1. Overview of ONC’s Consumer Preferences Requirements Document A HITSP eTown-Hall Meeting Presenters:Co-Chairs/Facilitators of the Consumer Preferences Tiger Team Mureen Allen, MD|Walter Suarez, MD Johnathan Coleman|Elliot Sloane enabling healthcare interoperability Tuesday October 13, 2009 | 11:00 am – 1:00 pm (Eastern) Co-Sponsored by the HITSP Consumer Preferences Tiger Team and the HITSP Education, Communications and Outreach Committee 0 enabling healthcare interoperability

2. Slide 1 HITSP – enabling healthcare interoperability Outline  Overview, Process, Timeline (5 minutes)  Consumer Preferences Defined; What is in scope; What is out of scope (20 minutes)  Stakeholders; Issues and Policy Implications; Perspectives and Scenarios (20 minutes)  Process Diagrams and Information Exchanges (35 minutes)  Functional Needs and Dataset Considerations (35 minutes)  Concluding Comments (5 minutes) [Slides will be available at the HITSP Webinars site - http://www.hitsp.org/webinars.aspx]

3. Slide 2 HITSP – enabling healthcare interoperability Learning and Discussion Objectives  During this 120-minute eTown-Hall, participants will: — Learn about the Consumer Preferences (CPs) Requirements Document released by ONC for public comment — Discuss specific areas of the document — Provide comments, questions, requests for clarifications and suggestions for improving the document — Focus discussion on information exchange needs and interoperability issues associated with CPs, as presented in the document  Comments, suggestions, clarifications will be brought to the Consumer Preferences Tiger Team (CP-TT) — CP-TT performing a more in-depth analysis an discussion/comment on the document — Consolidated comments will be prepared and finalized this week  Everyone encouraged to send comments to ONC — http://www.hhs.gov/healthit - go to ‘Standards and Certification’ on left panel, then ‘Use Cases and Requirements Documents’ http://www.hhs.gov/healthit

4. Slide 3 HITSP – enabling healthcare interoperability Overview  Consumer preferences and, in particular, privacy preferences has been an important priority topic for ONC — 2006-2007 – Use Cases included some of the core elements of CPs  2006 Consumer Empowerment  2007 Consumer Access to Clinical Information — 2008 – AHIC recommendations on gaps/extensions included CP — February, 2009 – Consumer Preferences Extension — October, 2009 – Consumer Preferences Requirements Document

5. Slide 4 HITSP – enabling healthcare interoperability National Health IT Process  ONC develops a document defining the scope, business processes, information exchanges, stakeholders, and functional requirements related to consumer preferences  HITSP evaluates the requirements, identifies needs for interoperability standards, evaluates and recommends standards to meet interoperability needs, identifies gaps and a roadmap to address the gaps  Recommended harmonized standards are tested and refined  Standards are incorporated into the Nationwide Health Information Network (NHIN), Health Information Exchanges (HIEs) and Electronic Health Record (EHR) certification requirements

6. Slide 5 HITSP – enabling healthcare interoperability Timeline  Draft document issued October 5; comments due October 16  ONC addresses comments (October/November 2009); a final detailed requirements document is expected by December, 2009  HITSP performs its standards harmonization work between October, 2009 and January, 2010, prepares and delivers HITSP products (Interoperability Specifications, Capabilities, Service Collaborations, and Constructs)

7. Slide 6 HITSP – enabling healthcare interoperability Consumer Preferences Defined (2.0) Per ONC document:  For the purposes of this document, the term “consumer preferences” is used to collectively represent several inter-related capabilities including, but not limited to: — The ability for a consumer to define permissions for who is permitted to access information in their EHR and under what circumstances this access is appropriate, — The ability for a consumer to express preferences for how and under what circumstances their health information would or would not be made available by their healthcare providers, — The ability for a consumer to authorize the release of their health information to another provider or third party; and — The ability to establish various types of consumer preferences including but not limited to consents, advance directives and other potential types outlined in the Dataset Considerations section of the document.

8. Slide 7 HITSP – enabling healthcare interoperability Consumer Preferences Defined (2.0) Consumer expressions of choices, desires or directives in two general areas:  Health information privacy (consents or authorizations)  Establishing access restrictions and management parameters on health information  Defining privacy preference “conditionants” including:  By type of information (all data, segmentation of data)  By role and criteria based access, including type of encounter, embargoed records (VIP, legal restrictions)  By time (start, end, duration)  By level of participation (opt-in, opt-out, with or without additional classifications, with or without additional granularity)  By purpose of use  Content, Communication and Representation  Status and/or designation, including advanced directives, DNR orders, healthcare proxies, living wills, medical surrogates, access to family members  Care or associated services needs and communication needs, including appointment reminders, lab results  Comfort needs, including non-medical dietary restrictions, language needs, cultural needs, clergy preferences

9. Slide 8 HITSP – enabling healthcare interoperability What is IN SCOPE? (2.2)  The Consumer Preferences Requirements Document describes a framework for handling the preferences that consumers may need in order to control access to their information and potentially sensitive health information (SHI). The scope of this Requirements Document includes a high level description detailing: — Key actors involved in the expression and creation of consumer preferences, namely the consumers, providers and organizations handling this information, — Descriptions of the expression, transmission and application of consumer preferences, — How consumer preferences are exchanged between electronic systems, — The exchange of health information authorized by a consumer preference, — The potential types of consumer preferences; — The location of a consumer preference’s origin and storage.

10. Slide 9 HITSP – enabling healthcare interoperability What is OUT OF SCOPE? (2.2)  Certain aspects of the handling of consumer preference data are outside of the scope of this document including:  The details surrounding consumer education processes and requirements,  The process for reconciling situations where multiple preferences exist for one consumer/patient  Policies regarding whether or not a consumer preference is expected to be honored or accepted when sent from one entity to another,  The consequences of not following appropriate consumer preference procedures as prescribed by state, local, or entity policy,  The process and requirements for classifying and segmenting demographic and clinical information supporting consumer preferences regarding what they have deemed as sensitive health information and;  The mechanics of consumer auditing and tracking of this information, this area has been addressed in the 2007 Consumer Access to Clinical Information Use Case.

11. Slide 10 HITSP – enabling healthcare interoperability Facilitated Guide to Q&A  Consumer Preferences Defined  Is definition sufficiently clear?  What are the challenges of combining privacy preferences with content/communication/representation preferences?  Are there areas or ‘conditionants’ of the privacy preferences missing?  Are there other areas within the content preferences that need to be considered?  In Scope / Out of Scope  Are there items currently in scope that need to be clarified or that need to be defined as out of scope?  Are there other/additional items that need to be considered in scope?  Are there items currently out of scope that need to be clarified or that need to be reconsidered as in scope?  Are there other/additional items that need to be defined as out of scope, for clarity purposes?

12. Slide 11 HITSP – enabling healthcare interoperability Consumer Preferences Stakeholders (3.0)

13. Slide 12 HITSP – enabling healthcare interoperability Issues and Policy Implications (4.0)  Consumer Participation  A national policy may be needed to address the variations in policies regarding Opt In/Opt Out, classifications, and granularity requirements  Consumer Education  The consumer must be educated on the content of their electronic health record, their rights and the implications of disclosing or not disclosing their medical information  Access Control and Disclosure  Privacy controls as well as the means for restricting data access are not standardized nor entirely supported by policies or regulations  Segmentation of Health Information  There is a lack of a definition of sensitive health information and how that information might be classified  Liability and Accountability  Additional guidance may be needed to reconcile and resolve situations where consumer preferences are in conflict

14. Slide 13 HITSP – enabling healthcare interoperability Perspectives and Scenarios (5.0)  Perspectives/Roles  Consumer: Any recipient or legal proxy of a recipient of healthcare who wishes to create preferences regarding aspects of their care and how their health-related information (HRI) is accessed or shared. `  Primary Receiving Organization: Any organization (provider, information exchange or other information recipient) who receives and may act on or manage a consumer preference and its related health information.  Secondary Receiving Organization: Any organization (provider, information exchange or other information recipient) who receives from another organization and may act on or manage a consumer preference and its related health information.

15. Slide 14 HITSP – enabling healthcare interoperability Perspectives and Scenarios (5.0)  Scenarios The Process Diagram explains business processes surrounding consumer preferences including descriptions of events and actions. The Diagram is broken into two scenarios and 29 events  Scenario 1: Creation of a Preference – The process by which the consumer creates a preference by expressing their preference an organization.  Scenario 2: Preference Management: Application, Exchange and Replacement – The process by which the an organization identifies and/or retrieves, applies, and exchanges a consumer’s preference to another organization.

16. Slide 15 HITSP – enabling healthcare interoperability Facilitated Guide to Q&A  Stakeholders  Are there differences between stakeholders? Stakeholders missing?  Are the roles/relationships of ALL stakeholders clearly described and noted throughout the document?  Issues and Policy Implications  Comments on the issues and policy implications?  Perspectives and Scenarios  Are the Actors/Perspectives/Roles clear and sufficient? Are there any missing actors or perspectives?  Are the two scenarios sufficient? Is the second scenario too complex by including both the management of consumer perspectives the exchange of consumer perspectives?

17. Slide 16 HITSP – enabling healthcare interoperability Process Diagrams (6.0) – Scenario 1

18. Slide 17 HITSP – enabling healthcare interoperability Process Diagrams (6.0) – Scenario 1

19. Slide 18 HITSP – enabling healthcare interoperability Process Diagrams (6.0) – Scenario 2

20. Slide 19 HITSP – enabling healthcare interoperability Process Diagrams (6.0) – Scenario 2

21. Slide 20 HITSP – enabling healthcare interoperability Information Exchanges (7.0)

22. Slide 21 HITSP – enabling healthcare interoperability Information Exchanges (7.0)

23. Slide 22 HITSP – enabling healthcare interoperability Facilitated Guide to Q&A  Process Diagrams  Are there any elements from the process flow in Scenario 1 not clear, incorrectly positioned or missing?  Any comments on the Scenario 1 Events and Actions?  Are there any elements from the process flow in Scenario 2 not clear, incorrectly positioned or missing?  Any comments on the Scenario 2 Events and Actions?  Information Exchanges  Are there any information exchanges that are not clear, incorrectly positioned or missing from the chart?  Is there a need to clarity any of the 11 legends/descriptions of information exchanges? Any additions/missing ones?

24. Slide 23 HITSP – enabling healthcare interoperability Functional Needs (8.0)  Functional Needs describe the combination of end-user needs and system behaviors that support interoperability and information exchanges  Universal Functional Needs  Identity Verification: Consumer, Primary Receiving Organization, Secondary Receiving Organization  Consumer Functional Needs  Express Preference  Amend Preference  Replace Preference  Primary/Secondary Receiving Organizations Functional Needs  Create Preference  Transmit Preference  View Preference  Store Preference  Apply Preference  Amend Preference  Request Exchange  Request Audit  Replace Preference  Transmit Update of Preference  Reconcile Conflicting Preferences  Acknowledge Receipt of Preference (or Update)  Maintain Audit Log of Preferences  Classify Data

25. Slide 24 HITSP – enabling healthcare interoperability Dataset Considerations (9.0)  General Considerations:  Consumers, at the highest level, require the capability to opt in or opt out of the exchange of their health information.  Consumers may also request that only certain classes of information be shared.  These classes of information and preferences could be classified at varying levels of granularity.  Defining the needed levels of granularity is not focus of this Consumer Preferences Requirements Document.  Data Set Considerations, provides a comprehensive (not exhaustive) framework that can be used to support standards development and to accommodate the major types of consumer preferences

26. Slide 25 HITSP – enabling healthcare interoperability Dataset Considerations (9.0)  Examples of Dataset Types (1):  Identity and Preference Verification  Consumer ID Information - addressed in 2006-2009 AHIC Use Cases  Primary/Secondary Organizational ID Information  Consumer Preference Information (identification and audit)

27. Slide 26 HITSP – enabling healthcare interoperability Dataset Considerations (9.0)  Examples of Dataset Types (2):  Data Classification (possible types of consumer preferences/classifications)  Access Restriction & Management  Consent & Disclosure of Information – Sequestering or disclosing PHI and/or sensitive health information (categories may include HIV/AIDS, Mental Health, Substance Abuse, Genetic Information, STDs, etc.)  Role & Criteria Based Access (Organization, Role, Encounter Based Access & Authorization, Embargoed Records, Time Limited Access, etc.)  Content preference – The actual preference surrounding delivering care or associated services  Status and/or designation (advanced directives, DNR, etc)  Care or associated service needs – Communication needs (appointment reminders, lab results, etc)  Comfort Needs or Palliative Care (non-medical dietary restrictions, language needs, cultural needs, etc)

28. Slide 27 HITSP – enabling healthcare interoperability Dataset Considerations (9.0)  Examples of Dataset Types (3):  Components of Access Restrictions/Management and Content Preferences  Level/Status of Participation (opt-in/opt-out, with/without granularity)  Consent Information (by type of requestor, purpose, type of data, etc)

29. Slide 28 HITSP – enabling healthcare interoperability Facilitated Guide to Q&A  Functional Needs  Are there any changes, additions or considerations needed on the Universal Functional Needs?  Are there any changes, additions or considerations needed on the Consumer Functional Needs?  Are there any changes, additions or considerations needed on the Primary/Secondary Receiving Organization Functional Needs?

30. Slide 29 HITSP – enabling healthcare interoperability Facilitated Guide to Q&A  Dataset Considerations  Are there any issues of clarity or scope regarding the general dataset considerations?  Any questions about the Identify and Preferences Verification dataset examples/considerations?  Any questions about the Data Classification – Access Restriction and Management examples/considerations? (i.e., are there other types of data segmentation to consider?)  Any questions about the Data Classification – Content Preferences examples/considerations?  Any questions about the Data Classification – Components of Access Restrictions/Management examples/considerations?

31. Slide 30 HITSP – enabling healthcare interoperability Additional Discussion / Questions