3. PharmaLedger’s IoT Medical Device Use Case

IoT Medical Device Use Case | Watch PharmaLedger’s Use Case presentation and topic-specific Q&A – Join us in our Trust-Centric Healthcare Journey.

PharmaLedger hosted our second public Open Webinar “A Trust-Centric Healthcare Journey Part II” at the beginning of 2021. It covered the challenges, solutions and added value of our four use cases under clinical trials and health data. You can be sure to rewatch this webinar on our YouTube channel if you have missed it – you will also be allowed to directly view each individual use case topic and listen to topic-specific questions answered by our presenters. We will share an individual article for each of our four clinical trial and health data use cases over the next weeks so you can easily follow the videos and find out their latest progress.

IoT Medical Device Use Case

Following Clinical Trial eConsent, the third use case covered in the webinar was IoT Medical Device, which was presented by its co-leads Disa Lee Choun (UCB) and Subject Matter Expert Francesca Rocchi (Bambino Gesù Children’s Hospital). You can rewatch the use case recording below, along with the Q&A related to this topic at the end of the video:

Here is a brief overview of the presentation, with minute markers to help you navigate the video recording.

Current State (1:00)

IoT medical devices, such as patches, phone applications and sensors, are creating data silos and many other challenges. These applications are often disconnected from each other since they use their own cloud or applications for data storage. The data cannot easily be accessed and used for studies, since it would have to be downloaded weekly or monthly to be used in clinical trials or by researchers. This time-consuming process is inefficient and the various devices that one patient might use create a disconnected ecosystem.

Challenges – Pain Points (2:24)

As mentioned in our previous article, “A Trust-Centric Healthcare Journey Part II: Challenges Found in Clinical Trials and Health Data,” there are certain challenges to overcome when it comes to IoT Medical Devices:

Intro to IoT (4:45)

Connected IoT health devices and technology using remote monitoring can provide an improved system for managing patient care. A patient can be at his or her home while physiological data is transmitted to a healthcare centre via a telephone, internet or video call. This innovative solution  could allow for early disease detection and intervention, which could lead to reduced mortality and hospitalisation. This would lead to greater patient education and self-management, thus improving overall health. Remote monitoring could also improve patient outcomes, reduce healthcare utilisation, decrease costs, provide data and increase physician satisfaction. 

Advantages of IoT (6:06)

Some of these remote devices can offer real-time monitoring, which would improve care and treatment, as well as overall patient health. As seen with the Covid-19 pandemic, these IoT devices would decrease any unnecessary visits to the hospital while still providing important patient data to medical centres. PharmaLedger’s  IoT Medical Devices use case aims to validate the dynamic acquisition and patient data processing from medical devices using blockchain technology. This could accelerate clinical development and thus bring effective solutions to patients faster. PharmaLedger is using a clinical trial study to validate and test this use case.

Clinical Study Using IoT (7:25)

The goal of PharmaLedger’s IoT Medical Device use case is to conduct a non-interventional study at the Bambino Gesù Children’s Hospital that will monitor pediatric patients with chronic heart failure. The study will use telemonitoring and manage it through models of integrated therapeutic interventions. The study will assess the tolerability and clinical impact of the telemonitoring system by monitoring heart failure in these 20 patients, ranging from 1-18 years of age for a period of three months. The aim is to see how blockchain can support the dynamic acquisition and processing of this health data from the patients.

IoT Medical Device Used on OPBG Pediatric Clinical Trial (9:30)

The devices used for this study consist of a patch-type non-invasive monitoring unit for the patient’s vital parameters, a transmission component and the software for collecting and presenting the vital parameters. Patients and parents will also be answering satisfaction assessments periodically with an eDiary throughout the study. 

Future State – Proposed Solution (10:50)

The proposed solution of this use case study begins with a clinical trial. After a patient grants permission through electronic consent to having his or her data used, various monitoring devices including eDiary on a mobile app will be granted or assigned to the patient to participate in the non-interventional clinical trial. The PharmaLedger platform will obtain the data collected from the mobile app and  from the various medical devices. On the platform, the data will be aggregated and analysed by a healthcare practitioner. Health data will also be sent to a hospital via the cloud and any key data will be transferred to the PharmaLedger platform that is necessary for the study. 

Why Blockchain? (12:20)

The IoT Medical Device use case leverages the following benefits of blockchain technology 

  • 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
  • Verifiable history of updates on patient’s data
  • Decentralization & permissioned access 
  • Transparency on data ownership by relevant participants

Blockchain technology will provide a tamper-proof trail of patient data that is being collected. By making it easier to access and analyse this patient data, it will allow for faster analysis and quicker decisions when it comes to patient or research participant’s health.

Value Proposition to Stakeholder (14:35)

There are different values added to the various stakeholders involved in the IoT Medical Device use case. The stakeholders include patients, clinical sites, sponsors of this study, device producers and regulators. You can read the summarised value-added for each stakeholder below.

An IoT Enabled Clinical Trial can strengthen patient empowerment and engagement, reach higher data quality and integrity, reduce clinical trial operational expenses and create improved remote patient monitoring. 

Poll Results (20:30)

What do you feel is the most important step in a clinical trial?

  • Informed consent (52%)
  • Data collection and analysis (36%)
  • Data sharing (12%)
  • Screening (0%)

Do you think this is a solution that your company would adopt in the near future?

  • Yes in 3-5 years (50%)
  • Yes in 1-3 years (30%)
  • Yes in 7 or more years (10%)
  • Yes in 5-7 years (5%)
  • No, they won’t (0%)

Q&A (21:14)

  • IoT is not a new technology. What is different in your offer from previous ones? (21:38)
  • I do not understand how blockchain is used in the IoT and personalised medicine use cases. How are you using blockchain? (25:03)
  • To IoT device. Do you see conflict for sponsors to have real-time access to aggregated data – in relation to being able to bias the outcome of the trial? (28:14) 
  • You mentioned a demo trial – will there be white papers on the outcomes and plans? (29:28) 
  • Blockchain has been used without specificity. Which ‘blockchain’ platform? And how do you intend to scale the voluminous data processing and use? (30:20)
  • Who/which suppliers would make these blockchains a reality? This is costly work and there are no off-the-shelf solutions (32:48)
  • How to join PharmaLedger ? We have developed a scalable use case that fits 100% (35:42)
  • Who will manage these Blockchain platform? (36:53)
  • When could patients expect solutions to be available? (37:40)
  • Given that there are other similar solutions in development, how will you build the critical mass to ensure yours is successful? (39:09)
  • Will Big Pharma own these solutions? (40:10)
  • How many ledgers and nodes do you have on a possible chain code? (41:04)

The next Health Data use case article we are preparing for you is Personalised Medicines, which you can look forward to in the next few weeks!

You can watch the full recording of PharmaLedger’s recent webinar, “A Trust-Centric Healthcare Journey Part II” below.

PharmaLedger has eight use cases in total covering supply chains, clinical trials and health data. PharmaLedger is a three-year project sponsored by the Innovative Medicines Initiative (IMI) and European Federation of Pharmaceutical Industries and Associations (efpia) that brings together a consortium made up of 29 partners who are working together to build a trusted platform using blockchain technology and in addition create many healthcare applications. 

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