Evaluation of an Incentive-based Intervention to Improve 90-day Adherence in PAP-Naive Patients
Phase: NA
Conditions: Obstructive Sleep Apnea
Sponsor: ResMed

Evaluation of an Incentive-based Intervention to 
Improve 90-day Adherence in PAP-Naïve Patients: 
Project Dahlia
Investigational Plan 
Version:  
2.0 
Date:  
08Jul2019 
Protocol Number: 
SLP-18-08-01 
Sponsor:  
ResMed Corp 
9001 Spectrum Center Blvd
San Diego, CA 92123
(800) 424-0737
This protocol has been written in accordance with current applicable guidelines (IDE for USA) as 
well as all other relevant additional references, medical and legal. 
The information herein is confidential and the property of ResMed Corp. It is to be used in 
confidence for the conduct of the clinical trial according to written agreement.
NCT Number:                       NCT03851094
IRB Approved at the 
Protocol Level 
Jul 24, 2019
20190087
Summary of Changes 
Begins on Page 2.

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Version History 
Version
Date
Notes
1.0
10Jan2019 
Original Version
2.0
08Jul2019 
Removed inclusion criteria for patients to have 
used their device less than an average of 3.5 
hours of usage in the first 3 days of therapy.  

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Protocol Summary 
Study Design: 
This is a prospective, randomized, open-label study to evaluate 
effectiveness of applying financial and social incentives via a 
smartphone-based app in helping participants achieve adherence 
to therapy. Randomization will consist of an allocation ratio of 2:1 
(control:treatment)  
This study will be conducted on patients with obstructive sleep 
apnea (OSA) who have been prescribed ResMed flow generator 
for positive airway pressure (PAP). 
Participants will be randomized to one of two groups: control or 
intervention with Wellth app, “Restful”. The study comprises up to 2 
participant contacts by phone, and 3 data collection timepoints. 
The first contact involves consenting and enrolling the participant, 
providing instructions based on the arm they are randomized to, 
and collecting baseline data including questionnaires. Those 
randomized to the intervention group will have a second contact, 
which involves onboarding to Restful. A second administration of 
the questionnaires will occur at +90 days from baseline.  
Intervention: 
Restful by Wellth. The intervention is use of the Restful app, 
which provides a small daily financial reward for achieving therapy 
usage goals and social support. The app will also send a daily 
reminder to participants to use their therapy. There is no clinical 
treatment intervention, as all patients included in this trial will be 
receiving PAP therapy per standard of care. 
Objectives: 
Evaluate whether a digitally delivered monetary and social reward 
scheme can increase 90-day adherence and/or increase average 
minutes of therapy usage over time. Therapy usage will be 
monitored using cloud-based technology in which data from each 
PAP device is automatically transmitted to a secure, HIPAA-
compliant system (AirView). 
Enrollment: 
Up to 300 participants 
Clinical Site(s): 
1 - 2 sites 
Patient Population: 
The intended population for the study are patients with a new 
diagnosis of OSA who have been prescribed a ResMed flow 
generator compatible with AirView. Participants will be recruited 
from the site’s database.   
Endpoint: 
Adherence to therapy (average hours per day) at 90-days 

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Duration of study: 
Each participant is expected to participate in the study for at least 
90 days following enrollment. Enrollment completion is expected 
within 16 weeks of enrollment initiation. Participants’ usage data 
will also be collected at 180 days following enrollment.

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TABLE OF CONTENTS 
1 
INTRODUCTION ......................................................................................................................... 6 
2 
OBJECTIVES .............................................................................................................................. 7 
3 
METHODS AND MATERIALS .................................................................................................. 7 
3.1 
POPULATION/PARTICIPANT SELECTION ................................................................. 7 
3.2 
STUDY DESIGN ....................................................................................................... 7 
3.3 
NUMBER OF PARTICIPANTS .................................................................................... 8 
3.4 
INCLUSION CRITERIA .............................................................................................. 8 
3.5 
EXCLUSION CRITERIA ............................................................................................. 8 
3.6 
SAMPLE SIZE .......................................................................................................... 8 
3.7 
STUDY ENDPOINTS ................................................................................................. 9 
3.8 
ANALYSIS POPULATIONS ........................................................................................ 9 
3.9 
DATA ANALYSIS ...................................................................................................... 9 
4 
STUDY SCHEDULE ................................................................................................................. 10 
4.1 
SCREENING FOR ELIGIBLE PARTICIPANTS: .......................................................... 11 
4.2 
INITIAL (ENROLLMENT) CONTACT ........................................................................ 11 
4.3 
90-DAY STUDY CONTACT .................................................................................... 11
4.4 
REPORT OF DEVICE USAGE DATA ....................................................................... 11 
4.5 
STUDY FLOW ........................................................................................................ 12 
4.6 
INFORMED CONSENT ............................................................................................ 13 
5 
INTERVENTION ........................................................................................................................ 13 
5.1 
WELLTH APP (RESTFUL) ...................................................................................... 13 
5.2 
AIRVIEW ............................................................................................................... 14 
5.3 
MYAIR ................................................................................................................... 15 
5.4 
CONTROL GROUP ................................................................................................. 15 
6 
DATA HANDLING AND RECORD KEEPING ..................................................................... 15 
6.1 
CONFIDENTIALITY ................................................................................................. 15 
6.2 
SOURCE DOCUMENTS ............................................................................... 15 
6.3 
CASE REPORT FORMS ............................................................................... 15 
6.4 
RECORDS RETENTION ............................................................................... 16 
7 
MONITORING ............................................................................................................... 16 
8 
ADVERSE EVENT REPORTING .................................................................................. 16 
9 
EXPECTED ADVERSE DEVICE EFFECTS ................................................................. 17 
10 NON SIGNIFICANT RISK DETERMINATION .............................................................. 17 
11 RISK MITIGATION ........................................................................................................ 17 
12 REFERENCES .............................................................................................................. 18 
APPENDIX A: PARTICIPANT QUESTIONNAIRES ............................................................. 20 
APPENDIX B: TAKE HOME INSTRUCTIONS ..................................................................... 21 
GROUP A ............................................................................................................ 21 
GROUP B ............................................................................................................ 22 
APPENDIX C: MYAIR PRIVACY POLICY ........................................................................... 23 
APPENDIX D: WELLTH PRIVACY POLICY ........................................................................ 31 

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1 INTRODUCTION  
 
Obstructive Sleep Apnea (OSA) is a condition characterized by the partial or complete 
collapse of the upper airway during sleep. OSA comprises a continuous spectrum of 
severity ranging from simple snoring and upper airway resistance through mild to severe 
symptomatic obstructive hypopnea and apnea. The prevalence of sleep disordered 
breathing in the adult population is 24% males and 9% for females1. The prevalence of 
symptomatic OSA in the adult population has been estimated to be 4% in males and 2% 
in 
females1. 
These 
patients 
demonstrate 
behavioral 
and 
neuropsychological 
consequences to varying degrees, including excessive daytime sleepiness, intellectual 
deterioration and depression2. More serious consequences include arterial systemic 
hypertension, arterial pulmonary hypertension and heart disease3.   
The treatment of choice for OSA is Positive Airway Pressure (PAP). PAP acts as a 
positive airway splint, delivering a fixed positive airway pressure to the upper airway via a 
tube and mask. Humidification is used during PAP therapy to improve comfort of the 
delivered air and alleviate nasal dryness/congestion.  
Although PAP therapy is the gold standard treatment for OSA, adherence to treatment is 
often poor. CMS guidelines define adherence as 4 or more hours per night of therapy use 
on 70% of nights during a consecutive 30-day window within the first 90 days of setup4. 
Anywhere from 30 to 85% of patients will be non-adherent according to this definition of 
adherence, which can be explained, in part, by factors such as socioeconomic status, 
age, gender, severity of presenting symptoms, health values/beliefs, and social support5. 
Importantly, patients who immediately adopt therapy, within the first 3 days, are 
significantly more likely to be adherent at 30 days6, and patients’ usage at 1 month is 
significantly predictive of adherence at 1 year7 . Without sustained, long-term therapy 
adherence, patients are at risk of negative health outcomes including but not limited to 
cardiovascular disease, stroke, diabetes, and depression. This study tests whether a 
combined financial plus social incentive can help users new become adherent to PAP 
therapy. 
Financial incentive schemes have demonstrated effectiveness in a wide range of behavior 
change efforts including physical activity8, smoking cessation9, glucose monitoring10, 
weight loss11, and medication adherence12. The primary mechanisms of action explaining 
the observed behavior change are loss aversion and timely reinforcement. Humans are 
strongly influenced by loss aversion, also known as the endowment effect, whereby the 
threat of losing something that has been endowed is a stronger motivator than the 
potential reward of gaining something not currently possessed. Timely reinforcement is 
also key, given that in order for learning to occur, the behavioral action and the 
subsequent reinforcement for doing said action must be closely coupled in time - 
otherwise it is difficult to associate the behavior with the reward.  
Additionally, there is an abundance of evidence that social support is a critical component 
to successful health behavior change13; however, the specific test of social support 

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provision in this project is novel. Social currency (e.g., pictures, video) will be delivered to 
the participant at intervals (e.g., after a participant hits a streak of therapy use), as well as 
a weekly summary report of therapy use. Testing the social component is especially 
intriguing as this is a long-term cost-effective and scalable solution. 
 
2 
OBJECTIVES  
 
Evaluate whether a digitally delivered monetary and social reward scheme can increase 
therapy usage and 90-day adherence. Adherence will be monitored using cloud-based 
technology in which data from each PAP device is automatically transmitted to a secure, 
HIPAA-compliant system (AirView). 
 
3 
METHODS AND MATERIALS 
3.1 POPULATION/PARTICIPANT SELECTION 
The intended population for the study are patients with a new diagnosis of OSA who have 
been prescribed a ResMed flow generator compatible with AirView. Participants will be 
recruited from the site’s database. 
Enrollment period for all participants is projected to be 16 weeks after IRB approval and 
enrollment commencement. 
3.2 STUDY DESIGN 
This is a prospective, randomized, two-arm, open-label study to evaluate effectiveness of 
applying financial and social incentives via a smartphone-based app in helping 
participants achieve adherence to therapy. Randomization will include an allocation ratio 
of 2:1 (control:treatment). 
Two ‘site to participant’ contacts are required during this study. These contacts can either 
occur at the clinical site or remotely (e.g., by telephone). During the initial contact, their 
interest in the study and eligibility will be confirmed, then they will be consented, asked to 
complete the Baseline Questionnaire, and their demographic information will be collected 
on case report forms (CRFs).  
Participants randomized to the intervention (Group B) will be provided with information 
and assistance in downloading Restful to their smartphone and registering with Wellth.  
At the final contact (90 days), the participant will be asked to complete an End of Study 
Questionnaire and the investigative staff will collect PAP therapy data for the trial period 
and record it on CRFs. Participants in Group B will have access to the Restful app 
discontinued. This completes the participant’s active participation in the study. 

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Daily usage data from AirView will be collected and transmitted electronically from usage 
initiation to 90 days, and then through 180 days. 
Study data will be captured on CRFs. See Appendix A for the Baseline and End of 
Study Questionnaires.  See Appendix B for Participant Instructions related to the 
study procedures and the Restful app. 
3.3 NUMBER OF PARTICIPANTS  
Up to 200 participants will be enrolled in the control arm and up to 100 participants will be 
enrolled in the treatment arm for a total of up to 300 participants enrolled in the study. 
3.4 INCLUSION CRITERIA  
All Participants enrolled into the study must meet the following criteria for entry:  
• 
Adult participants (≥18 years of age)  
• 
New diagnosis of OSA 
• 
Prescribed CPAP or APAP for treatment of OSA 
• 
Prescribed a ResMed flow generator compatible with AirView 
• 
Owns a smart phone and is willing to download an app on their phone 
• 
Willing and able to give informed consent 
• 
Can read and comprehend written and spoken English 
3.5 EXCLUSION CRITERIA  
The participant will be excluded from entry if any of the following criteria apply: 
• 
Have used PAP therapy in the past 
• 
Have been prescribed bi-level or adaptive servo-ventilation therapy 
• 
Are participating in another app-based research study 
• 
Cannot participate for the full duration of the study (at least 90 days) 
• 
Participants who have a medical history or concurrent illness that the investigator 
considers sufficiently serious to interfere with the conduct, completion, or results of 
this study, or constitutes an unacceptable risk to the participant for the duration of 
the study 
3.6 SAMPLE SIZE    
N= 300  
 
A minimum total sample size of 270 patients, with 2:1 randomization (180 in Control 
group, 90 in Test group) is required to yield an 80% probability of detecting a difference of 
0.8 hours in mean usage (160% of the minimally clinically significant difference) when the 
standard deviation is 2.5 and 2.0 in the Control and Test groups, respectively.  The 
required sample size was calculated in the Two Sample T-Tests Assuming Unequal 
Variances Procedure using NCSS Power Analysis Statistical Software, Version 16 (PASS 
1614) based on a one-sided, two sample t-test, using a significance level of 0.025.  

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Assuming a potential 10% drop-out rate due to study withdrawal or lost-to-follow-up, the 
final sample size will be 300 patients (270/0.9), equating to 200 in the Control group and 
100 in the Test Group. The 2:1 randomization ratio was chosen because it is more cost-
effective to enroll subjects in the control group. 
3.7 STUDY ENDPOINTS 
Primary Endpoint:  mean PAP usage at 90 days collected from participants’ flow 
generators 
 
Secondary Endpoints:   
• 
Percentage of participants that meet the Medicare compliance standard (at least 4 
hours per day on at least 70% of the days in a consecutive 30-day period any time 
in the first 90 days of therapy) 
• 
Change in ESS and FOSQ-10 questionnaire scores 
• 
Baseline scores of perceived disease severity, claustrophobia, coping skills, and 
health literacy as moderators of the intervention’s effectiveness 
3.8 ANALYSIS POPULATIONS 
Randomized Population:  all participants enrolled and randomized to treatment groups. 
 
Intent-to-Treat (ITT) Population: all participants randomized to control or intervention 
group, regardless of the actual intervention received. 
 
Evaluable Population:  all ITT subjects who complete the 90-day study period and 
complete the end-of-study questionnaire. 
3.9 DATA ANALYSIS 
Baseline demographic and psychosocial factors will be summarized for each randomized 
group for ITT and Evaluable Populations. For continuous variables, such as age and PAP 
usage, the mean, standard deviation, median, and range will be presented. For 
categorical variables, such as gender, the number and proportion of participants in each 
category will be presented.  Baseline demographics and psychosocial factors for the 
control and intervention groups will be compared with t-tests and Fisher’s exact tests, as 
appropriate. 
 
The primary analysis compares mean PAP usage at 90 days in the control and 
intervention groups using a two-way ANOVA on the ITT population.  Randomization group 
and myAir usage (Yes/No) will be included as factors in the model.  The interaction of the 
two factors will be considered, but will only be retained in the model if it is significant at the 
5% level.  Missing usage hours during a day will be imputed as 0 usage.  A secondary 
analysis of mean PAP usage will be conducted using the Evaluable Population.  A 
sensitivity analysis of the missing data assumption will be conducted by considering 
missing data as missing.  In this analysis, participants with no usage data will be assumed 
to have a mean usage of 0 hours; other participants’ mean usage will be calculated as the 
mean usage across nights for which there is data. 
 

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A subgroup analysis of the primary endpoint will be generated for patients who are 
identified as strugglers.   A struggler is defined as a patient who uses their device for less 
than or equal to 3.5 hours/night during the first 3 days of usage.  Mean PAP usage at 90 
days will be compared in the control and intervention groups using a two-way ANOVA on 
the struggler population as described above.  Descriptive statistics will also be presented 
for mean PAP usage, comparing strugglers and non-strugglers in control and intervention 
groups. 
 
Adherence will be calculated for the ITT population from daily usage data using the 
Medicare definition for adherence (a patient is adherent if they use the device for more 
than 4 hours per night for 70% of the nights during the first 90 days of usage).  Percent 
adherence will be compared between control and intervention groups using a logistic 
regression model on the ITT population.  Randomization group, myAir usage, and the 
interaction of these two factors will be included in the model.  Missing usage hours during 
a day will be imputed as 0 usage.   
 
Mean change in ESS and FOSQ questionnaire scales will be compared between control 
and intervention groups using a mixed-effects linear model on the ITT population and a 
two-sample t-test on the Evaluable population. In the mixed-effects model, the response 
variable will be the mean questionnaire score and the model will include randomized 
group, visit, and a randomized group by visit interaction as fixed effects and subject as a 
random effect.  
 
Baseline perceived disease severity, claustrophobia, coping skills, and health literacy will 
be tested as moderators of the intervention’s effectiveness. Baseline scores will be 
regressed on the primary outcome (usage), and then in a mixed-effects model, the 
response variable will be usage and the model will include baseline score, randomized 
group, and a randomized group by baseline score interaction as fixed effects and subject 
as a random effect. 
 
An exploratory analysis will examine how engagement with the study is associated with 
PAP usage.  Engagement will be measured as app usage (number of touches).  A linear 
regression model with PAP usage as the dependent variable and engagement as the 
independent variable will be fit to all ITT subjects (engagement is zero for all control 
subjects). An exploratory analysis will also test whether the intervention has a direct or 
indirect effect on the following psychosocial factors: the pros and cons of change, self-
efficacy, and social support. Finally, an exploratory analysis will test whether nomination 
of, and the extent of engagement with, a social support person moderates the intervention 
effectiveness. 
 
4 STUDY SCHEDULE 
Informed consent will be obtained prior to the initiation of any protocol related activities.  

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4.1 SCREENING FOR ELIGIBLE PARTICIPANTS: 
Patients who have been newly diagnosed with SDB and prescribed PAP for their 
treatment will be evaluated for eligibility, and if all entry criteria are met, they may be 
invited to participate in the study. This may be accomplished by phone or in person.  
 
 
4.2 INITIAL (ENROLLMENT) CONTACT 
1. Provide patient with access to informed consent document. 
2. When consent has been obtained, collect device information (device ECN, 
device settings, mask type), demographic, and baseline data into the electronic 
data capture (EDC) system. 
3. Randomize participant in EDC. 
a. Participants randomized to the Control group (Group A) will complete a 
set of baseline questionnaires.  
b. Participants randomized to the Treatment group (Group B) will complete 
a set of baseline questionnaires and provided with instructions to 
download Restful to their smartphone. 
c. Monitor both groups’ PAP device usage per your standard of care. 
4.3 90-DAY STUDY CONTACT 
1. Both Group A and Group B will be asked to complete a set of end of study 
questionnaires. Restful will be ‘turned off’ for Group B participants.  
2. Continue to monitor participants’ PAP device usage per your standard of care. 
3. Distribute compensation for study participation. 
4.4 REPORT OF DEVICE USAGE DATA 
1. A report of PAP usage data (including average hours used per day, leak, 
pressure, and AHI) will be generated by the ResMed Data Analytics group at 90 
days and 180 days and provided to the statistician for analysis. 
2. A user-level analytics report of myAir engagement (including participants who 
registered for myAir and number of times they engaged with the app during the 
study) will be generated by the ResMed Data Analytics group at 90 days and 
180 days and provided to the statistician for analysis. 
3. A user-level analytics report of Restful engagement (including participants who 
registered for Restful and number of times they engaged with the app during 
the study) will be generated by Wellth at 90 days and 180 days and provided to 
the 
statistician 
for 
analysis.

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4.5 
STUDY FLOW 

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4.6 INFORMED CONSENT 
IRB approved informed consent (21 CFR Part 50) will be obtained by the Investigator or 
delegated investigative staff. The Investigator or delegated staff will be responsible for 
confirming that each patient understands the nature, purpose, and risks associated with 
participating in this study.  
 
The investigative site will have the option of remotely consenting patients. Patients will be 
securely emailed a patient-specific link to access and create a login with the EDC system 
(Medrio). This website will contain the informed consent form, HIPAA, instructions on how 
to have any questions answered, and a knowledge assessment. The same login will also 
be used later in the study to complete participant questionnaires. 
 
Patients will be given sufficient time (either remotely or in clinic) to consider the study’s 
implications, ask any questions, and get these questions answered before deciding 
whether to participate. If consented remotely, patients will be clearly provided with 
information on how to contact an appropriate investigative staff member for questions 
about the study. Patients will not be able to authorize consent until they have confirmed 
that they have no further questions about the study. A copy of the consent form will be 
emailed or given to each participant for their records so they are able to access the 
consent form at any time throughout the course of the study. 
 
Participant consent for this protocol will be obtained prior to the initiation of any study 
procedures.   
 
 
5 INTERVENTION 
5.1 WELLTH APP (RESTFUL) 
The intervention is the use of Restful, the Wellth self-management application. There is no 
clinical treatment intervention, as all participants will be receiving PAP therapy per 
standard of care. 
Restful is a smartphone-based patient engagement tool that utilizes concepts from 
behavioral economics to help patients improve their adherence to therapy. The 
intervention includes: 
Financial incentive: 
The incentive is $75, and is distributed as follows: Participants unlock $5 after completing 
the app introduction/onboarding, and then $10 for successful nights on days 1, 2, 3, 5, 8, 
13, and 21. Successful nights are nights where therapy is used for ≥4 hours. Once money 
is “unlocked,” the reward is always visible to the participant. However, participants only 
receive the financial reward if they unlock all $75 by the end of the program. In between 

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“pay days,” participants receive positive reinforcement messages and visual cues but no 
financial reward is unlocked. 
Recognizing that participants are likely to struggle initially, and that there are 9 days in 
which participants can afford to have non-adherent nights (i.e., 30 – 21 = 9), the 
participants will be granted 9 hearts in the app. These hearts represent 9 the “misses” 
available to them, and they will lose a heart each non-adherent night. The program will 
deliver a tailored intervention message of support or encouragement after every 2 lost 
hearts (e.g., remind participants how close they were to a successful night). 
If the participant does not meet adherence in the first 5 weeks and/or they have lost 9 
hearts, then they will get a second chance. The intervention will "reboot." Participants will 
not be made aware of this opportunity at the outset. 
Social incentive: 
The social incentive will have two components: social currency and social support 
messages. Participants will have the opportunity to nominate a social support person 
during the Wellth onboarding process. This person will be contacted directly by Wellth via 
text message and provided with information that will explain their role in supporting the 
participant. The support person will be asked to provide social currency (described below) 
that they think will be meaningful to the participant, as well as some supportive messages. 
Over the course of the 90-day trial, Wellth will reach out to the support person to solicit 
additional currency and messages. If the support person is generally non-responsive, or if 
the participant does not nominate a social support person, then the participant will receive 
Wellth-designed content for the social currency and social support components.  
• 
Social currency: Pictures and/or videos that are meaningful to the participant. 
Delivered to the participant when they hit a therapy usage streak of 3 days in a row 
≥4 hours.  
• 
Social support messages: Encouraging messages that are meaningful to the 
participant. Delivered to the participant at seemingly random intervals throughout 
the 90 days (i.e., via a rules-based delivery algorithm).  
5.2 AIRVIEW 
AirView is the HIPAA compliant web-based system that is routinely used for 
telemonitoring. The PAP device contains built in wireless connectivity which transmits 
data via a mobile network to a secure data center. Data is transmitted at the completion of 
each period of use (e.g. after each night of use). Data can then be accessed, via a login 
code, by the respiratory/sleep team to assess items such as device efficacy (residual 
AHI), mask leak, and usage hours. 
AirView is compliant with HIPAA, EU 95/46/EC, and national privacy laws. Data are 
encrypted and all database accesses are logged and can be re-traced. 

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5.3 MYAIR 
In addition to AirView, a patient-focused version of the data is available through the myAir 
app. The myAir app can be accessed via the participant’s smartphone or computer and 
allows the participant to monitor their own treatment data. myAir also provides tips to the 
participant on things like coping with therapy, managing mask leaks, and adjusting 
comfort settings. These tips are personalized based on each individual’s data. The myAir 
app is not mandatory in this trial, but participants’ usage of myAir will be documented in 
both Group A and Group B. 
5.4 CONTROL GROUP 
The control group will be monitored and managed per the site’s standard of care with the 
exception of completion of questionnaires at baseline and again at 90 days after 
enrollment.  
 
6 DATA HANDLING AND RECORD KEEPING 
6.1 CONFIDENTIALITY 
Information about study participants will be kept confidential and managed according to 
the requirements of the Health Insurance Portability and Accountability Act of 1996 
(HIPAA).  Those regulations require a signed participant authorization informing the 
participant of the following:  
• What protected health information (PHI) will be collected from participants in this 
study 
• Who will have access to that information and why 
• Who will use or disclose that information 
• The rights of a research participant to revoke their authorization for use of their PHI  
• All the institutes involved in the study to keep the medical information confidential 
and managed according to the requirements of the Health Insurance Portability and 
Accountability Act of 1996 (HIPAA) 
6.2 SOURCE DOCUMENTS 
Source data is all information, original records of clinical compliance records, 
observations, or other activities necessary for the reconstruction and evaluation of the 
study.  Source data are contained in source documents.  Examples of these original 
documents and data records include: participants’ records, clinical and office charts, 
laboratory notes, memoranda, participants’ diaries or evaluation checklists, recorded data 
from automated instruments, copies or transcriptions certified after verification as being 
accurate and complete, participant files, and records. 
6.3 CASE REPORT FORMS 
Participant data will be collected through use of a CRF and Participant Questionnaires 
(Appendix A). Objective usage data will be collected directly from AirView.  

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The clinical site will provide study data to the Sponsor by recording data in the Medrio 
EDC System (21 CFR Part 11 compliant).  
6.4 RECORDS RETENTION 
Records to be kept at the site. Records retention includes electronic as well as hard copy 
records for 5 (five) years after the final analysis is complete. 
 
7 MONITORING 
The site will utilize internal monitoring procedures to review the flow of the study and 
make sure that all procedures are being performed in a timely manner and the project 
meets the timelines. 
 
8 ADVERSE EVENT REPORTING 
For the purpose of this protocol, an adverse event is any deviation from baseline health in 
a participant that can be attributed to the device, disease, or study procedures required by 
this protocol.  
A serious adverse event (SAE) is any event that is fatal or immediately life-threatening 
AND that requires a participant to be hospitalized or hospitalization is unduly prolonged 
because of potential disability or danger to life or because an intervention has been 
necessitated.  This includes events that cause fetal distress, fetal death, congenital 
anomaly or malignancy or any permanently disabling event.  
For the purposes of this protocol, ‘serious’ is defined as any significant adverse 
experience, including those which may be either life-threatening or involve permanent or 
long term injuries, but excluding injuries that are non-life-threatening and that are 
temporary and reasonably reversible. 
As noted above, changes in a participant’s health should be documented in the 
participant’s record and an assessment should be made regarding association with the 
study device or procedure. If it is determined that the event can be attributed to the device 
or procedure required by the protocol, the investigator should obtain and document all the 
information required to document the event, including cause, treatment, and resolution. All 
adverse events must be followed until resolution or until a stable clinical endpoint is 
reached.  If the event can be attributed to the device or study procedure, all required 
treatments and outcomes of the adverse event must be recorded on the CRFs. 
 
Unanticipated adverse device effects are defined as any serious adverse effect on health 
or safety or any life-threatening problem or death caused by, or associated with, a device, 
if that effect, problem, or death was not previously identified in nature, severity, or degree 
of incidence in the investigational plan, or any other unanticipated serious problem 
associated with a device that relates to the rights, safety, or welfare of participants.  
 

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Under the requirements of the FDA’s IDE Regulations, an investigator must submit to the 
manufacturer (or its designee) and to the reviewing Institutional Review Board any 
unanticipated adverse device effect occurring during the study as soon as possible, but in 
no event later than ten (10) working days after the investigator first learns of the effect. 
 
9 EXPECTED ADVERSE DEVICE EFFECTS 
This study is considered to be of very low risk to the participant.  
 
10 NON SIGNIFICANT RISK DETERMINATION 
This study is considered non-significant risk (NSR) based on standard of care procedures 
being employed and a review of the Code of Federal Regulations for significant risk 
devices. As required by FDA, the IRB will review this study and determine if it concurs 
with the NSR designation.  
 
11 RISK MITIGATION 
This study is considered to be of very low risk to the patient due to the non-invasive nature 
of the procedures. 
 

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12 REFERENCES
                                                 
1 Young T, Palta M, Dempsey J, et al. The occurrence of sleep-disordered breathing 
among middle-aged adults. NEJM. 1993. 328 (17); 1230-1234. 
2 Kingman P, Redline S. Recognition of obstructive sleep apnoea. Am J Respir Crit Care 
Med. 1996. Vol 154; 279-289. 
3 Young T, Peppard P, Gottlieb D. Epidemiology of obstructive sleep apnoea – A 
population health perspective. Am J Respir Crit Care Med. 2002; Vol 165; 1217-1239. 
4 Medicare Learning Network. 2016. Positive Airway Pressure (PAP) Devices: 
Complying with Documentation & Coverage Requirements. DEPARTMENT OF HEALTH 
AND HUMAN SERVICES, Centers for Medicare & Medicaid Services. Accessed 
20Nov18. <https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-
MLN/MLNProducts/downloads/PAP_DocCvg_Factsheet_ICN905064.pdf> 
5 Shapiro GK, Shapiro CM. Factors that influence CPAP adherence: An 
Overview. Sleep Breath. 2010 Dec;14(4):323-35 
6 Budhiraja R, Parthasarathy S, Drake CL, et al. Early CPAP use identifies subsequent 
adherence to CPAP therapy. Sleep. 2007 Mar;30(3):320-4. 
7 Chai-Coetzer CL, Luo YM, Antic NA, et al. Predictors of long-term adherence to 
continuous positive airway pressure therapy in patients with obstructive sleep apnea and 
cardiovascular disease in the SAVE study. Sleep. 2013 Dec 1;36(12):1929-37 
8 Van der Swaluw K, Lambooij MS, Mathijssen JJP, et al. Commitment Lotteries Promote 
Physical Activity Among Overweight Adults—A Cluster Randomized Trial. Ann Behav 
Med. 2018 52:342-351 
9 Halpern SD, Harhay MO, Saulsgiver K, et al. A Pragmatic Trial of E-Cigarettes, 
Incentives, and Drugs for Smoking Cessation. N Engl J Med. 2018;378:2302-10  
10 Wong CA, Miller VA, Murphy K, et al. Effect of Financial Incentives on Glucose 
Monitoring Adherence and Glycemic Control Among Adolescents and Young Adults With 
Type 1 Diabetes: A Randomized Clinical Trial. JAMA Pediatr. 2017. Dec 1;171(12):1176-
1183. 
11 Volpp KG, John LK, Troxel AB, et al. Financial Incentive–Based Approaches for Weight 
Loss. JAMA. 2008 Dec 10;300(22):2631-7 
12 Asch DA, Troxel AB, Stewart WF, et al. Effect of Financial Incentives to Physicians, 
Patients, or Both on Lipid Levels: A Randomized Clinical Trial. JAMA. 2015 Nov 
10;314(18):1926-35 
13 Berkman LF, Glass T, Brissette I, et al. From social integration to health: Durkheim in 
the new millennium. Soc Sci Med. 2000 Sep;51(6):843-57. 
 

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14 PASS 16 Power Analysis and Sample Size Software (2018). NCSS, LLC. Kaysville, 
Utah, USA, ncss.com/software/pass. 

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APPENDIX A: PARTICIPANT QUESTIONNAIRES 
 
Note: Study is using electronic case report forms and patient reported outcomes. The 
attached PDF is an outline of all participant questionnaires available in EDC. 
 
 
 
 

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APPENDIX B: TAKE HOME INSTRUCTIONS 
 
GROUP A 
Instructions for Research Study 
Thank you for participating in our confidential research study. The purpose of this 
study is to test whether a smartphone app can help people get used to and keep using 
their CPAP therapy. We value your comments and suggestions.  
 
Throughout this study please keep this list of instructions handy. 
  
• You will continue to use your CPAP therapy as prescribed.  
• You will be asked to complete 2 questionnaires as part of this research study. If 
you experience any problems with completing these questionnaires online, 
please contact your provider. 
• If you experience any problems with your therapy, using myAir, or your CPAP 
equipment, please contact your provider. 
• If you are unable to complete the study for any reason, please contact your 
provider immediately.  
 
Your participation in this evaluation is voluntary and it is your right to stop the evaluation 
at any stage. 
All aspects of the evaluation, including your identity, will be strictly confidential. 
While the study may be used for device improvement, education, regulatory and 
marketing activities, you will never be specifically identified. 
 
 
Provider contact if you have any concerns or questions: 
Provider name 
Provider address 
Provider phone number 
 

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GROUP B 
Instructions for Research Study 
Thank you for participating in our confidential research study. The purpose of this 
study is to test whether the Wellth app (Restful) can help people get used to and keep 
using their CPAP therapy. We value your comments and suggestions.  
 
 
Throughout this study please keep this list of instructions handy. 
  
• You will continue to use your CPAP therapy as prescribed.  
• You will be asked to complete 2 questionnaires as part of this research study. If 
you experience any problems with completing these questionnaires online, 
please contact your provider. 
• If you use your CPAP device for at least 4 hours a night for 21 nights within a 30-
day period, you will receive a $75 payment at the end of the study. 
• If you experience any problems with your therapy, using myAir, or your CPAP 
equipment, please contact your provider. 
• If you experience any problems with using Restful, please contact a Wellth 
representative. 
• If you are unable to complete the study for any reason, please contact your 
provider immediately.  
 
Your participation in this evaluation is voluntary and it is your right to stop the evaluation 
at any stage. 
All aspects of the evaluation, including your identity, will be strictly confidential. 
Wellth will receive your contact information (including name, address, and email 
address) to help you register for Restful and to mail your payment at the end of 
the study. The results of this study may be used for device improvement, 
education, regulatory and marketing activities, but you will never be specifically 
identified. 
Provider contact: 
Provider name 
Provider address 
Provider phone number 
Wellth contact: 
 
Wellth name 
Wellth phone number 
 
 

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APPENDIX C: MYAIR PRIVACY POLICY 
 
myAir™ Privacy Notice 
Effective: May 2018 
 
ResMed wants to share with you how we treat personal data we receive about you, 
including special categories of personal data relating to sleep data and device setting 
information. We collect personal data about you only with your consent or if you 
voluntarily submit the information to us. 
 
This Privacy Notice is delivered in accordance with data protection laws. We process 
and protect your personal data under the principles and safeguards in the legislation 
applicable to you. This Privacy Notice provides you with information about your rights, 
and the privacy practices that govern how we process your data. 
 
This Privacy Notice is specific to ResMed's myAir service (Service). Your relationship 
with us may also be governed by separate privacy notices if you use other ResMed 
products and services. 
 
Scope 
The myAir Privacy Notice applies to your use of the Service, which includes: 
• 
myair.resmed.com, 
• 
myair.resmed.eu, and 
• 
the mobile application known as myAir App, if available in your country. 
• 
 
In this Privacy Notice, the terms "you" and "yours" refer to the person using the Service. 
 
In this Privacy Notice, "we," "our," "us" and "ResMed" refer to: 
• 
ResMed Corp., a Minnesota corporation, headquartered at 9001 Spectrum 
Center Blvd. San Diego, CA 92123 United States (+1 858 836 5000), if your 
usual place of residence when you download the Service is in North, South or 
Central America; 
• 
ResMed SAS, a company incorporated in France (company registration number 
407775170) whose registered office is at Parc Technologique de Lyon, 292 
Allée Jacques Monod, 69791 Saint-Priest CEDEX, France (+33 426 100 200), 
if your usual place of residence when you download the Service is in France; 
• 
ResMed Deutschland GmbH, whose registered address is at Haferwende 40, 
28357 Bremen, Deutschland (+49 421 489 930), if your usual place of 
residence when you download the Service is in Germany; 
• 
ResMed (UK) Ltd., a company incorporated in England (company registration 
number 02863553), whose registered address is at London, 8 Wimpole 
Street, London, W1G 9SP, United Kingdom (+44 0 1235 862 997), if your 
usual place of residence when you download the Service is anywhere in 
Europe other than France or Germany; and 

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• 
ResMed Holdings Limited, a company incorporated in Australia (company 
registration number 28 003 765 133), whose registered address is at 1 
Elizabeth Macarthur Drive, Bella Vista, NSW 2153, Australia (+61 2 8884 
1000), if your usual place of residence when you download the Service is in 
the Asia-Pacific region or the Middle East. 
 
This Privacy Notice sets out: 
1. 
Why we process your personal data and the legal basis for the processing 
2. 
What personal data we collect about you 
3. 
How we obtain your personal data 
4. 
How we use your personal data 
5. 
How we protect your personal data 
6. 
Who we share your personal data with 
7. 
Where your personal data is currently hosted and processed 
8. 
How long we retain your personal data 
9. 
Your personal data rights 
10. 
Collection and use of anonymous data 
11. 
Your communication preferences 
12. 
Links to other sites 
13. 
Personal data from children 
14. 
Updates to this Privacy Notice 
15. 
Questions and complaints 
16. 
Your right to lodge a complaint with a supervisory authority 
17. 
Data Protection Officers (EU only) 
 
1. Why we process your personal data and the legal basis for processing 
We process your personal data only if you consent to this processing for purposes of 
providing you the Service outlined within this Privacy Notice. 
Under certain laws we are required to state the legal basis for processing your personal 
data and any special categories of personal data. We process your personal data on the 
legal basis that processing is required to meet the Service contract and for our 
legitimate interests to improve our product and services. We rely on your consent to 
process any health data that is classified as a special category of personal data or used 
for marketing purposes. You can withdraw your consent at any time by changing your 
preferences on the Service or by contacting us directly. 
 
2. What personal data we collect about you 
We may collect the following personal data about you: 
• 
First and last name 
• 
Date of birth and gender 
• 
Email address and location of residence 
• 
Phone number 
• 
Products and services you use for treatment 
• 
Where you took your sleep test and when therapy started 
• 
Sleep and settings data from your device(s) 
• 
Your baseline Apnea Hypopnea Index (AHI) 

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Through certain technologies employed by our websites and mobile applications, we 
also collect other information about you in accordance with our Cookie Notice. For more 
details about this type of data collection, please refer to our Cookie Notice. 
Special categories of personal data 
Other than the data described in this Privacy Notice, we will not intentionally collect or 
maintain, and do not want you to provide, any information regarding your race or ethnic 
origin, political opinions, religious or philosophical beliefs or other sensitive information. 
 
3. How we obtain your personal data 
• 
When you submit your personal data as part of the registration to create an 
account for the Service or engage in any transactions with us through the 
Service. 
• 
When you submit your device serial number as part of the online registration 
process, you consent to the ongoing transmission of your device data to the 
Service. 
• 
With your consent, we may collect information about you on your behalf from 
your healthcare or home medical equipment provider. 
• 
We may also collect demographic information about you from a vetted third party 
that works with leading national compilers of consumer and business data 
from public sources, such as telephone directories and consumer surveys. 
 
4. How we use your personal data 
• 
We use your first name, last name, email address and phone number to 
communicate with you via unencrypted email and text messages (SMS 
messages), as part of the Service, to send you therapy coaching messages, 
including but not limited to communications regarding your use of the Service. 
• 
We use the products you use for treatment (your device and your mask), 
together with data transmitted from your device (sleep and device settings), to 
provide you your nightly sleep therapy score and key metrics of your nightly 
therapy sessions. 
• 
We use your date of birth to ensure we do not collect data from children under 
the age of 13 or otherwise considered a minor under the laws of your country 
of residence. 
• 
We use your first name, last name, email address, and the products you use for 
treatment, to respond to your requests for information or materials, and to 
create, develop and maintain our relationship with you. 
• 
Depending on your communication preferences, we may use your first name, last 
name, email address, phone number, location of residence and the products 
you use for treatment to communicate with you via unencrypted email and 
text messages to send you newsletters, press releases or content relating to 
products, programs, services, or general information we believe may be of 
interest to you. 
• 
We may use your first name, last name, and email address to cross-reference 
information about you with other ResMed services for purposes of benefiting 
you (e.g. to provide you with the contact information of your current or last 
identified healthcare or home medical equipment provider) and to help us 

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better understand the sleep apnea population (currently applicable to the 
United States only). 
• 
Subject to local laws, we may use your demographic data to improve the Service. 
Depending on your communication preferences, we may also use your 
demographic data to provide relevant, timely marketing messages. 
• 
We may use aggregated, pseudonymous data transmitted from your device 
(sleep and device settings), such as sleep test location, therapy start date, 
baseline AHI, the number of apnea events per hour, year of birth, gender and 
location of residence to conduct statistical analyses, surveys and market 
research to enhance existing or develop new products and services. 
 
5. How we protect your personal data 
• 
We use a number of different security and privacy controls to protect your data 
and to comply with applicable data protection laws. For example, we use 
encryption to protect your personal data, both when it is in transit as you use 
the Service and when it is at rest in the servers we use. Despite the security 
measures we employ, you should be aware that it is impossible to guarantee 
absolute security of information sent through the internet. 
• 
If we confirm that your personal data has been subjected to a data breach, we 
will follow applicable data breach notification laws. 
• 
We will make reasonable efforts to ensure that the personal data collected is the 
minimum necessary to fulfill the purposes described in this Privacy Notice. 
• 
We will retain your personal data only for as long as you keep your account with 
the Service. Your personal data is deleted as soon as your account is 
deleted. 
 
6. Who we share your personal data with 
• 
We do not sell or rent your personal data. We only share your personal data in 
accordance to this Privacy Notice, with your consent, and only to the extent 
permitted by applicable law. 
• 
We may share your personal data with any affiliate or subsidiary of ResMed, and 
any company owned or controlled by ResMed. 
• 
We may share your personal data if some or all of the business of ResMed is 
transferred to another entity by way of merger, sale of its assets or otherwise. 
• 
We may share your personal data in limited circumstances and in a controlled 
and secured manner, with third-party data processors and service providers 
we engage to provide certain aspects of the Service on our behalf. These 
data processors and service providers are contractually required to keep your 
personal data confidential and to use your personal data for the sole purpose 
of performing the services we asked them to provide. They may not use your 
personal data for any other purpose. These third-party data processors and 
service providers include: 
o Data hosting providers 
o Online ad management providers 
• 
We may share your personal data if we are required to do so by law. 

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• 
We may assist healthcare or home medical equipment providers that use our 
AirView™ service to identify which of their monitored devices have not been 
registered with the Service. 
 
7. Where your personal data is currently hosted and processed 
+ North, South and Central America, and the Asia-Pacific region 
+ Europe and the Middle East 
 
8. How long we retain your personal data 
We will retain your personal data: 
• 
up to the point where you withdraw consent, which you have the right to do at 
any time; or 
• 
if there is a legal reason for retention. 
 
9. Your personal data rights 
Subject to local laws and when applicable, you can request that we: 
• 
provide a copy of personal data we have about you on file 
• 
delete your personal data from our systems 
o We delete personal data associated with your Service account when you 
decide to close your Service account. 
o If we have a legal obligation to retain any of your personal data, we will 
inform you of this obligation. 
• 
send you a copy of the personal data you knowingly and actively provided us 
(including any data we may generate by your activity) 
o We will transmit a copy of this data to another data controller upon your 
request. 
• 
restrict how we process your personal data if: 
o the accuracy of the data is being disputed; 
o processing is unlawful and you oppose its deletion; 
o the data is no longer needed by ResMed but needed for your personal 
legal reasons. 
 
You may have a right to object the processing of your personal data when we process 
your data for marketing. 
 
The Service includes a feature that allows you to perform some of these data requests 
on your own. For example, you can update or correct your personal data yourself when 
you visit your user profile through the Service. 
 
For those personal data requests that you cannot perform, please email us at 
privacy@resmed.eu if you are in Europe or privacy@resmed.com if you are anywhere 
else. Your rights are not absolute and we will assess them on your request. 
 
When you send us your request, we may need to verify your identity prior to disclosing 
your personal data or taking any action on it. 
 
10. Collection and use of anonymous data 

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• 
We may collect anonymous statistical information from your use of the device 
and the Service. For example, the number of visitors that visit a specific web 
page on the Service, how long they stay on that page, which hyperlinks, if 
any, they click on, and what features are used on the Service. 
• 
When applicable, we may collect this type of information through the use of 
cookies and other tracking technologies, which we discuss in detail in our 
Cookie Notice. We may disclose aggregate data to third parties, but this 
aggregate data will in no way personally identify you or any other users of the 
Service. 
• 
To help us understand how users interact with our mobile apps, we use a third-
party service provider. The provider does not collect or access personal data 
(or the handset identifier on an iOS™ device or the advertiser ID on an 
Android™ device) and does not link such data to your usage data of our 
mobile apps. Currently, you can opt-out at any time after you download one of 
our mobile apps. Otherwise, you consent to, and accept, the collection of 
anonymized information by our third-party provider. 
 
11. Your communication preferences 
• 
You may consent or withdraw your consent to our use of your personal data for 
marketing at any time by changing your preferences on the Service, or by 
following the instructions to unsubscribe included in each marketing-related 
email sent to you. 
• 
If you have signed up to receive text messages (SMS messages) and no longer 
wish to receive such messages, you may withdraw your consent. This may 
include replying "STOP" to the received text message (SMS message), or 
changing your preferences on the Service. 
• 
If you withdraw your consent to receive marketing information, we will use 
reasonable efforts to remove your personal data from our marketing database 
within five business days after receipt of your withdrawal of consent. 
• 
Communicating promotional information that may be of interest to you is not 
essential for your use of the Service. You control whether to receive 
marketing information or text messages (SMS messages) from us. 
• 
If you do choose not to receive marketing emails from us, we may still send you 
important administrative and transactional messages (i.e. service 
notifications) from the Service. 
 
12. Links to other sites 
For your convenience, the Service may from time to time include links to third-party 
websites whose personal data practices may be different to ours. We encourage you to 
review the privacy notices for these websites, as we have no control over information 
submitted to, or collected by, these third parties. Use of third-party websites may be 
subject to a third party's terms and conditions and is at your own risk. We are not 
responsible for these websites. 
 
13. Personal data from children 
We do not knowingly collect personal data from children. The content of our Service is 
not intended for, or directed to, children. If you are under 13 years of age or otherwise 

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considered a minor under the laws of your country of residence, please do not use or 
access our Service at any time or in any manner. If a parent or legal guardian becomes 
aware that their child has provided us with personal data without appropriate consent, 
please contact us by sending an email to privacy@resmed.eu in Europe or 
privacy@resmed.com if you are anywhere else. If we confirm that a user is a minor and 
has provided us with their personal data, we will delete their information from our 
databases. 
 
14. Updates to this Privacy Notice 
We may update this Privacy Notice from time to time. We encourage you to review this 
Privacy Notice regularly. Each Privacy Notice includes the date on which it was last 
updated. If we change this Privacy Notice, we will notify you as appropriate. If we make 
a material change, we will ask you to review and reaccept the Privacy Notice. Your 
continued use of the Service confirms your acceptance of our Privacy Notice, as 
amended. If you do not agree to our amended Privacy Notice, you may choose to 
discontinue using the Service. 
 
15. Questions and complaints 
If you have questions or concerns about this Privacy Notice, or if you want to make a 
complaint about a possible breach of local privacy laws, please contact one of the 
following offices: 
 
Europe:  
Privacy Office  
ResMed Deutschland GmbH  
Haferwende 40  
28357 Bremen  
Deutschland 
Tel. +49 421 489 930 
privacy@resmed.eu 
 
Outside Europe:  
ResMed Corp.  
9001 Spectrum Center Blvd.  
San Diego, CA 92123 
United States 
Tel: 1 800 424 0737  
privacy@resmed.com 
 
16. Your right to lodge a complaint with a supervisory authority 
If you are unsatisfied with our response to your personal data question or request, you 
have the right to complain to a supervisory authority in the location where you live or 
work, or where the alleged infringement of your personal data rights took place.   
If you ask us, we will try to provide you with information about relevant complaint 
options that may be applicable to your circumstances. 
 
17. Data Protection Officers (EU only) 

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German Data Protection Officers 
ResMed Deutschland GmbH 
Haferwende 40 
28357 Bremen 
Deutschland 
Tel. 0421 48993 0 
datenschutz@resmed.de 
ResMed Healthcare 
ResMed GmbH & Co. KG 
Fraunhoferstr. 16 
82152 Martinsried 
Deutschland 
Tel. 089 9901 00 
datenschutz@resmed.de 
French Data Protection Officer 
ResMed SAS 
Bureau du délégué à la protection des données 
Parc Technologique de Lyon 
292 Allée Jacques Monod 
69791 Saint-Priest CEDEX  
France 
Tel. +33 426 100 200  
privacy.france@resmed.eu 
EMEA Data Protection Officer 
ResMed Germany Inc.  
Data Protection Office  
Fraunhoferstr. 16  
82152 Martinsried  
Deutschland  
privacy.germany@resmed.eu 
 
If you are a resident of California, California Civil Code Section 1798.83 permits you to 
request information regarding the disclosure of your personal data to a third party for the 
third party's direct marketing purposes. This right is granted to California residents only 
for their activities within the State of California. To make such a request, please send an 
email to privacy@resmed.com. 
 
If you would like a list of all the data processors with whom we share personal data for 
direct marketing, please send us an email to privacy@resmed.eu in Europe or 
privacy@resmed.com outside Europe. Please allow 30 days for a response. 
2281440/1 2018-05 

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APPENDIX D: WELLTH PRIVACY POLICY 
 
I. INTRODUCTION  
Wellth, Inc. (collectively referred to herein as “we,” “us,” “our,” or “Wellth”), respects your 
privacy and the importance of the information you entrust to us. With this in mind, we 
provide you this privacy policy (the “Policy”) to help you understand the kinds of 
information we may gather about you when you use the Platform or any of our Services, 
how we may use and disclose the information, and how you can control, correct and/or 
update the information. By accessing or using the Platform or Services, you are 
accepting the policies and practices described in this Policy. Each time you visit or use 
the Platform or Services, you agree and expressly consent to our collection, use and 
disclosure of the information that you provide as described in this Policy. Any capitalized 
terms not defined herein shall have the meaning as set forth in the Terms of Use. 
 
Please note that this Policy does not apply to your use of third-party sites, services, or 
applications you may access through the Platform. We encourage you to review the 
privacy policies of those third parties for more information regarding their privacy 
practices. 
 
We may make changes to this Policy from time to time.  Your continued use of the 
Platform or Services after we make changes is deemed to be acceptance of those 
changes, so please check this Policy periodically for updates. 
 
II. CHILDREN UNDER THE AGE OF 18 
Our Service is not intended for use by anyone under 18 years of age. No one under age 
18 may provide any information to or on the Service. And no one providing information 
on behalf of another person may provide such information for anyone under the age of 
13.  We do not knowingly collect personal information from children under 18 or about 
children under 13. If you are under 18, do not use or provide any information on this 
Service or on or through any of its features.  If we learn we have collected or received 
personal information from a child under 18 without verification of parental consent or 
about a child under 13, we will delete that information.  If you believe we might have any 
information from a child under 18 or about a child under 13, please contact us at 
help@wellthapp.com. 
 
III. INFORMATION WE MAY COLLECT 
When you use the Platform or Services, we may collect information about you or your 
use of the Platform or Services.  Some of the Services require us to learn more about 
you so that we can best meet your needs. When you access the Services, we may ask 
you to voluntarily provide us certain information that personally identifies you or could 
be used to personally identify you (“Personal Information”). Personal Information 
includes (but is not limited to) the following categories of information: 
(1) contact data (such as your e-mail address and phone number); 
(2) demographic data (such as your gender, your date of birth and your zip code); 

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(3) medical data (your Healthcare Entities, your dates of medical visits, your medical 
history, and other medical and health information you choose to share with us); and 
(4) other identifying information that you voluntarily choose to provide to us, including 
without limitation unique identifiers such as passwords, and Personal Information in 
emails or letters that you send to us 
We may also collect additional information, which may be Personal Information, as 
otherwise described to you at the point of collection or pursuant to your consent. You 
may still access and use some of the Platform if you choose not to provide us with any 
Personal Information, but features of the Services that require your Personal 
Information will not be accessible to you. 
Other information we may collect includes (but is not limited to): 
- information regarding your mobile devices, including their locations, your mobile 
devices on which you have installed the Mobile App, and other information related to 
your use of the Services; 
- information that is about you but individually does not identify you; 
- information about your wireless or mobile internet connection, the equipment you use 
to access our Services and usage details; 
- information about your uses of services within the Platform, including Partners you 
visit, and any of your Healthcare Entities; 
- information about your device, such as the type and model, manufacturer, operating 
system (e.g. iOS or Android), carrier name, IP address, mobile browser (e.g. Chrome, 
Safari), and identifiers assigned to your device, such as its iOS Identifier for Advertising 
(IDFA), Android Advertising ID, or unique device identifier (a number uniquely allocated 
to your device by your device manufacturer); 
- log information, including the apps or websites visited, the time and your time zone, 
network connection type (e.g., WiFi, cellular), and cookie information; 
- the geo-location of your device (using GPS or other geo-location data), when location 
services have been enabled for the Mobile App or browser accessing our Platform or 
Services; 
 
INFORMATION WE COLLECT DIRECTLY  
We collect this information directly from you when you provide it to us, or as we process 
your transactions, for example: 
- information that you provide by filling in forms on our Platform or Services, including 
information provided at the time of registering to use our Service, setting up your 
Account, receiving care from a Healthcare Entity, redeeming Wellthpoints, or requesting 
further services relating to the Platform or your use of the Services; 
- records and copies of your correspondence (including email addresses), if you contact 
us; 
- your responses to surveys that we might ask you to complete for research purposes; 
and 
- your use histories within the Platform, including the Healthcare Entity where you have 
received healthcare or wellness service and the date of each interaction. 
 
INFORMATION WE COLLECT THROUGH AUTOMATIC DATA COLLECTION 
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As you interact with our Platform or Services, we may use automatic data collection 
technologies to collect certain information about your equipment, browsing actions and 
patterns, including: 
- details of your use of our Service, including traffic data, location data, logs and other 
communication data and the resources that you access and use on the Platform or 
Service; and 
- information about your device and Internet connection. 
- The information we collect automatically is statistical data and does not include 
personal information.  It helps us to improve our Platform or Service and to deliver a 
better and more personalized service, including by enabling us to: 
- estimate our audience size and usage patterns; 
- store information about your preferences, allowing us to customize our Service 
according to your individual interests; and 
- recognize you each time you use the Service. 
We may use third-party analytics services to provide us with analytic data collection and 
reporting.  We will not provide any personally identifiable information to such third 
parties. 
 
IV. HIPAA AND PHI 
Under a federal law called the Health Insurance Portability and Accountability Act 
(“HIPAA”), some demographic, health and/or health-related information that we collect 
as part of providing the Services may be considered “protected health information” or 
“PHI.” Specifically, when we receive identifiable information about you from or on behalf 
of your Healthcare Entities, this information is considered PHI. 
 
HIPAA provides specific protections for the privacy and security of PHI and restricts how 
PHI is used and disclosed. Wellth may only use and disclose your PHI in the ways 
permitted by your Healthcare Entity(s). In addition, you may be asked to sign the Wellth 
authorization form (the “Wellth Authorization”). Your decision to sign the Wellth 
Authorization is entirely voluntary. If you choose to sign the Wellth Authorization, you 
agree that Wellth may use and disclose your PHI in the same way it uses and discloses 
your Personal Information that is not PHI. These uses and disclosures are described in 
this Privacy Policy.  
 
To the extent any provision in the Wellth Authorization is inconsistent with this Privacy 
Policy or other provisions of the Agreement, then the provision in the Wellth 
Authorization only controls with respect to your PHI. If you do not sign the Wellth 
Authorization, then your Personal Information that is not PHI is governed by this Privacy 
Policy and your Personal Information that is PHI is used and disclosed only as permitted 
by your Healthcare Entity(s). 
 
V. USE OF INFORMATION 
We use the information we collect to provide and improve our Platform and our 
Services.  For example, we use such information to process your electronic signatures 
and account for electronic delivery of documents, and to optimize and improve our 
technologies and delivery of our Services.  We use information that we collect about you 
or that you provide to us, including any Personal Information or PHI: 
- to present our Services and its contents to you; 

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- to provide you with information, products or services that you request from us; 
- to fulfill any other purpose for which you provide it; 
- to carry out our obligations and enforce our rights arising from any agreements 
entered into between you and us, including for billing and collection; 
- to notify you about changes to our Services or any products or services we offer or 
provide though it; 
- to communicate with Healthcare Entities and Partners regarding the Wellthpoints you 
have earned; 
- to communicate with Partners and facilitate the redemption of Wellthpoints; 
- to allow you to participate in interactive features on our Platform or Services; 
- to show you ads for Wellth or our advertising partners that are more relevant to your 
interests. These interest-based ads may be presented to you while you are browsing 
our site or third-party sites not owned by Wellth.  We belong to ad networks that may 
use your browsing history across participating websites to show you interest-based 
advertisements on those websites. Currently, our Site does not recognize if your 
browser sends a “do not track” signal or similar mechanism to indicate you do not wish 
to be tracked or receive interest-based ads. To learn more about interest-based 
advertisements and your opt-out rights and options, visit the Digital Advertising Alliance 
and the Network Advertising Initiative websites (www.aboutads.info and 
www.networkadvertising.org). Please note that if you choose to opt out, you will 
continue to see ads on our Site, but they will not be based on how you browse and 
shop; 
- in any other way we may describe when you provide the information; 
- for any other purpose with your consent. 
This policy is not intended to place any limits on what we do with data that is 
aggregated and/or de-identified so it is no longer associated with any particular Patient 
User of the Platform or Services. For example, we may use Patient User data to 
generate, among other things, statistics about Patient Users, common health concerns, 
or the demographic distribution of Patient Users. 
 
VI. SHARING OF INFORMATION 
We may share or transfer information about you as follows or as otherwise described in 
this Privacy Policy: 
- With your Healthcare Entities in connection with providing the Services; 
- With Partners, and other service providers who need access to such information to 
carry out aspects of the Services on our behalf (including but not limited to hosting, 
billing, fulfillment, data storage, security, Website analytics, ad serving, mobile 
communications) and/or who make certain services, features or functionality available to 
our users; 
- In response to a request for information if we believe disclosure is in accordance with 
any applicable law, regulation, or legal process, or as otherwise required by any 
applicable law, rule, or regulation; 
- If we believe your actions are inconsistent with the spirit or language of our user 
agreements or policies, or to protect the rights, property, and safety of you, us, or 
others; 
- In connection with, or during negotiations of, any merger, sale of our assets, financing, 
or acquisition of all or a portion of our business to another company (should one of 

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these events occur, we will make reasonable efforts to notify you before your 
information becomes subject to different privacy and security policies and practices); 
- With your consent or at your direction, including if we notify you through the Platform 
that certain information you provide will be shared in a particular manner and you 
provide this information. 
We may also use or share aggregated or de-identified information, which cannot 
reasonably be used to identify you.   
 
VII. ANALYTICS SERVICES 
We may allow others to provide analytics services in connection with the Services. 
These entities may use cookies, web beacons, and other technologies to collect 
information about your use of the Platform or Services, including your IP address, web 
browser, pages viewed, time spent on pages, links clicked, and conversion information. 
We and others may use this information to, among other things, analyze and track data, 
determine the popularity of certain content, personalize the User experience, and better 
understand your activity.  Cookies may store unique identifiers, user preferences and 
other information. You can reset your browser to refuse all cookies or to indicate when a 
cookie is being sent. However, some Platform features or Services may not function 
properly without cookies. We use cookies to improve the quality of our service, including 
for storing user preferences, tracking user trends and providing relevant advertising to 
you. Also, we use Google Analytics, a web analytics service provided by Google, Inc. 
(“Google”) to collect certain information relating to your use of the Platform. Google 
Analytics uses “cookies”, which are text files placed on your computer, to help the 
Platform analyze how Users use and interact with the Platform. You can find out more 
about how Google uses data when you visit our Platform by visiting “How Google uses 
data when you use our partners’ sites or apps”, (located at 
www.google.com/policies/privacy/partners/). 
 
VIII. SECURITY 
We work hard to protect your information and take appropriate, industry standard 
physical, electronic, and other security measures to help safeguard personal information 
from loss, unauthorized access, alteration, or disclosure.  Our security practices include: 
encrypting many of our services using SSL; two-step verification for account access; 
and frequent review of information collection, storage and processing practices, 
including physical security measures, to guard against unauthorized access to systems.  
Although we make good faith efforts to store Personal Information and PHI in a secure 
operating environment that is not open to the public, we do not and cannot guarantee 
the security of your Personal Information and PHI. Any transmission of personal 
information is at your own risk. We are not responsible for circumvention of any privacy 
settings or security measures contained on the Service.  The safety and security of your 
information also depends on you. Where we have given you (or where you have 
chosen) a password for access to certain parts of our Service, you are responsible for 
keeping this password confidential. We ask you not to share your password with 
anyone.  Please note that e-mails and other communications you send to us through 
our “Contact Us” form are not encrypted, and we strongly advise you not to 
communicate any confidential information through these means. 
 
IX. OTHER WEBSITES 

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This Privacy Policy applies only to information we collect at and through our Platform.  
The Platform or Services may contain links to or embedded content from third-party 
websites. A link to or embedded content from a non-Wellth site does not mean that we 
endorse that site, the quality or accuracy of information presented on the non-Wellth site 
or the persons or entities associated with the non-Wellth site. If you decide to visit a 
third-party site, you are subject to the privacy policy of the third-party site as applicable 
and we are not responsible for the policies and practices of the third-party site. We 
encourage you to ask questions before you disclose your information to others. 
 
X. ACCESS TO YOUR INFORMATION AND CHOICES 
You can access and update certain information we have relating to your Account 
through the profile settings on the Mobile App. If you have questions about Personal 
Information we have about you or need to update your information, you can Contact Us, 
or email our support team at help@wellthapp.com.  You can opt-out of receiving 
marketing and promotional e-mails from us by using the opt-out or unsubscribe feature 
contained in the e-mails.  You can close your online account by going to the Settings 
tab in the Wellth app. If you close your account, we will no longer use your online 
account information or share it with third parties.  We may, however, retain a copy of the 
information for archival purposes, and to avoid identity theft or fraud. 
 
XII. CALIFORNIA PRIVACY RIGHTS 
California Civil Code Section 1798.83 permits Patient Users of the Platform that are 
California residents to request certain information regarding our disclosure of personal 
information to third parties for their direct marketing purposes. To make such a request, 
please send an email to help@wellthapp.com. 
 
XIII. QUESTIONS AND HOW TO CONTACT US 
If you have any questions, concerns, complaints or suggestions regarding our Privacy 
Policy or otherwise need to contact us, please Contact Us or contact us by US postal 
mail at the following address: 
 
Wellth, Inc. 
ATTN: Wellth Privacy Officer 
12130 Millennium Drive, Fl 3 
Los Angeles, CA 90094