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The HIPAA Privacy Rule: Scope, Structure, and Implementation

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The HIPAA Privacy Rule: Scope, Structure, and Implementation James G. Hodge, Jr., J.D., LL.M. Associate Professor, Johns Hopkins Bloomberg School of Public Health; – PowerPoint PPT presentation

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Title: The HIPAA Privacy Rule: Scope, Structure, and Implementation


1
The HIPAA Privacy RuleScope, Structure, and
Implementation
  • James G. Hodge, Jr., J.D., LL.M.
  • Associate Professor,
  • Johns Hopkins Bloomberg School of Public Health
  • Executive Director,
  • Center for Law and the Publics Health
  • at Georgetown and Johns Hopkins Universities

2
Principle Objectives
  • Discuss basic principles of health information
    privacy, confidentiality, and security.
  • Briefly assess the existing universe of legal
    protections for the privacy and confidentiality
    of health data.
  • Examine the scope, structure, and implementation
    of the HIPAA Privacy Rule.
  • Discuss the impact of the HIPAA Privacy Rule on
    public health authorities.
  • Explore the distinctions between public health
    practice and public health research for the
    purposes of applying privacy laws and policies.

3
Health Information Privacy - Key Terms
  • Privacy - an individuals right to control their
    identifiable health information.
  • Confidentiality - privacy interests that arise
    from a specific relationship (e.g.,
    doctor/patient, researcher/subject) and
    corresponding legal and ethical duties.
  • Security - technological or administrative
    safeguards or tools to protect identifiable
    health information from unwarranted access or
    disclosure.

4
Health Information Privacy - Key Terms
  • If the security safeguards in an automated
    system fail or are compromised, a breach of
    confidentiality can occur and the privacy of
    data subjects invaded.
  • Willis Ware, Lessons for the Future Dimensions
    of Medical Record Keeping, in Health Records
    Social Needs and Personal Privacy 43 (Task Force
    on Privacy, U.S. Department of Health and Human
    Services (1993) (http//aspe.hhs.gov/pic/pdf/4441.
    pdf

5
Health Information Privacy - Key Concepts
Disclosure
6
Health Information Privacy - Key Concepts
Acquisition
Use
Storage
Disclosure
7
Risks to Health Information Privacy
  • Accessibility and intimate nature of health data
    combine to cause social, psychological, and
    economic harms to those whose privacy is
    violated.
  • Emerging computer technologies and the
    development of longitudinal individual health
    records and national electronic health
    information infrastructures are perceived by many
    to threaten individual privacy.

8
Synergies of Health Information Privacy
  • Absent privacy protections, patients and others
    will avoid some clinical, public health, and
    research interventions.
  • Only through the responsible sharing of some
    health data may improvements in health care and
    community health be made.

9
Health Information Privacy - Communal Needs for
Identifiable Health Data
Individual privacy protections must be balanced
with legitimate communal uses of health data like
health research and public health.
10
The Universe of Health Information Privacy Laws
A host of laws of every type at every level of
government, affecting multiple types of entities,
and covering an array of health data are all part
of the universe of health information privacy laws
11
The Universe of Health Information Privacy Laws
Types of Laws
12
The Universe of Health Information Privacy Laws
Levels of Government
13
The Universe of Health Information Privacy Laws
Regulated Entities
14
The Universe of Health Information Privacy Laws
Types of Health Data
15
The Universe of Health Information Privacy Laws
  • Basic observations underlying these laws
  • Focus on individual (as contrasted with group)
    privacy interests
  • Identifiable health data is defined in different
    ways
  • Extent of privacy protections varies
  • Failure to address modern health information
    exchanges
  • Consistent need to balance individual and
    communal interests in health data

16
Health Information Privacy - Modern Protections
  • HIPAA
  • The Health Insurance Portability
  • and Accountability Act of 1996

17
HIPAA and the Basis for Health Info. Privacy
  • HIPAA seeks to
  • gt Increase access to health insurance
  • gt By reducing insurance costs
  • gt By lowering administrative costs
  • gt By transmitting electronic data gt
    Under enhanced health info. privacy
    protections
  • gt That encourage people to
    seek health care

18
Health Information Privacy - Modern Protections
  • HIPAA
  • includes
  • Administrative Simplification Provisions
  • which required the production of
  • Standards for Privacy of Identifiable Health
    Info.
  • also known as
  • Health Information Privacy Regulations
  • located at
  • 45 CFR Parts 160 164
  • and known collectively as the
  • Privacy Rule

19
HIPAA Privacy Rule A Brief Timeline
  • August, 21, 1996. HIPAA passes Congress and was
    signed into law.
  • August 21, 1999. Congress fails to pass health
    info. privacy law.
  • August, 1999 - January, 2001. Absent
    Congressional action, DHHS was authorized to
    produce administrative regulations.
  • April 14, 2001. After months of work and public
    commentary, DHHS finalizes its Privacy Rule with
    President Bushs approval.
  • August 14, 2002. Bush administration modifies
    original Rule.
  • April 14, 2003. The Rule becomes effective for
    most covered entities or one year later for
    small health plans.
  • April 14, 2004. The Rule is fully effective for
    all covered entities.

20
HIPAA Privacy Rule Scope, Structure, and
Implementation
  • What is covered?
  • Who is covered?
  • How is it covered?
  • How are disclosures/uses regulated?
  • What about other laws?
  • What about violations?

21
What Is Covered?
  • Protected Health Information (PHI)
  • individually-identifiable health information
    used or disclosed by a covered entity in any
    form, whether electronically, on paper, or
    orally.
  • 45 C.F.R. 160.103

22
What Is Not Covered?
  • PHI does not include
  • Education records covered by FERPA
  • Employment records held by a covered entity in
    its role as employer
  • Non-identifiable health information
  • 45 C.F.R. 160.103

23
Who Is Covered?
  • Covered Entities (CEs)
  • Health Plans
  • Health Care Clearinghouses
  • Health Providers - that exchange identifiable
    health data electronically
  • and their business associates
  • 45 C.F.R. 160.103

24
Who Is Covered?
  • Business associates include
  • Claims or data processors
  • Billing companies
  • Quality assurance providers
  • Utilization reviewers
  • Lawyers
  • Accountants
  • Financial service providers
  • 45 C.F.R. 160.103

25
Who Is Covered?
  • Beyond CEs and their Business Associates are
    those who engage in
  • Covered functions those functions of a covered
    entity the performance of which makes the entity
    a health plan, health care providers, or health
    care clearinghouse. 45 CFR 164.103
  • Hybrid entities performing covered functions
    may have to adhere to relevant portions of the
    Privacy Rule to the extent to which some part of
    the entity conducts these activities.

26
Who Is Not Covered?
  • Life insurances companies
  • Auto insurance companies
  • Workers compensation carriers
  • Employers
  • Others who may still acquire,
  • use, and disclose vast quantities
  • of health data

27
How is PHI Covered?
  • Boundaries - setting limits on uses and
    disclosures
  • Security - imposing security requirements
  • Fair Information Practices - allowing individuals
    some level of access to their health data
  • Accountability - making covered entities
    accountable for handling and abuses

28
How Are Uses/Disclosures Regulated?
  • Use the sharing, employment, application,
    utilization, examination, or analysis of PHI
    within an entity
  • Disclosure the release, transfer, provision of,
    access to, or divulging in any other manner of
    PHI outside the entity holding it.

29
How Are Uses/Disclosures Regulated?
  • Acquisition? Use
  • Disclosure the release, transfer, provision of,
  • access to, or divulging in any other manner of
  • PHI outside the entity holding it.

30
How Are Uses/Disclosures Regulated?
  • Acquisition Disclosure

31
How Are Uses/Disclosures Regulated?
  • CEs may use or disclose PHI without individual
    written authorization to carry out treatment,
    payment, or health care operations (aka. Standard
    transactions).

32
How Are Uses/Disclosures Regulated?
  • Otherwise, uses or disclosures of PHI require
    either individual opportunities to object or
    written authorizations pursuant to the
    anti-disclosure rule.
  • Except as otherwise permitted or required. . .
    , a CE may not use or disclose PHI without an
    authorization . . .
  • 45 CFR 164.508(a)(1)

33
How are Uses/Disclosures Regulated?
  • Some exceptions to the anti-disclosure rule
  • Law Enforcement
  • Judicial and Administrative Proceedings
  • Decedents
  • Health emergencies
  • Limited Commercial Marketing
  • Minors
  • Health Research
  • Public Health

34
What About Other Laws?
  • Federal/State Constitutions
  • Federal/State Statutory Laws
  • Federal/State Administrative Laws Federal/State
    Judicial Law

35
Does the Privacy Rule Supplant These Laws?
  • No
  • The Privacy Rule creates a floor of federal
    protections.
  • Existing federal or state laws that provide
    greater health information privacy protections or
    do not otherwise conflict with the Rule remain in
    effect. Like a patchwork quilt, they lay over
    Privacy Rule protections.

36
What About Violations?
  • Violations or breaches of the Privacy Rule may
    result in
  • Complaints filed with the Secretary of HHS
  • Ensuing investigation by the Secretary
  • Compliance reviews by the Secretary
  • Informal resolution by the Secretary whenever
    possible and
  • Imposition of civil penalties, which can be
    collected through release of federal debts owed
    to the entity.
  • Criminal sanctions against individuals
  • 45 CFR 160.300-.500

37
What About Violations?
  • Beyond formal or informal approaches to
    addressing violations pursuant to the Privacy
    Rule are
  • Judicial uses of the Privacy Rule as a per se
    standard for protecting health information
    privacy
  • Contractual obligations to adhere to the Privacy
    Rule
  • Business Associates
  • Limited Data Sets
  • Institutional, corporate, and organizational
    policies requiring adherence to the Rule

38
Impact of the Privacy Rule on Public Health
  • Externally how does the Rule impact the flow
    of identifiable health data into or out of public
    health agencies?
  • Internally what are ways that the Rule affects
    the practice of public health or public health
    research done by public health agencies or its
    partners?

39
Impact of the Privacy Rule on Public Health
  • Public Health Practice - Externally
  • How does the Privacy Rule affect the flow of
    health data to public health authorities?

40
The Public Health Exception
  • The public health exception to the
    anti-disclosure rule states that a covered
    entity may disclose PHI without specific,
    individual authorization to a public health
    authority that is authorized by law to collect
    and receive such information for the purpose of
    preventing and controlling disease, injury, or
    disability, including . . . reporting of disease
    . . . and the conduct of public health
    surveillance . . . .

41
The Public Health Exception
  • Beyond this general authorization, additional,
    specific public health-based exceptions include
  • Disclosures to maintain the quality, safety, or
    effectiveness of FDA products
  • Disclosures to notify persons exposed to
    communicable diseases
  • Disclosures concerning work-related injuries
  • Disclosures about victims of abuse, neglect, or
    domestic violence
  • Disclosures for health oversight activities
  • Disclosures to prevent serious threats to persons
    or the public

42
Who Is a Public Health Authority?
  • A public health authority is an
  • agency or authority of the United States, a
    State, a territory, a political subdivision of a
    State or territory, or an Indian tribe, or a
    person or entity acting under a grant of
    authority from or contract with such public
    agency . . . that is responsible for public
    health matters as part of its official mandate.

43
Who Is a Public Health Authority?
  • Public health authorities include
  • State or Tribal Health Departments
  • Local Health Departments
  • Contractors/others acting under authority of
    these agencies

44
What About State Public Health Reporting Laws?
  • The Privacy Rule does not pre-empt (or override)
    state law that provides for the reporting of
    disease or injury . . . or for the conduct of
    public health surveillance or investigation . .
    . .

45
Impact of the Privacy Rule on Public Health
  • Public Health Practice - Internally
  • To the extent that public health authorities use
    or disclose identifiable health data for public
    health purposes, they are not covered entities,
    and are thus not required to adhere to the
    provisions of the Privacy Rule.
  • Simply stated, public health authorities doing
    public health things are not covered by the Rule.

46
Internal Impact of the Privacy Rule on Public
Health
  • Public Health Authorities As Providers/Plans
  • A profound area of potential impact concerns the
    activities of public health authorities that
    resemble the provision of health care (e.g.
    direct delivery of health services to
    disadvantaged individuals) or administration of
    health plans (e.g., state well person programs).

47
Internal Impact of the Privacy Rule on Public
Health
  • PH authorities performing health care activities
    or acting as a health plan are engaged in
    covered functions, and accordingly must adhere
    to the Privacy Rule.
  • Most public health authorities at the state and
    local levels declare themselves as hybrid
    entities (or multi-functional organizations with
    covered entity components) pursuant to the Rule.

48
Internal Impact of the Privacy Rule on Public
Health
  • PH Authorities Doing Health Care/Plan Activities
  • As Hybrid Entities
  • The practical effect of hybrid status is that the
  • public health agency designates those
  • components of its practices that are covered, and
  • adheres to the Rule concerning those components.
  • Others within the agency may not have to adhere
  • to the same requirements concerning their duties,
  • although the agency is responsible for their
  • compliance with covered applications.

49
Distinguishing Public Health Practice vs. Research
  • The HIPAA Privacy Rule provides different
    standards for disclosing PHI without
    authorization for public health vs. research
    purposes.

50
Distinguishing Public Health Practice vs. Research
  • Disclosures for research purposes are more
    restrictive
  • IRB or Privacy Board Approval that the use or
    disclosure of PHI involves no more than a minimal
    risk to individual privacy based on
  • an adequate plan to protect the identifiers from
    improper use and disclosure
  • an adequate plan to destroy identifiers asap
  • adequate written assurances that PHI will not be
    reused or disclosed to anyone else except as
    required by law.
  • Preparatory to Research
  • Research on Decedents
  • Limited Data Sets

51
Distinguishing Public Health Practice vs. Research
  • Neither the HIPAA Privacy Rule nor the federal
    Common Rule (regulating the performance or
    funding of human subjects research by most
    federal agencies) clearly distinguishes public
    health practice activities from research
    activities.
  • Several dilemmas arise
  • Public health practice activities that assimilate
    research activities, such as some types of
    surveillance, may be misconstrued
  • Covered entities may deny access to PHI to public
    health authorities on the grounds that the
    requested bases for the data is research, and not
    practice and
  • Public health practice activities may ultimately
    be submitted for IRB approval as if they are
    research.

52
Distinguishing Public Health Practice vs. Research
  • A Report for Public Health Practitioners
    Including Case Studies and Guidance for Making
    Distinctions (2004)
  • Sponsored by the Council of State and
    Territorial Epidemiologists (CSTE), Atlanta, GA

53
Principal Objectives
  • To assess legal and ethical environments
    underlying public health practice and human
    subject research
  • To clarify existing definitions of public health
    practice and research
  • To provide meaningful cases on practice and
    research
  • To make distinctions between public health
    practice and research through foundational and
    enhanced guidance

54
Public Health Practice
  • The collection and analysis of identifiable
    health data by a public health authority for the
    purpose of protecting the health of a particular
    community, where the benefits and risks are
    primarily designed to accrue to the participating
    community.

55
Public Health Research
  • The systematic collection and analysis of
    identifiable health data by a public health
    authority for the purpose of generating knowledge
    that will primarily benefit those beyond the
    participating community who bear the risks of
    participation

56
Guiding Principles
  • Essential Features (e.g. foundations) of Public
    Health Practice and Research
  • Enhanced Guidelines
  • Checklist

57
Essential Features
  • Foundations of Public Health Practice
  • Involves specific legal authorization at the
    federal, state or local levels
  • Includes a corresponding governmental duty to
    perform the activity to protect the publics
    health
  • Involves direct performance or oversight by a
    governmental public health authority (or its
    authorized partner) and accountability to the
    public for its performance

58
Essential Features
  • Foundations of Public Health Practice (cont.)
  • May legitimately involve persons who did not
    specifically volunteer to participate (i.e., they
    did not provide informed consent)
  • Supported by principles of public health ethics
    that focus on populations while respecting
    individual rights and

59
Essential Features
  • Foundations of Human Subjects Research
  • Involves living individuals or identifiable
    information about them
  • Involves identifiable data that are not publicly
    available or for which the individual has not
    already consented to their use for research
    purposes
  • Involves research subjects who voluntarily
    participate (or participate with the consent of
    their guardian), absent a waiver and
  • Supported by principles of bioethics that focus
    on individual interests while balancing the
    communal value of research.

60
Enhanced Guidelines
  • General Legal Authority is there some general
    legal authority for the performance of the
    activity?
  • Relationships/Accountability what is the
    proposed relationship of the actors to those
    participating in the activity? Who is accountable
    for the health and safety of participants?
  • Specific Intent what is the specific intent of
    the actors performing the study?

61
Enhanced Guidelines
  • Specific Intent -
  • The intent of research is to test a hypothesis
    and seek to generalize the findings or acquired
    knowledge beyond the activitys participants.

62
Enhanced Guidelines
  • Specific Intent -
  • The intent of public health practice is to assure
    the conditions in which people can be healthy
    through public health efforts that are primarily
    aimed at preventing known or suspected injuries,
    diseases, or other conditions, or promoting the
    health of a particular community.

63
Enhanced Guidelines
  • Participant Benefits is the activity designed
    to produce some benefit to the participants or
    their population?
  • Interventions is the activity designed to
    introduce some non-standard or experimental
    methods or analyses to participants or their
    identifiable data?
  • Subject Selection are the participants selected
    randomly so that the results of the activity can
    be generalized to a larger population?

64
Checklist
  • Step 1 - Check Key Assumptions
  • Step 2 - Assess the Foundations of Public
    Health Practice
  • Step 3 - Assess the Foundations of Human
    Subject Research
  • Step 4 - Consider Enhanced Guidance
  • Step 5 - Conclusions

65
Distinguishing Public Health Practice vs.
Research Checklist
  • Key Update
  • Presently, the Office for Human Research
    Protections (OHRP) is working internally with
    federal agencies to review the bases for
    distinguishing research and non-research
    activities (including public health practice
    activities). OHRP is expected to release new
    guidance on these issues for public review and
    comment later this year.

66
Conclusions
  • The HIPAA Privacy Rule Presents National Health
    Information Privacy Standards
  • The Rule Creates a Floor for Privacy Protections
  • Existing Legal Protections at the Federal or
    State Level May Remain Effective
  • The Rule Impacts Public Health in Practice,
    Research, and Health Care/Plan Capacities in
    Multiple Ways
  • Distinguishing Public Health Practice and
    Research Is Essential to the Application of the
    Rule.
  • For more information, please contact me at
    jhodge_at_jhsph.edu
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