Besides the components designed to deliver clinically relevant results, digital therapeutic (DTx) solutions also need to include critical features to address the myriad of regulatory and data security requirements necessary to be compliant at 360º. The development, maintenance and legally-required updates of these “non-clinical” features can add significant development effort, investment and ongoing costs to any DTx solution. This is why Newel Health developed H.Core, a framework that provides the core functionalities of a DTx solutions that also takes into account the compliance, security, and specific needs of the healthcare industry in their implementation. H.Core therefore is used to optimize the process of developing and scaling DTx solutions and accelerating their path towards clinical validation, scalability, and commercial success.
As Head of Engineering at Newel Health, I lead the team of healthcare technology experts that have developed and are continuously expanding H.Core, our rapid-development software framework. H.Core is already being used by external partners for their own solutions and here at Newel Health H.Core plays a critical role in DTx pipeline product development which includes Amicomed, an app that delivers analytic insights on longitudinal blood pressure measurements and personalized behavioral lifestyle modification programs to help people lower their blood pressure, and Soturi, a Digital Therapeutics (DTx) solution for personalized medication and treatment plan optimization for people with Parkinson’s disease (PD).
H.Core includes a number of reusable modules which serve as the building blocks for creating various features of a DTx application. While some features are shared, they can also be used as individual building blocks to produce distinct medical solutions. This flexibility allows H.Core to be a powerful tool in developing a wide range of digital health solutions also allowing the effort and investment that goes into prototyping and testing DTx concepts to be expanded all the way to launching an already production-ready solution.
Let’s take a close look at each of H.Core’s module and how they are already revolutionizing the patient journey for people living with PD and cardiovascular conditions although they are not exclusive to those pathologies and can readily be adapted for other applications in areas like oncology and mental health, to name a few.
Content Management System
Across the board, our content management system allows us to create and manage content in various languages and personalize it to suit a diverse set of needs. With this feature, we can easily create localized versions of our DTx solutions, making them accessible to a wider audience. For example, in Soturi, we use the content management system of H.Core to create and categorize a collection of exercises that support rehabilitation programs for patients in Italian, German, Finnish and English. Similarly, in Amicomed, we use it to create a variety of educational articles in several languages that aim to improve the understanding of hypertension and empower users to autonomously manage their blood pressure. The content management features of H.Core enable us to provide relevant, accurate and up-to-date content to our users, which is essential for the success of our digital health solutions.
Patient Health Record
Then we have a module which is typically used in every application we develop: the PatientHealth Record. This component manages any type of structured health data such as height, weight, waistline measurements, and blood test results. Everything that is uploaded into the Patient Health Record is considered sensitive information, so H.Core protects it with special techniques. In both applications mentioned before, we do some basic profiling, such as asking if the patient is currently following a medication plan, their height, weight, gender, and blood type. The module is incorporated into Soturi to create a detailed diary that tracks the symptoms of a Parkinson’s patient. This data will ultimately help physicians optimize and personalize the treatment for each of their patients. While in Amicomed, H.Core is used to implement an intelligent survey tool used to manage a comprehensive and interleaved “smart” questionnaire for medical profiling so that every answer provided defines the type of questions coming next.
Auth
Auth is a module that is vital for the functionality of any application that requires regulating user access to data and thorough protection of stored information. It enables all the features necessary for the management of an account: registration, change of credentials and authentication In addition, it carries out consent tracking, or in more simple terms, it compliantly tracks where a user has provided granular consent to the data processing purposes declared in an app’s privacy policy or terms and conditions. It does also define permissions for every class of users. As a matter of fact, it has a central role in whether a doctor can access a patient’s health records, and if the doctor or the patient can modify those health records. Having this feature alone can save weeks of development and regulatory certifications effort in creating a DTx solutions
Coupon Feature
Very often procedures of a digital solution tend to be cumbersome and not really user friendly. This feature aims to simplify these scenarios creating coupons in the form of alphanumerical codes which can be distributed in a controlled fashion and can be leveraged in a wide number of use cases, from distribution of promotional codes to regulating the access to the DTS apps themselves. With Soturi, we deployed discount codes so to promote the usage of a smart wristband which would help in monitoring symptoms at home, while in Amicomed the unique codes determine the delegation of access feature. This allows physicians to provide patients with coupons that act as an invitation to use the app. The same coupon code then is used by H.Core to associate that specific patient to their physician, granting the latter access to the patient’s medical information within Amicomed. This step is critical to manage data access in a controlled and secure manner, with patients always in full control of who is gaining access to their personal information.
Patient Journey Builder
The patient journey builder is a tool that allows us to orchestrate and guide the user experience through a set of steps. It acts as a sort of “board game” for the patient journey, enabling the creation of dynamic gamification within the app and building personalized experiences that adapt to one’s needs. This feature enables the app to communicate the user’s progress, which in turn determines the next sequence in their personal journey.
In Soturi, we use this feature to create rehabilitation programs. Typically, the program explains which exercises should be performed each day, with an assessment at the end of the week to determine whether the patient should move on to the next week, repeat the current week, or perform exercises at a lower intensity.
In Amicomed, we use a similar approach for the Lifestyle Program, which is divided into three months (14 weeks) with a new topic for every month and week. From a content management perspective, one week a user might read about the role of salt in a healthy diet, and another week about how to measure blood pressure accurately. This dynamic approach helps guide patients through a program, assisting them in adapting to a new, healthier lifestyle, primarily focused on improving their diet and physical activity.
Features Exclusive to Amicomed
Blood pressure Tracking
One of the key functions of Amicomed is the ability to track and process blood pressure measurements through our module, Pascal. Pascal acts as the “brain” of the solution, analyzing and interpreting the data collected from blood pressure readings and providing personalized insights, evaluations, and recommendations to users. Ultimately, having more data points helps users understand what can be causing hypertension and how lifestyle changes and medication is affecting it. Its integration in the H.Core ecosystem makes it a powerful tool in managing hypertension and the reason why Amicomed is classified as a medical device software.
Physician Dashboard
The Physician Dashboard is an easy-to-use web application that allows doctors to view all patients connected to them, invite new users, and gain access to individual patient information, and specifically, view their blood pressure history. The dashboard also provides access to alarmsand priority list of patients based on their recent blood pressure data points, providing physicians with a comprehensive view of their patients’ health status and enabling them to make more informed medical decisions.
Dynamic Notifications
This feature of H.Core includes a basic engagement engine which allows users to receive notifications via e-mail, SMS, or push notifications in a reactive, proactive, or scheduled manner, or as defined as part of the DTx solution’s behavior modification strategy. Reactive notifications are triggered by a specific action taken by the user, while scheduled notifications are set to occur at a specific point in time. For example, in Amicomed when a user starts the three-month lifestyle improvement program, they will receive a sequence of notifications distributed over the course of the program to keep the user active and on track
Proactive notifications are the most advanced type, as they are tailored to the individual’s needs by sending alerts only when necessary based on how the user is interacting with the platform. In Amicomed, patients need to track their blood pressure regularly and if we see that they are deviating from their monitoring plan, we will send a proactive notification to encourage them to take a reading. This feature is designed as a behavioural lever to improve program adherence and personalize the user experience.
Features Exclusive to Soturi
Motion tracking
In the Soturi project, we utilize a dynamic system where patients wear a wristband 24/7, which continuously transmits data. This requires H.Core to have a robust and efficient storage system for handling the large volume of data collected, which can reach tens or even hundreds of megabytes per day. To streamline this process, we have incorporated a feature within Soturi that is built on the H.Core infrastructure. This feature allows for the seamless and efficient transfer of data into Soturi’s cloud-based archives while building up data collection statistics that define key performance indicators of the project.
Adherence
Medication management is a vital aspect of the patient’s journey, so we integrated the adherence factor into Soturi. It is designed to help users follow their treatment plan by allowing them to set up and manage their medication schedule, receive reminders at the scheduled time, and provide feedback on whether the treatment was followed.
One of the key advantages of this feature is the ability to correlate the therapeutical plan with important information such as the patient’s medical history, actual dosage, and the evolution of symptoms experienced. This data is used to reconstruct the patient’s pharmacological input, providing physicians with a comprehensive view of how the medication is affecting the patient’s condition. Additionally, this feature can be extended to other therapeutic areas such as medical visits, treatments, and examination, allowing us to evaluate overall adherence across all aspects of the patient’s journey.
Compliance and security at the core
As demonstrated, H.Core provides us with the necessary building blocks to test and deliver market-ready and regulatory compliant digital health solutions. The patient journey builder, content management system, physician dashboard, engagement engine, and adherence feature are just a few examples of the many capabilities that H.Core offers. However, it’s not just these features that set H.Core apart; it’s also the focus on compliance and security that ensures all data is kept safe and secure. H.Core guarantees the proper foundation to meet the vast compliance and security requirements of the healthcare industry, allowing us to develop digital therapeutics (DTx) and digital medications that improve the lives of people living with health conditions and their physicians.
