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Chapter 6 Physician Impairment: University Hospital Case Study from The Tracks We Leave: Ethics and Management Dilemmas in Health Care, 3rd. ed.
1. Discuss usual requirements for informed consent for surgery. Assume that at some point the patient was not conscious and couldn’t consent. What is required for consent in an emergency?
2. Discuss patient rights, patient safety, and disruptive physician guidelines.3. Discuss medical negligence and vicarious liability and how they would apply.4. Discuss the Emergency Medical Treatment and Active Labor Act (EMTALA) requirements, including emergency call requirements for physicians.5. Discuss Health Care Quality Improvement Act (HCQIA), Patient Safety Quality Improvement Act (PSQIA), and National Practitioner Data Bank (NPDB) reporting and when reporting would be required.6. Discuss medical record access by the following:• CEO request for the patient and physician medical records• Medical staff peer review committee access request for the patient andphysician medical records (including psychiatric records) as part of peerreview of the provider,What medical records could be released or shared? How should they bereleased? When would redaction of personal health information (PHI) apply torecords being released? What privileges would apply to limit release? Whenwould work product exclusion from discovery apply?7. Discuss how two professional Codes of Ethics apply.8. Address other legal and ethical issues identified by the group. Patient Care Rights Weeks 8 and 9
Informed Consent
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Barstow, C., et. al. Evaluating Medical Decision-Making Capacity in Practice. Am
Fam Physician. 2018 July 1, 98(10): 40-46
https://www.aafp.org/afp/2018/0701/p40.html
AMA Informed Consent. Code of medical Ethics opinion 2.1.1 https://www.amaassn.org/delivering-care/ethics/informed-consent
Maryland Treatment without consent
https://law.justia.com/codes/maryland/2015/article-ghg/title-5/subtitle-6/parti/section-5-607/
Limited English Proficiency
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Limited English Proficiency (LEP) https://www.lep.gov/
HHS Revised Limited English Proficiency (LEP) Guidance
https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-englishproficiency/index.html
Fact Sheet on the Revised LEP Guidance https://www.hhs.gov/civil-rights/forindividuals/special-topics/limited-english-proficiency/fact-sheetguidance/index.html
Minor Consent
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HHS Informed Consent FAQ https://www.hhs.gov/ohrp/regulations-andpolicy/guidance/faq/informed-consent/index.html
Maryland Consent and Treatment of Minors
https://health.maryland.gov/psych/pdfs/Treatment.pdf
Maryland code and Minor Consent to Treatment
https://codes.findlaw.com/md/health-general/md-code-health-gen-sect-20102.html
AMA 2.2.1 Pediatric Decision Making https://policysearch.amaassn.org/policyfinder/detail/pediatric%20decision%20making?uri=%2FAMADoc%
2FEthics.xml-E-2.2.1.xml
A Guardian’s Health Care Decision -Making Authority: Statutory Restrictions
https://www.americanbar.org/groups/law_aging/publications/bifocal/vol_35/issue_
4_april2014/guardianship_health_care_decisions_statutory_restrictions/
Research Consent
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Maryland Law on Human Subject Research
https://www.marylandattorneygeneral.gov/Pages/HealthPolicy/humansubject.asp
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HHS 2018 Common Rule on research consent and Institutional Review Boards
(IRB) https://www.ecfr.gov/cgibin/retrieveECFR?gp=&SID=83cd09e1c0f5c6937cd9d7513160fc3f&pitd=201807
19&n=pt45.1.46&r=PART&ty=HTML
HHS Revision of the Common Rule https://www.hhs.gov/ohrp/regulations-andpolicy/regulations/revision-of-the-common-rule/index.html
FDA Right to Try Act https://www.fda.gov/patients/learn-about-expanded-accessand-other-treatment-options/right-try
FDA Informed Consent: Draft Guidance for IRBs, Clinical Investigators, and
Sponsors (July 2014) https://www.fda.gov/patients/learn-about-expandedaccess-and-other-treatment-options/right-try
Patient Rights
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Maryland Patient Bill of Rights
https://health.maryland.gov/springgrove/Documents/Revised%20PATIENT%20BILL%20OF%20RI
GHTS.pdf
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Maryland Code Hospital Patient Rights
https://law.justia.com/codes/maryland/2005/ghg/19-342.html and
https://law.justia.com/codes/maryland/2019/health-general/title-19/subtitle-3/partvi/sect-19-343/
Maryland long term care ombudsman program Pages – Ombudsman Program
(maryland.gov)
Maryland Resident Rights Regulations
https://www.law.cornell.edu/regulations/maryland/COMAR-10-07-09-08
42 C.F.R. 483.10 Long Term Care Resident rights
https://ecfr.federalregister.gov/current/title-42/chapter-IV/subchapter-G/part483/subpart-B#483.10
Maryland Consumer Guide to Long Term Care MHCC Consumer Guides
(maryland.gov)
New York Abuse Reporting Law New York Abuse Reporting Law
https://www.nysenate.gov/legislation/laws/SOS/488
Restraints and Seclusion
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42 C.F.R. 483.358 Orders for the use of restraint or seclusion
https://www.law.cornell.edu/cfr/text/42/483.358
Maryland Regulations Restraints COMAR 10.21.12.02 Definitions
http://mdrules.elaws.us/comar/10.21.12.02 , through COMAR 10.21.12.12
Abuse and Neglect and Reporting
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Elder Justice Act 42 U.S.C. 1397j
https://www.law.cornell.edu/uscode/text/42/1397j
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42 C.F.R. 483.12 Freedom from abuse, neglect and exploitation
https://ecfr.federalregister.gov/current/title-42/chapter-IV/subchapter-G/part483/subpart-B#483.12
Maryland Department of Aging: Preventing Elder Abuse and Neglect
https://aging.maryland.gov/Pages/elder-abuse-prevention.aspx
Infectious Disease Reporting
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CDC: Mandatory reporting of infectious diseases by clinicians. MMWR (June 22,
1990) 33(RR-9) 1-11, 16-17
https://www.cdc.gov/mmwr/preview/mmwrhtml/00001665.htm
Maryland Department of Health Reportable Diseases
https://phpa.health.maryland.gov/pages/reportable-diseases.aspx
HIPAA and Public Health https://www.hhs.gov/hipaa/for-professionals/specialtopics/public-health/index.html
Mental Health Duty to Warn, and Substance Use Disorder (SUD)
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NCSL Mental Health Professional’s Duty to Warn
https://www.ncsl.org/research/health/mental-health-professionals-duty-towarn.aspx
Treatment Guidelines: Substance Use Disorders Treatment Guidelines: Substance
Use Disorders | cpnp.org
CMS Substance Use Disorders https://www.cms.gov/outreacheducation/american-indianalaska-native/behavioral-health/substance-usedisorders
SAMHSA National Guidelines for Behavioral Health Crisis Care: Best Practice
Toolkit https://www.samhsa.gov/sites/default/files/national-guidelines-forbehavioral-health-crisis-care-02242020.pdf
SAMHSA Use of Medication-Assisted Treatment in Emergency Departments Use
of Medication-Assisted Treatment in Emergency Departments | SAMHSA
Medical Error
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To Err is Human: Building a Safer Health System, Institute of Medicine, 2000
https://www.ncbi.nlm.nih.gov/books/NBK225182/
AHRQ Medical Error https://www.ahrq.gov/topics/medical-errors.html
AHRQ Disclosure of Errors (Sept. 2019)
https://psnet.ahrq.gov/primer/disclosure-errors
ACEP Disclosure of Medical Errors https://www.acep.org/patient-care/policystatements/disclosure-of-medical-errors/
JCAHO Speak Up Preventing Medical Errors
https://www.jointcommission.org/resources/for-consumers/speak-upcampaigns/preventing-medicine-errors/
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ISMP List of Confused Drug Names
https://www.ismp.org/recommendations/confused-drug-names-list
ISMP Targeted Medication Safety Best Practices for Hospitals
https://www.ismp.org/guidelines/best-practices-hospitals
Medical Negligence
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Medical Malpractice Overview https://www.findlaw.com/injury/medicalmalpractice/medical-malpractice-overview.html
Legal Concepts in a Medical Malpractice Case
https://www.alllaw.com/articles/nolo/medical-malpractice/legal-conceptscase.html
Defenses to Medical Malpractice https://www.findlaw.com/injury/medicalmalpractice/defenses-to-medical-malpractice-patients-negligence.html
Maryland Medical Malpractice Laws https://www.nolo.com/legalencyclopedia/maryland-medical-malpractice-laws.html
Vicarious Liability https://www.findlaw.com/injury/medical-malpractice/vicariousliability.html
Respondeat superior
https://www.law.cornell.edu/wex/respondeat_superior#:~:text=A%20legal%20doc
trine%2C%20most%20commonly,of%20the%20employment%20or%20agency.
42 C.F.R.483.70(n) Long Term Care: Binding arbitration agreements
https://ecfr.federalregister.gov/current/title-42/chapter-IV/subchapter-G/part483/subpart-B#483.70
NCSL Medical Liability/Malpractice ADR and Screening Panels Statutes
https://www.ncsl.org/financial-services/medical-liability-malpractice-adr-and-screening-panelsstatutes
Fraud
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Maryland fraud laws https://law.justia.com/codes/maryland/2010/criminallaw/title-8/
HHS OIG Fraud and Abuse Laws https://oig.hhs.gov/compliance/physicianeducation/01laws.asp#:~:text=It%20is%20illegal%20to%20submit,plus%20%241
1%2C000%20per%20claim%20filed.&text=Criminal%20penalties%20for%20sub
mitting%20false%20claims%20include%20imprisonment%20and%20criminal%2
0fines.
Health care Compliance Program Tips https://oig.hhs.gov/compliance/providercompliance-training/files/Compliance101tips508.pdf
Patient Safety – Violence and Disruptive Behavior
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OSHA Workplace Violence Workplace Violence – Overview | Occupational Safety and
Health Administration (osha.gov)
Joint Commission Sentinel Event Alert 40: Behaviors that Undermine a culture of
safety (Sept 2016) https://www.jointcommission.org/resources/patient-safetytopics/sentinel-event/sentinel-event-alert-newsletters/sentinel-event-alert-issue40-behaviors-that-undermine-a-culture-of-safety/
Joint Commission Sentinel Event Alert 59: Physical and verbal violence against
health care workers https://www.jointcommission.org/resources/patient-safetytopics/sentinel-event/sentinel-event-alert-newsletters/sentinel-event-alert-59physical-and-verbal-violence-against-health-care-workers/
AHRQ Patient Safety network – Disruptive and Unprofessional Behavior
https://psnet.ahrq.gov/primer/disruptive-and-unprofessional-behavior
MGMA Dealing with Disruptive physicians (May 1, 2016)
https://www.mgma.com/resources/human-resources/dealing-with-disruptivephysicians
AMA Code of Medical Ethics Opinion 9.4.4 Physicians with Disruptive Behavior
https://www.ama-assn.org/delivering-care/ethics/physicians-disruptive-behavior
Patient Safety – Falls
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AHRQ’s Safety Program for Nursing Homes: On-Time Falls Prevention
https://www.ahrq.gov/patient-safety/settings/long-termcare/resource/ontime/fallspx/index.html
CMS Compliance Group Fall Prevention Resources
Preventing Falls in Hospitals: A Toolkit for Improving Quality of Care Preventing
Falls in Hospitals: A Toolkit for Improving Quality of Care. | PSNet (ahrq.gov)
Health Care Quality Improvement Act (HCQIA)
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The Healthcare Quality Improvement Act (HCQIA) 42 U.S. Code § 11101 – Findings
| U.S. Code | US Law | LII / Legal Information Institute (cornell.edu)
Maryland Medical Review Committees (peer review)
https://law.justia.com/codes/maryland/2013/article-gho/section-1-401/
AMA Peer Review Survival Kit: Is your peer review process safe?
https://www.ama-assn.org/system/files/2019-11/i19-peer-review-survival-kit.pdf
Defending the Peer Review privilege: Guidance for Health are Providers and
Counsel After Wheeling Hospital, West Virginia Law Review (2017)
https://wvlawreview.wvu.edu/west-virginia-law-reviewonline/2017/11/17/defending-the-peer-review-privilege-guidance-for-health-careproviders-and-counsel-after-wheeling-hospital
Credentials Committee: Essentials Handbook
https://hcmarketplace.com/media/browse/10552_browse.pdf
Patient Safety and Quality Improvement Act (PSQIA)
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HHS PSQIA https://www.hhs.gov/hipaa/for-professionals/patient-safety/statuteand-rule/index.html
Patient Safety Improvement Act (PSIA)of 2020
https://psnet.ahrq.gov/issue/patient-safety-improvement-act-2020
Patient Safety Organization (PSO) https://pso.ahrq.gov/
Patient Safety Rule https://www.hhs.gov/hipaa/for-professionals/patientsafety/patient-safety-rule/index.html
Patient Safety Organizations and Patient Safety work product
https://www.law.cornell.edu/cfr/text/42/part-3
HHS Guidance for Patient Safety Rules https://www.hhs.gov/hipaa/forprofessionals/patient-safety/guidance/index.html
National Practitioner Data Bank (NPDB)
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National Practitioner Data Bank (NPDB) https://www.npdb.hrsa.gov/
National Practitioner Data Bank (NPDB) Guidebook
https://www.npdb.hrsa.gov/resources/aboutGuidebooks.jsp
National Practitioner Data Bank ( NPDB) What you Must Report to the NPDB
https://www.npdb.hrsa.gov/hcorg/whatYouMustReportToTheDataBank.jsp
Reporting Peer Review Organization Negative Actions or Findings
https://www.npdb.hrsa.gov/guidebook/EPeerReviewOrgQA.jsp
Medical Record Access and Reporting
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Maryland Department of Health For your Information: Medical Records
https://health.maryland.gov/mbpme/Pages/records.aspx
Maryland Record Retention and fees FAQs
https://www.mbp.state.md.us/resource_information/faqs/resource_faqs_medical_
records.aspx
Maryland Code, Health-General 4-304 https://codes.findlaw.com/md/healthgeneral/md-code-health-gen-sect-4-304.html
CMS 2023 Program Requirements https://www.cms.gov/regulationsguidance/promoting-interoperability/2023-program-requirements
Federal Rule 502 Attorney-Client Privilege and Work Product
https://sterlingmiller2014.wordpress.com/2019/06/05/ten-things-a-primer-on-thework-product-privilege/
Maryland Rule 2-402 Scope of Discovery https://casetext.com/rule/maryland-courtrules/title-2-maryland-rules-of-civil-procedure-circuit-court/chapter-400-discovery/rule-2-402scope-of-discovery
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The Work Product Doctrine
https://www.law.cornell.edu/wex/attorney_work_product_privilege
Ten Things: A Primer on the Work Product Privilege
https://sterlingmiller2014.wordpress.com/2019/06/05/ten-things-a-primer-on-thework-product-privilege/
HIPAA and medical record release
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HIPAA Medical Records Access https://www.hhs.gov/hipaa/forindividuals/medicalrecords/index.html#:~:text=Only%20you%20or%20your%20personal,payment%2
0or%20with%20your%20permission.
HIPAA and Research https://www.hhs.gov/hipaa/for-professionals/specialtopics/research/index.html
Special Topics in Health Information Privacy https://www.hhs.gov/hipaa/forprofessionals/special-topics/index.html
Employers and Health Information in the Workplace
https://www.hhs.gov/hipaa/for-individuals/employers-health-informationworkplace/index.html
HIPAA and family members and friends https://www.hhs.gov/hipaa/forindividuals/family-members-friends/index.html
HIPAA Court Orders and Subpoenas https://www.hhs.gov/hipaa/forindividuals/court-orders-subpoenas/index.html
HIPAA and your medical records https://www.hhs.gov/hipaa/forindividuals/medical-records/index.html
HIPAA Patient Rights to Access information https://www.hhs.gov/hipaa/forindividuals/guidance-materials-for-consumers/index.html
Hospital Emergency Room and EMTALA
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ACEP EMTALA Fact Sheet https://www.acep.org/life-as-a-physician/ethics-legal/emtala/emtala-fact-sheet/
EMTALA Law https://www.law.cornell.edu/uscode/text/42/1395dd
Medicare Conditions of Participation Hospitals Patient Rights 42 C.F.R. 482.13
https://www.law.cornell.edu/cfr/text/42/482.13
CMS State Operations Manual Appendix V – Interpretive Guidelines –
Responsibilities of Participating Hospitals in Emergency cases
https://www.cms.gov/Regulations-andGuidance/Guidance/Manuals/downloads/som107ap_v_emerg.pdf
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CMS S & C-02-34 On-Call Requirements EMTALA
https://www.cms.gov/regulations-andguidance/legislation/emtala/downloads/sc0234pdf
Derlet, R. and Richards, J. Ten Solutions to Emergency Department Crowding.
West. J. Emerg. Med. 2008 Jan, 9(1): 24-27
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2672221/
Patient Safety, Quality Improvement and Risk Management
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Joint Commission Patient Safety Resources
https://www.jointcommission.org/resources/patient-safety-topics/patient-safety/
Hughes, R. Tools and Strategies for Quality Improvement and Patient Safety.
https://www.ncbi.nlm.nih.gov/books/NBK2682/
FMP Care Management Tools (Includes checklists, letters, forms, for office use)
https://www.aafp.org/fpm/toolBox/viewToolType.htm?toolTypeId=2
Management of Non-Complaint Patients. Medical Protective: Clinical Risk
Management Department. (Oct. 2013)
https://www.server5.medpro.com/documents/11006/16738/Management+of+Non
compliant+Patients+Guideline_10-2013.pdf
KootenaiHealth Involuntary Detention, Leaving Against Medical Device
https://www.kh.org/involuntary-detention-discharge-against-medical-advicemandatory-reporter/
Advanced Directives
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Maryland Health Care Decisions Act
https://www.marylandattorneygeneral.gov/Pages/HealthPolicy/hcda.aspx
Maryland Advanced Directives
https://www.marylandattorneygeneral.gov/Pages/HealthPolicy/AdvanceDirectives
.aspx
COMAR 10.01.21.04 Use of the MOLST Form (Maryland)
http://mdrules.elaws.us/comar/10.01.21.04
Maryland Medical Orders for Life Sustaining Treatment (MOLST) Maryland’s
Medical Orders for Life-Sustaining Treatment (MOLST) Form | Nolo
Maryland State Advisory Council on Quality Care at the End of Life
https://www.marylandattorneygeneral.gov/Pages/HealthPolicy/sac.aspx
Maryland Health Decisions Policy
https://www.marylandattorneygeneral.gov/Pages/HealthPolicy/eolcare.aspx
Beginning and End of Life Decision Making
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Elson, N., et. al. Getting Real: The Maryland Heatlhcare Ethics Committee
Network’s COVID-19 working group debriefs lessons learned. HEC Forum. 2021
June 33 (1-2):91-107 doi: 10.1007/s10730-021-09442-y
https://pubmed.ncbi.nlm.nih.gov/33582886/
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Ethics Consultations: AMA Code of Medical Ethics Opinion 10.7.1
https://www.ama-assn.org/delivering-care/ethics/ethicsconsultations#:~:text=The%20goal%20of%20ethics%20consultation,and%20the
%20health%20care%20team.&text=Seek%20to%20balance%20the%20concern
s,the%20patient’s%20needs%20and%20values.
Howe, E. Mediation Approaches at the Beginning or End of Life. The Journal of
Clinical Ethics. 26(4) (Winter 2015): pp. 275-85. Mediation Approaches at the
Beginning or End of Life – PubMed (nih.gov)
Sanderson, C. et. al. Patient-centered family meetings in palliative care: a quality
improvement project to explore a new model of family meetings with patients and
families at end of life. Ann. Palliat. Med. (2017) Dec 6 (suppl 2):S195-S205, doi:
doi: 10.21037/apm.2017.08.11 https://pubmed.ncbi.nlm.nih.gov/29156901/
Futile Care
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Clark, P. Medical Futility: Legal and Ethical Analysis. AMA Journal Of Ethics
(May 2007) https://journalofethics.ama-assn.org/article/medical-futility-legal-andethical-analysis/2007-05
Baby K Case https://casetext.com/case/matter-of-baby-k
Futile Care https://www.patientsrightscouncil.org/site/futile-care/
Abortion Law
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Maryland Abortion Laws https://www.findlaw.com/state/maryland-law/marylandabortion-laws.html
Dobbs v. Jackson Women’s Health Organization (U.S. Supreme Court 2022)
https://www.supremecourt.gov/opinions/21pdf/19-1392_6j37.pdf
Stem Cell Laws
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NIH Guidelines for Human Stem Cell Research https://stemcells.nih.gov/researchpolicy/guidelines-for-human-stem-cell-research
NIH Stem Cell Basics Stem Cell Basics | STEM Cell Information (nih.gov)
NIH Human Subjects Research Overview
https://www.nidcr.nih.gov/research/human-subjects-research
NIH Human Subjects Research Policies and Policy Notices
https://grants.nih.gov/policy/humansubjects/policies-and-regulations/researchguide-notice.htm
Institutional Review Board (IRB) Written Procedures: Guidance for Institutions
and IRBs https://www.hhs.gov/ohrp/regulations-and-policy/requests-forcomments/guidance-for-institutions-and-irbs/index.html
Ethical Codes
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AMA Code of Ethics Overview https://www.ama-assn.org/deliveringcare/ethics/code-medical-ethics-overview
American College of Healthcare Executives (ACHE) Code of Ethics
https://www.ache.org/about-ache/our-story/our-commitments/ethics/ache-codeof-ethics
AMA code of Medical Ethics Opinion 7 .3.8 Research with stem cells
https://www.ama-assn.org/delivering-care/ethics/research-stem-cells
Health Care Compliance Association (HCCA) Code of Ethics for Health Care
Compliance Professionals https://www.hcca-info.org/code-ethics-health-carecompliance-professionals
American Health Information Management Association (AHIMA) Code of Ethics
http://bok.ahima.org/doc?oid=105098#.YJmhrLVKiUl
American College of Emergency Room Physicians (ACEP) Code of Ethics ACEP
// Code of Ethics for Emergency Physicians
