Healthentia

Healthentia is an eClinical solution that is already used to cover COVID-19 needs for symptom tracking, patient monitoring, epidemiological predictions and to support the lifting of lockdown measures

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Inspiration

Healthentia is an eClinical solution that is currently adapted to support COVID-19 pandemic needs. The solution is already deployed in Italy, while there are ongoing discussions with hospitals and governmental organization around the world for further deployments. We consider the COVID-19 pandemic an obligation for our company to offer Healthentia licenses free of cost and looking forward to team up with people that are interested to spread the word and help us to identify more organizations that are interested to use Healthentia for their needs.

What it does

Healthentia is a proprietary eClinical solution by Innovation Sprint Sprl that facilitates the clinical trial optimization, by accelerating the trial processes, reducing the failure rate, and validating drug/intervention efficacy and effectiveness with Real World Data insights. In this way, Pharmaceutical companies can achieve cost savings; accelerate the drug approval process and obtain useful insights to develop drugs and interventions of higher efficacy.

Starting from March 2020, we have adapted Healthentia SaaS version to support the enormous needs of the pandemic. The solution is based on 3 parts: a) the smartphone applications for citizens/patients; b) the smartphone applications for healthcare personnel; and c) the web portal for hospitals, healthcare system and civil authorities. Citizens and COVID-19 patients are using the app on any iOS/Android device to report their health status, either by responding to auto-generated questionnaires, or by indicating their symptoms. Healthcare personnel can use the app to report outcomes for the patients they are managing, including lab tests and imaging. Healthentia app allow the integration with tracking devices (e.g. Fitbit), however, it also allows the use of Android/iPhone sensors to monitor steps and activity, for the majority of the citizens who do not have such devices. In this way, it is possible to track activity of users, which is used to correlate this with their overall health in an automated manner using AI/ML algorithms. At the web portal level, healthcare system professionals and civil authorities can monitor with advanced BI and GIS maps, how the virus is progressing and be able to take decisions. The solution is managing data in an intelligent manner, using best of breed of AI/ML algorithms, to allow the grouping of users into risk categories, which is subsequently used for auto-generated messages and protocols.

Healthentia is following all GDPR requirements on privacy and security and has a scalable architecture to manage large scale deployments. Innovation Sprint has among other certifications, an ISO27001 for information security.

Impact Potential

The societal impact of Healthentia is significant as it addresses at the same time: a) citizens, b) COVID-19 patients, c) Healthcare organizations and d) Civil protection authorities, as follows:

FOR CITIZENS

  • To self monitor daily health status;
  • To monitor the changes in symptoms with scheduled daily questionnaires;
  • To receive notifications and communication from authorities;
  • To contribute to research.

COVID-19 PATIENTS

  • To monitor their health status;
  • To receive protocols based on the progression of the disease;
  • To be informed about pathways and next steps, based on the reported symptoms;
  • To be continuous auto-classified in risk clusters using AI/ML algorithms, following their patterns.

FOR HEALTH ORGANIZATIONS

  • To stop the virus spreading by keeping anxious citizens away from crowded hospitals;
  • To identify those at risk sooner, by monitoring symptom data on GIS and utilizing AI/ML algorithms;
  • To predict evolution of the epidemiological parameters;
  • To monitor chronic disease patients;
  • To follow up positively diagnosed patients;
  • To monitor health personnel, exposed to the virus.

FOR CIVIL PROTECTION AUTHORITIES

  • To identify geographical areas of higher risk;
  • To monitor the aggregated citizens' mobility in lockdown areas;
  • To have the tools to evaluate the efficiency of measures and decide on partial lifting of lockdown.

Today, there are several solutions that include mobile applications at a global level. None of them is addressing at the same time all stakeholders, giving hospitals and authorities the required tools to provide healthcare services with higher efficiency, saving lives and supporting the anxiety and stress of citizens and patients.

Technical Complexity & Novelty

Healthentia is an innovative solution both at technical and clinical level. The solution extends the use of a traditional ePRO/eCOA application by adding behavioral and health-related data collected from IoT devices. Utilizing AI and Machine Learning on this data, it is possible to discover behavioral biomarkers and cluster patients into behavioral phenotypes, which allows the activation of smart services to predict clinical outcomes, generate prevention alarms and link phenotypes with drug/intervention efficacy. On top of the in-vivo clinical studies, Healthentia allows the running of in-silico trials that use the deep phenotyping outcomes, together with legacy data, to create synthetic control arms and support Pharma to design optimized studies. Healthentia is available for clinical studies, under strict regulatory framework in PaaS model, but it is also open to the wider community in SaaS environment. The SaaS version includes further features, such as eRecruitment and eConsent and Virtual Coaching.

Prototype Completion

Healthentia is a commercial product, already used by Top5 Pharma companies and is also validated for Good Clinical Practice. The customization of the solution for COVID-19 is already finalized and used in Italy, after the submission of Ethical Dossier to the competent authorities.

Business Plan

The business plan of Healthentia is based on the hybrid PaaS and SaaS model with a fee per patient per month, following the tier-price list of Healthentia. For example, a Phase III clinical study with 500 patients for 12 month, is charged with 6,000 units. On top of this cost, sponsors pay a customization fee for the PaaS version and a monthly support. As described above, Healthentia has several features, e.g. IoT device integration, Virtual Coaching, etc. The license fees are based on the enabled features: a) Basic ePRO/eCOA; b) Integration of IoT and Medical Devices; c) AI/ML features; and d) In-silico trials. For scaling purposes, Healthentia revenues are mainly based on licenses, while customization services are provided only for the PaaS version and they are much less compared to the license costs.

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