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The HIPAA Privacy Rule: Safeguarding Health Information in

Research and Public Health Practice

Centers for Disease Control and Prevention

Beverly A. Peeples, J.D.

December 13, 2005

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Brief Overview of HIPAA

What is the Privacy Rule?

Who is covered by the Privacy

Rule?

What information is protected?

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What is the Privacy Rule?• Establishes a set of national

standards

• Promulgated by the US DHHS

• Addresses use and disclosure of individual’s health information

• Addresses standards and protection of individual’s privacy rights

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Major Goals of Privacy Rule

•Assures that individual’s health information is properly protected

•Strives to maintain balance

•Designed to be flexible and comprehensive

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Who is Covered by the Privacy Rule?

•Covered Healthcare Providers

Known as Covered Entities (CE)

•Health Plans

•Healthcare Clearinghouses

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What is a Covered Entity?

Health Care Provider

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Conducts electronic transactions

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What is a HIPAA transaction?

•health care claims

• health care payment

•coordination of benefits

•health care claim status

•enrollment and disenrollment in a health plan

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What is a HIPAA transaction?

•eligibility for a health plan

•health plan premium payments

• referral certification and authorization

•first report of injury

•health care claims attachments

•other transactions that the Secretary may prescribe by regulation.

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Protected Health Information (PHI)

Individual’s past, present or future physical or mental health

Provision of healthcare Past, present or future payment

for provision of healthcare Does not include FERPA records

What Information is Protected?

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Limits on Use of Individually Identifiable Health Information

-Privacy Rule sets limits

-Does not restrict ability of health care providers … to share information to treat patients

-May not be used for purposes unrelated to health care

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Limits on Use of Individually Identifiable Health Information

•Specific authorizations required before a CE can release information to a:

−life insurer

−bank

−marketing firm or

−school

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Limits on Use of Individually Identifiable Health Information

•Permits health care providers and other CEs to share information about:−treatment options

−disease-management programs

When they have a treatment relationship with the individual

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Limits on Use of Individually Identifiable Health Information

•A person or entity conducting certain functions on behalf of a CE --business associate

•CE may disclose PHI to a business associate

•CE must obtain satisfactory assurances to safeguard the information

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Limits on Use of Individually Identifiable Health Information

•Privacy standards do not affect state laws

•Privacy Rule sets a national “floor” of privacy standards

•State law providing additional protections would continue to apply

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What is the “Minimum Necessary” Standard?

- CE must make reasonable efforts to disclose only the minimum amount of PHI

- CEs may “reasonably” rely on public health authorities’ representation

- Applies to disclosures to a public health agency

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Exceptions to the “Minimum Necessary” Requirements

Minimum Necessary Standard does not apply if disclosures are: Required by lawAuthorized by individual Requested by health care

provider for treatment purposes

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Exceptions to the “Minimum Necessary” Requirements

•Disclosures to the individual

•Disclosures to HHS

•When required for compliance with other HIPAA rules −e.g. to fill out required or

situationally required data fields in standard transactions

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Uses and Disclosures of PHI

•A covered entity may not use or disclose PHI except either

−as the Privacy Rule permits or requires; or

−as the individuals …or their …representatives authorize in writing

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Permitted Uses and Disclosures without Authorizations

•To the individual

•For treatment, payment, and healthcare operations

•Opportunity to agree or object

•As incident

•Public interest and benefit activities

•Limited Data Set

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Permitted Uses and Disclosures without Authorizations

•A limited data set is PHI from which certain specified direct identifiers or individuals and their relatives, household members, and employers have been removed.

•May contain more identifiers than deidentified data stripped of the 18 identifiers-still PHI

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Written Authorizations

•Must be written in specific terms

•Must be in plain language

•Contain specific information

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Written Authorizations

•Allows use and disclosure of PHI by the covered entity or a 3rd party

•Examples of disclosures: to a life insurer to an employer To a school employee who is not a heath care provider

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Public Health Authority• Public Health Authorities are not

subject to the Privacy Rule

−When they are conducting public health activities as defined in the Rule:

−Even when they are covered entities acting in the capacity of a public health authority Funded by a federal (CDC) or state public health authority

With a grant of authority to conduct a public health activity

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Examples of PHAs

•Federal public health agencies Include:−CDC; NIH; SAMSHA; FDA; OSHA; and

tribal health agencies

•State public health agencies include:−public health departments or

divisions, state cancer registries; and vital statistics departments

•Local public health agencies include:−similar departments

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Public Health Authorities

Hybrid entities

•A hybrid entity is a single legal entity that is a CE, performs business activities that include both covered and noncovered functions, and designates its health care components as provided in the Privacy Rule.

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Public Heath Authorities that are CE’s or Hybrid Entities

•A university or school that includes an academic medical center’s hospital is a CE

• It may choose to be a hybrid entity via designating the hospital as its health care component

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Hybrid Entities

•A school clinic if it conducts electronic transactions−Bills for services

−Files insurance reimbursement claims

−Provides health care to students Physical or mental health services

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Highlights of the Privacy Rule

- Contains standards to protect privacy of individuals identifiable health information

- Sets minimum standards for how PHI may be used and disclosed; and

- Individuals can have control of their health information

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Highlights of the Privacy Rule

−Describes methods to de-identify health information

−Provides alternatives to obtaining an Authorization e.g. limited data sets

−Important steps toward understanding: how and why the Privacy Rule protects

How CEs implement the Rule’s standards

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Contact Information

Beverly A. Peeples, JDPrivacy Rule Coordinator

Office of Chief Science OfficerOffice of Scientific Regulatory

ServicesHealth Information Privacy

Officebpeeples@cdc.govPH: 404-371-5977