HIPAA Health Insurance Portability and Accountability Act

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HIPAAHealth Insurance Portability and
Accountability Act

• Lab Disclosures
• March 29, 2004
• UAB Health System

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Education Objective

• Review the HIPAA Privacy law segments most
  applicable to lab disclosures.
• Explain the UABHS Accounting of Disclosures
  electronic and manual processes.
• Distribute and explain a matrix of typical
  disclosures.
• Answer questions and de-mystify HIPAA privacy
  regulations.
• Provide resources to assist with future questions.

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HIPAA Privacy

• Under the HIPAA Privacy Regulations
• PHI may be used for treatment, payment,
  healthcare operations (TPO).
• PHI may be disclosed to other providers for
  treatment.
• PHI may be disclosed to other covered entities
  for payment.
• PHI may be disclosed to other covered entities
  that have a relationship with the patient for
  certain healthcare operations such as QI,
  credentialing and compliance.

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HIPAA PrivacyOther Permitted Uses Disclosures

• PHI my be used or disclosed without authorization
  under the following circumstances
• Public health agencies for purposes such as
  controlling or preventing disease or collecting
  vital statistics, i.e. notifiable or communicable
  diseases which must be reported to AL Dept. of
  Public Health, PKU Information Reporting.
• Public health or government authorities for law
  enforcement purposes, such as reporting on
  victims of abuse, neglect or domestic violence.

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HIPAA PrivacyOther Permitted Uses Disclosures

• Health oversight agencies for activities
  authorized by law, i.e. AQAF.
• Judicial and administrative proceedings, such as
  compliance with a court order or subpoena.
• Law enforcement officials seeking information for
  the purpose of identifying a suspect, witness, or
  victim of a crime.
• Coroners, medical examiners, and funeral
  directors to identify a deceased person or
  determine a cause of death.
• Organ donation.
• Workers compensation.

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HIPAA PrivacyOther Uses Disclosures

• Facility Directories unless patient opts out,
  their name, location and general medical
  condition may be disclosed to those asking for
  patient, by name.
• Individuals involved in care or payment for care
  PHI may be disclosed unless patient objects.

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HIPAA Privacy Marketing Fundraising

• Marketing
• Covered entities are prohibited from using or
  disclosing PHI for marketing purposes without the
  patients express authorization.
• Covered entities are prohibited from selling
  patient/enrollee lists to third parties.
• Providers CAN communicate with patients about
  treatment options or the covered entities own
  health-related products and services, common
  health care communications- such as disease
  management, wellness programs, prescription
  refill reminders and appointment notifications,
  recommending alternative treatments, therapies,
  or health-care products.
• Fundraising- limited PHI may be used if patient
  told how to opt out.

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HIPAA Privacy Incidental Uses and Disclosures

• Uses and disclosures that are incidental to an
  otherwise permitted use or disclosure may occur
  and is not considered a violation of the Rule
  provided that the covered entity meets reasonable
  safeguards and minimum necessary requirements.
• Waiting room sign-in sheets, patient charts at
  bedside, physician conversations with patients in
  semi-private room, and physicians conferring at
  nurses stations.

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HIPAA PrivacyResearch

• HIPAA regulations do not replace or reproduce
  other federal regulations (e.g. 45 CFR 46, 21 CFR
  56). All existing regulations remain in force.
• Unlike some other regulations, HIPAA applies
  regardless of whether the research is funded by
  the government.

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HIPAA PrivacyResearch

• HIPAA preempts all less stringent state laws
  regarding privacy of health information unless
  specific requirements are met.
• These requirements involve state mandated
  reporting related to health, safety, or welfare,
  as well as reporting that is necessary for a
  health plan to conduct auditing procedures.

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HIPAA PrivacyResearch

• Instructions for requesting an exemption - to
  follow the state law instead of HIPAA - are given
  in Subpart B (160.201-205).

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HIPAA PrivacyResearch

• Covered Entities are permitted to use or disclose
  PHI for research if the IRB has approved the
  research and one or more of the following
  conditions exist
• 1. Patient Authorization
• 2. Decedent Research
• 3. Preparatory Research
• 4. Limited Data Set
• 5. IRB grants a waiver of required authorization.

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Waiver of Authorization

• The IRB may waive the authorization, if the
  reviewing board finds that
• The use or disclosure of PHI involves no more
  than minimal risk to privacy.
• The proposed research could not practicably be
  conducted without the waiver or alteration and
• The research could not practicably be conducted
  without access to and use of the PHI.

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Research with Records of Deceased Individuals

• If a research subject is deceased, PHI may be
  used or disclosed provided that the researcher
  represents
• The use or disclosure is sought solely for
  research on PHI of decedents, and
• PHI for which use or disclosure is sought is
  necessary for research purposes.
• Upon request of the covered entity, the
  researcher must provide documentation of the
  death of the individual.

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Reviews Preparatory to Research

• A covered entity may use or disclose PHI for
  reviews preparatory to research if it obtains the
  following representations from the researcher
• Use and disclosure is sought solely to review PHI
  as necessary to prepare a research protocol or
  for similar purposes preparatory to research
  (e.g. recruitment)
• No PHI is removed from the covered entity by the
  researcher in the course of review and
• The PHI for which use or access is sought is
  necessary for the research purpose.
• Look to institutional policy to see if IRB
  approval is required.

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De-Identification Standard

• De-identified health information is health
  information that does not identify an individual
  and for which there is no reasonable basis that
  the information could be used to identify an
  individual.
• It is not considered individually identifiable
  information.
• There is no actual knowledge that the information
  could be used to identify an individual.

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De-Identification Standard (cont.)

• The Privacy Rule does not apply to information
  that has been de-identified under one or two
  standards set forth in the Privacy Rule.
• Removal of 18 identifiers.
• Certification by a biostatistician that the
  method for de-identifying the PHI has a very
  small risk that the information could be used,
  alone or in combination with other reasonably
  available information, to identify an individual
  who is the subject of the information.

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De-Identification Standard (cont.) Information
is presumed to be de-identified, if the following
identifiers of the individual or of relatives,
employers, or household members of the
individual, have been removed

• -Names
• -All geographic subdivisions smaller than a
  State, including street address, city, county,
  precinct, zip code, and equivalent geocodes
• -All elements of dates (except year), including
  birth date, admission discharge dates, date of
  death, and all ages over 89 and all elements of
  dates (including year) indicative of such age
• -Telephone numbers
• -Fax numbers
• -Electronic mail addresses
• -Social security number
• -Medical record numbers
• -Health plan beneficiary numbers
•  

• -Account numbers
• -Certificate/license numbers
• -Vehicle identifiers and serial numbers,
  including license plate numbers
• -Device identifiers and serial numbers
• -Web Universal Resource Locator (URL)
• -Internet Protocol (IP) address numbers
• -Biometric identifiers, including finger and
  voice prints
• -Full face photographic images and any comparable
  images and
• -Any other unique identifying number,
  characteristic, or code, except as allowed under
  the re-identification specifications 164.514(c).

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Limited Data Sets

• Similar to de-identified data sets except certain
  direct identifiers must be removed.
• Can be used for research, public health, and
  health care operations.
• Limited Data Sets can include identifiers such as
  date of birth, dates of hospital admissions and
  discharges, and an individuals residence by
  city, county, state, and 5 digit zip codes.
• Researcher may access and use the entire array of
  PHI without authorizations or waivers of
  authorizations.

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Minimum Necessary Standard

• When HIPAA permits use or disclosure of PHI,
  providers should disclose or use only the minimum
  necessary amount of PHI in order to do their
  jobs.
• Exceptions
• Treatment
• Anything for which a patient authorization is
  signed.
• Incidental disclosures.
• Disclosures required by law.

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HIPAA Privacy- Patient Rights

• Notice to Individuals of Information Practices.
• Authorization.
• Request Access.
• Request Accounting for Uses and Disclosures.
• Request Amendment and Correction (subject to
  approval by the covered entity).
• Request Confidential / alternate communication.
• Request Restriction on use of PHI (subject to
  approval by the covered entity).
• Complaints.

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What is an Accounting of Disclosures?

• Info. provided to the patient, upon request of
  certain disclosures made by UAB/UABHS in the six
  years prior to the date of the request, but not
  prior to April 14, 2003.
• Date of disclosure
• Name, address (if known) of entity/person
  receiving PHI
• Brief description of PHI disclosed
• Purpose of disclosure or copy of request

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Accounting of Disclosures

• A covered entity must provide an accounting to
  the individual of any research disclosure made
  pursuant to an IRB.
• No accounting is needed for disclosures made
  pursuant to an Authorization.

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Accountings of Disclosures are not required for
the following

• To carry out TPO,
• PHI to individuals about themselves,
• For facility directory purposes,
• Incidental to an otherwise permitted
  use/disclosure,
• To persons involved in the care of the pt.,
• National security or intelligence purposes,
• Correctional institutions or other law
  enforcement officials,
• For disclosures made prior to April 14, 2003,
• Pursuant to a valid authorization,
• For other such reasons as allowed under HIPAA.

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Mandatory Reporting Involving Protected Health
Information

• The state of Alabama requires reporting on the
  following
• Births
• Infants of Unknown Parentage
• Fetal Deaths/Induced Termination of Pregnancy
• Deaths
• Notifiable Diseases Health Conditions
• Infected Health Care Workers with HIV or
  Hepatitis B
• Head Spinal Cord Injuries
• Confirmed Cancer Cases (Tumor Registry)
• Child Abuse or Neglect
• Protection of Aged or Disabled Adults
• Victims of Domestic Violence

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UAB Health System Types of Disclosures

• Abuse, Neglect or Exploitation
• Administrative Hearing
• Adverse Outcomes
• ACS Consultation/Verification Review of Trauma in
  Hospitals
• Audits
• Autopsy Report
• Billing Records/Reports
• Birth Certificate (Vital Event)
• Bureau of Health Care Information
• Business Associates for Non - T.P.O.

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UAB Health System Types of Disclosures

• Center for Disease Control
• Civil/Criminal Investigation
• Communicable Diseases
• Complaint Investigation
• Consultants/Contractors
• Coroners/Medical Examiners
• Court Order
• Death Certificate (Vital Event)
• Department of Justice
• Department of Transportation (D.O.T.)

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UAB Health System Types of Disclosures

• Drug Enforcement Agency (D.E.A.) - Narcotics
  Reporting
• Environmental Protection Agency (E.P.A.)
• Federal Bureau of Investigation (F.B.I.)
• Federal Emergency Management Agencies (F.E.M.A.)
• Food and Drug Administration Reporting (F.D.A.)
• Funeral Homes
• Government Required Disclosures, Not Otherwise
  Specified
• Immunization Records
• Inspection
• Insurance Reviewers (N.C.Q.A., etc.)

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UAB Health System Types of Disclosures

• Law Enforcement (Aversion of Serious Threat)
• Law Enforcement (Crime on Premises)
• Law Enforcement (Suspicious Death, Location of
  Suspect/Witness)
• Law Enforcement (Victims of or Suspected Crime)
• Law Enforcement (Wounds, Injuries)
• Licensure/Disciplinary Action
• Military Command Authorities
• National Transportation Safety Board (N.T.S.B.)
• National Trauma Data Bank
• Neonatal Reporting to State
• Occupations Safety and Health Administration
  (O.S.H.A.)

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UAB Health System Types of Disclosures

• Organ, Eye and Tissue Donation/Procurement
• Paternity Testing/Affidavits
• Peer Review (A.Q.A.F./Alabama Quality Assurance
  Foundation)
• Poison Control Center
• Public Health Activities, Not Otherwise Specified
• Public Health Authorities, Not Otherwise
  Specified
• Registry Birth Defects
• Registry Births
• Registry Burns and Trauma
• Registry Cancer/Tumor

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UAB Health System Types of Disclosures

• Registry Cardiac
• Registry Child Abuse or Neglect
• Registry Deaths
• Registry Eye Injury
• Registry Fetal Deaths
• Registry Head and Spinal Cord Injury
• Registry Hearing Screening
• Registry Infants of Unknown Parentage
• Research (Preparatory, Decedent, or Requirements
  for Authorization Waived)
• Search Warrant

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UAB Health System Types of Disclosures

• Subpoena
• Summons
• Surveys (CAP, CLIA, FDA, JCAHO)
• Underage Pregnancy
• Unlawful Disclosure Discovered Post-Release
• Vendors
• Workers' Compensation, if not related to TPO

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Office of Civil Rights web-site

• FAQs or Frequently Asked Questions
• Accounting of Disclosures
• Research

www.hhs.gov/ocr/hipaa
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OCR Privacy FAQs

• List of FAQs
• Note multiple pages
• Click on line item for details

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OCR Privacy FAQs

• Review FAQ for information as it relates to
  Privacy

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UABHS Accounting Tool

• UAB Health System utilizes one central database
  for maintaining accounting of disclosures.

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Manual Documentation of Accounting of Disclosures
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Miscellaneous

• Reminder HIPAA Privacy requirement to maintain
  accounting of disclosures, from April 14, 2003.
• Questions?

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For HIPAA questions or to report a suspected
HIPAA violation contact

• Carlos Brown,UAB Hospital
• Corporate Compliance / Privacy Manager
• 934-2990
• Sheila Moore
• Institutional Review Board
• 934-3789
• Linda Lum
• Accounting of Disclosures
• 975-2622
• llum_at_uabmc.edu