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HL7 Patient Empowerment Group – FAQs and Discussion Points

Draft version 1 for discussion, Rachel Richesson, November 21, 2019

Please add comments in any form under any section and I will elaborate and edit for a more comprehensive and readable draft 2…!



Why is a patient perspective and representation important for health data standards?

Hasn’t HL7 always included patients?  (I.e., aren’t we all patients?)

What can we learn from research community related to the important but evolving role of patients in research?

Why would a dedicated group on Patient Empowerment be useful to HL7?

Do patients really need a formal working group?  Can’t they be pulled in as needed? Can’t they form an advisory group?

Why a Patient Empowerment Working Group? Why not a Patient Advisory Committee?

What is the status of the Patient Empowerment Group at HL7?

What would members of Patient Empowerment Group look like?

How do we envision this group to function?

What is the proposed mission/charter/area of focus for the PEW?

What are the benefits of PEW to HL7?





Why is a patient perspective and representation important for health data standards?

Patients are the contributors and users of health-related data. They are the users of patient portals and scheduling systems. Patients receive health care services as well as the bills. They see multiple providers and are often the first (and sometimes only) ones to know when systems are ineffective and slow and not interoperable. Patients experience any adverse consequences of if EHR systems are ineffective or if clinical decision support does not function as intended. Patients also contribute important data related to medical and family history, symptoms, exposures, and functioning. As experts on their health and their health-related goals and preferences, patients are uniquely positioned to identify and correct errors or omissions in data. As recipients and beneficiaries of health care services, patients arguably are critical stakeholders in virtually every data exchange and EHR function.

By definition, patients are central to the concept of “patient-centered care” and the patient perspective for goals and outcomes is fundamental to value-based care. Current legislation (21 st Century Cures Act) is mandating that health organizations make their data accessible to patients, which codifies patients as true end users of EHR systems via Patient Portals and other interfaces. Moving forward, there is no doubt that patients and caregivers – either as individuals or as patient advocacy groups – will continue to develope innovative apps and applications that will use the health data derived from EHRs and in time write back to EHRs.

Patients are also the “generators” of data (either patient generated data from devices or patient reported data) that is increasingly important to the delivery of patient-centered and value-based care.  Indeed, it has been said that only 20% of medical outcomes are explained/determined by medical care, and the rest is influenced by behavioral, lifestyle, genetic, social and environmental factors – all of which are sources of data to be incorporated in EHRs only with cooperation and permission of patients.

The world and society has changed dramatically in recent years with respect to growth in technology and availability of data. We have seen an exponential growth in computing power and the volume of data in electronic format. New devices are continually hitting the market, and consumer use of these devices changes over time. Consumer issues, such as drug pricing and surprise billing, have captured national (and congressional) interest, and are driving an ‘economic revolution’ in healthcare. Transparent information around price will support this economic revolution and subsequent  transformation of health care in the U.S., and this information will require the use of EHR systems and standards. There is also huge awareness and push for data security, privacy and notification or consent about the sharing of health-related information and personal health data. That pressure will only increase as cases of data breeches and sharing or selling of data are exposed by the media. Patient advocates are active in the demand for policies to protect and control personal health information, and EHR systems will need to evolve to address the requirements for data security and notification that derive from these policies.

“Over the last three decades, health care has begun changing in response to broad cultural changes facilitated by information availability and communication tools. At the level of care, patients are better informed about health and illness and are less dependent on their clinicians for information. They are more aware of choices, and more likely to want autonomy to arrange care that accommodates their values and preferences. This desire for autonomy is having and will continue to have profound effects on the patient-clinician relationship and on the systems and institutions involved in health care. At a systemic level, patients increasingly want to be involved in decisions and planning for research and health care delivery systems.”  (From U.S. Office of the National Coordinator for Health IT, Component 25: Patient-Centered Care, Health IT Workforce Curriculum Version 4.0/Spring 2016; )


Hasn’t HL7 always included patients?  (I.e., aren’t we all patients?)

Yes and yes. The HL7 organization and its members have always understood the value of patients as stakeholders and advisors in health data standards. In fact, the argument can be made that everyone is either a patient or caretaker, or will be in their lifetime. Undoubtedly, standards developers consider the patient role or experience in the systems they design, but when their primary focus is on the development of complex technical standards and systems dependencies, there is a risk that the patient experience is considered only superficially or late in the process to make an impact.

There is a need and value for the patient perspective to be added is a deliberate and formal way throughout the lifecycle of standards development.

Patients have different journeys, experiences, and perspectives. It is not likely that someone outside of the patient role at different point of time with unique constellation of circumstances, data, systems and people can truly understand the experience of a patient coping with or navigating a particular condition or specific health issue. Patients as users will have unique set of providers, goals, information and service needs, all of which drive system and data requirements.

Well-patient experience is very different from a sick (need better word here �� ) patient’s perspective. Patients with complex or rare conditions that need to interact with many different providers and organizations have a very different experience than those that use the system less regularly for routine activities.


What can we learn from research community related to the important but evolving role of patients in research?   

{note from Rachel – I need more time on this section in particular and will revisit it later.}

For the past 20 years, there has been a dramatic shift in the perceived value and contribution of patients in research. Patients have successfully developed research programs, registries, and drug development. The perceived benefit for including patients in research is increasing and almost universal, and patients’ roles in research have evolved from merely being participants to becoming key informants to ultimately being decision makers and co-designers. In PCORI, for example, patients drive decisions around research topics for funding calls, identify specific clinical questions, and review proposals. Over time, PCORI has developed criteria to ensure that patients are not only supportive or involved in research, but require evidence that patients participated in the decisions of what to study and in the development of the research proposal and often the study design. It is easy to imagine a similar transformation in the health care data exchange space – where patients and consumers play more prominent roles in deciding what projects are important and what systems or functions are needed.

Not only have patients observed that current research is too slow, many are expressing disappointment and frustration at the situation and driving change by demanding that healthcare use Information Technology in prudent and proactive ways to enable our ability to learn from our data and ultimately improve health care quality and costs. It is clear that research, which has historically had its own silo of data collection and exchange, must leverage clinical data and workflows – including EHR data and system functions – in order to address the many research needs in healthcare and our population health. In recognition of this, the FDA is actively exploring and promoting the concepts of Real World Data (RWD) and Real World Evidence (RWE).  (add links) Patients are being encouraged not only to participate in research, but in research design…. 

Also, there has been an evolution in how to think about patients and engage them in research.  Used to be you could get them to write a letter of support. Maybe look over the patient-directed QOL (after designed) or comment on the research protocol (after the study and question was already proposed , … ) …. But now it is considered best practice – and a requirement for many organizations that sponsor research – to include patients in research from the beginning and throughout.

The research community has generated and embraced the science of patient engagement. As part of this, it has become clear that the engagement of patients in research must be deliberate and purposeful.  There is a difference between average patient on the street and a trained (??) research advocate. I saw this evolve with the engagement of Patient Advocacy Groups in the Rare Disease Network and PCORI.  Both networks identified patient advocates with leadership and following, and also trained them to un [RR1]

There has been an evolution in the field of patient engagement. … Methods to include them in a meaningful way…. We can and will borrow from and build on these techniques and methods to ensure that patient engagement in HL7 and FHIR standards development is deliberate, efficient, and useful.



Why would a dedicated group on Patient Empowerment be useful to HL7?

The perspective of patients can inform the development and design of HL7 standards and artifacts.

As end users (of certain EHR systems and functions), patients can share and refine data and technical requirements.

They can also inform HL7 of their role (tasks, goals, context, and environment) in specific data exchange scenarios.

They can be ‘co-designers’ of various standards.

Can ensure that the FHIR standard is adopted widely to support innovative applications that inform and improve patient-centered care.

Other points to add?


Do patients really need a formal working group?  Can’t they be pulled in as needed? Can’t they form an advisory group?

We believe that the central role of patients in health care delivery and the fact that patients are end users of EHR systems warrants their participation in a deliberate and systematic way.

There is a lot of discussion and debate about what would be the most appropriate place for formal and bigtime patient representation in the HL7 organizational structure. We believe that a Working Group rather than an advisory panel is most appropriate moving forward.


Why a Patient Empowerment Working Group? Why not a Patient Advisory Committee?


Working groups are subject to regular participation and rules and protections of HL7 consensus process.

Working groups have mechanism to ballot and comment.

Working groups can introduce and work on new projects, and can co-sponsor projects with other working groups. Using this mechanism, we can easily identify.

What else??



What is the status of the Patient Empowerment Group at HL7?  


At present, a handful of interested individuals have come together to push the need for a Patient Empowerment Working Group, and to discuss the operations of such a group.. 


What would members of Patient Empowerment Group look like?

Members have a view as patient or care giver.

Many have leadership roles in non-profit or patient advocacy organizations.

Others are entrepreneurs or innovators, committed to developing solutions and products that help patients access and control and share their data.

Some are policy experts and understand the details (implications and requirements) of current and proposed legislation related to patient data and patient rights.

Others have experience with patient engagement in research.

Some are experienced software developers and standards developers that recognized the need for patient input and dialog throughout standards development and implementation.

All have personal (and diverse) experience with health care system and different health issues in themselves or their families.

Some have clinical background as well.

While any and all patients would be welcome to WG meetings, we predict that patients will self-select into HL7 based upon their comfort and familiarity with health IT.


How do we envision this group to function?

This is new and exciting frontier – for HL7 and globally.  We do not need to cause delates or slow the process. 

We intend to ensure that the group and its members exercise professional courtesy when interacting in HL7, which means doing research on status of projects and our role.


Are coming together on first the scope, then foundational principles for the group.  Clear consensus that the group should be positive, and useful. And advance the overall mission of HL7 (which is to …)

Need to understand importance of research .. Then understand acronyms, players, and models. Then business realities. Not about their kid but about all kids … [RR2]

Started with just stories but want more.. and have an impact on the functionality and interoperability of EHR systems and supporting applications.  Want to co-design…

Want to be positive and helpful.

Recognize that do not need to know all the technical specifications, but can provide input to developers at multiple stages when it is most useful.

Do not intend to be disruptive … (at least not immediately ��…)




What is the proposed mission/charter/area of focus for the PEW?

From the HL7 WG proposal:

        Ensure that (appropriate) impacts on patients (positive and negative) are a consideration of the standards development process and are appropriately documented in as part of all relevant HL7 standards.

        Provide an entry-point and give support to patients, caregivers and their advocates with respect to both influencing and leveraging HL7 standards.

        Provide patient centric guidelines for standards developers and implementers

        Assist in the standards development process by providing patient subject matter expertise

        Define, assist and/or coordinate standards and implementation guides related to interoperability with patient-facing systems.  These are some example use cases:

        Patient facing EHR and Payer Query APIs, patient corrections, patient consents, patient generated data (including health concerns, device data, notes, questionnaire responses), patient initiated scheduling requests.

        Provide the patient voice to the interoperability security and privacy conversation.



What are the benefits of PEW to HL7?


Can be a positive force for FHIR.


Maybe list some of the projects we have identified and where a patient voice could help? Maybe a table of illustrative (not exhaustive) examples?




From HL7 PEW Proposal:

Explanation of demonstrated need : While the objective of most, if not all, HL7 standards is improved patient care, we have never had an organizational structure whose purpose was to directly represent the viewpoint of patients and their care-givers as part of the standards process.  FHIR, in particular, offers the promise of interoperable systems whose primary users are patients and the friends and family who assist in providing their care.  Even within other healthcare applications, there’s increasingly a demand for patient-sourced data, integrating patients and their supports into the care planning process and closing the loop around the effectiveness of therapy.  As well, an increasing number of patients are moving to take advantage of HL7 interfaces to help understand their current health state and to take greater control of their care.


Patients need a voice at the table around the standards because they are the end user of most of the HL7 standards.  There is a need for standards guidance around standards for interoperability with patient-facing applications and devices.  Also, pat ients who are interested in leveraging and/or influencing HL7 standards need an entry point that can support and guide them as they work within the HL7 organization.


While a significant portion of this workgroup’s work will involve review and advocacy with respect to the work products of other work groups, this work group is expected to co-sponsor or occasionally even sponsor the development of standards artifacts.  For example, they will have ownership of certain pages within the core FHIR specification and may produce informative and normative specification related to patient-facing applications.  While the group may review and provide patient subject matter expertise on other specifications and provide feedback on patient-facing documentation, the intention is for the group to have open membership and not to act as a governance body.  As such, the recommendation is to create the group as a full work group, not a special interest group or user group. 




Other ideas that came up on the call on 11/21/2019:


Debi Willis – has lots of ideas on patient as end-user that she can add.

Physicians and nurses and pharmacists are in HL7.

There is a process to onboard them. 





(that make the case for patient engagement in health data and standards):


Here is a document from the American Medical Informatics Association (AMIA) that lists concepts that the organization believes (values) and supports (policies); the first set in the pdf below lists AMIA principle statements related to Patient Empowerment.   (see pages 3&4)  


This blog post - it's proven to be a useful tool for explaining what we have in mind.   It compares Kristina Sheridan's manual data-pounding workflow with Mike Morris's "health data spigots" powered by FHIR.

A tale of two patients: the difference #FHIR hopes to make with free-flowing data


Nice piece by Susannah Fox on why patients should care about interoperability:  

[RR1] Need to take out the first person stuff….  Just getting thoughts on paper now..

[RR2] I need to expand this later and probably move to research section.