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© 2017 American Health Information Management Association© 2017 American Health Information Management Association
Chapter 10: HIPAA Privacy Rule:
Part I
Fundamentals of Law for Health
Informatics and Information
Management, Third Edition
© 2017 American Health Information Management Association
HIPAA: Definition
• Health Insurance Portability and
Accountability Act (HIPAA) of 1996
– Focus of Title II (1 of 5 titles)
• Healthcare fraud and abuse prevention
• Medical liability reform
• Administrative simplification
– Privacy standards
– Security standards
– Transactions and code sets
– National provider identifiers
– Enforcement
© 2017 American Health Information Management Association
HIPAA: Comparison to Other
Laws
• Freedom of Information Act of 1967
• Privacy Act of 1974
• Federal drug and alcohol laws
• Medicare Conditions of Participation
• State laws
• Note: Professional ethical standards and
codes of conduct
© 2017 American Health Information Management Association
HIPAA: Applicability
• Who
– Covered entities (CE) and their workforce
– Business associates (BAs), their workforce,
and their subcontractors
• What
– Protected Health Information (PHI)
• Excludes de-identified information
• Privacy Rule-defined identifiers
• Excludes personnel and educational records
© 2017 American Health Information Management Association
HIPAA: Applicability (Who)
• Covered entities (CEs)
– Healthcare providers that conduct certain
transactions electronically
• Provider examples: Hospitals, pharmacies, physician
office practices, long-term care facilities, clinics
• Transaction examples: Health claims and encounter
information, health plan enrollment, health plan
premium payments, coordination of benefits, health
claim status
– Health plans: Insurance plans
– Healthcare clearinghouses: Intermediary billing
companies
© 2017 American Health Information Management Association
HIPAA: Applicability (Who)
• Business associates (BAs) and their
workforce
– What is a business associate?
• Person or organization (not a member of a CE
workforce) that performs functions on behalf of the CE
involving the use or disclosure of individually
identifiable health information
• A business associate agreement (BAA) should be
initiated to legally protect information handled by a BA
– Subcontractors of BAs are also BAs
© 2017 American Health Information Management Association
HIPAA: Applicability (Who)
• Business associates (BAs)
– HITECH: If it meets the definition of a BA, it is a
BA
• Organizations or individuals that meet the definition of a
BA must comply with HIPAA, even without a BAA
– HITECH: BAs must respond to CE non-
compliance through
• Required corrective action
• Severing relationship with CE
© 2017 American Health Information Management Association
HIPAA: Applicability (Who)
• Workforce members
– Include employees, volunteers, student
interns, trainees, and anyone else working
under the CE’s direct control
– Contractors working on a covered entity’s
premises may be considered workforce
members if they routinely work there
© 2017 American Health Information Management Association
HIPAA: Applicability (What)
• PHI
– Three-part test (shown on a subsequent slide)
• De-identified information
– Does not identify the individual
– Not subject to the HIPAA privacy rule
– What 18 elements must be removed to de-identify an
individual?
– Re-identification: Unrelated code permitted to link de-
identified information back to the individual
© 2017 American Health Information Management Association
HIPAA: Applicability—Identifiers
• Names
• Geographic subdivisions
of specified size
• Dates (except year)
relating to birth,
admission, discharge,
and death (age > 89)
• Telephone #
• Fax #
• E-mail address
• Social security #
• Medical record #
• Health plan beneficiary #
• Account #
• Certificate/license #
• Vehicle identifiers
• Device identifiers
• URLs
• IP addresses
• Biometric identifiers
• Photographic images
• Any other unique
identifier
© 2017 American Health Information Management Association
HIPAA: Applicability
• Per HITECH, individually identifiable
information of persons deceased >50
years is not protected by the HIPAA
privacy rule.
– In other words, it loses its PHI status.
© 2017 American Health Information Management Association
Three-Part Test for Determining
Whether Information is PHI
• Individually identifiable health information in any form
or medium (paper, imaged, electronic, oral) that
• Identifies the person or provides a reasonable basis to
believe the person could be identified from the
information given
and
• Relates to one’s health condition (physical or mental;
past, present, or future), or provision of healthcare, or
payment for provision of healthcare
and
• Is held or transmitted by a CE or its BA
© 2017 American Health Information Management Association
HIPAA: Other Key Terms
• Individuals
• Personal representatives
• Designated record set (DRS)
• Disclosure, use, and request
• Treatment, payment, and operations
(TPO)
© 2017 American Health Information Management Association
HIPAA: Organization Types
• Hybrid entity
• Affiliated covered entity
• Organized health care arrangement
• Covered entity with multiple functions
© 2017 American Health Information Management Association
HIPAA: Privacy Rule
Documents
• Notice of Privacy Practices
– Explains how PHI will be used and disclosed
– Explains individuals’ rights
– Healthcare providers must make it available upon
first encounter
– Must be posted in a prominent place, including
website if one exists
– HIPAA and HITECH outline content requirements
– Receipt must be acknowledged by individual
© 2017 American Health Information Management Association
HIPAA: Privacy Rule
Documents
• Consent
– To use or disclose PHI for TPO
– Optional document
– Revocation must be permitted
© 2017 American Health Information Management Association
HIPAA: Privacy Rule
Documents
• Authorization
– Is written permission for a specific disclosure
– Must contain HIPAA-required elements
– Is required unless a disclosure meets a HIPAA
authorization exception
© 2017 American Health Information Management Association
HIPAA: Uses and Disclosures
When Authorization Is Not
Required
• When uses and disclosures are required,
even without authorization
– Access or accounting of disclosures
requested by individual or personal
representative
– HHS investigation, review, or enforcement
action
© 2017 American Health Information Management Association
HIPAA: Uses and Disclosures
When Authorization Is Not
Required (continued)
• When uses and disclosures are permitted
without authorization
– 18 situations
– Includes situations where individual has
opportunity to agree or object (2)
– Includes situations where individual does not
have opportunity to agree or object (16)
– These uses and disclosures are permissive only
(HIPAA permits, but does not require)
• Must not violate a stricter/more protective state law
© 2017 American Health Information Management Association
HIPAA: Uses and Disclosures
When Authorization Is Not
Required (continued)
• Uses and disclosures permitted without
authorization
– Individual has the opportunity to agree or
object (2 situations)
• Facility directory/directory of patients
– Patient name (fact of admission, if requested by name)
– Location in facility
– Condition, in general terms
– Religious affiliation (to clergy)
• Notification to family or friends
© 2017 American Health Information Management Association
HIPAA: Uses and Disclosures
When Authorization Is Not
Required (continued)
• Uses and disclosures permitted without
authorization
– Individual does not have the opportunity to agree
or object (16 situations)
• Treatment, payment, and operations
• To the individual
• Incidental disclosures
• Limited data set
• Twelve public interest and benefit purposes (outlined
on next slide)
© 2017 American Health Information Management Association
HIPAA: Uses and Disclosures
When Authorization Is Not
Required
• Uses and disclosures permitted without authorization (12 public
interest and benefit)
– As required by law (for example, reporting specified wounds)
– Public health activities
– Victims of abuse, neglect, or domestic violence
– Healthcare oversight activities
– Judicial and administrative proceedings
– Law enforcement purposes
– Decedents
– Cadaveric organ, eye, or tissue donation
– Research
– Threat to health or safety
– Specialized government functions
– Workers’ Compensation
© 2017 American Health Information Management Association
HIPAA: Redisclosure
• Involves PHI created by and received from
another entity
• Redisclosure allowed for HIPAA-permitted
purposes
© 2017 American Health Information Management Association
HIPAA: Commercial Uses and
Disclosures of PHI
• Marketing: Communication about a product
or service that encourages its purchase or
use
• General rule: Use or disclosure of PHI for
marketing requires authorization
• Marketing activities that do not require an
authorization
– Occur face-to-face with the individual
– Concern promotional gifts of nominal value
© 2017 American Health Information Management Association
HIPAA: Commercial Uses and
Disclosures of PHI (continued)
• Activities not defined as marketing per HIPAA
(authorization not required)
– Communications by CE about health-related products and
services in a CE’s benefit plan
– Replacements or enhancements to a health plan, or
health-related products or services that are of value
(although not part of a benefit plan)
– For treatment of individual
– For case management/care coordination or alternative
treatments
• Remuneration to the covered entity must be disclosed
• Opt-out instructions must be provided
© 2017 American Health Information Management Association
HIPAA: Commercial Uses and
Disclosures of PHI (continued)
• HITECH: Clarifies and expands
communications considered to be
marketing
• HITECH: Limits covered entities’ ability to
categorize communications as operations
(and exempt themselves from marketing
requirements)
© 2017 American Health Information Management Association
HIPAA: Commercial Uses and
Disclosures of PHI (continued)
• Fundraising: Activities initiated by the covered entity to
generate money for the benefit of the covered entity
• Must inform individuals in Notice of Privacy Practices that PHI
may be used for fundraising
• Instructions on how to opt out in the future are required before
the first solicitation or as part of the fundraising materials
• Prior authorization required if fundraiser targets individuals
based on diagnosis
– For example, kidney patients targeted to raise funds for new
kidney dialysis center
• HITECH: Opt-out may apply to all future fundraising
campaigns or to the current campaign only
© 2017 American Health Information Management Association
HIPAA: Commercial Uses and
Disclosures of PHI (continued)
• Sale of PHI
– HITECH: CEs and BAs may not sell PHI without
patient authorization
– There are exceptions
• Public health and research data; treatment and
healthcare operations (such as PHI that is part of CE
sale or merger)
– Patient must declare in the authorization whether
the recipient of the PHI can exchange it further for
payment
© 2017 American Health Information Management Association
HIPAA: Minimum Necessary
Requirement
• People should only have access to the
amount of information needed to do their jobs
– Standard applies to CEs and Without further
clarification, “limited data set” (PHI with certain
direct identifiers removed) is the guideline
– Revert to “amount needed to accomplish
intended purpose” when limited data set definition
is inadequate
– Clarification of concept is pending

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Hm300 week 6

  • 1. © 2017 American Health Information Management Association© 2017 American Health Information Management Association Chapter 10: HIPAA Privacy Rule: Part I Fundamentals of Law for Health Informatics and Information Management, Third Edition
  • 2. © 2017 American Health Information Management Association HIPAA: Definition • Health Insurance Portability and Accountability Act (HIPAA) of 1996 – Focus of Title II (1 of 5 titles) • Healthcare fraud and abuse prevention • Medical liability reform • Administrative simplification – Privacy standards – Security standards – Transactions and code sets – National provider identifiers – Enforcement
  • 3. © 2017 American Health Information Management Association HIPAA: Comparison to Other Laws • Freedom of Information Act of 1967 • Privacy Act of 1974 • Federal drug and alcohol laws • Medicare Conditions of Participation • State laws • Note: Professional ethical standards and codes of conduct
  • 4. © 2017 American Health Information Management Association HIPAA: Applicability • Who – Covered entities (CE) and their workforce – Business associates (BAs), their workforce, and their subcontractors • What – Protected Health Information (PHI) • Excludes de-identified information • Privacy Rule-defined identifiers • Excludes personnel and educational records
  • 5. © 2017 American Health Information Management Association HIPAA: Applicability (Who) • Covered entities (CEs) – Healthcare providers that conduct certain transactions electronically • Provider examples: Hospitals, pharmacies, physician office practices, long-term care facilities, clinics • Transaction examples: Health claims and encounter information, health plan enrollment, health plan premium payments, coordination of benefits, health claim status – Health plans: Insurance plans – Healthcare clearinghouses: Intermediary billing companies
  • 6. © 2017 American Health Information Management Association HIPAA: Applicability (Who) • Business associates (BAs) and their workforce – What is a business associate? • Person or organization (not a member of a CE workforce) that performs functions on behalf of the CE involving the use or disclosure of individually identifiable health information • A business associate agreement (BAA) should be initiated to legally protect information handled by a BA – Subcontractors of BAs are also BAs
  • 7. © 2017 American Health Information Management Association HIPAA: Applicability (Who) • Business associates (BAs) – HITECH: If it meets the definition of a BA, it is a BA • Organizations or individuals that meet the definition of a BA must comply with HIPAA, even without a BAA – HITECH: BAs must respond to CE non- compliance through • Required corrective action • Severing relationship with CE
  • 8. © 2017 American Health Information Management Association HIPAA: Applicability (Who) • Workforce members – Include employees, volunteers, student interns, trainees, and anyone else working under the CE’s direct control – Contractors working on a covered entity’s premises may be considered workforce members if they routinely work there
  • 9. © 2017 American Health Information Management Association HIPAA: Applicability (What) • PHI – Three-part test (shown on a subsequent slide) • De-identified information – Does not identify the individual – Not subject to the HIPAA privacy rule – What 18 elements must be removed to de-identify an individual? – Re-identification: Unrelated code permitted to link de- identified information back to the individual
  • 10. © 2017 American Health Information Management Association HIPAA: Applicability—Identifiers • Names • Geographic subdivisions of specified size • Dates (except year) relating to birth, admission, discharge, and death (age > 89) • Telephone # • Fax # • E-mail address • Social security # • Medical record # • Health plan beneficiary # • Account # • Certificate/license # • Vehicle identifiers • Device identifiers • URLs • IP addresses • Biometric identifiers • Photographic images • Any other unique identifier
  • 11. © 2017 American Health Information Management Association HIPAA: Applicability • Per HITECH, individually identifiable information of persons deceased >50 years is not protected by the HIPAA privacy rule. – In other words, it loses its PHI status.
  • 12. © 2017 American Health Information Management Association Three-Part Test for Determining Whether Information is PHI • Individually identifiable health information in any form or medium (paper, imaged, electronic, oral) that • Identifies the person or provides a reasonable basis to believe the person could be identified from the information given and • Relates to one’s health condition (physical or mental; past, present, or future), or provision of healthcare, or payment for provision of healthcare and • Is held or transmitted by a CE or its BA
  • 13. © 2017 American Health Information Management Association HIPAA: Other Key Terms • Individuals • Personal representatives • Designated record set (DRS) • Disclosure, use, and request • Treatment, payment, and operations (TPO)
  • 14. © 2017 American Health Information Management Association HIPAA: Organization Types • Hybrid entity • Affiliated covered entity • Organized health care arrangement • Covered entity with multiple functions
  • 15. © 2017 American Health Information Management Association HIPAA: Privacy Rule Documents • Notice of Privacy Practices – Explains how PHI will be used and disclosed – Explains individuals’ rights – Healthcare providers must make it available upon first encounter – Must be posted in a prominent place, including website if one exists – HIPAA and HITECH outline content requirements – Receipt must be acknowledged by individual
  • 16. © 2017 American Health Information Management Association HIPAA: Privacy Rule Documents • Consent – To use or disclose PHI for TPO – Optional document – Revocation must be permitted
  • 17. © 2017 American Health Information Management Association HIPAA: Privacy Rule Documents • Authorization – Is written permission for a specific disclosure – Must contain HIPAA-required elements – Is required unless a disclosure meets a HIPAA authorization exception
  • 18. © 2017 American Health Information Management Association HIPAA: Uses and Disclosures When Authorization Is Not Required • When uses and disclosures are required, even without authorization – Access or accounting of disclosures requested by individual or personal representative – HHS investigation, review, or enforcement action
  • 19. © 2017 American Health Information Management Association HIPAA: Uses and Disclosures When Authorization Is Not Required (continued) • When uses and disclosures are permitted without authorization – 18 situations – Includes situations where individual has opportunity to agree or object (2) – Includes situations where individual does not have opportunity to agree or object (16) – These uses and disclosures are permissive only (HIPAA permits, but does not require) • Must not violate a stricter/more protective state law
  • 20. © 2017 American Health Information Management Association HIPAA: Uses and Disclosures When Authorization Is Not Required (continued) • Uses and disclosures permitted without authorization – Individual has the opportunity to agree or object (2 situations) • Facility directory/directory of patients – Patient name (fact of admission, if requested by name) – Location in facility – Condition, in general terms – Religious affiliation (to clergy) • Notification to family or friends
  • 21. © 2017 American Health Information Management Association HIPAA: Uses and Disclosures When Authorization Is Not Required (continued) • Uses and disclosures permitted without authorization – Individual does not have the opportunity to agree or object (16 situations) • Treatment, payment, and operations • To the individual • Incidental disclosures • Limited data set • Twelve public interest and benefit purposes (outlined on next slide)
  • 22. © 2017 American Health Information Management Association HIPAA: Uses and Disclosures When Authorization Is Not Required • Uses and disclosures permitted without authorization (12 public interest and benefit) – As required by law (for example, reporting specified wounds) – Public health activities – Victims of abuse, neglect, or domestic violence – Healthcare oversight activities – Judicial and administrative proceedings – Law enforcement purposes – Decedents – Cadaveric organ, eye, or tissue donation – Research – Threat to health or safety – Specialized government functions – Workers’ Compensation
  • 23. © 2017 American Health Information Management Association HIPAA: Redisclosure • Involves PHI created by and received from another entity • Redisclosure allowed for HIPAA-permitted purposes
  • 24. © 2017 American Health Information Management Association HIPAA: Commercial Uses and Disclosures of PHI • Marketing: Communication about a product or service that encourages its purchase or use • General rule: Use or disclosure of PHI for marketing requires authorization • Marketing activities that do not require an authorization – Occur face-to-face with the individual – Concern promotional gifts of nominal value
  • 25. © 2017 American Health Information Management Association HIPAA: Commercial Uses and Disclosures of PHI (continued) • Activities not defined as marketing per HIPAA (authorization not required) – Communications by CE about health-related products and services in a CE’s benefit plan – Replacements or enhancements to a health plan, or health-related products or services that are of value (although not part of a benefit plan) – For treatment of individual – For case management/care coordination or alternative treatments • Remuneration to the covered entity must be disclosed • Opt-out instructions must be provided
  • 26. © 2017 American Health Information Management Association HIPAA: Commercial Uses and Disclosures of PHI (continued) • HITECH: Clarifies and expands communications considered to be marketing • HITECH: Limits covered entities’ ability to categorize communications as operations (and exempt themselves from marketing requirements)
  • 27. © 2017 American Health Information Management Association HIPAA: Commercial Uses and Disclosures of PHI (continued) • Fundraising: Activities initiated by the covered entity to generate money for the benefit of the covered entity • Must inform individuals in Notice of Privacy Practices that PHI may be used for fundraising • Instructions on how to opt out in the future are required before the first solicitation or as part of the fundraising materials • Prior authorization required if fundraiser targets individuals based on diagnosis – For example, kidney patients targeted to raise funds for new kidney dialysis center • HITECH: Opt-out may apply to all future fundraising campaigns or to the current campaign only
  • 28. © 2017 American Health Information Management Association HIPAA: Commercial Uses and Disclosures of PHI (continued) • Sale of PHI – HITECH: CEs and BAs may not sell PHI without patient authorization – There are exceptions • Public health and research data; treatment and healthcare operations (such as PHI that is part of CE sale or merger) – Patient must declare in the authorization whether the recipient of the PHI can exchange it further for payment
  • 29. © 2017 American Health Information Management Association HIPAA: Minimum Necessary Requirement • People should only have access to the amount of information needed to do their jobs – Standard applies to CEs and Without further clarification, “limited data set” (PHI with certain direct identifiers removed) is the guideline – Revert to “amount needed to accomplish intended purpose” when limited data set definition is inadequate – Clarification of concept is pending