HEALTH CARE RESEARCH UNDER HIPAA RULES

1. HEALTH CARE RESEARCHUNDER HIPAA RULES New Privacy Rules for Health Care Research

2. What is HIPAA and Why Do We Care? • Health Insurance Portability and Accountability Act • Intent: better access, less fraud, more privacy • HIPAA restricts use and disclosure to some health data (This is why we care!)

3. Core Elements of HIPAA • Portability • Standardization of electronic data • Privacy & Security standards

4. The Privacy Rule • New standards for protecting health information • Need permission to use or disclose protected health information

5. Protected Health Information • IIHI and PHI defined in handouts • Protected Health Information = Health information + identifiers that are transmitted or maintained in any form by a Covered Entity.

6. What is a Covered Entity? • A health plan • A health care clearinghouse • A health care provider who transmits any health information in electronic form

7. HIPAA Privacy Rule Does Not Apply to the Whole World • Applies to covered entities and their business associates • Excludes health data held by non-covered entities

8. HIPAA Changes Research . . . • New rules for disclosing & obtaining health data • Privacy boards are new (in addition to IRBs) • New requirements for authorizations & for waiver of authorization • New rules for tracking release of data • New penalties (fines & jail time)

9. . . . But Some Things Stay the Same • Common Rule(HHS Protection of Human Subjects Regulations - Title 45 CFR Part 46) • California state laws still apply, unless less stringent • Data without personal identifiers not affected

10. State Laws Still Apply Some examples: • California Information Practices Act • Confidentiality of Medical Information Act • Lanterman-Petris-Short Act • Program Specific Laws with Confidentiality ProvisionsNOTE: Most stringent law prevails.

11. Use & Disclosure • Use = Sharing, application, utilization, examination or analysis of data with PHI within an entity that maintains such data • Disclosure = Release, transfer, divulging or providing access of PHI to persons or organizations outside the Covered Entity

12. Uses And Disclosures Exempted from HIPAA • Required by law • Public health activities • Victims of abuse, neglect or domestic violence • Health care oversight • Judicial & administrative proceedings • Law enforcement

13. Minimum Necessary • Use, disclose, or request only the minimum amount of PHI necessary to accomplish the purpose

14. Common Rule & HIPAA • Research involving human subjects and PHI is subject to the HIPAA Privacy Rule and the Common Rule • Higher privacy protection prevails • IRBs still exist

15. Disclosing Health Care Data for Research • Limited data set, or • De-identified data, or • Authorization from person whose health information is needed, or • Waiver of authorization from IRB or Privacy Board

16. Option 1: Limited Data Set • Limited data set for the purposes of research, public health or health care operations • Disclosures may not contain direct identifiers • “Data Use Agreement” must be in place

17. Data Use Agreement The Data Use Agreement Establishes: • Permitted uses and disclosures • Identity of recipient • Limits future disclosure or use for other purposes • Safeguards to protect data • Limits on subcontractors • Cannot re-identify the data or contact individuals

18. Names Postal address Tel & fax number Email address SSN Medical record number Health plan number Certificate/license number Vehicle ID or license Device identifiers Web URLs Internet protocol Biometric ID Full face, comparable image The Limited Data Set Excludes:

19. Limited Data Set Allows • City, state and 5 digit zip code • Dates

20. Option 2: De-identified Data Set • De-identified by statistical expert, or • Specific identifiers are removed from the data

21. Removing Specific Identifiers • Remove direct identifiers • Remove all geographic identifiers smaller than a state, except: Can keep initial 3 digits of zip code when pop >20K But use “Zero” for zip codes for pop <20K • Remove month & day from dates (Year OK) • Remove specific ages for people over 89

22. Allowed in De-identified Data • Gender • Specific age under 90 • Grouping for ages 90+ • Codes for re-identifying the data

23. Option 3: Authorization • Written permission from individual • It must contain specific elements

24. 6 Required Core Elements • A description of the PHI requested • Who is authorized to make the disclosure • Who is requesting the data • The purpose • An expiration date • Signature • (State law requirement: 14 point font)

25. 3 Required Statements • The individual’s right to revoke • Whether treatment is conditioned by authorization • Risk of future re-disclosure

26. Authorization vs. Informed Consent • Authorization focuses on privacy risk • Informed consent focuses on risks and/or benefits of study and confidentiality of records • May get both authorization & consent • HIPAA allows combining consent & authorization but State law does not

27. Re-Disclosure • Privacy Rule does not continue to protect PHI • Other State & federal regulations may apply • An IRB may impose further restrictions

28. Option 4: A Waiver • Get IRB/PB to waive requirement for individual authorization • IRB established in Common Rule • Privacy Board established by HIPAA

29. Criteria for Waiver of Individual Authorization IRB / PB can grant a waiver of individual authorization/alteration if it determines: • Minimal risk to the privacy of individuals • Research not practicable without access to PHI • Research not practicable without waiver/alteration Note: Data Use Agreement can be required even with a waiver

30. Waiver – 5 Required Elements • Name of IRB/PB & date waiver approved • Minimal risk • Description of the PHI • Statement of approval • Signature of IRB/PB chair

31. Other strategies to Access Data with PHI • Research on decedents’ data • Reviews preparatory to research

32. Tracking (Accounting) for Research Disclosures Include: • Disclosures within a 6 year period • Disclosures without authorizations Exclude: • Data disclosed with authorizations • Limited data set disclosures • Disclosures for TPO • Disclosures prior to April 14, 2003

33. Accounting for Multiple Disclosures • Permitted for multiple disclosures of PHI to same person/entity for a single purpose • Must include: • Date of initial disclosure • Name & address of who received the PHI • Brief description of what was disclosed • Purpose of disclosure • Frequency/periodicity of disclosure • Date of most recent disclosure

34. Alternative Multiple Accounting Disclosure of PHI for 50 or more people: • Name of research activity • Plain-language description of protocol, purpose and criteria • Description of PHI disclosed • Date/period of disclosure • Name, address, tel # of recipients • Statement that individual’s PHI may / may not have been disclosed

35. Issues for Health Care Researchers • New liability for Covered Entities • IRBs/PBs workload increase • Privacy Rule permits release of data with PHI • Minimum Necessary requirement • Common Rule Still Applies (including IRB requirements)

36. Burden of Research on Covered Entities • Reviews of research proposal • Review IRB/PB documentation • Assess risk/benefits • Write data use agreement • Minimum necessary review • Maintain record of PHI disclosures

37. Research Begun Prior to April 14, 2003 • Limited grandfather clause • Research allowed to continue if the following was obtained before April 14, 2003: • Express legal permission, • Informed consent, or • IRB-approved waiver

38. Penalties • Civil monetary penalties$100 per violation$25,000 maximumEnforced by HHS/Office of Civil Rights • Criminal penaltiesMaximum of $250,000 fine & 10 years in prisonEnforced by Dept. of Justice

39. and decide whether to disclose the PHI Inquiring Minds Need to Know . . . • Privacy Rulehttp://www.hhs.gov/ocr/hipaa • California Office of HIPAA Implementationhttp://www.ohi.ca.gov/state/calohi/ohiHome.jsp • Federal HIPAA Guidelines for Researchhttp://www.hhs.gov/ocr/hipaa/guidelines/research.pdf • Committee for the Protection of Human Subjects http://www.oshpd.state.ca.us/cphs