IoT Medical Devices | Topic #3 of PharmaLedger's 2nd Open Webinar

This project has received funding from the Innovative Medicines Initiative 2 Joint Undertaking under grant agreement No 853992.
This Joint Undertaking receives support from the European Union’s Horizon 2020 research and innovation programme and EFPIA.
Disclaimer: Any information on this presentation solely reflects the author’s view and neither IMI nor the European Union or EFPIA
are responsible for any use that may be made of the information contained herein.
Open Webinar
A TRUST-CENTRIC HEALTHCARE JOURNEY PART II
Clinical Trial & Health Data Use Cases
24
FEB
3
MAR

Open Webinar
A TRU ST- C E N T R IC HEALT H C A R E J OURNE Y PART II
TOPIC 3 | IoT Medical Device
Disa Lee Chou n (UCB)
Fr ancesca Rocchi
(Os pedale Pediatric o Bambino Ges ù)
24
FEB
3
MAR

Copyright © 2021 PharmaLedger - All Rights Reserved
Current State
B A C K G R O U N D
• Disconnected Ecosystems’ Applications
• Security and Data Breaches (Ad-Hoc Cybersecurity Mechanisms)
• Centralization & Access Limitations: Manufacturers essentially are data silos.
• Lack of Data Standards & Formats: Emergence of EHR
• Time Delays: Data Updates, Notifications
• No smart analytics with traceable and verifiable notification over large data
volumes
Weekly download
Data analysis
Research/ Investigator
Patient Patient ID
Devices 1
Patient ID
Devices 2
Patient ID
Devices 3
Device
Company 1
Device
Company 2
Device
Company 3
Processed &
Aggregated in
Proprietary platform
Gathering information
and applying the
standards
Aggregated Data in
template formats
(CRF – AE)
Challenges

I N T R O T O I O T
Connected Health Devices + Remote Monitoring Technology
Innovative strategy to promote health and improve patient management and care.
Physiological data of the patient and their data
related to the disease are digitally transmitted
to a healthcare center providing clinical
information
Early detection of diseases enables:
• Early intervention
• Reduction of mortality and hospitalization
• Allows patient education and self management
Even within the framework of a clinical trial, remote patient monitoring can improve
Patient Outcome Reduce healthcare
utilization Decrease costs
Provide abundant
data for research
Increase physician
satisfaction

A D V A N T A G E S O F I O T
The devices
Intelligent and Noninvasive
biosensors
Wearable
health devices
Implanted monitoring
devices
Specially now we feel the importance of tele-medicine in the clinical and research setting and secure data sharing avoiding unnecessary
access to the hospital during the Covid era.
REAL TIME DATA
potential to improve
care, boost treatment
adherence and improve
health outcome
This use case aims at validating how blockchain
enhances and supports the dynamic acquisition and
processing of data from patients and medical devices in
one consolidated view, to accelerate clinical development
and bring solutions to patients earlier.
Connected health devices and remote patient
monitoring (RPM) technologies can facilitate and
enrich healthcare decisions made by doctors,
principal investigators and other stakeholders in
clinical trials, through continuous health
monitoring.

T H E C L I N I C A L S T U D Y U S I N G I O T
• 20 patients
• from 1-18 years of age
• Chronic heart failure
• 3 months of telemonitoring
A non-Interventional Study will
be used to validate the use
case. The study will be
sponsored by Ospedale
Pediatrico Bambino Gesù
(OPBG), Italy.
H E A R T F A I L U R E I N P E D I AT R I C A G E G R O U P
A recent analysis has shown that structure telephone support and telemonitoring significantly reduces the risk
of mortality and re-hospitalization related to heart failure.
Currently we have no telemonitoring data in heart failure in pediatric patient age group.
The aim is to measure the tolerability and clinical impact of telemonitoring in the management of heart failure.
Validate how blockchain enhances and supports the dynamic acquisition and processing of data from patients and medical devices.
The study

I O T M E D I C A L D E V I C E
U S E D O N O P B G P E D I A T R I C C L I N I C A L T R I A L
Noninvasive health data monitoring devices
used in the study:
• Transcutaneous in patch type for the chest*
• Oximeter applied to the finger*
• E-diary to discuss device satisfaction
ECG Oxymeter eDiary
Devices used on the
clinical trail
*sent to a private cloud stored in a medical patient record
The trial is currently under review of the
ethic committee and will start soon.

F U T U R E S T A T E | P R O P O S E D S O L U T I O N
Clinical Trial Participant
PharmaLedger Patient
Mobile Application
IoT Medical /
LifeStyle Devices
PharmaLedger
Platform
Data transmission
Data transmission
Device
provider Cloud
Hospital
Database
PharmaLedger
User Interface
Clinical Trial Staff

W H Y B L O C K C H A I N ?
Cybersecurity Framework using
decentralized identifiers (DID)
and verifiable credentials (VC)
Trusted & verifiable data
retrieval from multiple sources
Verifiable and traceable
real-time notifications for
Patients & Clinicians
Encryption and access control
ensuring security & privacy
Verifiable history of
updates on patient's data
Decentralization &
permissioned access
Transparency on data
ownership by relevant
participants
Standardized and traceable
data for enhanced analytics

IoT Enabled Clinical Trial
• Patient Empowerment & Engagement
• Integral info. Trial Design*
• Higher Data Quality & Integrity
• Reduced Operational Expenses
• Remote patient monitoring
Patients
• Reduce burden for patient
• Less visits to trial site
• Flexibility to participate in
clinical trials
• Secure access
• Improved visibility of own
data
• Ownership and
empowerment
• Self management of health
data
Clinical Sites
• Real time data visibility
for all devices
• Reduce site burden
managing multiple
platforms
• Eliminate complexity of
data access management
• Efficiency in patient safety
matters
• Traceability and
auditability of data access
and exchange
Sponsors
• Continuous, remote and
trusted trial progress
overview
• Long-term outcomes
traceability and auditability
• Transparency over the
safety and efficacy of the
treatment
• Real time access to key
aggregated data
• Cost reduction
• Quicker decision making
and safety reporting
Device Company
• Reduced efforts of system
integration
• Increased traceability
• Simplified qualification
process and due diligence
• Device certifications in
multiple countries
• Harmonized data standards
and analytics
Regulatory Agency
• Simplified validation
• Simplified verification of
devices
• Reduced audits and
inspections efforts
• Transparency of certified data
• Compliance to data privacy
and legislation
V A L U E P R O P O S I T I O N T O S T A K E H O L D E R
* Essential or fundamental information collected part of the trial design.
These IoTs are collecting patient assessments which will be used to
determine patient’s health.

V A L U E C H A I N - U S E C A S E S V I E W
Clinical Trial
eRecruitment
Clinical Trial
eConsent
Clinical Trial
IOT devices
Personalized
Medicines

T H A N K Y O U

IoT Medical Devices | Topic #3 of PharmaLedger's 2nd Open Webinar

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