Delivered by Dr. Andrew Rut, CEO of MyMedsandMe at MedTec 2018 in Stuttgart.

1. Is Big DataAlwaysGood Data?
MEDTEC EUROPE 2018
STUTTGART
17 APRIL 12:00 – 12:30
DR. ANDREW RUT
CHIEF EXECUTIVE
OFFICER

2. “
”
Each year about a million biomedical
studies are published in the scientific
literature. And many of them are
simply wrong.
Rigor Mortis: how sloppy science creates worthless
cures, crushes hope and wastes billions*
*Richard Harris
** Six red flags for suspect work C. Glenn Begley

3. What is big data?
“Data of a very large size, typically to the extent that its
manipulation and management present significant and logistical
challenges.” – OxfordEnglishDictionary
“The ability of society to harness information in novel ways to
produce useful insights or goods and services of significant
value [and] things one can do at a large scale that cannot be
done at a smaller one, to extract new insights or create new
forms of value.” – ViktorMayerSchönberger and Kenneth Cukier;BigData

4. Medical big data
“The totality of data related to patient
healthcare and wellbeing.”
– Raghupathi 2014

5. ‘The amount of data you slough off everyday—in lab tests, medical
images, genetic profiles, liquid biopsies, electrocardiograms……is
overwhelming…...
Throw in … medical claims, clinical trials, prescriptions,
academic research, and more, and the yield is ~ 750 quadrillion
(1015) bytes every day—or some 30% of the world’s data
production. ’
Fortune Magazine. April 2018

6. Sources of medical data
Medical research
Clinical trials
Cohort studies
Clinical information systems
Electronic health records
Patient examinations
Medical imaging
Mobile devices
Web searches
Social media
Insurance claims data
Public records
Routine population statistics and
major disease surveillance
Data reported by patients

7. AORTA (Always On Real Time Access): Continuous
Monitoring of Health Status
• New technologies and real-time, remote monitoring of health
status and treatment compliance – wearables, sensors, social
media
• New patterns of consumer/patient interaction with the healthcare
system and healthcare professionals (“expanded touch points”)
• Progressive evolution of a seamless blend of online and
physical services for clinical care and individual health risk Mx

8. Mobile devices, Wearables, Sensors and
Continuous Monitoring plus Social Media ……Your
Behaviour in now measurable
• Our actions can now be tracked and
measured with (GPS) precision
• Big data sets identify predictable behaviours
and individual risk patterns
• Ethical and legal issues – Security, Privacy,
ownership……… GDPR

9. Challenges
Quality
Inconsistency
Instability
Purity
Availability
Security
Cost
Access
Size
Regulation

10. Big data characteristics: 3Vs
Volume
• Scale of data
Velocity
• Rate of increase
Variety
• Different forms of data

11. What makes big data good data
Validity
‒ Information must be factually sound and reliable
Value
‒ Data must be meaningful, i.e. will it help people make decisions about
healthcare in the real world?

13. Plots show updated GFT model estimates compared with weighted CDC ILI-Net data for
(B) Mid-Atlantic HHS-2 Region States (New Jersey, New York), and local ILI surveillance
from emergency department ILI visit data for (C) New York City. (Olson et al; 2013)
Scatter plots of weekly excess influenza-like illness (ILI) visit proportions against
updated Google Flu Trends (GFT) model

14. Challenges of prospective use of internet
search algorithms:
Substantial flaws in GFT models identified
‒ missing and overestimating the intensity of the
epidemic
Reasons
‒ changes in internet search behavior
‒ differences in seasonality or geography
‒ Changes in age-distribution of the epidemics

15. Good
Small
data
teaches
us Big
things

16. An adverse event (AE) is any untoward medical occurrence in a patient or clinical
investigation subject administered a pharmaceutical product and which does not
necessarily have a causal relationship
An adverse drug reaction (ADR) is suspected to be causally related to the drug.
Safety of Medicines

17. AER Volumes rising (FDA data)

18. Consumer AE reports rising (FDA data)

19. “
”
Adverse drug events (ADEs) are an
increasingly relevant issue for healthcare
systems as they are associated with
poorer health outcomes and avoidable
misuse of resources
The Economic Burden of Inappropriate Drug Prescribing, Lack of Adherence and Compliance,Adverse Drug
Events in Older People;A Systematic Review; Carlos Chiatti,1 Silvia Bustacchini,1 Gianluca Furneri,1 Lorenzo
Mantovani,2 Marco Cristiani,3Clementina Misuraca4 and Fabrizia Lattanzio

20. H e a l t h c a r e b u r d e n o f A D R s
3.7% 39% 40%
ADRs account for
3.7% of hospital
admissions in the
Developed world.
~39% of ADRs in
pediatric patients
can be life
threatening or fatal.
Non-
adherence
Howard RL, Avery AJ, Slavenburg S, Royal S, Pipe G, Lucassen P, et al. Which drugs cause preventable
admissions to hospital? A systematic review. Br J Clin Pharmacol. 2007;63:136–47.

21. U SA AE R epor ts 2016; D ata G a p s
Rx
4.5B
AERs
1.7M
Serious AERs
>50% basic data missing
37% Age missing
0.57M
Institute for Safe Medicines; Quarter Watch Annual Report: July 2017

22. High Value Safety Data informs understanding of
products & their effect on patients
Value of Safety reports
directly proportional to the
amount
of clinically relevant
information.
Overall, only 1 in 8 of
reports provide the
desired level of
information
Physicians & consumers
using e-reporting tools
generate greater proportions
of well-documented reports

23. Dismissed importance
“Doctor said would have to live with side effects and did not seem to
care. Ignored complaints about symptoms”
“Acted as if it was in imagination. Don’t think
doctor believed me.”
Dismissed existence
Source: Beatrice A. Golomb et al, Physician Response to Patient Reports of Adverse Drug
Effects Implications For Patient-Targeted Adverse Effect Surveillance, Drug Safety 2007

24. Getting Purer data, faster from the
source
Get the right data first time on medicine
safety

25. Reportum
Multi-lingual, multi-platform safety
data capture solution

26. Configurable, intuitive design – Simple safety data collection
in real time
• Web, mobile APP (on/offline)
• Multi-language
• High availability on AWS GxP cloud
• Active workflow triggers questions based upon Event & Product
• Attachments and images supported (pathology data etc)
• Fully coded data (XML )
• Feeds AI and ML engines (learning and further processing)

27. User Interface flexibility is key
• Simple screens for rapid collection
• Body map selection mapped to a medical coding
library (MedDRA)
• Local languages available with coding libraries

28. BODY MAP SELECTOR

30. MULTI-LANGUAGE SOLUTION

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33. Big & Good Data: Focus on the Individual
Real time
Monitoring &
Data integration
Data
Analytics
Individual risk
assessment &
Management
Genomics,
Diagnostics, Lifestyle
plus efficacy-safety
profile of medicines
AI/ML
Health
management plans
and optimized RX
A Drive to Personal Prediction, Prevention &
Management

34. Discover more at:
www.mymedsandme.com/Reportum