1. Consumer Workgroup Interoperability Roadmap Comments Workgroup Discussion March 11, 2015 Christine Bechtel, chair

2. AGENDA I. Call to Order/Roll Call Michelle Consolazio, Office of the National Coordinator Meeting Objective: Review Interoperability Roadmap II. Review of Agenda Christine Bechtel, Chair III. Consumer Role in Interoperability Workgroup Discussion IV. Review Comments on Interoperability Roadmap – Section C - Workgroup Discussion V. Next Steps – Review Section D Next Meeting: Tuesday, March 24, 2015; 9:30 – 11:00 a.m. 2

3. HITPC – Interoperability Road Map Consumer Workgroup - Charge WorkgroupConsumer General Questions (as they apply to the assigned Roadmap sections) Are the actions proposed in the draft interoperability Roadmap the right actions to improve interoperability nationwide in the near term while working toward a learning health system in the long term? What, if any, gaps need to be addressed? Is the timing of specific actions appropriate? Are the right actors/stakeholders associated with critical actions? Roadmap Sections C. Individuals are empowered to be active managers of their health D. Care providers partner with individuals to deliver high value care 3

4. Definition of Interoperability For purposes of this Roadmap, interoperability is defined as the ability of a system to exchange electronic health information with and use electronic health information from other systems without special effort on the part of the user.* In simple terms, this means all individuals, their families and their health care providers have appropriate access to electronic health information that facilitates informed decision-making, supports coordinated health management, allows individuals and caregivers to be active partners and participants in their health and care and improves the overall health of the nation’s population. * Derived from the Institute of Electrical and Electronics Engineers (IEEE) definition of interoperability. 4

5. Principle-based Interoperability 5

6. Member Comments Report needs to be more specific and provide: – A realistic vision of what interoperability will/should look like in 2024. If truly patient-centric model, the patient will be the dominant curator of health information – A succinct explanation of the current and future barriers to interoperability – Why is the long term goal an LHS rather than a fully interoperable system? 6

7. Global Comments on Language Delete “others”: replace with “authorized family members and other authorized caregivers.” Replace “care team” with :“Services and supports team” 7

8. Section C: Individuals are Empowered, Active Partners in Their Health and Health Care Review and Discussion Section C: Individuals are Empowered, Active Partners in Their Health and Health Care 8

9. Category 1.Are the actions the right actions to improve interoperability nationwide in the near term while working toward a learning health system in the long term? 2. What, if any, gaps need to be addressed? 3. Is the timing of specific actions appropriate? 4. Are the right actors/stakeholders associated with critical actions? 2021-2024 Achieve nationwide LHS C1. Cultural change for individuals including demanding and using their electronic health information 1. Call to action: A majority of individuals and their caregivers should demand access to their electronic health information in a format they can use to manage their health or that of others. 2. Call to action: An increasing proportion of individuals and caregivers should demand and ask for access to their electronic health information in a format they can use to manage their health or that of others. 3. Call to action: Individuals should contribute clinically relevant patient- generated health data and request corrections to their electronic health information to effectively manage their interactions with the care delivery system and to manage their health and wellness where they live, work and play 4. Call to action: Individuals and their extended care teams (including family and caregivers) should utilize care planning to capture individual goals and preferences as part of longitudinal health information used across care settings. 5. Call to action: Individuals should regularly access and contribute to their health information in health IT, send and receive electronic health information through a variety of emerging technologies and use the information to manage and participate in shared decision making with their care team. 9

10. 1.Are the actions the right actions to improve interoperability nationwide in the near term while working toward a learning health system in the long term? 2. What, if any, gaps need to be addressed? 3. Is the timing of specific actions appropriate? 4. Are the right actors/stakeholders associated with critical actions? 2015-2017 Send, receive, find and use a common clinical data set Comments 1.Call to action: A majority of individuals and their caregivers should demand access to their electronic health information in a format they can use to manage their health or that of others. Replace: “Demand” with “Will” …Discuss…. New call to action: Institutional purchasers and vendors should include individuals and caregivers in the co-creation of digital health information tools that can securely exchange health information. ONC should instead focus on facilitating and enhancing individuals’ ACTIVE USE of online access, VDT, BlueButton, and other methods of health info access Consumer education, understanding their rights and delivered in language and file format of their choice. 2018-2020 Expand interoperable health IT and users Comments 2. Call to action: An increasing proportion of individuals and caregivers should demand and ask for access to their electronic health information in a format they can use to manage their health or that of others. Information should be useful and delivered in language of choice 10

11. 1.Are the actions the right actions to improve interoperability nationwide in the near term while working toward a learning health system in the long term? 2. What, if any, gaps need to be addressed? 3. Is the timing of specific actions appropriate? 4. Are the right actors/stakeholders associated with critical actions? 2018-2020 Expand interoperable health IT and users Comments 3. Call to action: Individuals should contribute clinically relevant patient- generated health data and request corrections to their electronic health information to effectively manage their interactions with the care delivery system and to manage their health and wellness where they live, work and play Request corrections: this is already possible – issue is how to implement with technology Rephrase: “Individuals and their family caregivers are contributing clinically relevant patient- generated health data and requesting corrections....”. 11

12. 1.Are the actions the right actions to improve interoperability nationwide in the near term while working toward a learning health system in the long term? 2. What, if any, gaps need to be addressed? 3. Is the timing of specific actions appropriate? 4. Are the right actors/stakeholders associated with critical actions? 2018-2020 Expand interoperable health IT and users Comments 4. Call to action: Individuals and their extended care teams (including family and caregivers) should utilize care planning to capture individual goals and preferences as part of longitudinal health information used across care settings. Strongly support; This goal aligns with consumers’ vision for next generation care planning in an electronic environment – needs to happen sooner! Q: Are portals being built with this functionality or is the call to action to vendors & developers to add this functionality? Care team -include patients, their families/designee and non traditional care givers; care team roster harmonized and standardized in the care plan The disability field is uncomfortable with the phrase “care” planning; we use “integrated person-centered planning;” we use “services and supports” rather than “care” The concept of care planning also needs to be added to the education section (C4) Patient goals, preferences, values and direction (advance directives, specific instruction related to religious beliefs) should be included :Patient taxonomy 2021-2024 Achieve nationwide LHS Comments 5. Call to action: Individuals should regularly access and contribute to their health information in health IT, send and receive electronic health information through a variety of emerging technologies and use the information to manage and participate in shared decision making with their care team. Person centered & care planning – should work seamlessly together and must include social determinants of health 12

13. 1.Are the actions the right actions to improve interoperability nationwide in the near term while working toward a learning health system in the long term? 2.What, if any, gaps need to be addressed? 3.Is the timing of specific actions appropriate? 4.Are the right actors/stakeholders associated with critical actions? Category 2015-2017 Send, receive, find and use a common clinical data set C2. Providers and technology developers supporting individual empowerment 1. ONC, government and the industry will identify best practices for the incorporation of patient- generated health data in health care delivery. 2. Call to action: Providers should encourage their patients to access their health information online and will enable patients to view, download and transmit that information to a destination of the patient’s choice. 3. Call to action: Providers and technology developers should provide a majority of individuals with the ability to send and receive their health information and make decisions with the providers of their choice, including but not limited to their existing care team based on their preferences. 4. ONC will work with the technology community to increase the use of Blue Button through implementation of a portfolio of standards to support consistency in the way that individuals receive information. 5. ONC and government ensure that patients understand their ability to access, send and receive health information. 13

14. Member Comments A Common Clinical Data Set  Patient name  Sex  Date of birth  Race  Ethnicity  Preferred language  Smoking status  Problems  Medications  Medication allergies  Laboratory test(s)  Laboratory value(s)/result(s)  Vital signs  Care plan field(s), including goals and instructions  Procedures  Care team members  Immunizations  Unique device identifier(s) for a patient’s implantable device(s)  Notes/narrative Potential Data Gaps  Goals for Care  Direction o Advance directives o Values base direction  Care giver/support team  HHS/IOM Standards for Race/Ethnicity, Language  Social Determinants of Health?  include – “community living and related social factors, identified by the individual, influencing one’s health and wellness  WG should discuss above additions in context of timeline 14

15. 1.Are the actions the right actions to improve interoperability nationwide in the near term while working toward a learning health system in the long term? 2.What, if any, gaps need to be addressed? 3.Is the timing of specific actions appropriate? 4.Are the right actors/stakeholders associated with critical actions? Category 2018-2020 Expand interoperable health IT and users 2021-2024 Achieve a nationwide LHS C2. Providers and technology developers supporting individual empowerment 6. Call to action: Providers and technology developers should support the incorporation of patient-generated health data in health care delivery, which may include advance directives, remote monitoring, glucose levels and other data individuals are tracking 7. Call to action: Technology developers should deploy innovative aggregation platforms and tools that allow individuals and caregivers to receive and compile health information from multiple sources in one place, send their data to a destination of their choice and find and use the information they need (as determined by the individual), to support for example, the individual participating in shared decision-making with their care team. 8. Call to action: Providers should welcome and use information from other providers to avoid duplication of tests and ensure coordinated care. 9. Call to action: Providers and health IT developers should provide a majority of individuals/caregivers the ability to contribute as needed to their electronic health information and support the incorporation of patient-generated health data. 15

16. 1.Are the actions the right actions to improve interoperability nationwide in the near term while working toward a learning health system in the long term? 2. What, if any, gaps need to be addressed? 3. Is the timing of specific actions appropriate? 4. Are the right actors/stakeholders associated with critical actions? 2015-2017 Send, receive, find and use a common clinical data set Comments 1.ONC, government and the industry will identify best practices for the incorporation of patient- generated health data in health care delivery. Significant work has been done to identify the value, challenges, and approaches to implementing patient generated health data. We should be moving beyond ‘establishing best practices’ in the next three years to something more robust and concrete. Timeline needs to be addressed overall in this area. 2.Call to action: Providers should encourage their patients to access their health information online and will enable patients to view, download and transmit that information to a destination of the patient’s choice. New call to action: Providers should identify and remove barriers so that patients can view, download and transmit their information to a destination of the patient’s choice. ”Set and Forget” patients register the destination app of their choice so that all changes occurring (TOC) automatically sent to the app of their choice (Bluebutton Plus) Providers also need to participate in the education process so that consumers are comfortable using these tools and accessing their health information. 3. Call to action: Providers and technology developers should provide a majority of individuals with the ability to send and receive their health information and make decisions with the providers of their choice, including but not limited to their existing care team based on their preferences. Technology developers should be creating open tools that allow the consumer to easily send and receive their health information. With the input of consumers! 16

17. 1.Are the actions the right actions to improve interoperability nationwide in the near term while working toward a learning health system in the long term? 2. What, if any, gaps need to be addressed? 3. Is the timing of specific actions appropriate? 4. Are the right actors/stakeholders associated with critical actions? 2015-2017 Send, receive, find and use a common clinical data set Comments 4. ONC will work with the technology community to increase the use of Blue Button through implementation of a portfolio of standards to support consistency in the way that individuals receive information. Revise statement: :ONC will work with the technology community to implement a portfolio of standards to support consistency in the way that individuals receive information. “ Patient specific education materials tied to VDT; ”Set and Forget” patients register the destination app of their choice so that all changes occurring (TOC) automatically sent to the app of their choice (BlueButton Plus) 5. ONC and government ensure that patients understand their ability to access, send and receive health information. Revise statement: ONC and government will ensure that patients know about and understand their ability to access, send and receive health information. It’s not just the ABILITY to access, send, and receive health information, but WHY patients/family caregivers need to do this that is even more important. Possible role for consumers, families, and advocates? This should include tool kits for providers, health literacy standards, digital literacy initiative and top five languages nationally. 2018-2020 Expand interoperable health IT and users Comments 6. Call to action: Providers and technology developers should support the incorporation of patient- generated health data in health care delivery, which may include advance directives, remote monitoring, glucose levels and other data individuals are tracking Agree and support but 1) PGHD construct is evolving beyond just data generated by patients, and 2) essential in this time frame to have created ways that providers can easily receive, upload, understand and act upon patient-sourced data in usable, safe ways. Patient taxonomy Care team roster Common care data set Secure email and transparent directories Links to data repositories e.g. My Directives CIT advocate o CIT/HIT interoperable standards 17

18. 1.Are the actions the right actions to improve interoperability nationwide in the near term while working toward a learning health system in the long term? 2. What, if any, gaps need to be addressed? 3. Is the timing of specific actions appropriate? 4. Are the right actors/stakeholders associated with critical actions? 2018-2020 Expand interoperable health IT and users Comments 7. Call to action: Technology developers should deploy innovative aggregation platforms and tools that allow individuals and caregivers to receive and compile health information from multiple sources in one place, send their data to a destination of their choice and find and use the information they need (as determined by the individual), to support for example, the individual participating in shared decision- making with their care team. This needs to happen sooner if consumers are going to utilize Blue Button. -Support as a way to combat portal proliferation, portal fatigue ”Set and Forget” patients register the destination app of their choice so that all changes occurring (TOC) automatically sent to the app of their choice (Bluebutton Plus) Patient power broker o Education o Consents o (no HIPAA lite) 8. Call to action: Providers should welcome and use information from other providers to avoid duplication of tests and ensure coordinated care. Provenance; “tamper proof seal” ; Equal level of assurance for all stakeholders to include transparent directories for public level secure email exchange This needs to happen sooner. There is no reason this should not be happening today!! 2021-2024 Achieve a nationwide LHS Comments 9. Call to action: Providers and health IT developers should provide a majority of individuals/caregivers the ability to contribute as needed to their electronic health information and support the incorporation of patient- generated health data. This reads as an overarching set of issues, perhaps even a goal, rather than a specific call to action. Isn’t aggregation one outcome of interoperability? How is this different from #6? This needs to happen sooner. At this point (2021 – 2024), stakeholders should be tweaking this process to best inform a learning health system. Patient response for shared decision making and care planning; Patient response questionnaire standards HL7, CCDA Documents, Secure email, Links to data repositories e.g. My Directives Certified decision aid patient response 18

19. Workgroup Comments: Category 2015-2017 Send, receive, find and use a common clinical data set 2018-2020 Expand interoperable health IT and users 2021-2024 Achieve nationwide LHS C3. Privacy and Security for Individuals 1. Call to action: Public and private sector stakeholders should assess whether people understand how to safeguard their health information and the need for resources related to this topic. 2. Call to action: Providers should provide individuals with secure access to their own behavioral health information in a manner that is easy to use and enables them to make choices about disclosure of specific information that is sensitive to the individual and/or legally protected. 3. Call to action: Individuals should be able to trust that their health information (such as that generated/collected via home monitoring devices or other emerging technologies) is protected and secure. 4. ONC and the industry will continue to provide individuals with relevant and updated resources based on current technology to assist with increasing their digital health literacy. 1.Are the actions the right actions to improve interoperability nationwide in the near term while working toward a learning health system in the long term? 2. What, if any, gaps need to be addressed? 3. Is the timing of specific actions appropriate? 4. Are the right actors/stakeholders associated with critical actions? 19

20. 1.Are the actions the right actions to improve interoperability nationwide in the near term while working toward a learning health system in the long term? 2. What, if any, gaps need to be addressed? 3. Is the timing of specific actions appropriate? 4. Are the right actors/stakeholders associated with critical actions? 2015-2017 Send, receive, find and use a common clinical data set Comments 1. Call to action: Public and private sector stakeholders should assess whether people understand how to safeguard their health information and the need for resources related to this topic. Are all the necessary safeguards in place? Or is the task assessing and educating people about the risks and benefits of using digital technologies and electronic health information exchange? Not just ASSESS, but create plain language education in this area, as well. A need to educate consumers on how the information is used and how to safeguard that information. Information should include data use once it is downloaded and consumer role and provider role in protection of data, pitfalls and potential privacy concerns including levels of identity assurance. 2. Call to action: Providers should provide individuals with secure access to their own behavioral health information in a manner that is easy to use and enables them to make choices about disclosure of specific information that is sensitive to the individual and/or legally protected. The phrase “behavioral health information” is used three times in this draft (this seems to be its first appearance) yet there is no clear explanation of why this subset of PHI is being given exceptional treatment Important to include the behavioral health community (and other providers not eligible for Meaningful Use), although I was under the impression individuals already had the right to access their own behavioral health information per HIPAA Segmentation of data should include ANY data that a patient feels is sensitive. 20

21. 1.Are the actions the right actions to improve interoperability nationwide in the near term while working toward a learning health system in the long term? 2. What, if any, gaps need to be addressed? 3. Is the timing of specific actions appropriate? 4. Are the right actors/stakeholders associated with critical actions? 2018-2020 Expand interoperable health IT and users Comments 3. Call to action: Individuals should be able to trust that their health information (such as that generated/collected via home monitoring devices or other emerging technologies) is protected and secure. Tamper proof seal; Data provenance This is an immediate need. If we wait until 2018, the initiative will be undermined without consumer/patient trust. Consumers will not embrace health IT or Blue Button if it is delayed. 2021-2024 Achieve nationwide LHS Comments 4. ONC and the industry will continue to provide individuals with relevant and updated resources based on current technology to assist with increasing their digital health literacy. Rephrase: “ONC and the industry will continue to collaborate with individuals to create resources and tools that adapt to digital health literacy differences” Is this supposed to read “data privacy and security literacy”? If not, this item seems out of place. Same as #3 re: timing. If we wait until 2021 to address digital health literacy, we won’t have a majority of consumers and patients who can participate and benefit. 21

22. Workgroup Comments: 1.Are the actions the right actions to improve interoperability nationwide in the near term while working toward a learning health system in the long term? 2. What, if any, gaps need to be addressed? 3. Is the timing of specific actions appropriate? 4. Are the right actors/stakeholders associated with critical actions? Category 2015-2017 Send, receive, find and use a common clinical data set 2018-2020 Expand interoperable health IT and users 2021-2024 Achieve nationwide LHS C4. Education and digital health literacy for individuals 1. Call to action: Consumer advocacy groups in collaboration with government agencies, associations and payers should develop and disseminate resources (toolkits and best practices) based on consumer needs to assist individuals with increasing their digital health literacy. This supports consumer participation in shared decision making with their care team based on more complete and accurate information 2. ONC, government and the industry should work with individuals to help the majority understand the value of health IT for managing their health by providing individuals with easy resources to assist with increasing their digital health literacy. 3. ONC and the industry should continue to provide individuals with relevant and updated resources based on current technology to assist with increasing their digital health literacy 4. ONC and the industry should work with individuals to ensure that a majority understand the value of sustained engagement in managing their health, supported by health IT. 5. ONC and the industry should continue to provide individuals with relevant and updated resources based on current technology to assist with increasing their digital health literacy. 22

23. 1.Are the actions the right actions to improve interoperability nationwide in the near term while working toward a learning health system in the long term? 2. What, if any, gaps need to be addressed? 3. Is the timing of specific actions appropriate? 4. Are the right actors/stakeholders associated with critical actions? 2018-2020 Expand interoperable health IT and users Comments 2. ONC, government and the industry should work with individuals to help the majority understand the value of health IT for managing their health by providing individuals with easy resources to assist with increasing their digital health literacy. Rephrase : ONC, government and the industry should communicate the risks and benefits of health IT for managing and exchanging health information. Needs to happen sooner. And must be accompanied by K – 12 education. Commend emphasis on digital health literacy as a critical component of broader health literacy. Agree that efforts to improve digital health literacy may lead to more complete and accurate information stored in health records and used in shared decision-making, we underscore the need to create digital tools that address the varying states of digital health literacy. - Activities to enhance individuals’ understanding and engagement should be taking place now (rather than the next six to ten years), if we are to move towards a Learning Health System by 2024. Need certified shared decision aids Add– “consumer advocacy groups” ? 2018-2020 Expand interoperable health IT and users Comments 3. ONC and the industry should continue to provide individuals with relevant and updated resources based on current technology to assist with increasing their digital health literacy Rephrase: ONC and the industry should provide individuals with relevant and updated technology tools that adapt to digital health literacy differences. Industry convened for creation and maintenance of digital health literacy tools Needs to be combined with #2. It is not significantly different to stand on its own. 23

24. 1.Are the actions the right actions to improve interoperability nationwide in the near term while working toward a learning health system in the long term? 2. What, if any, gaps need to be addressed? 3. Is the timing of specific actions appropriate? 4. Are the right actors/stakeholders associated with critical actions? 2015-2017 Send, receive, find and use a common clinical data set Comments 1. Call to action: Consumer advocacy groups in collaboration with government agencies, associations and payers should develop and disseminate resources (toolkits and best practices) based on consumer needs to assist individuals with increasing their digital health literacy. This supports consumer participation in shared decision making with their care team based on more complete and accurate information Education on VDT and Blue Button and how consumers can utilize it needs to be added to this section. Consumer advocacy groups have unique knowledge of consumer/patient issues and priorities and are well positioned to inform and guide but do not have the resources to undertake such efforts on their own. Need Patient specific education in care and connected to VDT; Certified shared decision aids; Plain language requirements for patient specific education materials. Top 5 languages nationally for patient specific education, Digital literacy tools ; Mobile capable EMR delivered and PHR connected 24

25. 1.Are the actions the right actions to improve interoperability nationwide in the near term while working toward a learning health system in the long term? 2. What, if any, gaps need to be addressed? 3. Is the timing of specific actions appropriate? 4. Are the right actors/stakeholders associated with critical actions? 2021-2024 Achieve nationwide LHS Comments 4. ONC and the industry should work with individuals to ensure that a majority understand the value of sustained engagement in managing their health, supported by health IT. This would be one part of an overall communication strategy but not a standalone action. Should we add “consumer advocacy groups”? Suggested Rephrasing: “The role of health IT, interoperability, patient-generated health data, and patient engagement in a learning health system are clearly understood by individuals and families.” 5. ONC and the industry should continue to provide individuals with relevant and updated resources based on current technology to assist with increasing their digital health literacy. Delete, this it is duplicative Industry convened for creation and maintenance of digital health literacy Suggested rewording: “As technology evolves, ONC and the industry should continue to customize consumer-facing education on the components of a learning health system and the role of consumers in making it successful.” 25

26. Member Comments Privacy and Security Privacy and Security is not addressed in depth An imbalance between privacy and security, with most attention being paid to security. Need to engage with consumer/patient privacy advocates to develop a workable model of interoperable privacy. Is “greater transparency” (page 21) the only lever – would additional privacy protections be considered Security Rule encryption – needs more research and clarification in reference to impact on interoperability Verification/authentication (page 60) is overly conservative; technology advanced enough to warrant finite policy imperatives Section G: consumer choice is not explicitly addressed but could be usefully integrated into the discussion of consumer choice-enabling technologies (page 63). Appropriate and consistent privacy/security protections or choice architectures should be considered with regard to technologies that generally are not subject to HIPAA Privacy and Security rules. 26

27. Member Comments Section D Section D should be revised to emphasize the clinical- patient partnership Sections C and D need to be integrated – at the very least an explanation of the broad principles and goals that underlie the section Missing: Call to Action across the ten-year trajectory explicitly encouraging the robust and meaningful participation of individuals, patients, caregivers, and consumer advocates in the evolution of nationwide coordinated governance. A specific Call to Action for providers to participate in governance was included in D1.1, and we urge ONC to include a similar recognition for individuals 27

28. Next Steps Review Section D Send feedback to chitra.mohla@hhs.gov by Tuesday, March 17 th, 2015chitra.mohla@hhs.gov Next Meeting: Tuesday, March 24, 2015; 9:30 – 11:00 a.m. 28