TH Observatory Epiwrist & HEpiTracker to track COVID-19 R&D

The Epiwrist & HEpiTracker smart devices should monitor COVID-19 related symptoms and other infectious diseases. Artificial intelligence algorithms will generate preliminary COVID-19 automatic reports for Health Professionals across several regions worldwide.

Dr. Joan Soriano (Project/Team Leader) has 25+ years of experience conducting translational clinical research, and recently at the COVID-19 Clinical Management Team of the WHO Health Emergency Programme, WHO HQs.

Many professional sectors have been severely affected by the ongoing COVID-19 pandemic since early 2020. Moreover, law enforcement officers and health professionals such as medical doctors, nurses, emergency response teams, other health technicians, etc. -who are the backbone of any ‘efficient response’ during this COVID-19 outbreak worldwide-, have been progressively hit.

The upcoming Epiwrist activity smart device should monitor the user’s cough, body temperature, respiratory rate, oxygen saturation, and co-oximeter smoke detector. Additionally, heart rate, sleep, steps activity will be synchronized with HEpiTracker which monitors pandemic-related symptoms. Artificial intelligence algorithms generate daily automatic reports by center, service and job category.

The device settings generate pandemic and epidemics key daily symptom ratings and individual summary results. Additionally, pooled data are sent to a server which, through artificial intelligence algorithms, manage easy-to-understand infographic reports, that should enable hospital directors to periodically monitor the spread of infectious diseases in nearly real-time within each hospital/clinical center and determine any interventions. Epiwrist includes a movement gyroscope sensor and spatial data, synchronized with our HEpiTracker app which obtains further information from users to design and implement clinical measures and strategies with a critical objective: to contain the spread of any infectious disease.

• The ultimate goal of this innovative initiative is to assist those in critical need to control COVID-19 and upcoming infectious diseases to address challenges in nearly real-time as well as to find effective solutions for tackling growing global health threats. It constitutes a sustainable project with a powerful impact in the global health system with a complementary business channel while developing international clinical trials. A percentage of the benefits from the global commercialization of the final product should be transferred to cooperation and development actions aligned with the Agenda 2030 in developing countries most affected with COVID-19.
• Target audience / beneficiaries (process to engage them): In a first stage, our beneficiaries should be the hospital workforce, health centers’ professionals as well as the law enforcement officers. In further stages, beneficiaries could include specific personnel providing public services (primary care, educational centres) and vulnerable populations. 

TH Observatory Epiwrist & HEpiTracker device is an innovative mobile app to help monitor the spread of COVID-19 within hospitals. It was conceived after a state of emergency and full lockdown were declared in Spain on March 14, 2020. Following initial discussions and ethical approval, a stepwise approach was carried out by Aselcis software developers (Madrid, Spain) to create the first version of the new app within a week and then to enhance its functionalities regularly. After several iterations, a minimum set of variables to integrate in the HEpiTracker App were identified, including demographic and occupational data, symptoms, previous comorbidities, and lab testing variables. 

Considering the difficulty in adherence for longer than a few weeks in HEpiTracker participants, we envisaged an active monitoring system of an activity wristband with functionalities encompassing values and variables to support the assessment of fast COVID-19 infection. 

Therefore, this solution should provide public good in the form of (we list the most relevant 5):

• Pandemic know-how / knowledge
• Clinical data and biostatistics
• Data management
• Clinical research and consulting
• Efficient model of device and final product for intuitive use in the Health Sector for Health professionals besides their culture, location, or language.

The objective of the project is to strengthen crosscutting partnerships -Government representatives, clinical research professionals / the Health sector- which designs an evolutionary and innovative roadmap, aligned with the 2030 Agenda, that improves some fundamental tools in the Health sector to work effectively in clinical research within the scenario of current epidemics and new strain/new outbreaks of the COVID-19 pandemic.

The outcomes will be achieved through developing national capacity building frameworks, strengthening effective clinical investigation knowledge, skills, and capacity. And enhancing regional and international cooperation tackling future challenges far beyond patient care, especially in the regions of Europe, the Americas, and some sub-regions in Africa. 

Including cross-sectional actions such as motivating a continuous debate on the great number of benefits while working in clinical research and trials linked to unlock the clinical value embedded within unstructured information with multiple Health sector scenarios regardless of the geographic location. Most countries in the worst affected regions by the COVID-19 pandemic need resources and context-specific approaches not only to implement currently recommended mitigation strategies for infection prevention and control, and patient clinical management. Thus, the technology and global governance framework become smart tools to restructure the current roadmap targeting upcoming risks and challenges.

Impact over Year #1:

The combined Epiwrist activity smart device and the HEpiTracker app are aimed to collect in nearly real-time, and on a daily basis data to thoroughly assess any pandemic and other infectious diseases health risks, depending on the user’s health profile by implementing intuitive clinical questionnaires and several other external tools and actions to identify the spread of COVID-19 and/or upcoming epidemics and better design effective health interventions tailored to suit the needs of the user and/or patients to be reviewed.

Impact over Years #2 & #3: 

The ultimate goal of this innovative initiative is to assist those in critical need to control COVID-19 and upcoming infectious diseases to address challenges in nearly real-time as well as to find effective solutions for tackling growing global health threats. It constitutes a sustainable project with a powerful impact in the global health system with a multidisciplinary business channel while developing international clinical trials. A percentage of the benefits from the global commercialization of the final product should be transferred to cooperation and development actions aligned with the Agenda 2030 in developing countries most affected with COVID-19.

In a first stage, our beneficiaries should be hospital workforces, health centers’ professionals.

The project should be kept on track by constantly addressing these indicators (Themes): 

• Business case: providing knowledge about the project being worthwhile and achievable
• Organisation: related to defined roles and responsibility principle. Project Manager should have everyone’s roles and responsibility on record
• Quality: Related to the focus on products principle
• Plans: focusing on products, timescales, cost, quality, and benefits
• Risks: we should identify, assess and control uncertain events during the project. These should be recorded in a risk log. Negative risk = threats and positive risks = opportunities
• Change: handling change requests and issues that arise during the projects (3 years’ length)
• Progress: tracking the project on a quarterly basis. This should allow our PM and assistant to check and control where they are relative to the plan

We should also take into account the 6 variables of success:

• Cost
• Time
• Quality
• Scope
• Risk
• Benefits 

Finally, we should be monitoring 7 principles: 

• Continued business justification
• Learn from experience
• Defined roles and responsibilities
• Managed by stages
• Defined tolerances for each objective (related to time, cost, benefits, scope) = managed by exception
• Focus on products
• Tailored to suit the project: scope, complexity, relevance, capacity, and risks

• Financial barriers once completed the pilot period (first six months) for production of 10.000 devices.
• Legal and policy barriers in countries across some regions: Africa, Eastern Mediterranean, and South-East Asia.

POTENTIAL COMPETITORS - i.e. Fitbit, Google and other companies manufacturing biosensors:

Since COVID-19 started, innovators around the world started experimenting with hardware that could potentially detect the virus. Numerous prototypes and patents have come up (4). Epiwrist could be added to some of them –i.e. face masks: 

1. Face masks: PROS: Minimalistic and low complexity design / CONS: Part of the device must be disposed frequently; Limited functionality; Exceptionally low accuracy level.  
2. Smartwatches: PROS: Availability; Ergonomic design / CONS: Not equipped with all the necessary sensors to detect virus; Non-existence of Software/Firmware to detect COVID-19 accurately; Unable to process large amounts of data coming from dedicated sensors; Accessibility. Lengthy process to get approved and coordinate with the manufactures in order to access the hardware data; Intellectual Property. Software/Firmware, and additional hardware will be the manufacturer’s property.  
3. Smart rings: PROS: Low cost; Availability; Ergonomic design / CONS: Limited functions; Low accuracy level.     
4. Medical devices: PROS: High accuracy / CONS: High cost; Weight/Size. MD cannot be utilized unless the user is immobilized.

Faculty / Research Center:

• Fundación Teófilo Hernando (FTH), Madrid, Spain,
• Mix Research Center IFTH with University Universidad Autónoma de Madrid (UAM), Madrid, Spain,
• The Hospital Universitario La Princesa, Madrid, Spain, and
• COVID-19 Clinical Management Team of the UN agency.
  

We find several barriers before achieving our objective/s.

Financing our Solution for key budget lines such as Validation across 3 countries, Electronic data collection management, CRO Project management, and Manufacturing the final product are relevant to launch the Project.

Moreover, Legal and policy barriers in some countries are relevant to distribute our Solution, implement and develop Epiwrist & HEpiTracker smart devices to COVID-19 related symptoms and other infectious diseases for targeted professionals -i.e. Health sector, Law Enforcement officers- and vulnerable populations –i.e. persons living with HIV.

The Trinity Challenge should strongly support our Solution to overcome such barriers to achieve sustainable results since the proposed project will be instrumental to the implementation of the Agenda 2030 towards 3 SDGs:

• SDG 3 on ‘Good health and wellbeing’: contributing to draw a new roadmap rethinking healthcare in upcoming risks generated by the COVID-19 and other epidemics,
• SDG 9 on ‘Industry, Innovation and Infrastructure’: to make use of new technologies, especially ICT-based, to find lasting solutions to current challenges for health purposes,
• SDG 17 on ‘Partnerships for the Goals’: to build private-public partnerships to strengthen national and regional capacities in optimizing the use of clinical research and lessons learned for health sector purposes.

Relevant Stakeholders to sign partnerships and build networks:

• Europe: The EC.
• The Americas: ECLAC, OAS, and AACCLA.
• Africa: The Arab League, Arab Maghreb Union, COMESA, Community of Sahel-Saharan States, and ECOWAS.
• South-East Asia: Asia-Pacific Economic Cooperation (APEC), and ASEAN.
• Eastern Mediterranean: The Union for the Mediterranean.
• Key representatives of local and regional governments, UN agencies, the WTO, OSCE, and the OECD.

Developing partnerships with the above mentioned stakeholders should support our business case, financing and reduce risks and barriers (legal and political) to implement our Solution across other regions besides Europe such as Latin America and Africa.