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: The intended use of the device is: Software intended for monitoring of non-vital parameters to support decision making and virtual coaching of patients during clinical trials or under a medical or wellbeing treatment context.
User: Principal Investigators (PI) of clinical studies and their patients, as well as patients using it as a medical or wellbeing device.
Patient: Patients taking part of clinical investigation, or those using it as a medical or wellbeing device.
Environment: Clinical trials or under a medical or wellbeing treatment context.
EUDAMED registration: Healthentia v3 (Portal, App)
Current version: v3.11 [v3(241217) - Portal: 3.11.00 / App: 3.11.0]
Healthentia App is collecting several types of RWD like physiological and psychological allowing a dense description of peoples’ lifestyle through a collection of modules. Several modules are medical software covered by the CE mark:
- Virtual Coaching: It allows the user (subject/patient) to interact with an embodied conversational coach for informative and motivational purposes.
- 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 any time access to their electronic Diary and see the progress of their reported outcomes.
- Physical activity: The physical activity widget gives an overview on the steps walked.
- Sleep: The sleep widget gives an overview on the sleep duration.
- Liquid consumption: The liquid consumption widget gives an overview on the water consumed.
- Nutrition: The nutrition widget offers the ability to see and edit the consumption of different food categories of interest.
- Weight: The weight widget offers the ability to add manually and through a digital scale, measure and view the weight.
Caution: The study participants also have access to visualizations, only about themselves, via the mobile app. The vital signs and lifestyle visualizations service handles the output of data of a single participant towards the mobile application. This component is excluded from the validity of Class I CE mark, as Healthentia is not intended to monitor vital parameters. For the avoidance of doubt, such parameters are highlighted in the application, so that users are informed about them. Furthermore, there is no guarantee of the reliability of the data shown and the user should always refer to the display of the measurement device (e.g. activity tracker).
For any privacy-related questions or requests, you can contact: dpo@healthentia.com
For general questions, you can contact: info@healthentia.com
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
- Any physical or cognitive condition that, in clinical judgment, would prevent the patient from using Healthentia, e.g. dementia.
- The device is not intended to replace the care of a health care professional, including prescription, diagnosis, or treatment. The device should not be used during pregnancy.
- Healthentia has not been tested on the pediatric population. Therefore, Healthentia is intended for adult use only (>18 years old) and does not cover use by children.
- Consult periodically the Alerts dashboard as it may influence the follow-up of your patients.
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 communication 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 your situation.
- 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.
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
The healthcare provider of the final assessment of the diagnosis and treatment decided for the patient.
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.
