Cyber Security, Privacy

1
Cyber Security, Privacy HIPAA

• Brenda Cuccherini, Ph.D., MPH
• VA Office of Research Development Fall 2006

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A New Mind Set

• Old habit of mind is one of the toughest things
  to get away from in the world. It transmits
  itself like physical form and features
• Mark Twain
• A Connecticut Yankee in King Authors Court

3
VHA Privacy

• VHA privacy program is complex
• VHA must comply with 6 statutes that govern
  collection, maintenance release of information

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Privacy Related Statutes

• HIPAA
• Privacy Act of 1974
• FOIA
• VA Claims Confidentiality
• Confidentiality of Drug Abuse, Alcoholism
  Alcohol Abuse, HIV, and Sickle Cell Anemia
  Medical Records
• Confidentiality of Healthcare Quality Assurance
  Review Records

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• HIPAA Title II The Privacy Rule
• (45 CFR 160 and 164)

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HIPAA Topics To Be Covered

• HIPAA the Common Rule
• HIPAA Identifiers
• Limited Data Sets
• Business Associate Agreements
• De-identification
• Waiver of Authorization
• VA HHS Differences

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HIPAA the Privacy Rule

• Title I Health Care Access, Portability,
  Renewability
• Title II Preventing Healthcare Fraud Abuse
  Administrative Simplification Medical Liability
  Reform
• Privacy Rule,
• Transactions,
• Security
• Enforcement)

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HIPAA The Common Rule

• Represent 2 different but not contradictory
  regulations
• Many terms similar but not alike
• IRB must make 2 separate determinations when
  reviewing approving applicable research

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HIPAA IdentifiersRemove to De-identify for
HIPAA

• (1) Names
• (2) All geographic subdivisions smaller than a
  state, except
• for the initial three digits of the zip
  code if the
• geographic unit formed by combining all zip
  codes with
• the same three initial digits contains more
  than
• 20,000 people
• (3) All elements of dates except year and all
  ages over 89
• (4) Telephone numbers
• (5) Fax numbers
• (6) E-mail addresses
• (7) Social security numbers
• (8) Medical record numbers

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HIPAA Identifiers (Cont.)

• (9) Health plan beneficiary numbers
• (10) Account numbers
• (11) Certificate or license numbers
• (12) Vehicle identifiers and license plate
  numbers
• (13) Device identifiers and serial numbers
• (14) URLs
• (15) IP addresses
• (16) Biometric identifiers
• Full-face photographs and any comparable
• images

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HIPAA Identifiers (Cont.)

• Any other unique identifying number,
  characteristic
• or code, unless otherwise permitted by
  the Privacy
• Rule for re-identification
• Scrambled SSNs
• Initials
• Last four digits of SSN
• Employee numbers
• Etc.
• (19) A caveat HIPAA also states that the
  entity does not have actual
• knowledge that the remaining
  information could be used alone
• or in combination with other
  information to identify an individual
• who is the subject of the information
• If you can strip all 18 identifiers, it still may
  not be de-identified

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Applicability of Identifiers

• HIPAA identifiers apply to
• The individual
• The individuals relatives
• The individuals employers
• The individuals household members

13
Whats De-identified?

• If some one tells you data is de-identified, ask
  them how they define it!
• Definition of de-identified
• All HIPAA identifiers must be removed, plus The
  entity must have no knowledge the caveat from
  the last slide and
• It meets the Common Rule definition of
  de-identified

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Limited Data Sets

• Does not require a HIPPA authorization or waiver
  of authorization
• Only allowed for research , public health, or
  health care operations
• Requires a DUA
• May contain identifiable information such as
  scrambled SSNs, are still PHI
• May still be human subjects research

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Limited Data Set (Cont.)

• Excludes certain direct identifiers
• Excluded identifiers apply to
• The individual,
• The individuals relatives
• The individuals employers
• The individuals household members
• May contain
• City, state, ZIP code,
• Elements of a date other numbers,
• Characteristics or codes not listed as direct
  identifiers

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Limited Data Sets Direct Identifiers

• (1) Names
• (2) Postal address other than town, city, state,
• and ZIP code
• (3) Telephone numbers
• (4) Fax numbers
• (5) SSNs
• (6) Medical Record number
• (7) Health plan beneficiary numbers
• (8) Account numbers

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Limited Data Set Direct Identifiers (Cont.)

• (9) Certificate/license numbers
• (10) Vehicle identifiers and serial numbers
• including license plate numbers
• (11) Device identifiers serial numbers
• (12) Web universal resource locators (URLs)
• (13) Internet protocol (IP) address
• (14) Biometric identifiers, including
  fingerprints
• voice prints
• (15) Full-face photographic images and any
• comparable images

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Business Associate Agreements

• Business Associate An individual or entity who
  on behalf of VHA
• Performs or assists in performing functions or
  activities involving the use or disclosure of PHI
  or
• Provides certain services to VHA which include
  use or disclosure of PHI by VHA.
• Activities must be related to treatment, payment,
  or health care operations

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Business Associate Agreements

• BAAs required for
• Any person or entity meeting the definition of
  Business Associate
• BAAs not required for research or research
  sponsors
• Research is not a function or activity regulated
  by HIPAA (treatment, payment, or health care
  operations)

20
Waiver of Authorization

• IRB or Privacy Board (PB) may approve
• Full waiver of authorization
• Partial waiver of authorization
• Alteration of the disclosure
• IRB or Privacy Board
• Must make specific determination prior to
  approving waiver
• Must document specific findings

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Required Determinations 3 Criteria

• 1. The use or disclosure of PHI involves no more
  than a minimal risk to the individual based on
  at least the presence of the following elements
• An adequate plan to Protect the identifiers from
  improper use disclosure
• An adequate plan to destroy the identifiers at
  the earliest opportunity consistent with the
  conduct of the research unless there is health
  or research justification for retaining them or
  retention or the retention is required by law
  and
• Adequate written assurance that the PHI will not
  be reused or disclosed to any other person or
  entity, except as required by law, for authorized
  oversight of the research study, or for other
  research for which the use of disclosure of PHI
  would be permitted by this subpart

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Required Determinations 3 Criteria (Cont.)

• 2. The research could not practicably be
  conducted without the waiver
• 3. The research could not practicably be
  conducted without access to and use of the
  protected health information

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Required Documentation

• Name of IRB or PB date approved
• Statement IRB or PB determined the alteration or
  waiver of authorization, in whole or in part,
  satisfies the 3 criteria in the Rule
• A brief description of the PHI for which use or
  access has been determined to be necessary
• A statement that the alteration or waiver of
  authorization has been reviewed and approved
  under either normal or expedited review
  procedures, and
• Signature of the chair or other member, as
  designated by the chair, of the IRB or PB, as
  applicable.

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Investigators Responsibility

• Include all necessary information in the
  submission to the IRB or PB
• Request use of the minimal necessary information
  to conduct the research
• Use of data consistent with the protocol
• No re-use or sharing of data without approvals

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How Does VHA Differ from HHS

• Preparatory To Research
• Authorization Elements
• Accounting for Disclosures
• Data Use Agreements

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Prepatory to Reach

• VHA Handbook 1605.1 states that contacting
  research subjects or conducting pilot studies are
  not Prepatory to Research activities
• HHS states that the Prepatory to Research
  provisions allow an investigator to use PHI to
  contact prospective research subjects

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HIPAA Authorization

• VHA requirements differ from HHSs
• A description of the information to be used or
  disclosed AND specifically identify HIV, Sickle
  cell anemia, drug and/or alcohol abuse treatment
  information

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Accounting for disclosure

• Not so much a difference but a clarification
• VHA research is conducted inside a single covered
  entity MOST research does not involve
  disclosure, only use of PHI

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Data Use Agreements

• VHA and HHS requires DUA for use of limited data
  sets only
• ORD policy will additionally require a DUA for
  anytime you transfer data within VHA for research
  purposes

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• Privacy Act of 1974

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• An American has no sense of privacy.
• He does not know what it means.
• There is no such thing in the country.
• George Bernard Shaw

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Privacy Act of 1974

• Purpose To balance the governments need to
  maintain information about individuals with the
  rights of individuals to be protected against
  unwarranted invasions of their privacy
• Background Watergate era and Congress concerned
  with
• Curbing illegal surveillance investigations
• Potential abuses presented by governments
  increasing use of computers to store retrieve
  personal data

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Privacy Act Objectives

• Restrict disclosure of personally identifiable
  records by agencies
• Grant individuals
• Increased rights of access to agency records
• The right to seek amendment of agency records
• Establish code of fair information practices for
  agencies

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A Privacy Act Requirement

• Agencies that maintain a system of records "shall
  promulgate rules, in accordance with notice and
  comment rulemaking
• Systems of Records (SOR) A group of records
  under agency control from which information is
  retrieved by the name of the individual or by
  some identifying number, symbol, or other
  identifying particular assigned to the
  individual.

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System of Records Content

• Category of individuals covered by the system
• Categories of records in the system
• Purpose of the records
• Routine uses of records
• Storage (storage medium)
• Retrievability (name, numbers or identifier)

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SORs and Research

• 34VA12 -- Veteran, Patient, Employee, and
  Volunteer Research and Development Project
  Records
• 121VA19 -- National Patient Databases - VA

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SORs Impact on Research

• All release/disclosure of information must be
  consistent with the SOR and routine uses
• Investigators can not release information to
  non-VA investigators or institutions unless
• Written permissions/authorization from individual
  or
• Permission of the USH
• Release of information is through the Privacy
  Office

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Privacy Issues Resources

• VHA Privacy Officer Stephania Putt
• Local privacy officer
• VHA privacy program
• http//vaww.vhaco.va.gov/privacy/
• Links to all Federal statutes, regulations,
  policies including security policies
• Privacy Fact Sheets

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• Cybersecurity

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• To err is human and to blame it on a computer
  is even more so.
• Robert Orben
• Magician and Comedy Writer

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Reporting of Security Incidents

• OMB requires reporting of an incident within 1
  hour of discovery to US-CERT
• US-CERT US Computer Emergency Readiness Team is
  the operational arm of National Cyber Security
  Division (NCSD), Department of Homeland Security
  (DHS).
• Suspected and confirmed breaches must be reported

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How to Report Security Incidents

• Immediately report to
• Supervisor
• ISO
• Privacy Officer
• Others (Your facility may require reporting to
  other facility administrators)
• ISO will report it to the VA-Security Operations
  Center (VA-SOC)
• Privacy Officer will enter it into the Privacy
  Violations Tracking System (PVTS)
• VA-SOC will notify US-CERT key VHA/VA officials

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It is VA policy that

• VA information may not reside on non-VA systems
  or devices unless specifically authorized by VA
  guidance/policy
• Federal Information Security Management Act of
  2002 (FISMA) Federal Security requirements apply
  to when contractors or other organizations on
  behalf of an agency possess or use Federal
  information
• You must obtain authorization to remove
  confidential Privacy Act protected information
• Approved protocol
• Consult with supervisors/obtain permission
• Consult with supervisor and ISO to ensure that
  the data is properly encrypted and password
  protected in accordance with VA policy
  Secretarys memo June.6, 2006

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VA policy on Government Laptops or Other Equipment

• Updated property pass
• Updated virus protection
• House protect it from
• Environmental threats hazards
• Unauthorized access, use, or removal
• Laptops, external hard drives, or other storage
  devices must be under lock key when not in your
  immediate vicinity if it
• Contains sensitive/protected information (VAPI)
  or
• Software to access VA private networks

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VA Policy on Protection of Data

• Data system backups or copies
• Same confidentiality classification as originals
• Laptops portable media must NOT contain the
  only copy of the data
• VAPI stored on computers or other storage media
  outside VA facilities must be encrypted per VA
  approved protection mechanisms
• Password or other authentication information
• Do not store on remote systems unless encrypted
• Data can not be transmitted by remote access
  without VA-approved protection mechanisms

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Investigators Responsibilities

• Protocols contain sufficient information on
  security issues
• Who uses information
• How it will be stored and secured
• Who has copies where
• Will it remain within VA if not, will all data
  be returned to VA if not why
• Disposition of the data after protocol completed)
• Allowing access only to authorized individuals

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Investigators Responsibilities (Cont.)

• Safeguarding laptops, portable drives, flash
  drives, and other medium
• Ensuring all contracts, DUAs, and BAAs contain
  required language
• Encrypting/password protecting all sensitive data

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Policy Documents

• VA Directive 6504 Waiver of requirements
• Granted only by the VA Chief Information Officer
  in CO
• Waiver request only from an Administration Head,
  Assistant Secretary, or other key official
• Majority of IT security documents being
  redrafted on a very fast track

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Finding Policies

• www.va.gov/vhapublications
• Link on left banner to VA publications
• www.va.gov/research
• Call or e-mail
• Brenda Cuccherini, Ph.D. at [phone] or
• brenda.cuccherini_at_va.gov

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• A single question can be more influential
• than a thousand statements.
• Bo Bennett
• Businessman