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Integrating

Patient-Generated Health Data


into Electronic Health Records
in Ambulatory Care Settings:
A Practical Guide
Prepared for:
Agency of Healthcare Research and Quality
U.S. Department of Health and Human Services
5600 Fishers Lane
Rockville, MD 20857
http://www.ahrq.gov

Contract No. 75Q80120D00019

Prepared by:
Dave Boston, MD 1
Deborah Cohen, PhD 2
Julie Stone, MPA 1
Erica Edwards, MS 1
Angelea Brown, MPH 1
Martha Snow, MPH 3
LeAnn Michaels 3
Lourdes González, MPH, CPH 1

1 OCHIN, Inc., Portland, OR


2 Department of Family Medicine, Oregon Health & Science University, Portland, OR
3 Oregon Rural Practice-based Research Network, Oregon Health & Science University,
Portland, OR
AHRQ Publication No. AHRQ 22-0013 December 2021

Disclaimer: This practical guide was funded under contract number 75Q80120D00019 from the
Agency for Healthcare Research and Quality (AHRQ), U.S. Department of Health and Human
Services. The authors are solely responsible for this document’s findings and conclusions, which
do not necessarily represent the views of AHRQ. Readers should not interpret any statement
in this product as an official position of AHRQ or of the U.S. Department of Health and Human
Services. None of the authors have any affiliation or financial involvement that conflicts with the
material presented in this practical guide.

Public Availability Notice: This document is made publicly available by AHRQ and may be used
and reprinted without permission in the United States for noncommercial purposes, unless
materials are clearly noted as copyrighted in the document. No one may reproduce copyrighted
material without the permission of the copyright holders. Users outside the United States must
get permission from AHRQ to reprint or translate this product. Anyone wanting to reproduce
this product for sale must contact AHRQ for permission.

Integrating Patient-Generated Health Data into Electronic Health Records in Ambulatory Care Settings: ii
A Practical Guide
Acknowledgments

We would like to give gratitude to the Technical Expert Panel who has
given us permission to share their knowledge and experience in this
practical guide:
• Victoria Tiase, PhD, RN-BC, New York-Presbyterian Hospital
• James McCormack, PhD, Oregon Health & Science University
• James Pantelas, Patient Partner, Michigan
• Richelle Koopman, MD, MS, University of Missouri
• Matthew Roman, DPT, Duke Health
• Steven Kassakian, MD, MS, FACP, Humana Health

Integrating Patient-Generated Health Data into Electronic Health Records in Ambulatory Care Settings: iii
A Practical Guide
Table of Contents
FOLIO 1: Introduction: What is Patient-Generated Health Data
and Why is it Important?........................................................................................ 1
Key Learning Concepts.................................................................................... 2
What is PGHD?................................................................................................ 4
PGHD Referred to in This Guide...................................................................... 5
What Does It Mean to Integrate PGHD into the EHR?.................................... 7
Benefits of PGHD Integration ......................................................................... 7
PGHD Increases Patient Engagement and Satisfaction................................... 8
PGHD Integration into the EHR Provides a Fuller Picture of Patient Health... 8
Better Care Quicker: PGHD for More Timely, Personalized Interventions...... 9
Trends in Support of PGHD Integration and Use.......................................... 10
Health Equity and Integrating PGHD............................................................. 11
FOLIO 2: Assessing Readiness for PGHD Program Implementation..................... 13
Key Learning Concepts.................................................................................. 14
Preparing to Launch a PGHD Program in Your Practice................................ 15
Where to Start?............................................................................................ 15
Assess Staff Readiness.................................................................................. 15
Assess Patient Readiness.............................................................................. 17
Determine What Support Your Patients Need to Collect PGHD................... 17
ACTIVITY 2.1: Organizational Readiness.............................................. 20
ACTIVITY 2.2: Gauge Motivation and Concerns from
Patients and Colleagues........................................................................ 23

Integrating Patient-Generated Health Data into Electronic Health Records in Ambulatory Care Settings:
A Practical Guide
ACTIVITY 2.3: Roadmap to PGHD Implementation:
Key Considerations Relevant to Patient Participation........................... 25
FOLIO 3: Assembling a Team to Manage Change................................................ 28
Key Learning Concepts.................................................................................. 29
Build the Team: Identify Stakeholders and Find Your Champions................ 30
Who Are Your Stakeholders?........................................................................ 30
The Role of the Champion in Change Management..................................... 30
Where to Find Champions: Who is Already Using PGHD in Clinical Care?.... 31
Designate a PGHD Coordinator to Support Patients and Staff...................... 31
Include Community Partner Organizations and Agencies............................. 32
ACTIVITY 3.1: Assemble Your Team of Champions............................... 34
ACTIVITY 3.2: Assemble a PGHD Workgroup....................................... 42
FOLIO 4: Making the Right PGHD and Information Technology
Decisions for Your Practice................................................................................... 43
Key Learning Concepts.................................................................................. 44
Choose Information Technology that Meets Your Needs............................. 45
Selecting Devices for Your PGHD Program.................................................... 46
Pathways to PGHD Integration into the EHR................................................. 46
Consider Your Approach to Patients Choosing Their Own Devices............... 48
Legal, Compliance, and Security Frameworks.............................................. 48
Data Governance.......................................................................................... 50
Privacy and Security...................................................................................... 51
ACTIVITY 4.1: Roadmap to PGHD Implementation:
Key Health IT, Legal, Compliance, and Security Considerations............ 54

Integrating Patient-Generated Health Data into Electronic Health Records in Ambulatory Care Settings:
A Practical Guide
FOLIO 5: Evaluating the Costs of PGHD Implementation..................................... 61
Key Learning Concepts.................................................................................. 62
Big Picture Factors that Influence Your Program’s Financial Health............. 63
Billing and Reimbursement........................................................................... 63
Explore Other Sources of Funding................................................................ 64
Return on Investment................................................................................... 65
Incentive and Quality Reporting Programs................................................... 66
Develop a Budget to Implement, Grow, and Sustain Your Implementation. 67
Considerations for Your Cost Spreadsheet................................................... 67
ACTIVITY 5.1: Roadmap to PGHD Implementation:
Key Financial, Reimbursement, and Reporting Considerations............ 71
FOLIO 6: Steps to Successfully Implement a PGHD Program.............................. 73
Key Learning Concepts.................................................................................. 74
Developing Your PGHD Implementation....................................................... 75
Set Realistic and Measurable Goals for Your PGHD Implementation........... 75
Effectively Engage Your Target Group of Patients......................................... 77
Develop Diagrams and Detailed Workflows................................................. 78
Learn from Your Experience Before Scaling Your PGHD Implementation..... 80
Rapid-Cycle Testing and End-User Feedback................................................ 82
Support Staff Awareness Through Training and Messaging. ........................ 87
Scale with a Strong Internal and External Communication Plan................... 87
Share Success Stories.................................................................................... 89
Monitoring Environmental Factors............................................................... 89

Integrating Patient-Generated Health Data into Electronic Health Records in Ambulatory Care Settings:
A Practical Guide
Resources for Implementation, Scaling, and Environmental Monitoring Your
PGHD Program ............................................................................................. 89
ACTIVITY 6.1: Bringing It All Together: Your PGHD Implementation.... 91
ACTIVITY 6.2: Craft Your First SMART Goal.......................................... 95
ACTIVITY 6.3: Develop Workflows....................................................... 96
ACTIVITY 6.4: Evaluate and Refine....................................................... 98
ACTIVITY 6.5: Scale Up and Monitor.................................................. 100
References.......................................................................................................... 102

Integrating Patient-Generated Health Data into Electronic Health Records in Ambulatory Care Settings:
A Practical Guide
Integrating
Patient-Generated Health Data
into Electronic Health Records
in Ambulatory Care Settings:
A Practical Guide

FOLIO 1: Introduction: What is


Patient-Generated Health Data
and Why is it Important?
Estimated reading time: 11 minutes

IN THIS FOLIO
Key Learning Concepts
• Definition of patient-generated health data (PGHD).
• Integration of PGHD into the electronic health record (EHR).
provides clinical decision making support.
• Benefits of PGHD include increased patient engagement, fuller pictures of
health, and more timely interventions.
• The uptick in virtual care adoption provides support for PGHD.
• Efforts to attain health equity should be baked into program planning.
• How to Use This Practical Guide.

Integrating Patient-Generated Health Data into Electronic Health Records in Ambulatory Care Settings: 2
A Practical Guide
FOLIO 1
Introduction: What is Patient-Generated Health Data and Why is it Important?

This guide is intended to support ambulatory care settings of all types—including offices of
physicians and other health professionals, outpatient departments, community health centers,
ambulatory surgical centers, and urgent care clinics and specialty clinics—in the design and
implementation of successful PGHD programs that can improve patient outcomes.

It is intended to accompany Integrating Patient-generated Digital Health Data into Electronic


Health Records in Ambulatory Care Settings: An Environmental Scan, which summarizes the
most current evidence on PGHD integration into clinical settings. 1

The guide is organized into folios that help your ambulatory practice—in partnership with your
patients—navigate the many steps from design, to launch, to maintenance of a successful,
sustainable PGHD integration program. Folios include planning considerations and practical
activities to support your effort to deploy a new and complex care delivery modality into
your practice.

Included in this practical guide:


Folio 1: Introduction: What is Patient-Generated Health Data and Why is it Important?
Folio 2: Assessing Readiness for PGHD Program Implementation
Folio 3: Assembling a Team to Manage Change
Folio 4: Making the Right PGHD and Information Technology Decisions for Your Practice
Folio 5: Evaluating the Costs of PGHD Implementation
Folio 6: Steps to Successfully Implement a PGHD Program

Because your success will be highly linked to the capacity and interests of your practice staff
and the unique needs and preferences of your patients, PGHD programs are likely to differ
greatly across settings. The content of this guide is designed to support your unique journey—
pick and choose content in this guide that is useful to you. You may choose to read these folios
from beginning to end or to skip around to review content that has the greatest relevance to
your current needs. Additionally, the guide is completely searchable by keyword. Simply type
CONTROL + F (COMMAND + F for Mac users) to open the search bar.

Integrating Patient-Generated Health Data into Electronic Health Records in Ambulatory Care Settings: 3
A Practical Guide
To make learning more meaningful, consider applying data from your own practice to inform
decisions and develop practical solutions to real challenges. Use real-life examples and patient
stories to inform your decisions around the design and implementation of your program.

Tips, Ideas, and Activities

Look for special icons that callout quick tips and ideas for easy scanning.

Tip Idea
Learning exercises and checklists invite active participation to tailor solutions
to your needs.

Activity

Write on a printout or type directly into the pages using free


Adobe Reader software.

Let’s get started.

What is PGHD?
The Office of the National Coordinator for Health Information Technology (ONC)
defines PGHD as “health-related data created, recorded, or gathered by or from
patients (or family members or other caregivers) to help address a health concern.” 2
This includes patient-reported data gathered from surveys, and data generated from
remote monitoring devices, such as mobile health apps and wearable devices.

Integrating Patient-Generated Health Data into Electronic Health Records in Ambulatory Care Settings: 4
A Practical Guide
PGHD Referred to in This Guide
For the purposes of this practical guide, we will consider the following categories and
domains of PGHD:

• Data gathered through queries or prompts—


◦ Health and Treatment Histories
◦ Lifestyle Choices or Social Histories
◦ Patient-Reported Outcomes
• Patient-Measured Biometric Data

Health and Treatment Histories


Health and treatment histories may influence screening and diagnosis of disease, care
planning, and prescribing. This includes a patient-reported history of personal and family
conditions, illnesses, and surgeries. This information is commonly captured at check-in
for new patients and is reviewed or updated as needed. 3

Comprehensive health and treatment histories can also include patient-reported


information about mental and behavioral health, such as nutrition; physical activity
level; alcohol, tobacco, and drug use; sleep habits; stress management; and healthy
relationships. 4 Social history may include occupation, education, living situation, military
service, hobbies, spiritual beliefs, and activities of daily living. 5

PGHD regarding the patient’s health-related quality of life, functional status, health
behaviors, symptoms, and symptom burden are collected via self-report. These are often
called patient-reported outcomes (PROs).

PROs are defined as “information providing the status of a patient’s health outcomes
that comes directly from the patient, without interpretation of that patient’s response
by a clinician or anyone else.” 6

There are a wide range of validated instruments to collect PROs. For example, PROMIS®
(Patient-reported Outcomes Measurement Information System) is an inventory of
validated, person-centered measures for adults and children that includes physical,
mental, and social health measures in English and Spanish, and may be administered on
paper, computer applications or software, or tablet apps.
Integrating Patient-Generated Health Data into Electronic Health Records in Ambulatory Care Settings: 5
A Practical Guide
Patients may be asked to complete these instruments in the office, via the patient
portal, or through an app. PROs play a vital role in patient care, yet may not be routinely
captured in the EHR. 7

Biometric Data
Patient-generated biometric data include vital sign measurements and other indicators
of health such as blood pressure, blood glucose, and weight. These data can be captured
through patient-facing technology in between visits to better inform care, provide
trends, and monitor chronic conditions. Depending on the device and vendor, biometric
data may be integrated as discrete data into the EHR.

Table 1: Biometric Data Types and Patient-Facing Devices

Type Patient-Facing Device Example


Blood pressure Blood pressure cuff
Blood glucose Blood glucose monitor
Physical activity Wearable, smartphone
Heart rate Heart rate monitor
Blood oxygen saturation Pulse oximeter
Weight Bluetooth/Wi-Fi enabled scale
Sleep Actigraphy monitor
Temperature Remote temperature monitor

NOTE: We will not address implantable devices such as pacemakers in our discussion.

Integrating Patient-Generated Health Data into Electronic Health Records in Ambulatory Care Settings: 6
A Practical Guide
What Does It Mean to Integrate PGHD into the EHR?
In keeping with the Clinical Decision Support (CDS) Five Rights, 8 PGHD need to be actionable
at the time of clinical decision making to make the greatest impact on patient care. PGHD
may indicate the need for further screening, medical intervention, behavioral counsel, or
medication adjustments.

When PGHD are integrated into the EHR, they are added to a patient’s health record and can be
used for clinical decision-making. These data can provide a more complete picture that informs
longitudinal, continuous care.

PGHD can be input manually into the EHR by patients, clinicians, or staff, or transmitted directly
from the patient to the EHR via a third-party vendor. Data will be entered either into a discrete
data field or as free text. This depends on the type of PGHD and the capabilities of the EHR
and third-party vendor device. PGHD collection and integration functionality may include an
additional cost from your vendor. If PGHD are entered into discrete fields, your EHR may
contain native applications that enable clinicians and patients to view PGHD data in
dashboards that assist with visualizing trends. 9

The rate and frequency by which PGHD may be transmitted and ingested into the EHR vary by
device. Some PGHD, particularly biometric data related to chronic diseases such as diabetes
or hypertension, may generate a high volume of data. To condense large volumes of data
points, batch transfers and binning algorithms can bucket data into units that can be more
easily managed by your EHR. High volumes of data, such as readings from a continuous glucose
monitor, are generally translated into data visualizations.

Benefits of PGHD Integration


Integration of PGHD into the EHR has the potential to inform clinical decision making
and improve ambulatory care. In ambulatory settings, the health benefits of PGHD are
most evident when these data are leveraged and aligned with a specific clinical focus. 1

PGHD can facilitate patient and clinician management of conditions such as diabetes, high blood
pressure, chronic obstructive pulmonary disease, congestive heart failure, and pregnancy.

PGHD can help improve the care of homebound patients, those with mobility limitations, and
patients with transportation barriers.
Integrating Patient-Generated Health Data into Electronic Health Records in Ambulatory Care Settings: 7
A Practical Guide
PGHD Increase Patient Engagement and Satisfaction
Using PGHD to inform medical care decisions offers patients the opportunity to become more
engaged, empowered, and connected to their health. 10 Increased patient engagement and
empowerment can contribute to better health outcomes and increased patient satisfaction with
their care. 11, 12, 13, 14 Further, PGHD provide patients reassurance in their self-management. 1, 15

PGHD Integration into the EHR Provides a


Fuller Picture of Patient Health
For most patients, visits with their doctors are short and infrequent. The health data collected in
the office during these visits provide a few isolated snapshots that may not be representative of
patients’ health as experienced in the routine course of daily life. PGHD have the potential to
offer clinicians, patients, and caregivers a more complete and nuanced picture of the patient’s
health within the context of everyday living.

Three Clinical Use Cases for Home Blood Pressure Readings

Home blood pressure monitoring is an excellent example of PGHD integrated


into the EHR to enhance diagnosis and treatment of hypertension. 16, 17
Fifty-four percent of U.S. adults diagnosed with hypertension report
measuring their blood pressure at home. Evidence suggests that home
blood pressure predicts cardiovascular outcomes even after accounting for
in-clinic blood pressures, prompting the U.S. Preventive Service Task Force
(USPSTF) and professional society guidelines to promote inclusion of home
data for hypertension diagnosis and management. 1, 18 Dr. Richelle Koopman,
a leading investigator in PGHD research at the University of Missouri School
of Medicine in Columbia, Missouri, says, “Patient home blood pressure is an
independent, valuable, predictive piece of information.” 19
Three clinical use cases for home blood pressure readings include:
• Diagnosing hypertension per the USPSTF recommendation.
• Monitoring the effects of medication changes to control hypertension.
• Detecting hypotensive episodes. 19, 20

Integrating Patient-Generated Health Data into Electronic Health Records in Ambulatory Care Settings: 8
A Practical Guide
Better Care Quicker:
PGHD for More Timely, Personalized Interventions
When your PGHD integration is supported by EHR-based data visualization tools, clinicians and
patients can visualize trends and spot irregularities earlier, creating opportunities to make care
plan adjustments. Dr. Richelle Koopman explains, “People receive care during a visit, and then
they go too long between visits before we make another intervention. This goes for treatment
of everything from depression to hypertension. There are ways that PGHD—patient feedback
about what’s going on—can help us get to better care and improvement quicker.” 19

Figure 1. Example of an Idealized Data Visualization for Blood Pressure in the EHR 21

Blood Pressure (BP) Values BP Focus


Systolic 164 149 150 134 127 159 131
Home In clinic
Diastolic 92 88 90 78 77 87 75

Key
180 Home Reading - Confirmed
PCP Clinic
160 Systolic BP
140 Diastolic BP
Note
Blood Pressure

Systolic

120
Range

Goal

100 Notes
01/15/2019 - R. Doctor, MD
Diastolic

80
Range

Goal

Lisinopril added due to lack of


60 response to HCTZ alone.

40 Additional stress from Medication


substantial dental
20 appointment.
09/19/2019 - R. Doctor, MD
Additional stress from substantial
Year 2018 2019 2020 dental appointment.
Stress
Medication Timeline

HCTZ 25

lisinopril 10

2018 2019 2020

For more detailed information on the health benefits associated with the incorporation of
PGHD, please see the environmental scan.

Integrating Patient-Generated Health Data into Electronic Health Records in Ambulatory Care Settings: 9
A Practical Guide
Trends in Support of PGHD Integration and Use
Figure 2. Drivers of PGHD Integration into the EHR in Ambulatory Care Practices

MRN: XXXX9999

PGHD Integration

New Healthcare Federal and Evolving Market


Technologies State Policy Payment Models Competition

Emerging healthcare technologies, Federal and State policies, evolving payment models,
and an increasingly competitive virtual healthcare marketplace, taken together with the
Nation’s collective pivot to virtual care during the COVID-19 pandemic, are among the factors
accelerating the shift to and support for PGHD integration.

This shift is further supported by technology advancement, including the development


and lower cost of advanced biosensors, greater broadband coverage, widespread use of
smartphones, and digital solutions that streamline interoperability.

This is not new territory for clinicians, who have relied on PGHD to inform treatment decisions
for decades. For example, home blood pressure measurement is not new, and it can effectively
identify white coat effect and masked hypertension. 16, 17

Integrating Patient-Generated Health Data into Electronic Health Records in Ambulatory Care Settings: 10
A Practical Guide
Health Equity and Integrating PGHD
Through increased communication, fuller data, earlier intervention, improved self-
management, and higher engagement, the use of PGHD in ambulatory clinics may
have the potential to improve care for patients who are disproportionately impacted
by chronic disease—those with higher social risk factors such as low income, food
insecurity, and housing instability. 22, 23, 24

Yet, disparities in access and ability to use patient portals, devices, and other technologies
persist. These tools are not equitably distributed or available to those who may benefit from
PGHD most—a truth which has become more exposed throughout the COVID-19 pandemic. 25,
26, 27
Factors that potentially exacerbate the digital divide include broadband and device access,
digital health literacy, and lack of inclusive design. 1

Include health equity in your planning to help your practice identify barriers to PGHD adoption
within your patient population. This could be internet access, cost of devices, language, or
technical proficiency barriers.

The following are some considerations for building health equity into your PGHD program:

• Keep barriers in mind when selecting PGHD types and devices. If specific devices or
methods are not optional, lessen their impact with baked-in resources.

• Refer eligible patients to subsidized internet programs.

• Look for Federal and State grant opportunities.

• Create or find a device loaner library to reduce costs.

• Produce educational support in multiple languages to bridge language gaps.

• Rely on visuals to help illustrate instructions and troubleshooting advice.

• Community partners can help fill other gaps. This could be a local library who can host
device technical support classes, or a peer support group that can share tips and tricks.

• When recruiting patients to participate in a PGHD program, offer the same opportunities
to all patients. Don’t assume lack of interest based on factors such as income, living
situation, or education. These patients may be eager and ideal candidates.

Integrating Patient-Generated Health Data into Electronic Health Records in Ambulatory Care Settings: 11
A Practical Guide
This guide offers tips and ideas for ambulatory care practices of diverse sizes and resource
capacities, and provides suggestions for serving patients with limitations in digital literacy,
internet access, and English-language proficiency.

Integrating Patient-Generated Health Data into Electronic Health Records in Ambulatory Care Settings: 12
A Practical Guide
Integrating
Patient-Generated Health Data
into Electronic Health Records
in Ambulatory Care Settings:
A Practical Guide

FOLIO 2: Assessing Readiness for


PGHD Program Implementation
FOLIO 2
Assessing Readiness for PGHD Program Implementation

Estimated reading time: 11 minutes

IN THIS FOLIO
Key Learning Concepts
• PGHD integration may mark a significant change in your practice.
• Incorporate perspectives of staff into PGHD implementation planning.
• Incorporate patient perspectives on PGHD to achieve greater equity
and satisfaction.
• Assess your practice and patients for readiness.
Active Learning Exercises
• ACTIVITY 2.1: Organizational Readiness
• ACTIVITY 2.2: Gauge Motivation from Patients and Colleagues
• ACTIVITY 2.3: Roadmap to PGHD Implementation:
Key Considerations Relevant to Patient Participation

Integrating Patient-Generated Health Data into Electronic Health Records in Ambulatory Care Settings: 14
A Practical Guide
FOLIO 2
Assessing Readiness for PGHD Program Implementation

Preparing to Launch a PGHD Program in


Your Practice
Imagine a scenario in which patients use the patient portal to securely enter their
home blood pressure readings directly into the EHR, where they can be visualized by
both the clinical team and the patient. These visualizations can include graphs and
dashboards viewable within the EHR. They can enable you to easily view trends in
clinic blood pressures and home blood pressures over time. Annotations can clearly
show when patients started and stopped hypertension medications, as well as the
impacts of these actions. In just moments, you and your patients can assess blood
pressure management. Medication modifications, if needed, can be made quickly,
possibly even without the need for an office visit.

Reaching this point in PGHD implementation requires numerous operational changes in your
practice that will impact your EHR, clinical teamwork, workflows, care delivery, and patient
engagement in care.

Where to Start?
It should not be difficult to find areas in your practice that would likely benefit from the
integration of PGHD into your EHR. Often, the more difficult task is prioritizing the best
opportunities for starting your program and addressing potential barriers to successful
implementation.

Assess Staff Readiness


We recommend starting by talking with your colleagues about their interest and experience
with PGHD. Make sure to hear from your care team of all different professional roles and
backgrounds. Ask them what they know about PGHD. Ask them if they have ever used it
in practice. If they have, ask them about their experiences. How important is it to them to
integrate PGHD into clinical care? Where do they think their patients might gain the most
benefits from doing so?

Integrating Patient-Generated Health Data into Electronic Health Records in Ambulatory Care Settings: 15
A Practical Guide
FOLIO 2
Assessing Readiness for PGHD Program Implementation

Your colleagues might even identify possible challenges to PGHD implementation.

Challenges may include:

• Low confidence in patient data collected in the home.

• Inadequate financial and/or staff resources to implement a new PGHD program.

• Concerns that staff time needed to review PGHD will increase clinical staff workload.

• Uncertainty about billing and reimbursement.

• Lack of knowledge about how to select the right devices for patient use.

• Reservations about security and privacy of patient data.

The concerns you may surface about PGHD integration are important to understand, as these
can pose substantial challenges to obtaining buy-in and successful PGHD implementation.
These experiences need to be carefully considered and addressed as you begin PGHD program
implementation.

Explore your organization’s readiness in more depth with Activity 2.1: Organizational Readiness
beginning on page 20.

Idea: Take an inventory of ways PGHD are currently being used.


Taking inventory of the ways PGHD are currently utilized in your practice
will help you assess:
• Where you currently are on the continuum of PGHD integration.
• Which clinicians and/or conditions are already relying on PGHD in
some form.
• Which clinicians and/or other staff have familiarity with PGHD
integration and/or recognize the value of its integration.
When you conduct the organizational readiness assessment in Activity 2.1,
be sure to investigate what types of PGHD the practice already uses
routinely in clinical care.

Integrating Patient-Generated Health Data into Electronic Health Records in Ambulatory Care Settings: 16
A Practical Guide
FOLIO 2
Assessing Readiness for PGHD Program Implementation

Assess Patient Readiness


A critical part of clinic readiness for PGHD implementation includes the readiness of your
patients. As the creators of PGHD, patients are indispensable stakeholders. Therefore, PGHD
implementation should be aligned with patient needs, resources, barriers, and concerns. 1 It is
important to engage patients early in the PGHD implementation process as stakeholders with a
prominent voice. 1

Start by assessing your patient’s motivation and challenges to collecting PGHD with Activity 2.2:
Gauging Motivation from Patients and Colleagues.

Idea: Work with your patient and family advisory council.


Consider convening a patient and family advisory council or engaging
patient advocates as part of your baseline readiness assessment. Be sure to
include patients who are eager to engage in PGHD collection and those who
might be more reticent. Understanding the obstacles patients may face to
using health devices and uploading PGHD will be critical.

Determine What Support Your Patients Need to Collect PGHD


A patient readiness assessment can identify the different types of support patients may
need to use digital PGHD devices, collect data, and upload it into your EHRs via the patient
portal. If there are unmet needs, consider what solutions you can fold in as you plan
your implementation.

Essential Resources Patients Need to Benefit from PGHD

There are several factors that can limit patient’s use of PGHD.
• Digital health literacy (e-health literacy)
• Health literacy
• Language proficiency
• Technical proficiency
• Access to broadband or Wi-Fi
• Access to devices (i.e., smartphone, tablet, remote monitoring device)

Integrating Patient-Generated Health Data into Electronic Health Records in Ambulatory Care Settings: 17
A Practical Guide
FOLIO 2
Assessing Readiness for PGHD Program Implementation

Other possible barriers to using PGHD tools must be considered are:


• Low dexterity
• Visual or hearing impairment
• Intellectual/developmental disability
• Barriers related to age/culture/illness/chronic condition

You may find that some patients who could benefit from PGHD will need extra support. Learn
from your patients what kind of additional support would be helpful. Your practice may be
able to provide appropriate patient education, instructions, and technical support in multiple
media formats and languages that can enable a broader range of patients access to the benefits
of PGHD. 28 29

Idea: Look outside the clinic walls to meet needs.


Consider hosting help sessions or partnering with community-based
organizations located in the neighborhoods where your patients live to
deliver culturally appropriate education and support.
These may include:
• YMCA
• Public libraries
• Community centers
• Faith-based organizations
• School-based health centers
Federal programs may also provide resources. This could include:
• Lifeline program for affordable telecommunications
• Emergency Broadband Benefit (EBB) Program
Including a mix of community partners will expand your capacity to engage
patients with various backgrounds and needs. Community partners may
also be able to address certain shortfalls by providing services such as
Wi-Fi hotspots. See Figure 1 on page 19 for various potential solutions to
common patient barriers to PGHD use.

Integrating Patient-Generated Health Data into Electronic Health Records in Ambulatory Care Settings: 18
A Practical Guide
FOLIO 2
Assessing Readiness for PGHD Program Implementation

Figure 1: Potential solutions to common patient barriers to PGHD use

Barriers

Lack of Low health IT


Internet access proficiency Dexterity Vision Language
Solutions

Patient education
and instructions

Technical support

Multiple media

Multiple languages

Community
partnerships

Wi-Fi hotspots

Integrating Patient-Generated Health Data into Electronic Health Records in Ambulatory Care Settings: 19
A Practical Guide
FOLIO 2
Assessing Readiness for PGHD Program Implementation

ACTIVITY 2.1: Organizational Readiness


The purpose of this activity is to begin to assess your organization’s readiness for change.
Ask clinicians, clinical staff, the practice manager, and other healthcare professionals to
think about their attitudes toward PGHD integration into the EHR. This information will
inform your approach to PGHD program planning and help prioritize your staff’s needs.
Consider compiling findings into a recommendation for your executive leadership.

Instructions: Type answers directly into the field or print to handwrite.

What PGHD are currently in use at your practice? For example:

• What are examples of routine care in which patients bring PGHD to their appointments?
• What are examples of PGHD providers routinely request from patients to inform
clinical care?
• What are examples of screenings, surveys, or questionnaires routinely collected as part of
clinical care?
• What forms of remote patient monitoring are in use?

Collect information to fill in the answers.

PGHD IN USE AT YOUR PRACTICE

PGHD patients provide (e.g., blood glucose, blood pressure, weight):

PGHD clinicians request (e.g., measurements, questionnaires):

Screenings, surveys, or questionnaires (e.g., PHQ-2, SDoH, health history):

Remote patient monitoring (e.g., heart rate, blood pressure):

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FOLIO 2
Assessing Readiness for PGHD Program Implementation

PRIORITY AND EXCITEMENT

Describe your organization’s level of enthusiasm for PGHD integration into the EHR.

Why does your organization want to focus on PGHD?

What will your practice gain by integrating PGHD?

What resources will executive leadership commit to providing (budget, staffing, dedicated time,
etc.) to execute this project?

Do you have a patient and family advisory committee or other venues to recruit patient
stakeholders or elicit input?

Who can be identified as a PGHD Coordinator from your practice who can champion this work?

Which processes will be used to execute new programs and quality improvement?

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FOLIO 2
Assessing Readiness for PGHD Program Implementation

Do you have a process for developing policy, protocol, training, and other needs for a new
health IT implementation?

What are staff attitudes about PGHD integration into the EHR to improve patient care?

Do staff have capacity to learn new workflows, protocols, and messaging for PGHD integration
into the EHR?

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FOLIO 2
Assessing Readiness for PGHD Program Implementation

ACTIVITY 2.2: Gauge Motivation and Concerns from


Patients and Colleagues
The purpose of this activity is to help your practice understand the motivations and
concerns of patients and staff around implementing a PGHD program. It can be helpful
to dig into the reasons patients and staff might be initially resistant and be prepared
with solutions to address barriers. Findings may also help inform choices and decisions
as your executive leadership steers your practice through PGHD implementation.

Instructions: Type answers directly into the field or print to handwrite.

MOTIVATION TO PARTICIPATE

Gather information from patients and colleagues about their motivations to participate. 30

What conditions are patients most likely to manage and improve by collecting PGHD? (e.g.,
hypertension, depression, diabetes)

Does PGHD integration fill a patient care gap or unmet patient care need?

Are patients seeking new ways to communicate and share data about their conditions?

CHALLENGES

Conversely, it is important to get an idea of what your patient’s hesitations may be.

Are your patients worried about privacy and security?

Are they concerned about degree of added burden?

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FOLIO 2
Assessing Readiness for PGHD Program Implementation

Do they have access to reliable internet?

Are the tools or devices cost-prohibitive?

Do your patients rely on interpretation services?

Do your patients have low-English proficiency?

Do your patients have adequate digital literacy?

Do your patients have physical barriers such as low dexterity, visual or hearing impairment, or
age-related barriers?

Do your patients have intellectual or developmental disability?

Are there cultural barriers?

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FOLIO 2
Assessing Readiness for PGHD Program Implementation

ACTIVITY 2.3: Roadmap to PGHD Implementation:


Key Considerations Relevant to Patient Participation
Use the following list of key considerations to guide decision-making and identify
potential gaps in your PGHD program implementation.

Your responses from previous activities in this folio will help guide you through these
considerations. This will begin forming your customized roadmap to implementation and assist
your work in Folio 6, Activity 6.1: Bringing It All Together: Your PGHD Implementation.

Instructions: After each consideration, use the form field to record notes. Type directly into
the field or print to handwrite.

PATIENT PARTICIPATION CONSIDERATIONS

• Does this offering fill a patient care gap or meet an unmet patient care need?

• How do you identify patients or patient populations that are good/poor candidates?

• What are the motivations of patients to use PGHD? (e.g., improve BP control, monitor
symptoms of depression or anxiety, IVF/fertility medicine, lose weight)

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Assessing Readiness for PGHD Program Implementation

• Do patients have sufficient resources to benefit from PGHD? (e.g., digital literacy, health
literacy, English proficiency, access to broadband or Wi-Fi, means to purchase devices)

• Are supports available to fill gaps (e.g., subsidized smartphones and data plans, lending
library of wireless devices, interpreter services, caregiver assistance)

• Do many of your patients use smartphones?

• Have you considered how you might address inequities in access and care among
your patients?

ACCESS TO IT INFRASTRUCTURE AND INTERNET CONSIDERATIONS

• Is broadband widely available in your community?

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FOLIO 2
Assessing Readiness for PGHD Program Implementation

• Are there community partners (conventional and nonconventional) that might potentially
serve as sites for patient education and technical assistance?

• Have you considered how you might leverage resources external to your clinic in order
best engage your patients?

• Who in your practice can provide technical assistance to patients?

Integrating Patient-Generated Health Data into Electronic Health Records in Ambulatory Care Settings: 27
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Integrating
Patient-Generated Health Data
into Electronic Health Records
in Ambulatory Care Settings:
A Practical Guide

FOLIO 3: Assembling a Team


to Manage Change
FOLIO 3
Assembling a Team to Manage Change

Estimated reading time: 9 minutes

IN THIS FOLIO
Key Learning Concepts
• Build the team: Identify stakeholders and find your champions.
• A PGHD Coordinator could be crucial to success.
• External partners are powerful allies.
Active Learning Exercises
• ACTIVITY 3.1: Identify Your Team of Champions
• ACTIVITY 3.2: Assemble a Core PGHD Workgroup

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FOLIO 3
Assembling a Team to Manage Change

In Folio 2, you explored the readiness and enthusiasm of your practice to undertake PGHD
implementation, identified if you are already receiving any type of PGHD, and spoke with
patients and staff about what matters most to them. All of this was done to help you prioritize
and make informed decisions.

Folio 3 focuses on a next key step in the change management process: how to identify and
assemble your team that will lead the change.

Build the Team:


Identify Stakeholders and Find Your Champions
Who Are Your Stakeholders?
To start, identify the individuals, departments, vendors, contractors, and other groups
that will directly or indirectly be touched by or have expertise to lend to the PGHD
implementation. This includes considering the resources, skills, and expertise you will
need to carry out PGHD implementation and ensure its sustainability.

Who will influence the success or failure of your implementation? These are the stakeholders
in your PGHD program implementation. Activity 3.1: Assembling Your Team of Champions has
a comprehensive, customizable list of possible stakeholders and champions. Depending on the
size of your operation, one person may fill multiple roles or one role might be filled by multiple
people. Activity 3.2 offers a table where you can name and organize your PGHD design and
implementation core team.

The Role of the Champion in Change Management


Champions provide crucial support for change efforts in ambulatory care settings, often
facilitating change through their influence, knowledge, and skills in concert with ready
enthusiasm. 31 Champions lead program planning and implementation, build buy-in, connect
resources, and assist in overcoming obstacles. 32 Your champions will be indispensable resources
as you develop, implement, and grow your PGHD program.

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FOLIO 3
Assembling a Team to Manage Change

Where to Find Champions:


Who is Already Using PGHD in Clinical Care?
In Folio 2, you identified if you have examples of current PGHD applications in your practice.
If you are already using PGHD applications, the clinicians, patients, and clinical support staff
already engaged in these activities are prime candidates for your team of champions.

Promising staff champions include:


• Staff with a particular interest in PGHD tools and apps.
• Staff who use PGHD tools and apps to improve their own health and fitness.
• Staff that have been involved in leading health IT solutions or customizing your EHR build
within your practice.

As a way of building support and consensus early on, you might even consider influential staff
who have resisted change or virtual care ideas in the past.

Promising patient champions include:


• Those who have shared PGHD from a fitness tracker, app, or device
• Patient populations with obvious clinical use cases (e.g., patients with diabetes who use
continuous glucose monitors or patients self-monitoring their blood pressure).

Tip: If you have a clinical informaticist on staff, bring in this individual. A


clinical informaticist can assist your practice in identifying the best strategy
to ensure patients can easily upload their data into the EHR and in making
the right data available at the right time to impact clinical decision making.

Designate a PGHD Coordinator to Support Patients and Staff


Formally name and resource the PGHD coordinator as a key role within the program. This
person supports the implementation team in numerous ways, from project management to
quality improvement (QI).

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FOLIO 3
Assembling a Team to Manage Change

Responsibilities of the PGHD Coordinator

The responsibilities that can be assigned to a PGHD Coordinator include:


• Recruit and align stakeholders.
• Provide critical project management support.
• Develop cultural norms.
• Build policies and workflows.
• Organize staff training.
• Track rates of PGHD uptake and patterns of use.

See Activity 3.1: Assemble Your Team of Champions for a more detailed list
of responsibilities and tasks for the PGHD Coordinator and other roles.

Idea: Assign multiple PGHD coordinators.


For large practices, you may consider identifying more than one staff
person to the role of PGHD Coordinator. Consider engaging distinct program
coordinators, such as people who support patients with hypertension,
diabetes, and congestive heart failure.

Idea: Network with peers from other organizations.


PGHD coordinators benefit from peer relationships with colleagues from
other practices who have done this type of work, bringing back lessons
learned and use case ideas, among others.

Include Community Partner Organizations and Agencies


Practices can partner with local organizations such as public libraries and community centers to
offer patients PGHD education and technical support. Mobile telemedicine technicians (MTTs)
can provide patients with technical support in their homes. Payers may subsidize PGHD devices
and apps. The Federal Communications Commission supports several programs intended to
subsidize access to mobile devices and broadband connectivity for eligible patients.

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FOLIO 3
Assembling a Team to Manage Change

Partnering with local organizations and stakeholders has demonstrated long-lasting health
benefits to diverse groups of patients. For example, one study partnered with local barbershops
to support blood-pressure reduction among Black male barbershop patrons. This collaboration
resulted in significant blood-pressure reduction when coupled with medication management
by specialty-trained pharmacists. 33 This is one creative partnership your organization could
consider to strengthen your PGHD implementation and patient engagement.

Idea: Get insight from external partners.


Consider inviting external partners, such as representatives from your
EHR vendor, medical device vendors, payers, and interested community
stakeholder organizations to join your PGHD program planning and
implementation team. Partners from organizations in your community, such
as the library or public health department, might be able to partner with
you to ensure health equity is a part of your PGHD implementation.

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FOLIO 3
Assembling a Team to Manage Change

ACTIVITY 3.1: Assemble Your Team of Champions


Using the form below, enter the name of each champion in the provided blank. This is a
comprehensive list intended to accommodate the wide variation in size and scope across
ambulatory care practices. For smaller practices, individuals may assume multiple roles
and responsibilities among those identified here.

Modify responsibilities to fit your practice needs, structure, and resources and choose
champions from this list to form your core PGHD workgroup.

Instructions: Type names directly into the field or print to handwrite. Click the checkbox to
indicate if this person(s) is a member of the core PGHD workgroup.

PGHD COORDINATOR

Name: 
Core workgroup member

• Recruit and align stakeholders.


◦ Support and manage team of PGHD implementation champions.
◦ Help team effectively use QI and change management frameworks.
◦ Provide structure to set program goals and measures of success.
◦ Track key decisions, action items, and progress on meeting goals.
◦ Help the team apply performance measure data to inform decisions and plans.

• Provide critical project management support.


◦ Take user-centered approach to PGHD implementation, clinical decision support,
data visualization solutions, and workflows to ensure clinicians and patients have
the right data at the right time.
◦ Serve as a point of contact for patients and staff participating in the design and
implementation of the PGHD program.
◦ Manage the team’s overall work, including scheduling meetings, taking minutes,
managing timelines and budgets, and activities.
◦ Manage the implementation and ongoing monitoring of this improvement effort.
◦ Manages staff and patient PGHD education, technical support,
and troubleshooting.

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FOLIO 3
Assembling a Team to Manage Change

• Develop cultural norms.


◦ Build a library of clinical evidence for the value and necessity of PGHD.
◦ Encourage staff to use PGHD in their own care.
◦ Normalize PGHD as integral to routine care.
◦ Standardize PGHD implementation trainings, practices, and messaging across
the practice.

• Build policies and workflows.


◦ Define terms of use for PGHD.
◦ Establish processes for reviewing PGHD data uploaded into the EHR and
responding in a timely fashion.
◦ Design, test, and refine workflows for—
▪ Gathering patient consent.
▪ Prescribing PGHD devices and apps from a digital formulary.
▪ Validating PGHD tools and devices.
▪ Setting patient PGHD safety ranges.
▪ PGHD triage and response.
▪ PGHD applications in care management.
◦ Develop documentation to support workflows with clear protocols and policies.

• Organize staff training.


◦ Develop and updates trainings for staff, patients, and their families.
◦ Increase staff familiarity with devices and methods for PGHD integration into
the EHR.
◦ Ensure support staff is familiar with how patients experience PGHD interfaces.
◦ Coach staff on specific PGHD implementation.

• Track rates of PGHD uptake and patterns of use.


◦ Report data from the EHR, patient surveys, and other sources to monitor the
frequency and consistency of the data uploaded into the EHR by patients.
◦ Track PGHD implementation performance metrics and provide progress reports.
◦ Monitor clinicians’ review of PGHD, including timeliness and frequency.

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FOLIO 3
Assembling a Team to Manage Change

CLINICAL CHAMPION(S)

NOTE: Include clinicians and clinical support staff involved in PGHD implementation in your
practice. (e.g., physicians, physician assistants, nurse practitioners, nurses, care managers,
clinical pharmacists, medical assistants)

Name: 
Core workgroup member

• Identifies clinical use cases for PGHD.


• Build a library of peer-reviewed clinical evidence to support PGHD implementation.
• Establish clinical criteria for PGHD triage and interpretation.
• Inform PGHD implementation policy, protocols, and data governance with
clinical considerations.
• Participate in selecting a digital formulary of preferred PGHD devices, tools, and apps
• Consult on PGHD implementation workflows.
• Prescribe PGHD to patients.
• Communicate the value and necessity of PGHD in quality routine care.
• Engage and seek feedback from colleagues.
• Consult with informatics champion to determine goals for data visualization to support
point-of-care decision making.

PATIENT(S)

NOTE: Include patients from your patient and family advisory council, if applicable.

Name: 
Core workgroup member

• Serve as a voice for patients and patient experiences.


• Advocate for features and functionalities patients want and need.
• Participate in piloting and critiquing PGHD implementation from the patient perspective.

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FOLIO 3
Assembling a Team to Manage Change

QUALITY REPORTING CHAMPION

Name: 
Core workgroup member

• Ensure your practice meets PGHD implementation reporting requirements for regulatory
programs, certifications, alternative payment programs (e.g., patient-centered medical
home recognition, uniform data system reporting, accountable care organizations).
• Monitor for opportunities to participate in PGHD implementation incentive programs.
• Partner with EHR vendors to automate PGHD-related data capture for reporting purposes.

INFORMATION TECHNOLOGY CHAMPION

Name: 
Core workgroup member

• Assess bandwidth and equipment needs in various settings (e.g., exam room, remote
office, patient home).
• Consult on technology solutions and equipment vendors.
• Install, configure, test, and maintain PGHD implementation hardware and software.
• Support patients with initial setup/validation/calibration for prescribed remote monitoring
devices, fitness trackers/wearables.
• Assist with staff and patient PGHD implementation training and troubleshooting.
• Coordinate with MTT assisting patients in their homes.
• Work with EHR vendor to ensure interoperability for seamless, bidirectional
PGHD exchange.

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FOLIO 3
Assembling a Team to Manage Change

INFORMATICS CHAMPION(S)

Name: 
Core workgroup member

• Partner with clinicians and the EHR vendor to automate clinical criteria for PGHD triage.
• Design effective dashboards or data visualization tools to present the right PGHD at the
right time to inform clinical decision making.
• Work with clinician champion to Identify segments of the patient population that are good
candidates for PGHD.
• Participate in developing solutions to streamline interoperability between PGHD devices
or apps and the EHR (e.g. SMART on FHIR APIs, SMART Markers). See the following sidebar
for more information.
• Communicate the importance of ingesting PGHD as discrete data elements rather than
free text.
• Advocate for standardized codes for PGHD-related services and procedures (e.g., CPT,
SNOMED, LOINC).

SMART Health IT

SMART (Substitutable Medical Applications, Reusable Technologies) on FHIR


(Fast Healthcare Interoperability Resources) APIs (Application Programming
Interfaces) bridge health IT applications with various EHRs through an
open, standardized platform that leverages reusable interface components
already built into an EHR. 34 By using the FHIR data standard to enhance
interoperability, applications using SMART on FHIR can securely deploy
within any EHR.
Built off the SMART on FHIR specification, SMART Markers is a mobile device
software framework for the capture and submission of PGHD such as PROs,
health tests, and measurements. By streamlining interoperability, SMART
Markers stand to improve PGHD app end-user experience for both patients
and clinicians. 35

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FOLIO 3
Assembling a Team to Manage Change

BILLING/FINANCE CHAMPION

Name: 
Core workgroup member

• Stay current on PGHD billing and reimbursement policies and rates (local, regional, State,
Federal, CMS, Medicaid, private payer).
• Ensure billing codes and modifiers (e.g., ICD-10, CPT, SNOMED, LOINC) are optimized for
reimbursement and data collection purposes.
• Track PGHD-related costs, fees, penalties, incentives, revenue and variable
financial dynamics.
• Monitor for PGHD implementation incentive opportunities with private payers or
major employers.
• Project PGHD implementation return on investment (both revenue and cost savings).

LEGAL CONSULTANT

Name: 
Core workgroup member

• Ensure legal and regulatory compliance with Federal, State, and payer guidelines.
• Vet vendors and providers; negotiate and manages external contracts.
• Oversee Business Associate Agreements and Data Use Agreements with contracted device
and app vendors.
• Review liability and cybersecurity issues related to PGHD implementation.
• Advise on top-of-license clinical support staff functions related to PGHD implementation.
• Consult on legal aspects of PGHD implementation policies, protocols, and workflows.

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FOLIO 3
Assembling a Team to Manage Change

EXECUTIVE SPONSOR/OPERATIONS CHAMPION

Name: 
Core workgroup member

• Liaise between executive leadership and PGHD Implementation Team of Champions.


• Advocate for PGHD implementation resources and policies.
• Tout benefits of PGHD implementation from C-suite standpoint.
• Facilitate cultural acceptance/normalize change/leadership buy-in.
• Create budget and projections for maintenance and growth.
• Ensure staff and patients have appropriate hardware, software, infrastructure and capacity
to collect, transmit, interpret, and store PGHD.
• Support processes that fulfill needs for quality reporting.
• Partner with organizations to assist patients facing barriers to using PGHD.

EHR VENDOR REPRESENTATIVE

Name: 
Core workgroup member

• Partners with clinicians, informaticists, and IT specialists to pair existing and native EHR
features to support clinical use cases for PGHD implementation.
• May offer a menu of proven interoperable PGHD apps and devices
(e.g., SMART on FHIR gallery).
• May offer “plug and play” PGHD kits with one or more devices tailored to specific
clinical applications.
• May offer solutions to ingest or translate PGHD in languages other than English.
• May offer staff technical training and support.
• May offer patient education and technical support.

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FOLIO 3
Assembling a Team to Manage Change

COMMUNITY PARTNER OGRANIZATIONS AND AGENCIES

List potential partner organizations and agencies:

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FOLIO 3
Assembling a Team to Manage Change

ACTIVITY 3.2: Assemble a PGHD Workgroup


Fill in the table with the core members belonging to your PGHD workgroup. Core
workgroup members will work together to coordinate and facilitate planning and
implementation.

Your core workgroup may include a mix of champions and other representatives who
will support your PGHD implementation.

Instructions: Type names directly into the field or print to handwrite.

CORE PGHD WORKGROUP MEMBERS

Executive Sponsor: 

PGHD Coordinator: 

Patient Representative(s): 

Practice Manager/Operations: 

Quality Reporting: 

Health IT: 

Billing/Finance: 

Other: 

Other: 

Integrating Patient-Generated Health Data into Electronic Health Records in Ambulatory Care Settings: 42
A Practical Guide
Integrating
Patient-Generated Health Data
into Electronic Health Records
in Ambulatory Care Settings:
A Practical Guide

FOLIO 4: Making the Right PGHD


and Information Technology
Decisions for Your Practice
FOLIO 4
Making the Right PGHD and Information Technology Decisions for Your Practice

Estimated reading time: 11 minutes

IN THIS FOLIO
Key Learning Concepts
• Identify information technology best suited to your PGHD implementation.
• Legal, compliance, and security factors must be considered ahead
of implementation.
Active Learning Exercises
• ACTIVITY 4.1: Roadmap to PGHD Implementation: Key Health IT, Legal,
Compliance, and Security Considerations

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FOLIO 4
Making the Right PGHD and Information Technology Decisions for Your Practice

Choose Information Technology


that Meets Your Needs
Your practice has choices to consider concerning the devices and instruments to use
in your PGHD program. A good place to start is with your EHR and your EHR vendor.

Reach out about the following:

Compatibility With Your EHR


As described in Folio 1, there are various types of PGHD and different ways to get these data
into your EHR. Which types of PGHD are ingestible into your EHR? Determine the types that
are supported, how these data are ingested or entered into the EHR, and how these data
populate (e.g., discrete fields, text data). Which digital PGHD devices, apps, and
smartphone operating systems are most compatible? Compatibility should be assessed for
devices in terms of whose products produce data that can be easily integrated into the EHR
via the patient portal.

EHR functionality for visualizing PGHD


Determine which native PGHD integration features are included in your EHR package,
such as visualizations and flagged data elements. Does your EHR have built-in dashboards,
graphs, pie charts, or other data visualization tools to help clinicians more efficiently
interpret PGHD? Are there PGHD data visualization solutions available to help patients use
their own data to better manage their health?

Building your own customizations


You may want to talk with your EHR vendor about developing customized ways of ingesting
PGHD and displaying these data on dashboards for viewing PGHD in the patient chart. If you
want to pursue a custom build, find out how long it will take and what costs are involved.
If your practice has a vendor relationship with a population health aggregator, consider
reaching out about visualization options.

Cost
Whether you would like customization or not, be sure to talk with your EHR vendor about
cost, as functions related to integrating PGHD into your EHR are likely to have a cost. See
Folio 5: Evaluating the Costs of PGHD Implementation for more information.

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FOLIO 4
Making the Right PGHD and Information Technology Decisions for Your Practice

Selecting Devices for Your PGHD Program


By consulting with your EHR vendor to identify the best device options for your EHR, you will
narrow your range of options. You may want to test some sample devices to compare quality,
costs, usability, and functionality on different mobile devices, such as iPhone and Android
smartphone platforms. Your selection decisions should also be informed by the following
considerations. For specific considerations, see Activity 4.1

Tip: The good news is that you do not have to do all this research and
testing yourself. Some EHR vendors furnish PGHD device kits tailored to
specific clinical conditions. There are also third-party vendors who offer
PGHD packages and/or facilitate EHR integration. Identifying these available
options will significantly lighten your workload.

Pathways to PGHD Integration into the EHR


PGHD integration is often complex and dynamic. Some vendors facilitate the integration of
data into the EHR directly, while others may require the use of a third-party aggregator that
accepts the PGHD data from devices and prepares the data for upload. Additionally, the patient
portal may be utilized for patient identification and other communications. Figure 1 illustrates
a simplified connection network that PGHD might follow between the patient’s device (or app)
and the EHR.

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FOLIO 4
Making the Right PGHD and Information Technology Decisions for Your Practice

Figure 1. Simplified Connection Network Between a Device and the EHR

Patient
PGHD Source Device
(& Device
App)

API

Mobile
Third-party Data
Health API
Vendor Aggregator
App(s)

API API

Clinic Patient
EHR
Portal

Simplified map of possible connections for interfaced PGHD data


from measurement device to the EHR.
*API (Application Programming Interface) typically used for connection.

Carefully Evaluate PGHD Apps, Devices, and Instruments

There are a staggering number of consumer health apps. Some of these


apps meet the FDA’s definition of a medical device. The majority of mHealth
apps are not regulated at all. Some meet HIPAA compliance for security and
privacy, but most do not. There are currently two smartphone operating
systems—Apple iOS and Android—that can facilitate seamless interoperability
between many mHealth apps and various EHRs. Further, some apps collect
PGHD as free text, and others collect responses as discrete data elements.

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FOLIO 4
Making the Right PGHD and Information Technology Decisions for Your Practice

Consider Your Approach to Patients Choosing Their Own Devices


Another key consideration is whether your practice is open to a “bring your own device” (BYOD)
model in which patients may use the device or app of their choosing for integrating PGHD
into your EHR. BYOD offers patients the advantage of flexibility and fosters a patient-centered
approach. On the other hand, a BYOD model may make it more challenging to ensure data
quality and seamless integration into the EHR.

Be mindful of scenarios that call for multiple devices. This will increase the complexity for both
your practice and your patients. For example, while kits of devices can be helpful for patients
to track COVID-19 symptoms (digital thermometer, blood pressure cuff, and pulse oximeter)
or diabetes (wireless glucometer, blood pressure cuff, and weight scale), they also require
sophisticated patient tracking of data from each device and a more complex and timely process
for uploading data via the portal for each device.

Idea: Use a digital formulary.


Consider using a digital formulary of validated devices and screening
instruments for certain types of PGHD, such as a specific wireless
glucometer that is an FDA-regulated medical device used to help manage
diabetes; and also allow patients to use unregulated consumer mHealth
apps to track calories, sleep patterns, or moods.

Tip: Start a patient lending library of devices, such as validated wireless


blood pressure cuffs, glucometers, and pulse oximeters, to address
potentially prohibitive equipment costs for some patients.

Legal, Compliance, and Security Frameworks


Developing a legal, compliance, and security framework within which to operate your PGHD
program is key for your executive team. Because Federal, State, and payer policies are
continually evolving, this section summarizes just what we know today. You can leverage
your stakeholders, staff, and external partners to help keep your practice up-to-date on new
developments in these areas.

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FOLIO 4
Making the Right PGHD and Information Technology Decisions for Your Practice

Practice-Level Policy and Protocols


Your practice may want to pay particular attention to the legal and financial policies that
may impact the use of PGHD in your practice, as well as rules pertaining to the security and
privacy of data moving from the patient to the practice.

Legal and Compliance Considerations


Ideally, a designated staff member or a contracted expert will be available to review
all policy and protocols for compliance with regulatory requirements such as HIPAA
requirements. Adhering to legal and regulatory requirements will protect your practice from
reprimands, fines, or reputational damage. Continually evaluate your PGHD project against
current and upcoming local, State, and Federal changes.

Provider-Level Medical Insurance


Another consideration for PGHD integration is practice- and provider-level medical
insurance. Be sure to check that your insurance covers any liabilities from PGHD use for
clinical care, including cybersecurity coverage.

Consent
Finally, work with your legal and compliance team to ensure that proper consent is collected
from adults and minors with respect to PGHD. For example, the Children’s Online Privacy
Protection Act requires parent or guardian consent before collecting personal identifiable
information from patients under 13 years of age. 36

Legal and Compliance Resource

Center for Connected Health Policy

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Data Governance
Establishing a data governance plan will help you build an organization-wide framework of
policies and standards to manage and protect your health information data assets. 37 A data
governance plan can also help you inform policies and protocols to establish your practice’s
response time to address abnormal PGHD values. It will also help your practice set patient
expectations about such things as terms of use for PGHD in clinical care, turnaround time for
communications, and instructions for urgent or emergent symptoms related to PGHD.

Consider building a data governance framework that can help your practice with the
following topics:

Patient Consents
It may be necessary to obtain signed privacy and security consent forms from your patient
population. For example, rules for collecting and sharing PGHD may differ for pediatric
patients with type 1 diabetes using continuous glucose monitors compared to adult
hypertension patients uploading information into their patient portal.

EHR Ingestion
Your practice may find it useful to set parameters around how often certain types of PGHD
should be ingested into the EHR. PGHD may be collected and transmitted daily, weekly,
or monthly. Devices such as heart monitors can transmit data every few seconds. In such
instances, data governance may help determine the binning algorithms to manage large
volumes of data. Ensure that data do not become too abundant and indigestible to the
clinical care teams.

Data Quality
In the context of PGHD integration into the EHR, data governance can help ensure that
PGHD are reliable, validated, timely, and clinically actionable. It may determine how often
your practice sends PGHD requests, PRO surveys, or other prompts for patients to provide
PGHD. Your data governance plan can include specifications for the length of survey
instruments and free text data elements.

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Use of PGHD within the EHR


Your data governance plan can frame decisions about how your practice uses such things as
automation to streamline processes, data visualization, and data aggregation—potentially
from multiple sources—to help clinicians efficiently parse out the most significant data and
trends for clinical decision making. What is the ideal data density to ensure clinicians do not
miss key indicators? How might these parameters vary between patients?

Privacy and Security


Concerns about patient privacy and security surround PGHD. All data are subject to security
risks. PGHD have unique vulnerabilities to consider when integrating them into the EHR. This
includes the transmission of the data, reliance on vendors, device management, and use of
cloud-based services. A security breach could compromise the integrity of the data and subject
patients to data theft. It is a good idea to rely heavily on your health IT expert to continually
monitor the integrity of these processes while ensuring that patients upload their data
exclusively through the patient portal or secure application programming interface (API).

Federal and State regulatory oversight may become more standardized as broader adoption
grows, particularly pertaining to consumer health devices. In the meantime, it can be difficult to
assure patients, clinicians, and practices that PGHD are private and protected. This is what we
know so far.

HIPAA
The Health Insurance Portability and Accountability Act of 1996’s (HIPAA) Privacy and
Security Rules apply to PGHD when data become part of your practice’s health record.
PGHD should be de-identified in transit, which flow from the patient’s device, often via
multiple intervening connections into the practice’s EHR. Because the practice cannot
control each step of this process, it is crucial to seek HIPAA-compliant vendors and platforms
that perform privacy and security measures such as encryption. As noted by the Office of
the National Coordinator for Health Information Technology (ONC), prior to reaching the
EHR, PGHD are open to higher security risk because they are not necessarily protected
by the same HIPAA regulations, potentially increasing their vulnerability to cyber threats
and breaches. 38

To comply with HIPAA regulation, it is prudent to work with your practice’s security and IT

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staff to ensure safe transit of PGHD into the EHR through appropriate physical, technical,
and administrative safeguards.

Tip: When using third-party vendors that will handle protected health
information, use a Business Associate Agreement to stipulate that security
and privacy practices of the vendor uphold HIPAA regulations.

Idea: Bolster your data security with available resources.


SMART on FHIR technology, validated devices, and vetted third-party
vendors help to protect your practice from increased risk. Use of the
patient portal and certain APIs can be part of your practice’s data
security approach.
Beyond your efforts to secure data transmission, you may also consider making patients
aware that cyber threats are a possibility that increases with device software maintenance
and third-party management of devices and apps. Educating your patients about these risks
and the measures they can take to minimize them can significantly reduce the likelihood of a
security breach.

Addressing Common Misunderstanding


of Data Security Among Your Patients

Patients sharing PGHD may have a limited or incorrect understanding of


when data about their health are protected by law, and when they are not.
For example, they may incorrectly think HIPAA provides standards for privacy
and security in all contexts, where no such universal protections exist. They
also might not know that HIPAA-covered entities such as a health practices
cannot share patient data without their consent unless it is for treatment,
payment, or other exceptions. 39 It is important to make sure patients
understand how their data will be used, who will have access to it, and what
protections exist.

Because the legal and policy environment around PGHD continues to evolve, practices with the
capacity may consider assigning a staff role to monitor new developments in this area that may
affect your programs and patients.

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Making the Right PGHD and Information Technology Decisions for Your Practice

Tip: Leverage your stakeholder group for guidance and assistance. Convene
representatives from the clinical team, patients, support staff, and legal and
compliance to review your protocols and practices and look for gaps.

PGHD Privacy and Security Resources

Department of Health and Human Services (DHHS) Health Industry


Cybersecurity Practices: Managing Threats and Protecting Patients
DHHS HIPAA and Health Apps
Office of the National Coordinator for Health Information Technology (ONC)
and HHS Office for Civil Rights (OCR) SRA Tool
Xcertia mHealth App Guidelines
National Institute of Standards and Technology (NIST) Guidelines:
https://www.nist.gov/programs-projects/security-health-information-
technology
https://www.nccoe.nist.gov/sites/default/files/library/sp1800/rpm-nist-
sp1800-30-2nd-draft.pdf
https://www.nccoe.nist.gov/healthcare/electronic-health-records-
mobile-devices

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FOLIO 4
Making the Right PGHD and Information Technology Decisions for Your Practice

ACTIVITY 4.1: Roadmap to PGHD Implementation:


Key Health IT, Legal, Compliance, and Security Considerations
Use the following list of key considerations to guide decision making and identify
potential gaps in your PGHD program implementation.

These considerations will help form your customized roadmap to implementation and assist
your work in Folio 6, Activity 6.1: Bringing It All Together: Your PGHD Implementation.

Instructions: After each consideration, use the form field to record notes. Type directly into
the field or print to handwrite.

HEALTH INFORMATION TECHNOLOGY DECISIONS

Device Considerations

• Will you permit a BYOD model?

• Will you standardize a formulary of validated devices, screening instruments, and apps?

• Who manages the devices—the patient, the vendor, or the clinic?

• Will devices be bundled as part of a kit tied to a clinical focus?

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• Does your EHR permit multiple device inputs for one patient?

Device Selection

• How will devices be integrated with the smartphone, computer, apps, and the EHR?

• Do devices connect via Bluetooth or a wireless network?

• Which devices work equally well on both iPhone and Android phones?

• Have devices been validated for accuracy? Can you locate evidence from the device
vendor or elsewhere that demonstrates that the data collected are accurate?

• Do your payers have specific requirement for device use linked to reimbursement? For
example, as of 2021, Medicare requires that medical devices supplied to patients for
remote physiologic monitoring services are valid, reliable, and meet FDA criteria.

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Making the Right PGHD and Information Technology Decisions for Your Practice

PGHD INTEGRATION INTO THE EHR CONSIDERATIONS

• What kinds of PGHD will you bring into the EHR?

• Which types of devices, mHealth apps, or interfaces do you intend to support?

• How are devices validated?

• Which staff will manage PGHD to EHR integration workflows?

ADDITIONAL CONSIDERATIONS

• What types of data can be ingested via your health information exchange?

• Which digital interfaces are compatible with your EHR?

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• What kinds of digital visualization tools or dashboards might you use to interpret and
monitor PGHD values? Might these data visualization tools have applications for
patient education?

LEGAL, COMPLIANCE, AND SECURITY FRAMEWORKS

Legal Considerations

• Does monitoring the PGHD to be collected during the PGHD implementation require
additional medical liability coverage?

• What are the Federal, State, regional, and local regulations and policies governing the
PGHD to be collected in the implementation?

• How do you collect consent from adult patients?

• How do you collect consent from pediatric patients?

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Data Governance Considerations

• Have you developed criteria to ensure data are clinically relevant, valid, accurate,
and timely?

• Have you established safety ranges tailored to each patient?

• Can you automate methods to flag clinically significant data; parse signal from noise?

• Can you trace provenance of data (i.e., what is the data’s origin and what steps took place
for it to reach its destination)?

• Where do you house data in the EHR?

• Can you support active and passive PGHD integration?

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• Can PGHD integration be independent of the patient portal?

Policy and Protocol Considerations

• What legal, regulatory, clinical, technological, patient safety, and communications policies
and protocols need to be in place?

• What are the expectations and obligations for clinicians to respond to passive/continuous
PGHD with abnormal values?

• How will patients reporting PGHD with abnormal values during off hours be managed?

• What is the course of action if a patient sending abnormal results does not respond
to outreach?

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Making the Right PGHD and Information Technology Decisions for Your Practice

Privacy and Security Considerations

• What issues might arise regarding patient privacy?

• How might PGHD integration into the EHR increase vulnerabilities to cyberattacks?

• What mitigation steps should be taken?

• How will you educate your patients about their protections under HIPAA?

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FOLIO 5: Evaluating the Costs


of PGHD Implementation
FOLIO 5
Evaluating the Costs of PGHD Implementation

Estimated reading time: 9 minutes

IN THIS FOLIO
Key Learning Concepts
• Identify factors that will influence your program’s financial sustainability.
• Develop a budget to implement, grow, and sustain your program.
• Estimating initial and ongoing costs.
• Identify sources of funding and cost savings.
Active Learning Exercise
• ACTIVITY 5.1: Roadmap to PGHD Implementation:
Key Financial, Reimbursement, and Reporting Considerations

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FOLIO 5
Evaluating the Costs of PGHD Implementation

This folio will help you consider the financial costs and potential gains of your PGHD program.

Beginning with broader factors such as billing, reimbursement, return on investment (ROI), and
funding sources that will impact your program, the remainder of the folio offers guidance on
how to estimate the initial costs associated with PGHD implementation, as well as resources
needed to maintain your PGHD program in the future.

As you read through this folio, keep in mind that PGHD program implementation is an
organizational change that will involve all aspects and people in your practice. Work with your
team to identify all of the different resources and staff support that you will need to get PGHD
implementation off the ground.

Big Picture Factors that Influence Your Program’s


Financial Health
Billing and Reimbursement
Historically, many PGHD-related clinical activities are not billable, and reimbursement
rates for the PGHD activities that are billable do not generate enough direct
revenue to offset costs. However, as digital healthcare solutions become more
commonplace reimbursement for PGHD-related activities is increasing. Federal and
State laws continue to evolve, particularly those that may cement payment parity for
virtual care.

Medicare
Since 2018, the Medicare Chronic Care Management (CCM) program has reimbursed providers
and care managers for collecting and interpreting PGHD in the management of hypertension,
diabetes, asthma, and several other chronic diseases. 40

The Medicare physician fee schedule for calendar year 2021 41 finalized reimbursement policies
for remote physiological monitoring (RPM) services performed by both physicians and non-
physician providers (NPP). These services may be medically necessary for acute care as well as
managing chronic conditions.

Devices patients use for RPM services must meet the FDA’s definition of a medical device. The
patient must collect and transmit their PGHD electronically. These rules go into effect after the
COVID-19 Public Health Emergency ends.
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Medicaid
According to a 2021 survey conducted by the Center for Connected Health Policy (CCHP),
Medicaid programs in 26 States reimburse for remote patient monitoring. 42 Policies and rates of
reimbursement for PGHD services vary widely from State to State. The CCHP updates its online
State Telehealth Laws and Reimbursement Policies report twice per year. 43

Private Insurance
A growing number of private insurers offer subsidized fitness trackers and digital medical
devices to incentivize participation in individual or employer-sponsored fitness and
wellness programs. Many are also beginning to cover the use of RPMs to support chronic
care management.

Your team’s billing and reimbursement champion might investigate the opportunities to bill for
services related to PGHD implementation. It will be crucial to determine the reimbursement
rates for those services and restrictions tied to reimbursement. For example, reimbursement
might be contingent on whether the service is rendered by a physician or NPP. It may depend
on the particular device or app the patient uses to collect and share their PGHD. Your practice’s
payer mix will help guide where to focus research.

Explore Other Sources of Funding


Consider investigating other funding options that may supplement your program:

• Federal incentive programs designed to enhance interoperability.

• Federal, State, and local government agencies that may offer grant opportunities to
support PGHD implementation.

• Collaborative relationships with community partners involved in conducting PGHD


research or developing affiliated services to fund some of your PGHD activities.

• Funding from private foundations, including companies that manufacture PGHD devices
and apps.

• Discount programs or price breaks may be available. For example, inquire with your EHR
and medical device vendors about PGHD on large volume purchases of equipment or
software licenses.

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Evaluating the Costs of PGHD Implementation

• Risk-sharing models or other value-based payment ideas with local payers and healthcare
organizations. Such funding arrangements may provide incentives to integrate PGHD to
improve care outcomes.

Return on Investment
ROI is a common analysis to gauge value. There are multiple ways to look at the financial ROI for
PGHD programs in your practice. The billing and reimbursement champion on your team will be
able to provide information about the payer rates of reimbursement for various PGHD related
services. These figures can be used to develop projections for future PGHD-revenue streams
based on anticipated billing volume.

At present, rates of reimbursement are relatively low and will likely not offset all costs related
to your PGHD program. As this changes, consider the indirect cost savings generated by a
PGHD program.

Estimating Indirect Cost Savings


If you have access to claims and/or EHR data and an expert data analyst, you may be able to
guestimate some indirect cost savings. To do this, you may consider conducting some before
and after comparative analyses of patients participating in your PGHD program on such topics
as healthcare utilization and costs. Ideas you might investigate include the following:

• Frequency of in-office appointments and canceled appointments.


• Increased patient engagement and retention. 44 45
• Better patient self-management and health outcomes.
• Fewer missed appointments.

In addition, systemic cost savings related to PGHD integration may be possible. 46 Work with
your payers to determine if there are shared benefits for your practice.

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Incentive and Quality Reporting Programs


Many ambulatory care practices participate in quality reporting or incentive programs that
include metrics on PGHD integration into the EHR.

Examples include:

• Patient-centered medical home (PCMH) certification

• Health Resources and Services Administration (HRSA) Uniform Data System (UDS)
reporting program

• Centers for Medicare and Medicaid Services (CMS) Clinical Quality Measures
(CQMs) program

Regional accountable care organizations as well as certain Medicare services, such as the
Initial Preventive Physical Exam, Annual Wellness Visit, and CCM program, also require
reporting on electronic PGHD integration into the EHR.

Examples of PGHD in Regulatory Reporting

As of 2020, the HRSA UDS Controlling High Blood Pressure measure will
only accept blood pressure readings collected by a clinician or a remote
monitoring device. This UDS measure aligns with CMS clinical quality
measure CMS165.
Under the Medicare Access and CHIP Reauthorization Act of 2015, CMS
established a pair of payment structures to support RPMs. xv Eligible
clinicians may participate in Medicare fee-for-service activities that reward
use of PGHD through the Merit-Based Incentive Payment System (MIPS).
47
Providers exempt from participating in MIPS may choose the Advanced
Alternative Payment Models structure that provides financial incentives for
using PGHD to offer more flexible and timely care that improves outcomes
and reduces costs. 48

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Idea: Identify quality reporting programs with metrics


that may include PGHD
It may be useful for your quality reporting champion to identify your
practice’s reporting programs that include digital PGHD metrics and
the desired thresholds for each of these programs. Factor in this
information as your team engages in writing aim statements and setting
implementation goals.

Develop a Budget to Implement, Grow,


and Sustain Your Implementation
After determining sources of revenue and funding from your PGHD implementation,
it is necessary to evaluate its outgoing costs. To create your budget and projections,
you will need to know associated implementation costs and maintenance fees for
integration of PGHD into your EHR. These costs will vary depending on your practice,
vendors, and choices. Examples of questions to ask your EHR vendor are offered in
Folio 4. These questions will help you determine which PGHD devices and apps are
compatible with your EHR, if there is another vendor (third-party) involved in PGHD
integration with your EHR, and if your EHR vendor offers end-to-end support for
certain PGHD medical devices or apps.

Use the following section as a guideline of considerations as you build the budget for your
PGHD program.

Considerations for Your Cost Spreadsheet


When developing your cost spreadsheet for your PGHD program implementation, consider
expenditures associated with your EHR, third-party device vendors, data aggregator, staffing,
communications, and operations. The following lists provide examples of the types of costs you
may want to account for when building out your budget. For each item, there may be initial
costs, as well as those associated with scaling and/or maintaining your PGHD program in the
long term. These are broken down into initial costs and ongoing costs.

NOTE: This list is not comprehensive and will need to be customized to meet the unique needs
of your practice.

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Initial Costs

1. Electronic Health Record


Additional costs may be associated with modifications to your EHR for PGHD integration and
visualization. Talk to your EHR vendor to get an estimate of associated costs for the following:
• Updates, add-ons, and/or custom build for PGHD integration features.
• Data storage.
• Interfaces with application programming interfaces.
• Modules to support connectivity, documentation, visualization and interpretation.
• Fees for device bundles or kits.

2. Third-Party PGHD Device Vendors and Aggregator


Third-party PGHD device vendor and aggragator costs may include:
• New purchases of hardware and/or software.
• Workstation upgrades.
• Tablets.
• Devices.
• Software licenses.

3. Staffing
Consider if you have the capacity and expertise on staff to lead the PGHD implementation in-
house, or whether your will contract with a consultant. If the latter, you will need to estimate
consultant time and costs.
Staffing costs may include:
• Dedicated planning, testing, and implementation time.
• New roles added to staff model (i.e., PGHD Program Manager).
• Development and delivery of staff training.
• External contracts.

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4. Communications
Consider the costs associated with building your communications plan regarding PGHD
implementation and use. Communications will likely be targeted to practice staff and patients.
Examples of communications activity costs include:
• Patient-facing campaign to tout benefits and boost uptake of PGHD.
• Patient instruction materials in a variety of media and languages.
• Writing and publicizing success stories to gain PGHD implementation support.

Idea: Leverage experts to maximize reimbursement.


Some of these new costs might be offset by reimbursement. Engage the
people in your organization with policy, reimbursement, and/or practice
transformation expertise to assist with understanding these reimbursement
opportunities. If you organization does not have this expertise in-house,
consider identifying someone, such as a consultant, to help you taking
advantage of all reimbursement opportunities available.
Ongoing Costs
There will be ongoing operational costs associated with your PGHD program that should be
factored into longer-term budgets. These items will vary from practice to practice.
Examples include:
• EHR costs associated with maintenance and sustainability.
• Software and hardware upgrades.
• Per-transaction fees.
• Annual licensing fees and costs.
• Device replacements or upgrades.
• Refresher staff training courses.
• Periodic updates to communication materials.

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Idea: Plan ahead for ongoing costs and reducing clinician burden
Consider including lines in your budget for ongoing staff training on evolving
PGHD implementation best practices or scaling up your program. Your
financial champion may also want to consider the financial implications of
strategies to relieve clinician burden such as:
• Using clinical support staff working at the top of their licenses.
• Using triage pools to monitor and flag PGHD coming into the EHR.
• Developing algorithms and data visualization tools to efficiently use
PGHD for clinical decision making.

Your practice may benefit from coordinating with other like practices engaged in PGHD
integration, including possibly sharing PGHD coordinators across practices to help you build on
and implement learnings from your peers. You may also consider engaging medical societies
who can connect you to resources and other practices doing similar work. Finally, you may even
be able to engage students from local colleges and universities to aid your practice in the design
and/or evaluation of your new program.

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FOLIO 5
Evaluating the Costs of PGHD Implementation

ACTIVITY 5.1: Roadmap to PGHD Implementation:


Key Financial, Reimbursement, and Reporting Considerations
Use the following list of key considerations to guide decision making and identify
potential gaps in your PGHD program implementation.

These considerations will help form your customized roadmap to implementation and assist
your work in Folio 6, Activity 6.1: Bringing It All Together: Your PGHD Implementation.

Instructions: After each consideration, use the form field to record notes. Type directly into
the field or print to handwrite.

BILLING CONSIDERATIONS

• Which types of PGHD activities are billable and reimbursable?

• For billing purposes, does it matter which clinical role performs various aspects of
the work?

• Do payers subsidize devices that generate PGHD?

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FINANCIAL CONSIDERATIONS

• Do reimbursements for billable PGHD-related activities adequately offset costs/staff time?

• Will your practice create a loaner library to assist patients unable to afford
validated devices?

REPORTING CONSIDERATIONS

• Which PGHD might be useful to capture for quality reporting or incentive programs?

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FOLIO 6: Steps to Successfully


Implement a PGHD Program
FOLIO 6
Steps to Successfully Implement a PGHD Program

Estimated reading time: 20 minutes

IN THIS FOLIO
Key Learning Concepts
• Set realistic and measurable goals.
• Effectively engage your target group of patients.
• Develop a workflow to support staff engagement and program design.
• Learn before scaling your PGHD program.
• Conduct rapid-cycle tests of change and applying end-user feedback.
Active Learning Exercises
• Activity 6.1: Bringing It All Together: Your PGHD Implementation
• Activity 6.2: Set SMART Goals
• Activity 6.3: Develop Workflows
• Activity 6.4: Evaluate and Refine
• Activity 6.5: Scale Up and Monitor

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FOLIO 6
Steps to Successfully Implement a PGHD Program

Developing Your PGHD Implementation


To this point, you have done pre-work in folios 2, 3, 4, and 5 to focus and build your
PGHD implementation. Use the activities at the end of this folio to bring all the
pieces together.

Throughout this folio, an example of a PGHD implementation for patients with uncontrolled
hypertension helps illustrate concepts such as developing SMART goals and using Plan-Do-
Study-Act (PDSA) cycles.

Set Realistic and Measurable Goals for


Your PGHD Implementation
Consider testing your PGHD implementation on a small scale before scaling up to other provider
and/or patient groups. To move forward, it will help to break big goals into smaller parts. We
recommend using the SMART goal framework for this task.

Figure 1. SMART Goals Framework

Specific
What are you trying to accomplish?
Who is responsible?
How will you accomplish it?
Measurable
What quantifiable benchmarks does your project have?
How many or how much?

Attainable/Achievable
Is this goal actually doable within the timeframe?
Do you have the resources needed to reach this goal?

Reasonable/Relevant
What is the benefit of reaching this goal?
Why are you embarking on this project?

Time-Bound
What is your deadline to meet this goal?

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FOLIO 6
Steps to Successfully Implement a PGHD Program

Engage the core PGHD workgroup to set your small-scale PGHD implementation goals and
ensure they are realistic. Collectively determine what success will look like for your practice and
how to quantify it.

The following is an example of a clinical use case being transformed into an implementation
plan using the SMART framework.

The clinic has just been awarded a grant for the purchase of home blood pressure
(BP) devices.

During our first stakeholder meeting, we decided to focus on a select set of hypertensive
patients for our PGHD implementation. We chose hypertension because we have
a large volume of our uncontrolled hypertension patients. We thought we would
try incorporating PGHD in a small subset to see if we could move the needle before
extending this intervention to a larger patient population. We also have a clinician who
is very interested in championing this topic and has energized her team of medical
assistants and the nurse pool about this endeavor.

Our goal is to provide 25 patients with Bluetooth-enabled cuffs to collect blood pressure
readings that will integrate into the EHR within 3 months and then measure our target
population’s pre and BP measurements and their device usage data. We decided to also
conduct post-intervention surveys to assess both the patient’s and staff’s satisfaction
with our implementation. Our stakeholder team will then reconvene to review the
implementation data and discuss next steps. The following example displays this use
case using a SMART framework to support our implementation design and intervention.

A PGHD SMART Framework: Example


S – Specific: Improve BP in 25 patients with uncontrolled hypertension through PGHD.
M – Measurable: Patient BP and BP cuff device usage data are structured and easily retrievable.
Survey responses can be summarized, and comments coalesced into prevailing themes.
A – Attainable: Three months is adequate for our clinic to identify patients, disperse devices,
and train participants. A subsequent 3 months is adequate to capture and review patient data,
schedule followup appointments, assess performance using our metrics, and conduct and
assess surveys.

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R – Reasonable: It is certainly a worthy goal to improve BP in this population and reduce risk
of cardiovascular events. This will also provide valuable insight into the use of PGHD in future
population health initiatives.
T - Time-bound: These are clear and achievable. Six months is a tight cycle, but the program
involves only a small group of staff and patients.

Activity 6.2 will guide you through a SMART goal activity on page 96. Methods and strategies
for evaluation of goals will be discussed in the second half of this folio.

Effectively Engage Your Target Group of Patients


As one of the most important stakeholders in your implementation, it is essential
to prioritize patient engagement with PGHD integration for your initial group and
beyond. Patient input allows you to tailor your program to your patients’ needs.

More information on selecting the initial group of patients to enroll in your program can be
found in Folio 2.

When it is time to engage with your patients for your PGHD implementation, you could collect
information using a patient focus group or through individual patient interviews to hear their
interests, concerns, and questions about the specific project. We recommend asking patients
the following questions as you develop your program.

• What reasons do you have to participate in a PGHD program?

• Do you have the desire to share digital data?

• Do you share data currently, such as bringing in handwritten logs, inputting data into the
portal, or asking about health-related apps or devices?

• From your past experience with illness, what data would have been useful to share with
your medical team?

• Do you have access to reliable internet and/or ample data plans?

• What is your comfort level with technology such as apps and devices?

• What are your communication preferences?

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• In your opinion, would receiving patient digital health data help meet unmet care needs?

• What are your concerns about privacy and security?

• Do you worry about how much added time collecting PGHD will take?

• What else would you like the practice to know about getting digital data from patients?

Idea: Provide training and support before patients use their device.
Before sending patients home with a new device or app, offer opportunities
for training and technical support. Make educational materials available in
a variety of media and languages. Additional considerations should be given
to those with dexterity, vision, or hearing impairments. Understanding
cultural values can be very helpful as well. You might consider non-clinical
resources to engage patients and improve adoption, such as working with
community centers, faith-based organizations, even barber shops. 49

Tip: Some practices have added mobile telemedicine technicians


(MTT) to the care team or contract with third parties that furnish para-
telemedicine services. MTTs travel to the patient’s home to set up and
troubleshoot technology to enable virtual care, including the use of remote
monitoring devices. The MTT serves as an in-person liaison between the
remote provider and the patient. In some models, MTT roles are filled by
telehealth-enabled EMTs. 50

Develop Diagrams and Detailed Workflows


Involving clinic staff in program design is an effective approach to build buy-in and
increase program success. Develop and distribute detailed workflows based on input
from all those impacted.

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Swimlane Diagrams
Swimlane diagrams (also known as flowcharts) can be an effective way to demonstrate
chronology and responsibility. This, combined with adequate time and training, can also
help alleviate staff resistance to change. Each step in a process is identified by which role
is responsible and at what point in the process it occurs. Icons can be used to further
communicate about particular steps in the process, such as where the process starts and
ends, if a decision needs to be made, or if another workflow needs to be referenced or used
in between steps. For more information on how to build and use swimlane diagrams, see
AHRQ’s Workflow Assessment for Health IT Toolkit section on flowcharts.

Figure 2 is an example of a swimlane diagram showing one clinic’s workflow for getting an
integrated device and instructions for use to a patient. Activity 6.3 provides a blank swimlane
diagram to practices thinking through a PGHD process.

Figure 2: Example Swimlane Diagram for Patient Device Workflow

Device Workflow

This workflow describes the process of prescribing, receiving, and registering device for a patient.
July 21, 2021

Attend Receives device Begins


Patient

Sign up for in-person or and prepares to monitoring


patient portal virtual visit monitor per and tracking
with clinician instructions

Verify that Order the Alert support


Clinician

patient is device or make Order device staff that


eligible for referral order monitoring for device is
free device 1 for the device patient portal needed for
from clinic in EHR the patient
Support Staff

Call patient to Send


Click on patient Enter device instructions for
receiving information 2 inform them of
instructions for device use
the device into the EHR through patient
device pick up
portal

1 Devices include blood pressue machine, optimeters, glucose monitors, thermometers, etc.
2 Information includes vendor, serial number, date of distribution, date of mailing, date of patient receipt

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Workflows are Integral to Success


The success of your program hinges on workflows that maximize ease and convenience for
patients and minimize clinician burden by furnishing the right data at the right time to best
inform clinical decision making. Workflows are simultaneously one of the most important
and most challenging components of PGHD integration into the EHR. Workflows should be
considered from the perspective of each stakeholder involved—support staff, clinicians,
patients, and others. It is the workflow that will coalesce the technology, the culture, and the
human factors that can make PGHD integration successful. Clinicians should be involved in
clinical workflow development to address and resolve hesitations around added workload.
While studies show mixed results, it is the hope that PGHD integration lessens clinician burden
rather than exacerbates it.

Learn from Your Experience Before


Scaling Your PGHD Implementation
So far, we have suggested starting with small scalable implementations to rapidly
test change and focusing first on your simplest clinical use case for integrating PGHD
into the EHR. The unique characteristics of your practice and the activities described
in Folios 2, 3, 4, and 5 should have helped you design your implementation. After
implementation, it is time to collect feedback.

Collect Qualitative Input from End Users


While designing your implementation, you probably came up with quantitative goals to use
to evaluate the impact of your program, like measuring blood pressure or HbA1c levels. It is
important to also assess the qualitative impact of your program on both clinic staff and patients.

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Some techniques include—

• Short user experience surveys or focus groups can be used to collect valuable information
about what various end-users like about the PGHD integration process as well as aspects
they would improve. Consider seeking patient input on their experience with the following
topics:

◦ Patients’ ability to easily use and understand the device, including its interface and
language settings.

◦ Ease of uploading patients’ data into the EHR via patient portal.

◦ Frequency with which practices have asked patients to upload data.

◦ Whether patients received timely and comprehensive technical support with


device and patient portal setup.

◦ Patient awareness about how their data are being used at the point of care.

• You may also consider soliciting feedback from all the involved staff members. Examples of
questions you might ask include:

◦ How satisfied are staff with training and onboarding into the program?

◦ How well do workflows deliver actionable data for clinical decision making?

◦ How well do staff understand patient eligibility criteria for participation?

◦ How are those criteria are being using to screen for participation?

◦ How comfortable are staff assisting patients with questions or delegating to


designated technical support staff?

◦ Do staff feel they have the technical skill to locate PGHD data in the EHR and
visually display them in a way that is easy to interpret?

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Idea: PGHD Coordinators can help onboard new clinicians and patients.
If you are a larger organization or plan to apply a PGHD program across
multiple use cases, it may be beneficial to assign distinct PGHD coordinators
to oversee and share responsibility. If you are a smaller organization and
need to assign this role to clinical staff, you may want to monitor how much
time this takes away from patient care. Ideally, your practice can identify
nonclinical technical specialists with the expertise and dedicated time to
focus on supporting patients and clinicians. These technical support staff
may work with clinicians and patients on site, in the clinic, or virtually via
phone or videoconference.

Tip: Ensure training and technical support resources keep pace with
program expansion. Perhaps the most critical piece of scaling up is to
ensure both staff and patients have abundant education to correctly use
PGHD devices, apps, and instruments, as well as knowledgeable and timely
technical support to help troubleshoot when things go wrong. Engaging
care coordinators, home health providers, and community organizations can
be helpful to serve as trainers or coordinators to augment clinic staff.

Rapid-Cycle Testing and End-User Feedback


As your practice tackles each benchmark, it can be helpful to borrow from a quality
improvement framework to observe, learn, and iteratively refine processes through rapid-cycle
testing. Conduct these rapid-cycle tests, such as a PDSA cycle, for only as long as necessary to
see a consistent pattern emerge that can inform next steps. Activity 6.4 offers a PDSA cycle
template that can be used as you evaluate small changes.

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Figure 3. Plan-Do-Study-Act (PDSA) Cycle

• Choose a measurable change you would like to test. Remember to start small. This
can be a minor tweak to a routine process.
• Determine the units of measurement you will use.
• Plan the actions to make this happen.
• Describe why you want to perform this change and what you hope to achieve.

• Carry out your change.


• Collect data for analysis.
• Note pain points.

• Study the data with your team to interpret the impact of the change.
• Identify what you have learned.
• Decide on next steps.

• Apply your learnings to plan your next change cycle.


• If you are satisfied with your results, halt your iterative cycles of change and go
to implementation.

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Let’s continue with the hypertension program example to demonstrate observing, learning, and
refining processes using this framework.

To review, we came up with an implementation plan to provide integrated BP cuffs and


introductory training to 25 patients over the first 3 months, followed by another 3
months of BP recordings, automated support, and periodic check-in phone calls from
the pharmacist. Find more details for this stage of the cycle above on page 76, including
the use of the SMART goal framework to manage goals.

The plan was implemented, and we are now at the 6-month mark. Operational details
for this stage of the cycle can be found on page 76 and 77, including the use of project
management tools such as a Swimlane Workflow Diagram.

We are ready to review the operational, BP, and qualitative survey data.

Operational Data:
• 21/25 patients completed the program, returning their devices and having a post-
intervention visit with the clinician. Two devices didn’t work adequately, one was lost, and
one was broken.

• There were 56 critical alerts from 12 patients; 50 of them were appropriate and responded
to within 2 business days.

• There were 11 alerts that were triggered due to a patient neglecting to indicate on their
smartphone that their medication was taken for 5 days. Upon reaching the patients, they
all reported 100% compliance but forgot about checking off the reminders on their phone.

• The pharmacist had a 40% connection rate with phone calls, averaged 1.8 successful calls
per patient, and connected with 23/25 patients at least once.

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Blood Pressure (Outcome) Data:


• 294 blood pressures were added to the medical record: 31% interfaced and 69% manual.

• 16/21 showed improvement post- vs pre-intervention 3-day average (average


improvement 8.1/3.3mmHg), three mixed, two worse (overall change -5.9/-2.5).

• 11/21 uncontrolled hypertension patients are now controlled.

• Three cases of white-coat hypertension and two cases of resistant hypertension were
added to the problem list.

Survey Data:
• Patient surveys were returned by 19/25 patients. Overall satisfaction score was 4.1/5.
The main barrier identified was difficulty getting the cuff readings to sync with the portal.
Many also found the process a little tedious, especially the educational materials and daily
prompts. Facilitators included the phone calls and the IT help desk.

• Staff surveys were returned by 7/8 staff members and overall satisfaction was 3.9/5. The
main themes identified EHR usability on the plus side and inadequate time to perform
PGHD duties on the minus side.

Though clearly a truncated version of a real evaluation process, the data summary
nevertheless highlights the vital information that can be obtained from the Study
portion of a PDSA cycle.

How might this team act on this information?


• Appreciate the high patient engagement and continue to use phone calls as a way to keep
folks engaged.

• Eliminate the compliance alerts. This is addressed with the phone calls anyway.

• Continue with the critical value alerts, but plan on carving out 30 minutes of protected
time for responses and followup. Look further into the data to see if we can raise the
alert limit.

• Celebrate the BP response, but there are still too many patients with uncontrolled
hypertension. The clinical team will enhance the algorithm, extending the program for
those who were making progress but didn’t reach goal, while removing some of the
automated content found to be more annoying than useful.
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• Chart review of the five patients who had mixed or negative responses.

• Provide patient education and collaborate with their IT team and device vendor to get the
percentage of electronically interfaced BPs over 50%.

Incorporate the suggested modifications and repeat testing for as many cycles as necessary. This
process can be especially valuable to fine tune PGHD integration workflows.

When you are satisfied with the results within the limited group of providers and patients
participating in your implementation, consider replicating it across other groups of providers
and/or patients. This will enable you to validate that your PGHD solution performs well under a
variety of circumstances and settings with different portions of your patient population. Based
on findings from this round of testing, make further modifications as needed. Activity 6.4
provides a blank PDSA template as an option to use in your practice.

Resources for Using PDSA Cycles

There are many resources and guidance on how to carry out PDSA cycles.
Follow these links to learn more.
Institute for Healthcare Improvement (IHI): Science of Improvement: Tips
for Testing Changes
IHI: Why You Should Be Curious about PDSAs
LifeQI: Understanding PDSA Cycles
LifeQI: Benefits of PDSA Cycles
AHRQ: Health Literacy Universal Precautions Toolkit, 2nd Edition
AHRQ: Fillable Plan Do Study Act (PDSA) Tool for Health Care
Quality Improvement (QI)

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Support Staff Awareness Through Training and


Messaging.
Work with members on your team of champions to create documentation, training,
and scripted messaging (discussed in the next section) to support uptake of this
change among staff and patients. You are now ready to spread this tailored instance
of PGHD integration broadly across your practice.

Scale with a Strong Internal and External Communication Plan


A coordinated communications plan customized for your practice will improve the chance of a
successful PGHD implementation. It is also an essential component of a change management
framework. Messaging around PGHD integration can influence attitudes and shape culture.

It begins with your statement of purpose that explains your practice’s rationale for PGHD
integration. Your team’s communications champion might think about creating standard
phrasing to use in staff education and training that focuses on the benefits of PGHD integration
from the perspectives of the staff that might gain from using it in routine care.

Tip: Draw on past experiences developing promotional campaigns for new


technologies and services. For example, your practice might have mounted
a communications campaign to boost the use of your EHR’s patient portal.

Consider creating scripts or talking points that staff can reference when speaking with patients
about the benefits of PGHD integration. These can help prepare staff for fruitful conversations
with patients who approach the care team about using PGHD in their care. Focus on real
benefits patients will experience, such as:

• Collecting PGHD can provide data from your daily life to help your clinician see a fuller
picture of your health.

• PGHD can support your self-management of [condition] and help you feel better.

• PGHD integration makes collecting data easy and convenient.

• We are here to partner with you every step of the way.

Scripting can also offer language that supports new cultural norms. For example, a medical

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assistant might introduce the idea of using a wireless BP cuff to control hypertension by saying,
“Your doctor would like you to try this easier way that we can monitor your blood pressure
together, stay in closer touch, and more quickly make changes to your medications as needed.”

Encourage patients to participate in this new program by using various communication media.
Here are some ideas:

• Create patient messaging that uses consistent language and graphics across multiple
communications channels. These may range from printed patient education brochures and
postcards to online information accessible via the patient portal or direct email messages

Figure 4. Sample Clinic PGHD Postcard and Brochure

• Consider recording phone loops touting PGHD that patients can listen to while waiting on
hold or video loops that can play on monitors in waiting rooms. What languages do your
patient speak? If you have significant populations of non-English speakers, offer materials
in languages that best accommodate your patients.

• Provide small incentives or rewards to patients who participate in the program, or


clinicians who prescribe the greatest number of PGHD devices and apps, such as:

◦ For Patients: small gift cards, gym passes, or other item from community partners.
◦ For Clinicians and other care team members: lunch at a local restaurant, small care
package, movie night bundle, or staff outing.

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Share Success Stories


Develop mechanisms to reward milestone achievements, funnel clinician and patient PGHD
integration success stories to your communications champion, and publicize positive outcomes.
Personal stories of patients and clinicians experiencing success using PGHD in clinical care are
key to spreading PGHD integration across your practice.

See Activity 6.5 for potential considerations prior to scaling up.

Monitoring Environmental Factors


In addition to advancing technologies and trends, Federal and State policies impacting
PGHD integration are in a period of flux. For example, Federal legislation, such as the
21st Century Cures Act, paved the way for new ONC interoperability standards and
CMS rules that incentivize SMART on FHIR APIs (Substitutable Medical Applications,
Reusable Technology (SMART) on Fast Healthcare Interoperability Resource (FHIR)
Application Programming Interfaces (APIs)) to ensure that patients can easily access
their heath information data from the EHR via a smartphone app. It is anticipated
that HHS will soon update HIPAA provisions to bolster patient health data privacy
and security.

Staying current on this changing environment can help ensure that your practice’s
activities remain compliant with Federal and State rules, and that you can maximize
available reimbursement.

Resources for Implementation, Scaling, and Environmental


Monitoring Your PGHD Program
Take a moment to familiarize yourself with each of the links below. Bookmark those you
find particularly useful and periodically return to them to keep up with this rapidly changing
landscape.

Implementation and Scaling


• Institute for Healthcare Improvement: Set-Up for Spread

• Institute for Healthcare Improvement: How-to Guide for Sustainability and Spread

• The Model for Improvement

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• Cambridge Management Sciences for Health: Implementing Best Practices Consortium:


A guide for fostering change to scale up effective health services

• Guide for monitoring scale-up of health practices and interventions: MEASURE evaluation

• Management Systems International (MSI): Scaling Up—From Vision to Large-scale Change:


A Management Framework for Practitioners

Environmental Monitoring
• The Center for Connected Health Policy (CCHP) updates a report twice a year on state
telehealth laws and reimbursement policies.

• CCHP also maintains a database of federal telehealth laws and policies for Medicare and
private payers.

• The Federal Trade Commission offers an overview of the laws that may apply to mHealth
mobile apps and the various agencies that oversee compliance.

• Rock Health is a digital health venture capital firm that publishes The Rock Weekly, a
weekly newsletter about emerging developments in digital health technology.

• The UCSF Center for Vulnerable Populations publishes research findings about equitable
digital health solutions designed to bridge the digital divide.

• The Duke Mobile App Gateway for Digital Health is a project of the Duke Clinical &
Translational Science Institute (CTSI) focused on digital health and mobile health app
research and innovation.

• The Office of the National Coordinator for Health Information Technology (ONC) maintains
information about digital health technologies, policies, and regulations.

• HIMSS Health App Guidelines Work Group (formerly known as Xcertia) is a consortium of
health leaders to create mHealth app guidelines and set standards for privacy, security,
content, usability and other criteria.

• Centers for Medicare and Medicaid Services Electronic Clinical Quality Measures Resource
Center continually updates its FHIR education page to assist with implementing this
standard to accelerate data exchange. Find many open source tools to test and evaluate
FHIR APIs.

• Health Level Seven International maintains a webpage and a Twitter feed (follow @
FHIRnes using #FHIR) for updates on FHIR development.

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ACTIVITY 6.1: Bringing It All Together: Your PGHD Implementation


At this stage, you have determined that integrating PGHD into clinical practice is a
priority. We recommend starting with a small-scale implementation of PGHD integration
to strengthen the plan before rolling out on a large scale. Use this activity to plan for
your PGHD implementation.

As you begin this activity, reference your work from Folios 2, 3, 4, and 5 to build the
PGHD implementation.

• Review the list of strengths, gaps, and resources needed to begin PGHD integration.
• Convene the core PGHD workgroup to create the PGHD implementation, identify
resources needed, lead team members, and create an implementation timeline.
• The PGHD Coordinator leads brainstorming and guides action steps to build the
PGHD implementation.

Instructions: After each consideration, use the form field to record notes. Type directly into
the field or print to handwrite.

CONSIDERATIONS RELEVANT TO PATIENT PARTICIPATION

Designing the PGHD Implementation:

• Which patient populations will you target?

• How will patients be invited to participate?

• Who will be involved?

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HEALTH IT DECISIONS

Designing the PGHD Implementation:

• Which PGHD will be collected?

• How will the practice receive PGHD?

• What data will be reviewed to monitor implementation?

• Who will be involved?

LEGAL, COMPLIANCE, AND SECURITY FRAMEWORKS

Designing the PGHD Implementation:

• Develop and distribute processes and standard operating procedures for consent,
monitoring and outreach for the PGHD you will implement.

• Describe what happens when PGHD are clinically out of range. How are the data points
identified? Who is notified? Who will follow up with the patient?

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• Who will be involved?

BILLING, REIMBURSEMENT, AND REPORTING CONSIDERATIONS

Designing Your PGHD Implementation:

• Will you bill for PGHD activities?

• What is your payer mix?

• What conditions that could benefit from PGHD do you bill for most often?

• Are you able to sustain the program until it becomes more cost efficient?

• How will you fund your program?

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YOUR PGHD IMPLEMENTATION

Instructions: Type answers directly into the field or print to handwrite.

What

Target patient population: 

PGHD to be collected: 

PGHD Device: 

PGHD out of clinical range: 

Implementation tracking plan: 

Team members involved: 

How

Inviting patient participation: 

Receiving PGHD: 

Clinician and patient notifications: 

Measures to monitor: 

Team members involved: 

Bring all the pieces together with a summary:

Your PGHD workgroup has developed the details for your PGHD implementation. Now your
team can set a timeline to begin testing.
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ACTIVITY 6.2: Craft Your First SMART Goal


Using your PGHD implementation plan, create a SMART goal for an initial benchmark in
your PGHD program. Begin by identifying each element, and then bring them together
to form your SMART goal.

Instructions: Type answers directly into the field or print to handwrite.

Benchmark goal:

S (Specific):

M (Measurable):

A (Attainable/Achievable):

R (Reasonable/Relevant):

T (Time-bound):

Synthesize the above for your SMART goal:

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ACTIVITY 6.3: Develop Workflows


When mapping your workflow, give each role a swimlane, or row that contains each
step that role takes throughout the task process. Place steps in a coded shape or icon to
further indicate the type of action or decision necessary. For example, a capsule shape
indicates the beginning or end of a process, and a diamond represents a decision point.
See Figure 5.

The swimlane template on the following page (page 98) is intended for practice. It can
be printed or edited directly in PDF reader software.

Figure 5. Icons for Workflow Swimlane diagram.

Start or end of a process Specific step, task, or activty within


the process

Point where a yes/no question Reference or connection to


is required another workflow

Operational decision Reference point that is not


part of a decision point

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Instructions: Type directly into the workflow name, description, date, and role title fields or print to handwrite. Fill in tasks according to role
and place in the process. Not all fields need to be filled in. Icons can be hand drawn or placed using some PDF reader software.

Workflow Name:

Description:
Date:

Role 1:

Role 2:

Role 3:

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ACTIVITY 6.4: Evaluate and Refine


Use this PDSA template to perform successive rapid-cycle testing and track improvement
for your PGHD implementation.

Instructions: Type answers directly into the field or print to handwrite.

Project Title:

Cycle Number:

Start Date:

End Date:

Brief description:

Objective for this cycle: Collect data Test a change Implement a change

Aim Statement: (Tip: Use a SMART goal):

Plan: Ask questions, predict results, determine what data need to be collected by whom.

Questions:

Predictions:

Data to be collected:

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Team and Assignments:

Do: Make the change/do the activity and collect data. Document what happened both
positive and negative.

Positive +

Negative -

Study: Summarize your learnings, ask new questions, identify new issues. How does this
compare with your predictions?

Learnings:

Results:

New questions/issues:

Act: Identify next steps based on your learnings.

Next cycle:

Team members:

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ACTIVITY 6.5: Scale Up and Monitor


Once you have successfully implemented PGHD with a specific device and health
condition with a small patient population, it is time to slowly scale up by expanding
PGHD to more patients, more care teams, adding devices, adding health conditions, and
so on. The method in which your organization scales up is flexible and can be tailored to
your patient and clinic capacity.

Use the following checklist to determine key considerations with your PGHD team. Use
Activities 6.1-6.4 as you slowly scale up and expand your PGHD capacity.

Instructions: After each consideration, use the form field to record notes. Type directly into
the field or print to handwrite.

PATIENT CONSIDERATIONS

• How do you want to scale up your implementation to a larger group of patients? Do you
want to offer PGHD to a larger subset of patients? All of your patients with a specific
chronic condition?

• How will this be communicated across patients? What health IT support will be in place
for them?

TEAM MEMBER/STAFFING CONSIDERATIONS

• How do you want to scale up your implementation to a larger group of clinic staff? Do you
want to expand your implementation to additional care teams, clinical groups, and/or
across your organization?

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• What steps need to be taken to scale up staff training and messaging?

• In what ways will your internal and external communication plan need to be modified?

HEALTH IT CONSIDERATIONS

• What additional devices or apps would be most beneficial to your patients and staff next?

• How does your EHR support these devices and additional information?

LEGAL/ENVIRONMENTAL CONSIDERATIONS

• What, if any, internal and external legal, regulatory, clinical, technical, patient safety,
communications, and protocols have been updated that may impact expanding PGHD?

FINANCIAL CONSIDERATIONS

• What funding and billing reimbursement guidelines best support expanding PGHD?

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D, Dolor R. Integrating patient-generated digital health data into electronic health
records in ambulatory care settings: an environmental scan. Prepared under Contract
75Q80120D00019 / 75Q80120F32001. AHRQ Publication No. 21-0031. Rockville, MD:
Agency for Healthcare Research and Quality. May 2021.

2 The Office of the National Coordinator for Health Information


Technology. What are patient-generated health data? January 19, 2018.
https://www.healthit.gov/topic/otherhot-topics/what-are-patient-generated-health-data.
Accessed March 22, 2021.

3 Nichol JR, Sundjaja JH, Nelson G. Medical History. [Updated 2020 Sep 7]. In: StatPearls
[Internet]. Treasure Island (FL): StatPearls Publishing; 2021 Jan. Available from:
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