This document summarizes Anurag Singhal's presentation on engineering for connected patients in the IoT era. Singhal is the director of engineering at Clinical Ink, which provides mobile apps and a platform called CentrosHealth to enable clinical trials to capture data from patients using connected devices and sensors. The presentation discusses how Clinical Ink uses MongoDB to store diverse clinical trial and sensor data, ensuring data security, audit trails, and compliance with regulations. It also describes challenges around processing large volumes of data from wearable sensors and finding solutions to issues like data deduplication and streaming.

1. 1
Engineering for Connected
Patients in the IoT Era
Anurag Singhal
Director of Engineering
Clinical Ink Inc.
Sep 17, 2015

2. 2
Introductions
Anurag Singhal, MS
Director of Engineering
anurag.singhal@clinicalink.com
@anurag_singhal
www.linkedin.com/in/singhalanurag

3. 3
About Clinical Ink
 Founded in 2007, ~100 Employees
 Winston-Salem, NC, Horsham, PA and Cambridge, MA
 Acquired CentrosHealth, VC Funding 2015
 SureSource & CentrosHealth Platforms
 Various Awards & Recognitions
Society for Clinical
Data Management
2014 Best
Practices
eClinical Company of the
Year
Founders 50 Club
Center for
Entrepreneurs

4. 4
About You!

5. 5
Agenda
• Introduction to CentrosHealth Platform
• MongoDB in Healthcare Environment
• Tackling Data from Wearables & Sensors
• Q&A

6. 6
CentrosHealth Platform
 Clinical Trial Specific Mobile Apps
 For Connected & Engaged Patients
 In Partnership with Novartis
 Intro Video
http://youtu.be/U2fYY0KBtJ4
 Website www.centroshealth.net

7. 7
CentrosHealth Platform
 Surveys, Diaries
 Tasks & Reminders
 Medication Adherence
 Sensor Integration
 Communications with Clinic
 Education Content
 Configured Per Study Needs

8. 8
MongoDB @ Clinical Ink

9. 9
MongoDB within CentrosHealth
 Single Replica Set in AWS
 Single database  Database per Tenant
Self-Service Access
End of Study Exports / Archival
Study Level Software Upgrades
 Separated Database for Personally Identifiable Data
HIPAA Security

10. 10
HIPAA, 21 CFR Part 11, Safe Harbor &
EU Data Privacy
 Does Mongo do HIPAA?
 MongoDB Consulting Helped!
 Recognized need to upgrade
to Enterprise edition
Admin Audit Trails
Stronger Encryption
Point in time recovery
Support is Awesome!

11. 11
Key DB Requirements / MongoDB Fit
Requirement DB Implications
 Store Surveys Document / Name - Value Pairs
 Capture Sensor Data Big Data
 Varied Research Applications Flexible Schema Design
 Global scale clinical trials Data locality
 Startup Low cost & fast to develop
 Critical Data / Enterprise Security, Scalable, Availability
 Audit Trails for Compliance Transactional Documents
Strong Fit Good Fit Worked Out Unmet Requirement

12. 12
Limitations / Workarounds
 Tech Support
Not allowed to directly edit JSON
Offer Data Correction APIs
MongoChef for Queries
 Ad Hoc Reporting for Business Users
Not easy over JSON / NoSQL
Offer ETL APIs
Implement Data Marts

13. 13
Tackling Data from Wearables &
Sensors
CentrosHealth now offers streamlined connectivity for a wide range of
medical devices!

14. 14
Business Case
 Enable clinical trial data capture
at patient’s home
using patient’s phone
 End to End Medical Device Connectivity
 Medical grade health data integrity & security
 Integrate Qualcomm Life’s 2net Platform
An open medical device ecosystem

15. 15
An End to End Business Process Flow
Configure
Study & Kit
Devices
Patients
Wirelessly
Capture
Data
Transport,
Transform &
Store Data
Deliver
Actionable
Insights to
Clinicians
& Pharma

16. 16
Wearables & Biometric Sensors = Big Data
10’s of
Months
100’s of
Clinical
Trials
100’s of
Patients
Millions
of
Measur-
ements
~100s of Billions
of
Measurements

17. 17
Engineering Sensor Data with MongoDB
Device Memory -> Firmware Data
Format
2net SDK Normalized Device Data
CentrosHealth Sensor Logs (Device
Specific)
CentrosHealth Aggregated
Measurement Data (Device Agnostic)

18. 18
Embedded 2net Data as Subdocuments
 Schema within
collection varies by
device!
 Seamlessly embed 3rd
party JSON data as a
subdocument
 Store all data
received!
Note: Data Model shown is similar,
NOT actual

19. 19
Love that Aggregation Framework!
 4GB Test Data
 100M Data Points!
 De-dupe to 33K
Records
 No Indexes
 223 Seconds
 On Macbook Air!
 Two function calls

20. 20
Wrestling with Wearable Activity
Tracker Data
 Activity Tracking device sends Last 15 days of data over
and over every 15 minutes!
 Clinicians needed to monitor all data using our web UI!
 Server side challenges with reporting over sensor data
De-duplication
Data streaming to resolve memory issues

21. 21
Market Waves!
 Successfully Completed a Pilot Clinical Trial
 A Partnership Effort by Clinical Ink, Novartis, PPD, Qualcomm

22. 22
Questions? Comments?

23. 23
Thank You Folks!
BTW, We’re hiring a team of full stack,
server, web and mobile nerds!
Email careers@clinicalink.com