Health Insurance Portabililty & Accountability Act (HIPAA) part 3

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Introduction

HIPAA (cont)

A Covered Entity must designate a privacy official, called the HIPAA Privacy Officer

  • must be an individual - not a board or committee
  • skill sets
    • knowledge & experience of information privacy laws & HIPAA
    • should have a basic understanding of information technology
    • should have some sensitivity to public relations
  • covered entity must designate a contact cerson to receive privacy complaints if they arise
  • conducts certain healthcare business transactions in electronic form
    • the privacy officer may also be the contact person

Duties of HIPAA Privacy Officer

  • performs initial & ongoing information privacy risk assessments
  • conducts compliance monitoring activities
  • ensures & maintains:
    • appropriate privacy consent & authorization forms are used
    • appropriate notices and materials are used for:
      • organization practices
      • legal practices & requirements
  • ensures, maintains, & monitors business associate agreements
    • establishes, manages, & monitors tracking system for qualified individuals to review or receive a report on their PHI disclosures, as required by HIPAA

The Privacy Officer oversees, ensures, tracks & manages education & training in a covered entity

  • initial privacy & security awareness training
  • ongoing privacy & security training program
    • change management training (if appropriate)
  • the privacy officer is accountable for training:
    • employees
    • volunteers
    • medical & professional staff
    • contractors (if appropriate)
    • alliances (if appropriate)
    • business associates (if appropriate)
    • all new employees

The HIPAA Privacy Officer

  • establishes & manages the process for complaints
    • receiving complaints
    • documenting complaints
    • tracking complaints
    • investigating complaints
    • acting on complaints
  • manages & ensures compliance
  • deals with sanctions for non-compliance & violations
  • establishes, promotes, & maintains activities to foster privacy & security awareness
  • monitors & reviews all information system-related security plans to ensure alignment with HIPAA

Responsibilities:

  • the privacy officer is the 'knowledge officer' for:
    • applicable federal & state privacy laws
    • accreditation standards
    • industry 'best practices'.
  • the privacy officer accepts resposibilityfor the entity's privacy plans, policies, & overall HIPAA compliance with HIPAA & other applicable laws

The Security Rule

  • creates & regulates 'ePHI' 'Electronic Protected Health Information' i.e. PHI in digital form
  • covers all electronic, individually identifiable data that is transmitted or stored by a HIPAA covered entity
  • covers administrative operations, financial healthcare transactions, & internal transactions
  • only regulates ePHI, while the privacy rule covers all PHI.
  • applies to all covered entities covered by HIPAA's privacy rule
  • covers nearly every electronic device in a covered entity's facilities that can transmit, receive, store, process, display, or print PHI
  • purposes
    • protects systems & data from unauthorized access & misuse
  • encompasses
    • nearly everything in a covered entity's facility, including
      • information systems (hardware, software)
      • personnel policies
      • information practice policies
      • disaster preparedness

Electronic PHI (ePHI) is increasingly at risk

  • the age of 'point & click' hacking is here.
    • formerly:
      • expert hackers - the 'old days' (Unix machines)
      • to 'script kiddies' - less knowledge required
      • to 'click kiddies' - no knowledge required
  • vast & growing base of Windows PC's
  • universal dependence of society on computers
  • universal connectedness of computer systems
  • proliferation of hacker websites, newsgroups, & IRC channels

Risk for abuse of PHI? (losses in 2005 in millions of dollars)

  • virus = 42
  • unauthorized access = 31
  • denial of service = 7.9
  • insider net abuse = 6.8
  • laptop theft = 4.1
  • financial fraud = 2.5
  • miuses of public web application = 2.2
  • system pentration = 0.8
  • abuse of wireless network = 0.5
  • sabotage = 0.3
  • telecom fraud = 0.2
  • website defacement 0.1

HIPAA's Security Rule contains 36 specifications for implementing specific security standards (2 kinds)

  • 'required' standards (14 Specs)
    • essential & must be implemented
  • 'addressable' standards (22 Specs) - offers 3 choices
    • if 'reasonable & appropriate', must be implemented.
    • if not 'R&A',then Covered Entity must
      • document why, &
      • must implement a comparable security measure that accomplishes the same purpose
    • if not 'R&A', & the Standard can be met without an alternative measure, then covered entity must:
      • document that decision, &
      • document why it's not 'reasonable & appropriate', &
      • document how the standard is being met

HIPAA Security Standards: administrative, physical, & technical standards

  • administrative procedures
    • certification review
    • chain of trust agreement
    • policies & procedures
    • access authorization
    • proactive internal audit
    • personal authorization
    • security management process
    • termination process
    • training
  • physical safeguards
    • assigned responsibility
    • media controls: hardware/software
    • access controls
    • workstation policies e secure workstations
    • training
  • technical mechanisms
    • access Controls
    • audit Controls
    • authorization Controls
    • use & disclosure
    • data authentication
    • entity authentication

HIPAA's Legal Risks: Legal attacks can come from many directions

  • from patients & the public
  • from employees & whistleblowers
  • from boards, directors, & management
  • from regulators & law enforcement
  • from others (business associates, affiliates, etc.)

Legal Attacks may be founded on many things

  • privacy violations
  • security violations
  • transactions & code sets violations
  • multitude of other Federal, State, County, & Local Laws
  • may be for 'Acts of Omission' or 'Acts of Commission'

Under HIPAA, the 'Secretary of Health and Human Services' (HHS) can audit & investigate nearly any part of a covered entity's operations or records

  • for oversight purposes
  • to determine compliance
  • to investigate alleged HIPAA violations

Legal Insights for Privacy Officers

  • having no disaster recovery plan violates fiduciary standards of care & due diligence (& HIPAA)
  • there is no direct 'private cause of action' under HIPAA for patients to sue CE's - but there are other ways
  • injured plaintiffs will argue that HIPAA is 'a de facto federal standard of care' for privacy & security
  • plaintiffs may seek punitive damages, in addition to compensatory damages, for HIPAA violations
  • jurors & Judges will look to see if defendants had 'knowledge' & 'control' regarding offenses
  • if 'outside experts' are consulted, jurors tend to place less blame on the company if a problem occurs

HIPAA Success Strategies

  • document everything
    • decisions, & the people & processes behind them
    • keep minutes of all important meetings
    • policies, procedures, guidelines, templates, etc.
  • involve legal counsel at every stage of compliance
  • create 'summary compliance documentation' for your entire HIPAA project
    • tells everything you did, when, why, & who was involved
    • understandable to laypeople (JURORS)
  • periodically play devil's advocate & analyze possible legal weaknesses an attacker could exploit
    • 'tiger teams' simulate hackers & attackers, & reveal weaknesses or gaps in compliance

Security: Verification of Identity for PHI Releases

  • by telephone
    • example: individual
      • should provide SSN and DOB, checked against internal records
    • example: guardian or personal representative requesting patient records
      • must be on record as a personal rep or guardian
      • must give SSN and DOB of individual they represent
      • check representative status and individual information against record
    • example: another provider (covered entity) requesting patient records
      • should give their health provider I.D. number
      • determine if this is a permitted disclosure under HIPAA?
      • check against records carefully
    • example: business associate requesting patient records
      • get a phone number to return the call; call the requestor back to verify
      • check records carefully for a match
  • in-person
    • requestor should provide driver's license, work ID badge or other picture ID.
    • if personal representative, they must be on record as such

HIPAA Success Strategies use 'guerilla' tactics - think outside the box

  • find PHI-related activities inside & outside your practice
    • STOP, LOOK, LISTEN
  • act like the enemy - civil attorneys, National Inquirer, etc.
  • conduct 'clip board' & 'fly on the wall' assessments
  • sign in sheets - should have limited info (no 'reason for visit' entries)
  • medical charts - should be face down or faced away from sight
  • plastic chart holders - are OK if chart's face pages are covered
  • daily schedule - most of these contain PHI
  • sticky notes - don't use these for passwords
  • telephone & Fax - verify the numbers you call are correct
  • transporting of files - use lockboxes, out-of-sight in trunk, have policies
  • computer screens, fax machines, printers, voice mail devices
  • staff taking work home is risky - policies & procedures are critical
  • conversations at restaurants, church, soccer games, etc. can be overheard

HIPAA Success Strategies

  • top-level 'buy-in' is critical
  • see HIPAA as a Business Initiative, not an 'IT problem'.
  • incorporate HIPAA requirements into transaction/code set solutions
  • develop a basic understanding of HIPAA regulations
  • thoroughly assess your 'state of the union'
  • understand effort required & the complexity
  • acquire necessary expertise to address HIPAA
  • develop a clear work-plan & timeline for compliance
  • communicate with business partners.
    • train & educate all employees

Additional terms

References

  1. Prescriber's Letter 12(9): 2005 HIPAA Confusion and Fear about Protected Health Information Includes: HIPAA Made Simple: A Survival Guide. Detail-Document#: http://prescribersletter.com/(5bhgn1a4ni4cyp2tvybwfh55)/pl/ArticleDD.aspx?li=1&st=1&cs=&s=PRL&pt=3&fpt=25&dd=210914&pb=PRL (subscription needed) http://www.prescribersletter.com