Aptible TR Webinar FINAL - Presentation

GETTING STARTED WITH RESEARCHKIT
SEE WHATS POSSIBLE.

Introduction to ResearchKit
TODAYS SPEAKERS
AJ Triano, VP, THREAD Research
Chas Ballew, Co-Founder, Aptible

TOPICS COVERED
ResearchKit Overview
Example Academic Study: EpiWatch
Regulatory, Security, & IRB Considerations
Translating clinical studies to digital UI/UX
High-level cost considerations

TEXT
WHAT IS RESEARCHKIT?
Health App HealthKit ResearchKit

iPhone
TEXT
Devices
Apps
Sensors

iPhone
TEXT
Devices
Apps
Sensors

iPhone
TEXT
Devices
Apps
Sensors

iPhone
TEXT
Devices
Apps
Active Tasks
Dashboard
Consent
Surveys
Sensors

iPhone
TEXT
Devices
Apps
Active Tasks
Dashboard
Consent
Surveys
Sensors
ResearchKit Your Database

Health App HealthKit
iPhone
IN-CLINIC
+HOMEWORK
WELCOME TO THE CLINIC SIR
EXAMPLE STUDY: EPIWATCH

EPIWATCH STUDY
Adrianna Williams/Corbis
http://bit.do/bS7DM
EPIWATCH STUDY
Challenging Clinical Need
http://bit.do/bS7DM
EPIWATCH STUDY
Limitation of current EEG measurement

capabilities
http://bit.do/bS7DM
EPIWATCH STUDY

capabilities
Researching the physiology of eight

seizure types
http://bit.do/bS7DM
EPIWATCH STUDY

capabilities

seizure types
Capturing contextual data
http://bit.do/bS7DM
EPIWATCH STUDY

capabilities

seizure types
- Seizure event: Type, duration,

frequency, responsiveness and
cognition
http://bit.do/bS7DM
EPIWATCH STUDY

capabilities

seizure types
- Seizure event: Type, duration,

frequency, responsiveness and
cognition
- Correlation factors: Triggers,

medication adherence and side effects
http://bit.do/bS7DM
EPIWATCH STUDY
Possibilities of Non-EEG Seizure Detection
http://bit.do/epiwatch
EPIWATCH STUDY
Clinical Manifestations
EPIWATCH STUDY
Convulsions, Shaking
Accelerometer
Accelerometer
EPIWATCH STUDY
Accelerometer
Falls
Accelerometer
Gyroscope
EPIWATCH STUDY
Accelerometer
Falls
Accelerometer
Heart Rate Increase (80%) Gyroscope

Heart Rate
EPIWATCH STUDY
Accelerometer
Falls
Accelerometer
Heart Rate Increase (80%) Gyroscope

Heart Rate
Unresponsiveness
UI
EPIWATCH STUDY
EPIWATCH STUDY
Contextual Data Gathering
EPIWATCH STUDY
Seizure Event
Type, Duration
and Frequency
EPIWATCH STUDY
Seizure Event
Type, Duration
and Frequency
EPIWATCH STUDY
Seizure Event
Type, Duration
and Frequency
Responsiveness
and cognition
EPIWATCH STUDY
Seizure Event
Type, Duration
and Frequency
Responsiveness
and cognition
EPIWATCH STUDY
Seizure Event
Type, Duration
and Frequency
Responsiveness
and cognition
EPIWATCH STUDY
Seizure Event
Type, Duration
and Frequency
Responsiveness
and cognition
EPIWATCH STUDY
Seizure Event
Type, Duration
Correlation Factors and Frequency
Triggers
Responsiveness
and cognition
EPIWATCH STUDY
Seizure Event
Type, Duration
Triggers
Responsiveness
and cognition
EPIWATCH STUDY
Seizure Event
Type, Duration
Triggers
Responsiveness
and cognition
Triggers
EPIWATCH STUDY
Seizure Event
Type, Duration
Triggers
Responsiveness
and cognition Medication
Adherence
Triggers
EPIWATCH STUDY
Seizure Event
Type, Duration
Emergency Care Triggers

Responsiveness
Delivery* and cognition Medication
Adherence
Triggers
SMS Alert
EPIWATCH STUDY
EPIWATCH STUDY
Study Goals
EPIWATCH STUDY
Study Goals
Clinical Research (now)
EPIWATCH STUDY
Study Goals
Patient & Caregiver

Engagement
EPIWATCH STUDY
Study Goals
Patient & Caregiver

Engagement
Algorithmic Detection
EPIWATCH STUDY
Design Process
EPIWATCH STUDY
Design Process
EPIWATCH STUDY
Design Process
EPIWATCH STUDY
Design Process
EPIWATCH STUDY
Design Process
REGULATORY, SECURITY, & IRB CONSIDERATIONS
Apps may be regulated
Data may be regulated
IRB will look for compliance + security + privacy

REGULATORY CONSIDERATIONS
FDA regulates mobile medical devices
HHS > HIPAA regulates protected health information
FTC + state agencies regulate personally identifiable

information, financial information, childrens privacy, and
more
REGULATORY CONSIDERATIONS: FDA

Strategy 1: Avoid classification as a mobile medical application
Avoid diagnosis, cure, mitigation, treatment, or prevention
Leverage user-initiated activities only (disease tracking)
http://bit.do/FDA

Medical Device
Any instrument, apparatus, implement,

machine, contrivance, implant, in vitro
reagent, or similar or related article,
including any component, part, or
accessory intended for use in the diagnosis
of disease or other conditions, or in the
cure, mitigation, treatment or prevention of
disease
http://bit.do/FDA

Medical Device Mobile Medical Application
Any instrument, apparatus, implement, Is a medical device when it is intended:

machine, contrivance, implant, in vitro
reagent, or similar or related article, to be used as an accessory to a regulated
including any component, part, or medical device; or
accessory intended for use in the diagnosis
of disease or other conditions, or in the to transform a mobile platform
cure, mitigation, treatment or prevention of (smartphone, tablet, etc.) into a regulated
disease medical device
http://bit.do/FDA
http://bit.do/FDA

Strategy 2: Qualify for enforcement discretion as a low risk device
Avoid medical intervention - do not diagnose or treat
Do not replace an existing medical device (e.g., electronic stethoscope)
Do not control an existing medical device (e.g. iPhone infusion pump settings app)
http://bit.do/FDA

http://bit.do/FDA

Enforcement Discretion
Apps that are medical devices, but pose lower risk to the public, and are therefore not
subject to FDA regulation at this time:
Apps that help asthmatics track inhaler usage, asthma episodes experienced, location of user
at the time of an attack, or environmental triggers of asthma attacks
Apps that use a checklist of common signs and symptoms to provide a list of possible medical
conditions and advice on when to consult a health care provider
Apps that allow a user to collect, log, track and create trend data, such as blood glucose, blood
pressure, heart rate, weight or other data from a device to eventually share with a health care
provider, or upload it to an online (cloud) database, personal or electronic health record
http://bit.do/regulatory
REGULATORY CONSIDERATIONS: HIPAA

HIPAA only regulates certain data
Protected health information - has to touch an insurance

transaction in its lifecycle
Academic studies often not regulated; ResearchKit can be

used for private studies or products
HIPAA requires privacy, security, &

breach notification controls
Vendors must be approved and sign special BAA contracts
Vendors must be secure and compliant

REGULATORY CONSIDERATIONS: OTHER LAWS
SECURITY CONSIDERATIONS
Authentication
How do users log in?
Access Controls
Is there an admin dashboard?
Do researchers have different levels of access?
Audit Controls
Integrity + Business Continuity
Data backup
Storage encryption
Transmission Security
Encryption
SECURITY CONSIDERATIONS
Security Management
Who will document the security controls applied?
Who will approve them?
Who will maintain them?
How and how often will you verify them?

IRB CONSIDERATIONS
Gain early buy-in from IRB for electronic consent process
ResearchKit framework for e-consent has achieved significant review and support
Guided by Sage Bionetworks review http://sagebase.org/e-consent/
HHS support in developing electronic research consenting process

IRB CONSIDERATIONS
Gain early buy-in from IRB for electronic consent process
ResearchKit framework for e-consent has achieved significant review and support
Guided by Sage Bionetworks review http://sagebase.org/e-consent/
HHS support in developing electronic research consenting process
Seek expedited IRB review for minimal risk research
Try to establish an early and often informal check-in throughout design/development
Prepare supporting documentation
Full description of the app, its functionality and potential risks
App copy manuscript, technical flows, designs and diagrams, scientific literature
Full description of the consent process
Fully-developed data security plan that has been approved by appropriate institutional officials
BONUS CONSIDERATION: IP PROTECTION

Disclose conflicts of interest, commercial interests to IRB up front
Many research efforts have algorithm aspirations
Are you validating/refining your algorithm hypothesis with the intention to make money?
BONUS CONSIDERATION: IP PROTECTION

Disclose conflicts of interest, commercial interests to IRB up front
Many research efforts have algorithm aspirations
Are you validating/refining your algorithm hypothesis with the intention to make money?
Consider patent, copyright, and trademark protection
Patent protection requires innovation: cant be just X + computers
Limited protection for apps
You cant simply implement an existing concept in software
Do a search to make sure you dont infringe on someone elses patent

TRANSLATING CLINICAL EXPERIENCES
INTO DIGITAL UI/UX

ADAPT TO THE SMALL SCREEN
BREVITY RULES:
Copy Density (Use Video)
BREVITY RULES:
BREVITY RULES: Text Input (Use Touchscreen & Sensors)

BREVITY RULES: Text Input (Use Touchscreen & Sensors)

Dic1on (Users arent scien6sts/researchers)
THINK FRESH
GOING DIGITAL
CHANGES
RECRUITMENT &
RETENTION
LAUNCH KIT
App Icon Brand Mark
BRANDING & APP ICON
RESPONSIVE SUPPORT MICROSITE
DIGITAL RECRUITING
SOCIAL MEDIA ACTIVATION
DOWNLOADABLE WALL CLINGS
DIGITAL RECRUITING
COST COMPARISON
TRADITIONAL RESEARCH
Medical Personnel
Office Staff
Clinic Space
Office Space
Survey Printing Postage & Data

Processing
Participant Recruitment
COST COMPARISON
TRADITIONAL RESEARCH
Medical Personnel
Office Staff
Clinic Space
Office Space
Survey Printing Postage & Data

Processing
Participant Recruitment
Cost Per Patient???

COST COMPARISON
MOBILE RESEARCH
COST COMPARISON
MOBILE RESEARCH
App Development:
Independent App
UCore Model for Organizations

COST COMPARISON
MOBILE RESEARCH
App Development:
Independent App
Digital Recruitment
COST COMPARISON
MOBILE RESEARCH
App Development:
Independent App
Digital Recruitment
Secure Data Hosting

COST COMPARISON
MOBILE RESEARCH
App Development:
Independent App
Digital Recruitment
Secure Data Hosting
Analytics Software
COST COMPARISON
MOBILE RESEARCH
App Development:
Independent App
Digital Recruitment
Secure Data Hosting
Analytics Software
COST COMPARISON
MOBILE RESEARCH
App Development:
Independent App
Digital Recruitment
Secure Data Hosting
Analytics Software
Cost Per Patient???

MORE THAN JUST CHEAPER
NEW TYPES OF DATA
CONTINUOUS DATA (NO MORE SNAPSHOTS)
HIGH-SPEED INSIGHTS (WEEKS NOT YEARS)
MORE THAN JUST CHEAPER

Have questions? Time to discuss . . .
Q&A https://www.aptible.com
www.threadresearch.com
https://www.aptible.com
Want to discuss further? Get in touch!
aj@threadresearch.com
chas@aptible.com
THANK YOU https://www.aptible.com


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Aptible TR Webinar FINAL - Presentation

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Hak Cipta:

Format Tersedia

GETTING STARTED WITH RESEARCHKIT

SEE WHATS POSSIBLE.

AJ Triano, VP, THREAD Research

Chas Ballew, Co-Founder, Aptible

Example Academic Study: EpiWatch

Regulatory, Security, & IRB Considerations

Translating clinical studies to digital UI/UX

High-level cost considerations

Health App HealthKit ResearchKit

Health App HealthKit ResearchKit

Health App HealthKit ResearchKit

Health App HealthKit ResearchKit

Health App HealthKit ResearchKit

ResearchKit Your Database

EXAMPLE STUDY: EPIWATCH

Limitation of current EEG measurement

Limitation of current EEG measurement

Researching the physiology of eight

Limitation of current EEG measurement

Researching the physiology of eight

Capturing contextual data

Limitation of current EEG measurement

Researching the physiology of eight

Capturing contextual data

- Seizure event: Type, duration,

Limitation of current EEG measurement

Researching the physiology of eight

Capturing contextual data

- Seizure event: Type, duration,

- Correlation factors: Triggers,

Heart Rate Increase (80%) Gyroscope

Heart Rate Increase (80%) Gyroscope

Emergency Care Triggers

Clinical Research (now)

Clinical Research (now)

Patient & Caregiver

Clinical Research (now)

Patient & Caregiver

REGULATORY, SECURITY, & IRB CONSIDERATIONS

Apps may be regulated

Data may be regulated

IRB will look for compliance + security + privacy

FDA regulates mobile medical devices

HHS > HIPAA regulates protected health information

FTC + state agencies regulate personally identifiable

REGULATORY CONSIDERATIONS: FDA

Avoid diagnosis, cure, mitigation, treatment, or prevention

Leverage user-initiated activities only (disease tracking)

REGULATORY CONSIDERATIONS: FDA

Avoid diagnosis, cure, mitigation, treatment, or prevention

Leverage user-initiated activities only (disease tracking)

Any instrument, apparatus, implement,

REGULATORY CONSIDERATIONS: FDA

Avoid diagnosis, cure, mitigation, treatment, or prevention

Leverage user-initiated activities only (disease tracking)

Medical Device Mobile Medical Application

Any instrument, apparatus, implement, Is a medical device when it is intended:

cure, mitigation, treatment or prevention of (smartphone, tablet, etc.) into a regulated

disease medical device

REGULATORY CONSIDERATIONS: FDA

Avoid medical intervention - do not diagnose or treat

Do not replace an existing medical device (e.g., electronic stethoscope)

REGULATORY CONSIDERATIONS: FDA

Avoid medical intervention - do not diagnose or treat