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Getting Started with ResearchKit

Getting Started with ResearchKit

THREAD Research and Aptible give an overview of ResearchKit. Learn what's possible, and key considerations for study design, deployment, and security.

View the talk at: https://youtu.be/zgQVi71TyGI

7ee78ba49eaf26113318ac3597887cc5?s=128

Aptible

May 17, 2016
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Transcript

  1. SEE WHAT’S POSSIBLE. GETTING STARTED WITH RESEARCHKIT

  2. TODAY’S SPEAKERS ▸ AJ Triano, VP, THREAD Research ▸ Chas

    Ballew, Co-Founder, Aptible Introduction to ResearchKit
  3. Introduction to ResearchKit ‣ ResearchKit Overview ‣ Example Academic Study:

    EpiWatch ‣ Regulatory, Security, & IRB Considerations ‣ Translating clinical studies to digital UI/UX ‣ High-level cost considerations TOPICS COVERED
  4. TEXT WHAT IS RESEARCHKIT? HealthKit Health App ResearchKit iPhone

  5. TEXT WHAT IS RESEARCHKIT? HealthKit Health App ResearchKit Sensors Devices

    Apps iPhone
  6. TEXT WHAT IS RESEARCHKIT? HealthKit Health App ResearchKit Sensors Devices

    Apps iPhone
  7. TEXT WHAT IS RESEARCHKIT? HealthKit Health App ResearchKit Sensors Devices

    Apps iPhone
  8. TEXT WHAT IS RESEARCHKIT? HealthKit Health App ResearchKit Sensors Devices

    Apps Consent Surveys Dashboard Active Tasks iPhone
  9. TEXT WHAT IS RESEARCHKIT? HealthKit Health App ResearchKit Sensors Devices

    Apps Consent Surveys Dashboard Active Tasks Your Database iPhone
  10. IN-CLINIC +HOMEWORK

  11. WELCOME TO THE CLINIC SIR

  12. None
  13. None
  14. None
  15. Introduction to ResearchKit EXAMPLE STUDY: EPIWATCH

  16. Introduction to ResearchKit EPIWATCH STUDY Adrianna Williams/Corbis http://bit.do/bS7DM

  17. Introduction to ResearchKit EPIWATCH STUDY Adrianna Williams/Corbis http://bit.do/bS7DM Challenging Clinical

    Need
  18. Introduction to ResearchKit EPIWATCH STUDY Adrianna Williams/Corbis http://bit.do/bS7DM Challenging Clinical

    Need • Limitation of current EEG measurement capabilities
  19. Introduction to ResearchKit EPIWATCH STUDY Adrianna Williams/Corbis http://bit.do/bS7DM Challenging Clinical

    Need • Limitation of current EEG measurement capabilities • Researching the physiology of eight 
 seizure types
  20. Introduction to ResearchKit EPIWATCH STUDY Adrianna Williams/Corbis http://bit.do/bS7DM Challenging Clinical

    Need • Limitation of current EEG measurement capabilities • Researching the physiology of eight 
 seizure types • Capturing contextual data
  21. Introduction to ResearchKit EPIWATCH STUDY Adrianna Williams/Corbis http://bit.do/bS7DM Challenging Clinical

    Need • Limitation of current EEG measurement capabilities • Researching the physiology of eight 
 seizure types • Capturing contextual data - Seizure event: Type, duration, frequency, responsiveness and cognition
  22. Introduction to ResearchKit EPIWATCH STUDY Adrianna Williams/Corbis http://bit.do/bS7DM Challenging Clinical

    Need • Limitation of current EEG measurement capabilities • Researching the physiology of eight 
 seizure types • Capturing contextual data - Seizure event: Type, duration, frequency, responsiveness and cognition - Correlation factors: Triggers, medication adherence and side effects
  23. Introduction to ResearchKit EPIWATCH STUDY Possibilities of Non-EEG Seizure Detection

    http://bit.do/epiwatch
  24. Introduction to ResearchKit EPIWATCH STUDY Possibilities of Non-EEG Seizure Detection

    Clinical Manifestations http://bit.do/epiwatch
  25. Introduction to ResearchKit EPIWATCH STUDY Possibilities of Non-EEG Seizure Detection

    Clinical Manifestations Convulsions, Shaking Accelerometer Accelerometer http://bit.do/epiwatch
  26. Introduction to ResearchKit EPIWATCH STUDY Possibilities of Non-EEG Seizure Detection

    Clinical Manifestations Convulsions, Shaking Falls Accelerometer Accelerometer Gyroscope http://bit.do/epiwatch
  27. Introduction to ResearchKit EPIWATCH STUDY Possibilities of Non-EEG Seizure Detection

    Clinical Manifestations Convulsions, Shaking Falls Heart Rate Increase (80%) Accelerometer Accelerometer Gyroscope Heart Rate http://bit.do/epiwatch
  28. Introduction to ResearchKit EPIWATCH STUDY Possibilities of Non-EEG Seizure Detection

    Clinical Manifestations Convulsions, Shaking Falls Heart Rate Increase (80%) Unresponsiveness Accelerometer Accelerometer Gyroscope Heart Rate UI http://bit.do/epiwatch
  29. Introduction to ResearchKit EPIWATCH STUDY Possibilities of Non-EEG Seizure Detection

    http://bit.do/epiwatch
  30. Introduction to ResearchKit EPIWATCH STUDY Possibilities of Non-EEG Seizure Detection

    Contextual Data Gathering http://bit.do/epiwatch
  31. Introduction to ResearchKit EPIWATCH STUDY Possibilities of Non-EEG Seizure Detection

    Contextual Data Gathering Type, Duration and Frequency Seizure Event http://bit.do/epiwatch
  32. Introduction to ResearchKit EPIWATCH STUDY Possibilities of Non-EEG Seizure Detection

    Contextual Data Gathering Type, Duration and Frequency Seizure Event http://bit.do/epiwatch
  33. Introduction to ResearchKit EPIWATCH STUDY Possibilities of Non-EEG Seizure Detection

    Contextual Data Gathering Type, Duration and Frequency Responsiveness and cognition Seizure Event http://bit.do/epiwatch
  34. Introduction to ResearchKit EPIWATCH STUDY Possibilities of Non-EEG Seizure Detection

    Contextual Data Gathering Type, Duration and Frequency Responsiveness and cognition Seizure Event http://bit.do/epiwatch
  35. Introduction to ResearchKit EPIWATCH STUDY Possibilities of Non-EEG Seizure Detection

    Contextual Data Gathering Type, Duration and Frequency Responsiveness and cognition Seizure Event http://bit.do/epiwatch
  36. Introduction to ResearchKit EPIWATCH STUDY Possibilities of Non-EEG Seizure Detection

    Contextual Data Gathering Type, Duration and Frequency Responsiveness and cognition Seizure Event http://bit.do/epiwatch
  37. Introduction to ResearchKit EPIWATCH STUDY Possibilities of Non-EEG Seizure Detection

    Contextual Data Gathering Correlation Factors Type, Duration and Frequency Responsiveness and cognition Triggers Seizure Event http://bit.do/epiwatch
  38. Introduction to ResearchKit EPIWATCH STUDY Possibilities of Non-EEG Seizure Detection

    Contextual Data Gathering Correlation Factors Type, Duration and Frequency Responsiveness and cognition Triggers Seizure Event http://bit.do/epiwatch
  39. Introduction to ResearchKit EPIWATCH STUDY Possibilities of Non-EEG Seizure Detection

    Contextual Data Gathering Correlation Factors Type, Duration and Frequency Responsiveness and cognition Triggers Triggers Seizure Event http://bit.do/epiwatch
  40. Introduction to ResearchKit EPIWATCH STUDY Possibilities of Non-EEG Seizure Detection

    Contextual Data Gathering Correlation Factors Type, Duration and Frequency Responsiveness and cognition Triggers Triggers Medication Adherence Seizure Event http://bit.do/epiwatch
  41. Introduction to ResearchKit EPIWATCH STUDY Possibilities of Non-EEG Seizure Detection

    Contextual Data Gathering Correlation Factors Type, Duration and Frequency Responsiveness and cognition Triggers Triggers Medication Adherence Emergency Care Delivery* SMS Alert Seizure Event http://bit.do/epiwatch
  42. Introduction to ResearchKit EPIWATCH STUDY Possibilities of Non-EEG Seizure Detection

    http://bit.do/epiwatch
  43. Introduction to ResearchKit EPIWATCH STUDY Possibilities of Non-EEG Seizure Detection

    Study Goals http://bit.do/epiwatch
  44. Introduction to ResearchKit EPIWATCH STUDY Possibilities of Non-EEG Seizure Detection

    Study Goals Clinical Research (now) http://bit.do/epiwatch
  45. Introduction to ResearchKit EPIWATCH STUDY Possibilities of Non-EEG Seizure Detection

    Study Goals Patient & Caregiver Engagement Clinical Research (now) http://bit.do/epiwatch
  46. Introduction to ResearchKit EPIWATCH STUDY Possibilities of Non-EEG Seizure Detection

    Study Goals Algorithmic Detection Patient & Caregiver Engagement Clinical Research (now) http://bit.do/epiwatch
  47. Introduction to ResearchKit EPIWATCH STUDY Design Process

  48. Introduction to ResearchKit EPIWATCH STUDY Design Process

  49. Introduction to ResearchKit EPIWATCH STUDY Design Process

  50. Introduction to ResearchKit EPIWATCH STUDY Design Process

  51. Introduction to ResearchKit EPIWATCH STUDY Design Process

  52. Introduction to ResearchKit REGULATORY, SECURITY, & IRB CONSIDERATIONS ▸ Apps

    may be regulated ▸ Data may be regulated ▸ IRB will look for compliance + security + privacy
  53. Introduction to ResearchKit REGULATORY CONSIDERATIONS ▸ FDA regulates “mobile medical

    devices” ▸ HHS —> HIPAA regulates “protected health information” ▸ FTC + state agencies regulate personally identifiable information, financial information, children’s privacy, and more
  54. Introduction to ResearchKit 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
  55. Introduction to ResearchKit 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) 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
  56. Introduction to ResearchKit 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) 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 Mobile Medical Application Is a medical device when it is intended: • to be used as an accessory to a regulated medical device; or • to transform a mobile platform (smartphone, tablet, etc.) into a regulated medical device http://bit.do/FDA
  57. Introduction to ResearchKit REGULATORY CONSIDERATIONS: 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
  58. Introduction to ResearchKit REGULATORY CONSIDERATIONS: 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
  59. Introduction to ResearchKit REGULATORY CONSIDERATIONS: 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) 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/FDA
  60. Introduction to ResearchKit REGULATORY CONSIDERATIONS: HIPAA http://bit.do/regulatory

  61. Introduction to ResearchKit REGULATORY CONSIDERATIONS: HIPAA http://bit.do/regulatory ▸ 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
  62. Introduction to ResearchKit REGULATORY CONSIDERATIONS: HIPAA http://bit.do/regulatory ▸ HIPAA requires

    privacy, security, & breach notification controls ▸ Vendors must be approved and sign special BAA contracts ▸ Vendors must be secure and compliant
  63. Introduction to ResearchKit REGULATORY CONSIDERATIONS: OTHER LAWS http://bit.do/regulatory http://bit.do/regulatory

  64. Introduction to ResearchKit REGULATORY CONSIDERATIONS: OTHER LAWS http://bit.do/regulatory http://bit.do/regulatory

  65. Introduction to ResearchKit REGULATORY CONSIDERATIONS: OTHER LAWS http://bit.do/regulatory http://bit.do/regulatory

  66. Introduction to ResearchKit REGULATORY CONSIDERATIONS: OTHER LAWS http://bit.do/regulatory http://bit.do/regulatory

  67. Introduction to ResearchKit 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
  68. Introduction to ResearchKit 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?
  69. Introduction to ResearchKit 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
  70. Introduction to ResearchKit 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, it’s 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
  71. Introduction to ResearchKit 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?
  72. Introduction to ResearchKit 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: can’t be just “X + computers” • Limited protection for apps • You can’t simply implement an existing concept in software Do a search to make sure you don’t infringe on someone else’s patent
  73. INTO DIGITAL UI/UX TRANSLATING CLINICAL EXPERIENCES

  74. BREVITY RULES: ADAPT TO THE SMALL SCREEN

  75. BREVITY RULES: ADAPT TO THE SMALL SCREEN Copy Density (Use

    Video)
  76. BREVITY RULES: ADAPT TO THE SMALL SCREEN Copy Density (Use

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

    Video) Text Input (Use Touchscreen & Sensors) Dic1on (Users aren’t scien6sts/researchers)
  78. THINK “FRESH”

  79. RECRUITMENT & RETENTION GOING DIGITAL CHANGES

  80. Introduction to ResearchKit LAUNCH KIT DIGITAL RECRUITING BRANDING & APP

    ICON DIGITAL RECRUITING App Icon Brand Mark RESPONSIVE SUPPORT MICROSITE SOCIAL MEDIA ACTIVATION DOWNLOADABLE WALL CLINGS
  81. COST COMPARISON TRADITIONAL RESEARCH ▸ Medical Personnel ▸ Office Staff

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

    ▸ Clinic Space ▸ Office Space ▸ Survey Printing Postage & Data Processing ▸ Participant Recruitment ▸ Cost Per Patient???
  83. COST COMPARISON MOBILE RESEARCH

  84. COST COMPARISON MOBILE RESEARCH ▸ App Development: Independent App UCore

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

    Model for Organizations ▸ Digital Recruitment
  86. COST COMPARISON MOBILE RESEARCH ▸ App Development: Independent App UCore

    Model for Organizations ▸ Digital Recruitment ▸ Secure Data Hosting
  87. COST COMPARISON MOBILE RESEARCH ▸ App Development: Independent App UCore

    Model for Organizations ▸ Digital Recruitment ▸ Secure Data Hosting ▸ Analytics Software
  88. COST COMPARISON MOBILE RESEARCH ▸ App Development: Independent App UCore

    Model for Organizations ▸ Digital Recruitment ▸ Secure Data Hosting ▸ Analytics Software
  89. COST COMPARISON MOBILE RESEARCH ▸ App Development: Independent App UCore

    Model for Organizations ▸ Digital Recruitment ▸ Secure Data Hosting ▸ Analytics Software ▸ Cost Per Patient???
  90. MORE THAN JUST CHEAPER

  91. MORE THAN JUST CHEAPER • NEW TYPES OF DATA •

    CONTINUOUS DATA (NO MORE SNAPSHOTS) • HIGH-SPEED INSIGHTS (WEEKS NOT YEARS)
  92. None
  93. Have questions? Time to discuss . . . Q &

    A www.threadresearch.com https://www.aptible.com
  94. www.threadresearch.com https://www.aptible.com

  95. Want to discuss further? Get in touch! aj@threadresearch.com chas@aptible.com www.threadresearch.com

    https://www.aptible.com THANK YOU