Medical Device
Software as a Medical Device (SaMD)
HEALTHENTIA is a medical decision support software developed by INNOVATION SPRINT and intended to monitor, offer virtual coaching services and generate automatic alerts regarding events, based on Real World Data.
Ιntended Use: Healthentia App is part of Healthentia solution, a software intended for: a) the collection and transmission of physiological data including heart rate, blood pressure, oxygen saturation, and weight directly to care providers via automated electronic means in combination with validated IoT devices; b) the visualization (subjects-based dashboards) and the mathematical treatment of data (trends analysis, alerts) related to the monitored chronic disease subject’s physiological parameters; c) the transmission of patient’s outcomes and outcome scores related to patient’s health status, health-affecting factors, health-related quality of life, disease knowledge and adherence to treatment through validated questionnaires; d) the user (subject/patient) interaction with a conversational virtual coach for informative and motivational purposes, in order to support subject telemonitoring, decision making and virtual coaching.
Clinical benefits: The use of Healthentia provides objective inputs for healthcare professionals to support diagnosis, to highlight evolution of physiological parameters by trends analysis of the patient’s inputs, and to allow healthcare professionals to provide the same quality of care and safety as the standard of care.
Clinical Indications: Telemonitoring of chronic disease patients (such as heart failure, cancer, COPD, etc.)
Patient Target Groups: Chronic disease patients taking part of clinical investigation or a medical treatment.
Intended users: Telemonitored patients and their healthcare professionals.
Use environment and duration: Healthentia App can be used as Remote Patient Monitoring solution for patients that are released from hospital and have to follow a certain treatment. Duration depends on the study or intervention or patient's will.
EUDAMED registration: Healthentia v4 (Mobile-app, Web-Portal)
Current version: v4.0.1 [v4(250301) - Portal: 4.0.1 / App: 4.0.1]
Basic UDI-DI: 54199801789HLTv4GY
The medical modules of HEALTHENTIA, including supporting modules, are described below. Detailed description of the modules, as well as reference to the Functional Requirement Specifications ID are available in the technical file:
- Portal services (for healthcare professionals):
- Subjects-based dashboard: The HEALTHENTIA system offers several subject-level dashboards. There are three broad categories of information to be presented through visualizations related to each subject: subject overview, their reports and their measurements.
- Subject list: The Subject list is using the library dev express to allow customization on the available columns per study.
- Study-level dashboard: The Healthentia Clinical Dashboard offers a study-level (a.k.a. population-level) overview. There are three broad categories of information to be presented through visualizations related to: study population overview, their reports and their measurements.
- Alerts: The Alerts functionality is using a user interface to set rules and thresholds regarding values collected from various sources like questionnaire answers or IoT devices as an absolute number for a period of time or relative to previous vectors in a period of time. These will then create alerts to clinicians or tag patients.
- Study services (supportive modules for healthcare professionals):
- Questionnaire editor: The questionnaire editor allows the portal user (healthcare professional) to create or edit questionnaires that will be delivered to the patients. The editor provides the functionality to create complicated questionnaires with advanced routing between the questions, as well as multiple types of questions and user interfaces, e.g., single, multiple, image selection, etc. The medical module supports only qualified questionnaires, i.e. standardized, validated instruments used to assess health outcomes directly from patients. Such qualified questionnaires include standardized set of questions and are validated through rigorous scientific processes to ensure reliability, validity, and responsiveness to change. This is described in the IFU of the healthcare professionals, the website,the portal of the healthcare professionals and RG-37-10 Questionnaires for Healthentia_v4.
- Composite questionnaire: This is a composite questionnaire editor that allows the healthcare professional to combine questionnaires based on conditions with a customized decision flow that can do a set of checks like the existence of tags, check questionnaire scores or questionnaire option scores to trigger alerts, assign tags and send more questionnaires. Similarly with the Questionnaire editor, only qualified composite questionnaires are supported by the medical module.
- Study configurator: Healthentia provides the means to the user to set up a Study according to the requirements that define it.
- Multisite study: Healthentia portal user is able to select many concurrent languages for a study to support.
- Hybrid services (for healthcare professionals and patients):
- Virtual Coaching: It is the functionality that allows the user (subject/patient) to interact with an embodied conversational coach for informative and motivational purposes. Users of the HEALTHENTIA Mobile app can interact with the virtual coach through natural language in a controlled manner (I.e., no free text/speech input). The dialogues that are supported by the virtual coach are scripted interactions, which are authored by our clinical experts. Users can navigate through the dialogues by choosing at each step of the conversation between a number of provided reply options. In this way, it is feasible to provide an engaging natural language user interface to the virtual coach, while keeping strict control over which information is provided to the user, or which advice is given.
- Mobile Widgets (for patients): The mobile services facilitate all interaction with the mobile app users, i.e., the patients/study participants. There is a single component group for all the widgets at the fingertips of the mobile app users.
- eDiary: The e-Diary enables the presentation of any reported outcomes of the patient, in the form of a list, grouped by day or outcome (symptom). In this way, patients can have anytime access to their electronic Diary and see the progress of their reported outcomes.
- Vitals: The vital signs are both collected from and viewed by mobile app users using widgets in this category. Supported vital signs from validated CE-marked medical devices are: a) Blood Pressure[1], b) Heart rate[2], and c) SpO2[3]. Any vital signs coming from validated, but not CE-marked medical devices are clearly marked. A detailed list of validated IoT devices, indicating which of them are medical devices is included in the technical file.
- Physical activity (non-medical module): The physical activity widget gives an overview on the steps walked today, and once accessed offers informative graphs on different physical data in daily, weekly and monthly views.
- Sleep (non-medical module): The sleep widget gives an overview on the sleep duration today, and once accessed offers informative graphs on the different stages of sleep in daily, weekly and monthly views.
- Liquid consumption: The liquid consumption widget gives an overview on the water consumed today, and once accessed offers the ability to see and edit the consumption of different types of liquids (mainly water, but also coffee, tea, beverages and alcohol) for any date.
- Nutrition: The nutrition widget offers the ability to see and edit the consumption of different food categories of interest for any date.
- Weight: The weight widget offers the ability to add manually and through a digital scale, measure and view the weight of the mobile app user in daily, weekly and monthly views.
- Core functionalities (supportive modules for backend)
- Scheduler: The scheduler provides the functionality that is used by the investigators to create rules for the automatic submission of questionnaires to specific recipients. These rules may include the registration date, or even the answers from the subject and the auto-tagging of a subject into a certain category.
- Security & regulatory: Components in this group address security and regulatory requirements.
- Management: These components facilitate the management of entities in the database.
- Data management (supportive modules for backend)
- Data handling: The components in this group manage the data collected about the patients/study participants.
- API & SDK: The Healthentia API provides the means to expose all the functionalities of the layers above to the outside world. Data importing and exporting is facilitated through it. The API endpoints are organized in three categories, so conceptually the API layer comprises three virtual components, all presented in the following subsections. Do note that in some cased of IoT integration an SDK from the device manufacturer is used instead of an API.
For more information, please visit: https://www.healthentia.com
For any privacy related questions or requests, you can contact: dpo@healthentia.com
For general questions, you can contact: info@healthentia.com
[1] iHealth Track (KN-550BT)
[2] iHealth Track (KN-550BT), iHealth Air (POM3)
[3] iHealth Air (POM3)
SECURITY
Innovation Sprint is committed to protecting the security of data subject’s information and takes reasonable precautions to protect it, including protection against unauthorised access, necessary to run the software as intended. In this context, Innovation Sprint regularly evaluates and reviews technologies, facilities, procedures and potential risks to maintain the security and privacy of users’ data, paying particular attention to role-based access and logging of health data access. Moreover, any potential changes to software applications, provided services and/or hardware systems are properly justified, evaluated and registered based on international best practices and standards.
- Avoid using public wi-fi networks to connect to Healthentia when you are about to add and/or manage health data and/or your profile details.
- Do not use jailbroken devices.
- Passwords should be at least eight (8) characters long, contain characters from three of the following four groups: Lowercase letters, Uppercase letters, Numbers (0-9), Special characters.
- Never store your passwords on your devices.
- Change your passwords at least every six months.
- Install an anti-malware program on your devices and update it regularly.
- Make sure that each e-mail you register in Healthentia corresponds to you.
- Ignore and delete messages of doubtful origin and do not follow links that include and refer to websites.
- Do not reveal by phone, e-mail, Internet form, or social media, confidential information such as your username, password.
- Always use the most up-to-date versions of your device operating system and Healthentia App.
- The user is suggested to keep the Bluetooth setting in “not discoverable” (transmission disabled) and switch to “discoverable” mode only when he/she wants to use it.
- The user should avoid storing critical information (account credentials) on his/her Bluetooth-enabled devices.
- If the user is going to connect with a device via Bluetooth, it is strongly suggested to activate this connection in a safe place.
PERFORMANCE
Provide objective inputs for healthcare professionals to support diagnosis and patient management;
Highlight evolution of physiological parameters by trends analysis of the patient’s inputs;
Increase patient’s adherence to treatment.
REQUIREMENTS
Supported hardware
Any personal computer that is using the supported Operating System (OS) and browser – see below- is a supported hardware device.
Operating system/browser requirements
Healthentia Portal requires a stable Internet connection and a compatible device (laptop, desktop, etc). The operating systems supported are:
- Microsoft Windows: version 8.1 and above
- MacOS: version 10.15 and above
- Linux: LTS distributions released after 2019
This device will need an up-to-date internet browser in order to consult the web application. It is suggested using one of the following browsers that were each tested:
- Google Chrome: version 93 and above
- Mozilla Firefox: version 88 and above
- Safari: version 12 and above
- Microsoft Edge: version 93 and above
Specific issues that come in at Innovation Sprint from the users (post-market surveillance) are analyzed and when a systematic error on one browser is detected, this is added to the backlog and prioritized for the correct version.
COMPATIBLE DEVICES
The accuracy requirements for IoT devices that are connected to Healthentia are listed below.
| measurement | Min. accuracy |
| Blood pressure | ≤10mmHg (at least 85% probability) |
| SpO2 | Arms ±2-3% of arterial blood gas values |
| Heart (RHR, max, …) | ±10% of the input rate or ±5 bpm |
| Weight | ±0.5-1.0 kg |
| Physical activity (steps, …) | n/a |
| Sleep | n/a |
Healthentia App is compatible with other devices to collect lifestyle information and vital signs. The supported devices intended for use together with Healthentia are:
- Garmin trackers and watches via the Garmin API (Android & iOS): Fenix 5 pro, Fenix 6 pro, Forerunner 945, Vivoactive 4, Vivosmart 4, Venu 2S,
- Fitbit trackers and watches via the Fitbit API (Android & iOS): Versa, Inspire 2
- iHealth devices via Bluetooth (Android & iOS): Connected Blood Pressure Monitor iHealth Track (KN-550BT), Smart body composition scale iHealth Fit (HS2S), Smart Pulse Oximeter - iHealth Air (POM3)
- Polar belt via the Polar API (Android & iOS): H9
* Device has acceptable accuracy for the intended purpose of Healthentia
** Device does not have acceptable accuracy for the intended purpose of Healthentia and can only be used for measurements that do not require accuracy (e.g. step counter, sleep).
In combination with Healthentia, use only measuring devices prescribed by your healthcare provider as it may affect the outcome of your monitoring.
These devices constitute a safe combination and currently there is no device-specific information on any known restrictions to combinations.
It is the responsibility of the healthcare provider to select the connected devices, among the validated ones listed above, that are appropriate for the intended purpose in terms of measurement accuracy, repeatability and range as it may affect the diagnosis of the patient. Healthentia displays values in international metrics (m, kg, s) regardless of the preference of the patient in his/her IoT device.
CONTRA-INDICATIONS
- Healthentia is not intended for the monitoring of patients in critical situations (operating room, emergency, intensive care).
- Any physical or cognitive condition that, in clinical judgment, would prevent the patient from using Healthentia, e.g. dementia.
- The device should not be used during pregnancy.
- Healthentia App has not been tested with paediatric population. Therefore, Healthentia App is intended for adult use only (>18 years old) and does not cover use by children without supervision.
PATIENT INFORMATION
Please inform your patient about the following information:
- Healthentia is not monitored in real-time by healthcare personnel; it is intended for non-emergency communication only. In case of an emergency, contact your care unit or the emergency number by phone.
- Telemonitoring does not replace regular check-ups with your doctor. Consult your doctor in case of severe and persistent symptoms.
- In some special cases, the self-care advice and instructions provided by Healthentia may not be applicable to your situation. If you have questions about your care, symptoms, and management, contact the healthcare team
WARNINGS
- Healthentia is not monitored in real time by healthcare personnel, it is intended for non-emergency only. In case of an emergency, contact your care unit or the emergency number by phone.
- In some special cases, the self-care advice and instructions provided by Healthentia may not be applicable to the patient's situation. If patients have questions about their care, symptoms and management, they should contact their health care team.
- If you have questions about your care, symptoms and management, contact your healthcare team.
- The device is not intended to replace the care of a healthcare professional, including prescription, diagnosis or treatment.
- Telemonitoring does not replace regular check-ups with your doctor. Consult your doctor in case of severe and persistent symptoms.
- In combination with Healthentia, use only measuring devices for which the technical performances (accuracy, precision) have been verified by your healthcare provider as it may affect the outcome of your monitoring.
- Verify the consistency of your clinical data and the good transfer of them to your healthcare provider as the quality of the diagnosis and treatment is partially based on this information.
- The device is not intended to replace the care of a health care professional, including prescription, diagnosis or treatment.
- Consult periodically the Alerts dashboard as it may influence the follow-up of your patients.
Report of serious incident
Any serious incident that has occurred in relation to the Healthentia Medical Device App, you can contact the manufacturer (Innovation Sprint Srl) in: support@healthentia.com and the authority having jurisdiction in your locale.
Technical support
Healthentia support service is offered at best-effort level.
For any technical support queries, you can contact: support@healthentia.com
Our support team will reply to you within 1 working day.
DISCLAIMER
Your healthcare provider is responsible of the final assessment of your diagnosis and treatment.
Healthentia is providing information to support diagnostic and therapeutic decision, but the overall clinical context should be taken into consideration before taking any decision.
Read more about medical modules and device functionalities that are covered under the CE mark.
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Healthentia medical device is a smartphone app for chronic disease patients and a clinical dashboard for healthcare professionals. Healthentia is offering advanced RPM features through its medical modules that empower patients with chronic diseases and contribute to better health outcomes. Its intended purpose includes the collection of physiological data, visualization and trend analysis, transmission of patient outcomes to healthcare providers, and the enabling of personalized interactions through a virtual coach. Further to the RPM features, Healthentia is addressing the root cause of chronic disease, the behavioral risk factors and through personalized virtual coaching, assists patients towards a lifestyle change.
Healthentia is also used for Decentralized Clinical Trials (DCT, leveraging best-of-breed of eClinical studies features, such as eRecruitment, eConsent, teleconsultation/ televisit, ePRO-IoT integration, and virtual coaching. Healthentia empowers patients and gives them an active role in taking trial’s actions, rather than bringing them to the trial sites; thus facilitating clinical trial optimization, accelerating trial processes, reducing drop-out and failure rates, and validating drug/intervention efficacy and effectiveness with Real World Data insights. Healthentia is used by Top5 Pharma and large hospitals and operates under the strict regulatory framework of Good Clinical Practice.
