1. University of Miami1 HIPAA Survival Skills An Introduction to HIPAA and Research University of Miami Human Subjects Research Office October 31, 2006 Evelyne Bital, MA Assistant Director Privacy and Regulatory Affairs

2. University of Miami2 What is HIPAA?  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

3. University of Miami3 What is Protected Health Information (PHI)? 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 Records E.g. Medical History, Diagnosis, Treatment  Payment Information E.g. Bills, Receipts  Ancillary Services E.g. X-Rays, Labs  Demographic Information (When Maintained with Health Information) E.g. Date of Birth, Social Security Number

4. University of Miami4 Who Must Comply with HIPAA? Covered Entity – Custodians of PHI They must make a good faith effort to comply with the rule Three types of “ Covered Entities”  Health Care Providers Includes organizations, individuals such as researchers when they provide health care, e.g. clinical trials  Health Care Plans Insurers and payors  Health Care Clearinghouses Billing services

5. University of Miami5 How is UM Approaching HIPAA?  Hybrid Entity  The University is not a covered entity. It is a hybrid entity with covered and non-covered components.

6. University of Miami6 UM – Hybrid Entity Covered Component s Treatment Payment Health Care Operations Non- Covered Components Research

7. University of Miami7 When are Researchers Covered? When providing health care to individuals, researchers are considered health care providers When accessing existing protected health information, HIPAA privacy rules applies

8. University of Miami8 What are Covered Entities Required To Do? 1. Keep records of certain disclosures 2. Provide only minimally necessary information, including: a. Use pursuant to waiver b. Use preparatory to research c. Use of decedents’ PHI d. Use of limited data sets 3. Provide an accounting of certain disclosures, including: a. Use pursuant to waiver b. Use preparatory to research c. 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.

9. University of Miami9 How does HIPAA Impact Research?  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

10. University of Miami10 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:

11. University of Miami11 What is De-Identified PHI? Information that does not identify the individual; and there is no reasonable basis to believe the information can be used to identify an individual.

12. University of Miami12  Removal of 18 Specified Identifiers:  Name  All Geographic Subdivisions Smaller Than a State (Street, City, County, Precinct, Parish, Zip Code, & their Equivalent Geo-codes Except for Initial 3 Digits of a Zip Code)  All Elements of Dates, Except Year (Admission Date, Discharge Date, Date of Death)  All Ages Over 89 & Dates and Elements Related to such Ages (Unless Aggregated into a Single Category of Age over 90) How do you De-Identify PHI?

13. University of Miami13 How do you De-Identify PHI ?  Telephone & Fax Number  E-mail, IP, Address, & URL  Social Security #, Medical Record #, Health Plan Beneficiary #, & Account #  Certificate License #, VIN, Device Identifiers, & Serial #  Full Face Photographs, Biometric Identifiers  Any Other Unique Identifying Number, Characteristic, or Code

14. University of Miami14 What is HIPAA Authorization (Form B) ?  Each study participant permits Use & Disclosure of their PHI for research purposes  Must contain Privacy Notice provisions

15. University of Miami15 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)

16. University of Miami16 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

17. University of Miami17 What is a Waiver of Authorization?  The IRB waives the authorization requirement  PI must justify the request for the waiver Note: Most applicable when authorization is impracticable E.g. Retrospective Medical Research, Identifiable Database Research

18. University of Miami18 What are the Criteria to Waive Authorization? 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

19. University of Miami19 Reviews Preparatory to Research (Form E) Preparatory work is PHI reviewed for the purpose of designing a research study or identifying potential subjects. - PI must complete a protocol application and a Certification Preparatory to Research (Form E) and/or (Form F) where form E representations were not satisfied. E.g: PI wishes to have some direct identifiers (phone #) to contact subjects.

20. University of Miami20 Reviews Preparatory to Research Certification requires investigator to represent that: 1.The use or disclosure is sought solely to review PHI as necessary to prepare a research protocol 2.No UM PHI is to be removed from the covered entity by the researcher in the course of the review 3.The PHI for which use or access is sought is necessary for research purposes; and 4.The researcher will only record de-identified information Clinicians wanting to review their own patient records for research purposes must follow this policy.

21. University of Miami21 Research with Decedents (Form D) 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.

22. University of Miami22 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

23. University of Miami23 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

24. University of Miami24 What is a 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

25. University of Miami25 Data Use Agreement (Form C) REQUIRED for Limited Data Set 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.

26. University of Miami26  At UM, investigators will serve dual roles: BAs of the covered 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)

27. University of Miami27 Business Associate Agreement  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.

28. University of Miami28 HIPAA Disclosures 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.

29. University of Miami29 Accounting for Research Disclosures (cont’d) 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.

30. University of Miami30 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 NOT Required Accounting for Disclosures (Form G):

31. University of Miami31 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 for each patient participating in the study.

32. University of Miami32 Transition Provisions 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

33. University of Miami33 Responsibilities of The Principal Investigator Document research team has completed HIPAA Privacy/Security Training and HIPAA Training for Researchers Submit project application to the IRB Assume responsibility for compliance with HIPAA Maintain logs of all access to, uses of, & disclosures of PHI Submit Data Use Agreements to the IRB

34. University of Miami34 Institutional Review Board for the Protection of Human Subjects 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

35. University of Miami35 Sources of Information in Presentation Federal Regulations for HIPAA 45 CFR 160 and 45 CFR 164 University of Miami HIPAA Policies and Procedures http://www.hhs.gov/ocr/hipaa/ http://www.hipaadvisory.com/ http://www.hipaadvisory.com/regs/

36. University of Miami36 Who do I contact about HIPAA Questions for Research? HIPAA Privacy Liaison for research is: Evelyne Bital (305)243-3195 e-mail: ebital@med.miami.edu ebital@med.miami.edu For general HIPAA information or to access standard HIPAA forms for research: hsro.med.miami.edu

37. University of Miami37 Questions?