HIPAA SURVIVAL SKILLS: An

Update

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Marisabel Davalos, M.S.Ed., CIPAssociate Director of Educational Initiatives

November, 2008

Responsible for review, approval and monitoring of human subject research conducted by UM faculty, staff and students

Includes ensuring compliance with University of Miami HIPAA policies

Plan must contain elements required under HIPAA

Documentation of compliance with Covered

Entity source of PHI University of Miami

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Health Insurance Portability and Accountability Act (HIPAA)

Effective on April 14, 2003

Federal law that protects the privacy of individually identifiable health information (PHI)

Title 45 of the Code of Federal Regulations Parts 160 and 164

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Covered Entity – Custodians of PHI

They must make a good faith effort to comply with the rule

Three types of “ Covered Entities”

Health Care ProvidersIncludes organizations, individuals such as researchers when they provide health care, e.g. clinical trials

Health Care Plans Insurers and payors

Health Care ClearinghousesBilling services

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Hybrid Covered Entity

The University is not a covered entity. It is a hybrid entity with certain health care components covered by HIPAA and research components that may not be covered by HIPAA and that fall outside the “covered entity”.

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UM – Hybrid Entity

Covered Components

Treatment

Payment

Health Care Operations

Non-Covered

Components

Research

Investigators who do not access or create health information from/with the “covered entity” because they are acting solely as researchers and not health care providers are not considered part of the UM/JHS “covered entity” and are not subject to HIPAA regulations.

Necessary compliance with State privacy laws and Institutional and IRB policies only.

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Obtained and access to PHI from a “covered entity” – those who create, use, or access health information while providing health care services to research subjects - must comply with HIPAA regulations as well as state privacy, institutional and IRB policies.

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Clinical trials

Chart reviews

Epidemiological studies

Behavioral and Social Science Studies

Some basic science research activities

Studies may include the provision of treatment but others may provide neither treatment or diagnosis. University of Miami

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Section 24.2 of the HSRO Policies & Procedures contains some important terms related to HIPAA:

P

HI – protected health information derived from the past, present, future physical or mental health care of an individual managed by a covered entity

RHI – Research-related health information, personally identifiable information distinct from PHI by not being associated with or derived from health care or payment for care.

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Protected Health Information (PHI) is any individually

identifiable information that is transmitted or maintained

in electronic medium, or in any other form or medium

Medical RecordsE.g. Medical History, Diagnosis, Treatment

Payment InformationE.g. Bills, Receipts

Ancillary ServicesE.g. X-Rays, Labs

Demographic Information (When Maintained with Health Information)E.g. Date of Birth, Social Security Number

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When providing health care to individuals, researchers are considered health care providers

When accessing existing protected health information, HIPAA privacy rules applies

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1. Keep records of certain disclosures

2. Provide only minimally necessary information, including:

a. Use pursuant to waiverb. Use preparatory to researchc. Use of decedents’ PHI

d. Use of limited data sets

3. Provide an accounting of certain disclosures, including:

a. Use pursuant to waiverb. Use preparatory to researchc. Use of decedents’ PHI

Note: This requires significant resources, e.g. time and labor, as well as strong internal controls on the part of the covered entity.

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Investigators will need to go through the covered entity’s “HIPAA-Hoops” to obtain data

UM IRB will need to consider research subjects’ privacy rights

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How Can PHI be Obtained for Research?

Authorization (Form B)

Limited Data Set / Data Use Agreement (Form C)

Waiver of Authorization (Form F)

Certification for Review Preparatory to Research (Form E)

Decedent Certification (Form D)

De-Identification

To Access PHI for Research:

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Each study participant permits Use & Disclosure of their PHI for research purposes

Must contain Privacy Notice provisions

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Authorization Core Elements:

Specific and meaningful description of information to be used or disclosed

Identification of the person or class of person releasing the information

Description of the investigator or class of persons receiving the information

Description of each purpose of the requested use or disclosure

Expiration date or event Signature and date

Authorization (Form B)

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Confidentiality

Other Authorization Contents:

Individual right to revoke authorization Covered entities are not permitted to condition

treatment on the provision of authorization Must explain potential for information to be re-

disclosed by the recipient and that the recipient may not be required to comply with the Privacy Rule

Must be written in plain language Copies must be provided to individual permitting

the use and disclosure of PHI

The IRB waives the authorization requirement

PI must justify the request for the waiver

Note: Most applicable when obtaining authorization is impracticableE.g. Retrospective Medical Research, Identifiable Database Research

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In order to obtain the waiver, researchers must

justify the following criteria:

The use or disclosure of PHI involves no more than a minimal risk to the privacy of individuals

Describe plan to protect identifiers e.g. Who has access to PHI?

Describe plan to destroy identifiers or return identifying information to the covered entity

Provide assurance that PHI will not be re-used or disclosed to others

The research could not practicably be conducted without the waiver or alteration to the authorization; and

The research could not practicably be conducted without access to and use of the PHI

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Decedent PHI is health information collected from deceased (prior to the study) subject’s records.

Investigator’s Certification for Research with Decedents (Form D) must be submitted.

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HIPAA requires that use and disclosure of, and requests for, protected health information (PHI) must be limited to the “minimum necessary to accomplish the intended purpose.”

Example: Only the information pertaining to a specific use should be given to researcher.

Minimum Necessary Requirement

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The requirements for de-identifying information are so extensive that often the data is of limited value to researchers.

The Privacy Rule permits the use and disclosure of PHI via a “limited data set” with a “data use agreement”.

Limited Data Set

Limited set of identifiers to be used for research, public health, and health care operations purposes

Permits use of some identifiable health information:

Five-Digit Zip Codes City, State Dates of Birth Age Expressed in Years, Months, Days or Hours Dates of Death Dates of Admission/Discharge/Service

Excludes direct identifiers

Recipient enters into a “data use agreement” with covered entity in a form mandated by HIPAA (Form C)

Recipient enters into a “Business Associate Agreement” with covered entity

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1. Defines who can use or receive data;

2. Defines for what purpose the data may be used;

3. Provides that PI will not re-identify the data or

contact the subject;

4. Provides that data will be safeguarded & not used

for unauthorized purposes;

5. Provides that researcher will report improper uses

& disclosures;

6. Provides that researcher will “push down” privacy

protection obligations to subcontractors.

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At UM, investigators will serve dual roles: BAs of thecovered entity in order to access the PHI to create the limited data set; and investigator/recipient of the LDS.

Prior to disclosing PHI to the business associate, UM is required to enter into a written agreement with the BA that imposes specified safeguards on the PHI used or disclosed by the BA.

HIPAA Business Associate (BA)

Form mandated by HHS, in which the recipients satisfactorily assures the covered entity (UM/JHS) that they will protect the information from further disclosure.

Before data is released, there needs to be specific descriptions of the methods the recipient will use to assure that the privacy of the information is protected. This is to be documented in a data use agreement or business associate agreement, depending on the situation.

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Physicians in the clinical setting may disclose identifying patient information to a researcher who wishes to recruit the patient for a study provided…

The physician first obtains the patient’s signed authorization to disclose the information to the researcher so the patient can be contacted.

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Jackson Health System (JHS)

Physicians who identify patients eligible for a research study must use the JHS form to obtain the patient’s authorization to release information to the researcher Form Available on HSRO Website, “JMH

Research Authorization”U

M A research referral authorization form is still

being devised.

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HIPAA regulations grant individuals the right to receive an accounting of disclosures of their PHI made by a covered component for the six years prior to the request or since the applicable compliance date.

Records must include specific information regarding each disclosure.

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WAIVERS

The Privacy Rule allows a simplified accounting by Covered Entities for disclosures of PHI for research purposes without an individual’s authorization.

Under simplified accounting provisions, covered entities may provide individuals with a list of all protocols for which PHI has been disclosed, as well as the researcher’s name and contact information.

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General Rules For Use and Disclosure of PHI for Research:

Disclosures made pursuant to an IRB waiver of authorization

Authorized disclosures (Authorization)

Disclosures made pursuant to certifications

PHI furnished in limited data sets

Accounting Required

Accounting NOTRequired

Accounting for Disclosures (Attachment 45):

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General Rules For Use and Disclosure of PHI for Research:

Disclosures made pursuant to an IRB waiver of authorization

Disclosures made pursuant to certifications

Accounting Required

UM must complete an accounting for disclosures form (G) and submit form to privacy office and disclose PHI to research staff.

Disclosure forms must be completed by the PI for each patient participating in the study.

Covered Entities may use and disclose PHI that was received or created for research before the compliance date (April 14, 2003) if they obtained one or more of the following prior to the compliance date:

An authorization or other express legal permission from an individual to use or disclose PHI for research purposes

The informed consent of the individual to participate in research

A waiver of informed consent granted by the IRB

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HSRO has “Written Policies and Procedures for the Protection of Human Research Subjects”.

Section, 24 specific to Privacy, Security, Confidentiality, and HIPAA were revised on August 6th, 2008.

Policies are available on our website under, “Investigator Resources”.

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Evelyne Bital, MS, CIP

Associate Director of Privacy & Regulatory Affairs, (305) 243-3195

e-mail: ebital@med.miami.edu

For general HIPAA information or to access standard HIPAA forms for research:

hsro.med.miami.edu

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Federal Regulations for HIPAA 45 CFR 160 and 45 CFR 164

University of Miami HIPAA Policies and Procedures

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http://www.hhs.gov/ocr/hipaa/

http://www.hipaadvisory.com/

http://www.hipaadvisory.com/regs/

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