Electronic Data Consent and Electronic Privacy Policy Domain Analysis

1. Electronic Data Consent and Electronic Privacy Policy Domain Analysis Ioana Singureanu Eversolve, LLC

2. Overview • Giving privacy protection options is a requirement for the adoption of secure Electronic Health Record systems • SAMHSA is a leader in promoting privacy protection • Long-term experience to inform future direction • HL7 standards enable communication/exchange over the web for • Privacy policy • Consumer preferences • Provider override

3. Consumer-driven Privacy Personal Health Records (including IIHI) Direct Care Research Request (based on consumer’s criteria) Data filtered (based on rules) Override Diagnosis Administrator Maintain Consumer Privacy Consent Directives+Privacy Policy

4. Terms and Concepts • Privacy Policy • A set of rules intended to protect specific aspects of PHR from abuse • Personal Health Records – identified personal health records that include: • PHI- Protected Health Information • IIHI • Privacy Consent Directives • Agreement/disagreement with policies • Directives • Identity (unique identifiers) • Consumer Identity • Used to protect privacy, in place of identifying traits • Information Identity • Object Identifier (OID

5. eConsent Management over time

6. Explicit Privacy Consent or Privacy Policy Enterprise-specific

7. ePolicy-based Privacy (implied consent) Personal Health Records (including IIHI) Direct Care Research Request (based on consumer’s criteria) Data filtered (based on rules) Diagnosis Administrator • The consumer cannot opt-in or opt-out. • Default policies are applied without consumer’s explicit involvement (e.g. HIPAA) Privacy Policy

8. Terms • Implied Consent Directives • Also referred as “deemed” privacy consent directives • Local privacy policies apply by default without explicit consumer sign-off

9. Manage Privacy Policy over time

10. Using Implied Consent for privacy protection

11. ePolicy-based Privacy (consumer signs-off) Personal Health Records (including IIHI) Request (based on criteria) Direct Care Research Data filtered (rules) Diagnosis Administrator The consumer signs-off on the consent policy as available. Agrees Consumer Privacy Policy

12. Consumer sign-off

13. The Role of ePolicy for eConsent Consumer Maintain Use/lookup Privacy Consent Directives National, Local, Organizational Policy

14. Policies and rules - Analysis • National • State • Organization • Consumer adds privacy consent directive • Collect • Access • Use • Disclose

15. 1 2 4 3 Sample Consumer Preferences Web Portal Policy Rule Sets (Venn Diagram) 3 1 1 2 4 2 3 4

16. I disallowrestricted info to be accessed by administrators for any purpose I allowrestricted info to be accessed by direct care providers for treatment

17. Policy and Consent Directives Common Terminology Consent Directives HL7 Standard Runtime Rules Engines Platform-specific Rules Privacy Policies Platform-independent, standard-based, interoperable, harmonized

18. Policy and Consent Directives HL7 Standard eConsent <XML> instance eConsent <XML> instance eConsent <XML> instance eConsent <XML> instance eConsent <XML> instance XACML Policy rules ODRL Policy rules XrML policies  rules ePolicy <XML> instance ePolicy <XML> instance XSDePolicy eConsent (XML Schemas) ePolicy <XML> instance ePolicy <XML> instance ePolicy <XML> instance Runtime Rules Engines Platform-independent,standard-based, interoperable, harmonized

19. Interoperable, standard-based, automated privacy protection National Jurisdiction State/Province/Local Jurisdiction Consumer’s Consent Directives eConsent <XML> instance ePolicy <XML> instance ePolicy <XML> instance

20. ePolicy synchronization • Automatic notification/publication of new privacy rules between jurisdictions State/Province Jurisdiction National Jurisdiction ePolicy <XML> instance

21. Manage Electronic Privacy Policy (ePolicy)

22. Actors (stakeholders) Consenterresponsible for maintaining privacy policies Responsible for maintaining privacy policies A patient is a consumer who receives medical services

23. Evaluation Engine

24. Sensitive = Policy Rule Elements = Constraint Catalog

26. ePolicy used in Personal Health Records • Information references the privacy policy or category type Discharge Summary Like confidentialityCode confidentialityCode RESTRICTED HIV-RELATED

27. eConsent Structure

29. eConsent Override

31. ISO 13606 Part 4: Functional roles Additional coversheets/proposals CompletedProposal Vocabulary proposals NewProposal

32. Terminology - 1 Condition may be redundant re: purpose CBCC WG CBCC WG Security WG CBCC WG CBCC WG CBCC WG CBCC WG CBCC WG

33. Obligation, Condition, and Purpose • Obligation Code • Action that is required to receive the permission specified in the privacy rule • Condition Code • Prerequisite for a permission to collect, access, use, or disclose personal health records (e.g. trusted computing environment). • Purpose Code • It specifies the purpose of a allowing or denying a permission.

34. Terminology – 2 Security WG CBCC WG Security WG Security WG Security WG Security WG Security WG