authorization or Waiver Requirements......Page 547
Transitional Rule......Page 548
Use of De-Identified Information and Limited Data Sets......Page 549
Certificates of Confidentiality......Page 550
State HIPAA Statutes......Page 552
State Common Law......Page 553
Applicability......Page 554
Exporting of Medical Data......Page 555
United Kingdom......Page 557
Canada......Page 558
Japan......Page 559
International Conference on Harmonisation......Page 560
Conclusion......Page 562
APPENDIX A – Glossary: Acronyms and Definitions......Page 564
Index......Page 582