1. Introduction
Impakt Health is a product of AKT Health. AKT Health values the privacy of your personal data and your usage of our Services.
The mission of Impakt Health is to create an IoT enabled Patient Support application. To achieve its mission, AKT Health is also utilizing its product website.
This Privacy Policy addresses to natural persons (also mentioned herein as “data subjects”) and refers to how AKT Health collects and processes your personal data through the website and informs you about your rights in accordance with national legislation and the General Data Protection Regulation
2.What is personal data?
Personal data means any information relating to you, which allows us to identify you, such as your name, contact details, information about your access to Impakt Health App and other embedded services, as well as any other information related to your health status, registered by you on a consent basis.
3.Impakt Health description, data collection and purpose of use
To achieve its mission, Impakt Health makes various features and functionalities available to you using Impakt Health App as an individual end-user. Moreover, Impakt Health App can also be used as a tool to enable data collection on a consent basis during Clinical Studies or during long-term research activities conducted by AKT Health on anonymized data, as part of the AKT Health services (“Services”).
Impakt Health is a medical decision support software developed by AKT Health and intends to monitor, detect, offer virtual coaching services, and generate automatic alerts regarding events, based on Real World Data gathered from patients taking part of clinical investigation, or using it as a medical or wellbeing device. In this context, Impakt Health is a 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. Impakt Health 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. Impakt Health e-Clinical solution is collecting data from patients and investigators by means of the Impakt Health App. Collected data is used for the needs of clinical studies of affiliated sponsors as described in their separate privacy policies (when AKT Health acts as processor), while processing of anonymized data allows the provision of smart services to the patients, as well as the long-term research activities of AKT Health. In this way, the pharmaceutical industry can achieve cost savings, accelerate the drug approval process, and obtain useful insights to develop drugs and interventions of higher efficacy in order to improve the life quality of humans.
In the context described above, Impakt Health collects and processes your data based on:
- Your agreement to use Impakt Health App as a software tool and accept the privacy terms and terms of use before registration.
- Your explicit consents that are related to self-reporting of health-related data and/or allowing sponsors to contact you for clinical studies. When you give your consent, you will be given further details on how to change your consent preferences or visit the ‘Your rights’ section (Section 12) of this Policy for more information.
- Our legitimate business interests, for example, fraud prevention, maintaining the security of our network and services, and the improvement of our services. Whenever we rely on this lawful basis to process your data, we assess our business interests to make sure they do not override your rights. Additionally, in some cases you have the right to object to this processing. For more information, visit the ‘Your rights’ section (Section 12) of this Policy.
- Compliance requirements with a mandatory legal obligation, including for example accounting and tax requirements, which are subject to strict internal policies (such as retention periods), procedures, and your right to restrict usage of your data, which control the scope of legal assistance to be provided.
- Your consents are registered in Impakt Health mobile App.
- Details of the Personal Data we (AKT Health) may collect follows in the next section (Section 4) and in Sections 5, 6 and 9.
4.Types of collected personal data
Registering an account in Impakt Health App is possible from the mobile application with the use of your E-mail address, i.e. as an initial step, Impakt Health App only collects the Email address, which is required for the registration purpose.
You are then left free to provide further personal information in a voluntary manner, to complete your own profile, monitor your daily activities, participate in clinical studies on a consent basis, and/or conduct video conferencing with a practitioner of choice.
In general, Impakt Health App collects the following information you provide:
- Activity data such as: number of steps taken, distance covered, number of calories burned, body weight, heart rate, sleep stages, active minutes, type of physical activities and related information (these may be collected by 3rd parties, as well, after you enable the ACTIVITY sync setting – see Section 6 below), or health-related data (you can visit MY CONSENTS menu of the App for further details);
- Personal information such as your name (to be used as an extra identification feature and for personalization-better user experience purposes), gender, weight and height (provided in a voluntary manner);
- Location (after informing you and receiving your consent) – in this case, you will have the option to provide your location information from your device location service, or by typing your postal code and country, or not answering this question; This information will be used for location analytics purposes (legitimate interests pursued by AKT Health);
- Answers to questionnaires (including personal details, medical- or wellbeing-data, photos) in the context of clinical studies conducted by affiliated sponsors (such e.g., pharmaceutical industries, hospitals, investigators), having AKT Health acting as data processor on behalf of these sponsors;
- Phone number for App functionality and security-fraud purposes (2-factor authentication) in the context of clinical studies conducted by affiliated sponsors;
- Device and Tracking Data (see Section 5 and Section 9 below).
AKT Health , as data controller, may use collected, anonymized data for long-term research, such as creating behavioral and lifestyle models.
If you accept to be contacted for participating in clinical studies conducted by sponsors/promoters (e.g., pharmaceutical industries, hospitals, investigators) through an explicit consent (you can visit MY CONSENTS menu of the App), your profile will be available in a voluntarily manner in search queries of interested partners (e.g., investigators, pharmaceuticals) to receive invitation for future studies.
In addition, you can participate in a clinical study by using a code, or by selecting a running study, or via E-mail invitation. If you are admitted to a study, which is managed by another party, you will receive additional privacy terms from that party, who will be the controller of the collected data for that study, having INNOVATION SPRINT SPRL acting as processor. For these studies, you will be first asked to read additional terms from the data controller before you give your consent.
Impakt Health App also provides video conferencing capabilities between a data subject and a practitioner of his/her choice. It should be noted than no video recording is allowed during the provision of this service. This processing includes hosted or cloud video conferencing and messaging services, involving the collection, organization, storage, retrieval, consultation and use of such personal data, video conferences products and technology and related support services and account management: provisioning, reporting, customer/end-user support & billing. Video conferencing services include the processing of the following categories of data: call record logs (which contain statistics such as the time and duration of calls made or attended by an individual, the number of participants on each call, circumstances of the individual disconnecting from the call, statistics on the version of endpoint used to make the call), contact information (including the individual’s user name, E-mail address, Display name used to join the call, IP address, telephone number).
Imapkt Health App may collect (based on your consent and the specific context of the clinical studies you participate) information about your device and your App usage activity (see Sections 5 and 9 below).
5.Device information
When you access Healthentia app, our servers may record data regarding your device and the network you are using to connect with AKTHealth, such as IP, date/time stamp, connection- and device-related information for fraud prevention, maintaining the security of our network and services, and the improvement of our services. Impakt Health App may temporarily use the exact location of your device, after your permission, to connect with medical devices such as scale, oximeter, blood pressure etc. through the Bluetooth protocol.
6.Information from third – parties
We may collect information about your activities from 3rd parties, such as activity data information, e.g., steps from device providers, or nutritional information from other services, in case you provide your consent to the relevant provider based on your preferences and your agreement to use your data from 3rd parties (you can visit the ACTIVITY TRACKING menu of the App for further details).
7.Personal information disclosed to third – parties
AKTHealth ensures that access of personal data by affiliated sponsors in the context of clinical studies is subject to the terms of this Policy and concerns exclusively the defined by AKTHealth purposes as described above. Disclosure of data to other 3rd parties is realized only for analytics purposes (as described in Section 9 below). For that reason and in any case, we adopt contractual agreements whereby the usage of specific technical safety measures is mandated, in order to safeguard that your personal data remain secure and is processed only for lawful purposes.
If you accept to be invited to clinical studies by other affiliated parties (sponsors) acting as data controllers, you will also grant access to the data controllers of the study, who will provide you with additional privacy terms and obtain your consents accordingly.
8.Security measures
AKTHealth is committed to protecting the security of your information and takes reasonable precautions to protect it. Once we receive your data transmission, we make all commercially reasonable efforts to ensure its security on our systems:
We implement and maintain appropriate technical and organizational measures to ensure a security level appropriate to protect personal data provided to us from accidental or unlawful destruction, loss, alteration, unauthorized disclosure, or access to personal information transmitted, stored or otherwise processed. We train all our employees meticulously to follow the principle of strict compliance with all legal requirements. Certain AKTHealth Services support the use of standard SSL encryption to protect data transmissions. Your personal information and data stored in our systems is protected by various physical, electronic and procedural safeguards. It is housed in a secure facility, and AKTHealth and our hosting partners restrict physical and network access to this facility to select trained staff. Your AKTHealth password is protected by encryption so that only you have access to it.
We regularly evaluate and review our technologies, facilities, procedures, and potential risks to maintain the security and privacy of our users’ data. In any case we will destroy or de-identify personal information once we no longer require it for our business purposes as explained herein, or as required by law.
AKTHealth is not responsible for any 3rd party’s actions or their security controls with respect to personal information they may collect or process via their websites, services or otherwise.
9.Cookies – Tracking data
Impakt Health App does not use cookies. However, Impakt Health App collects (upon your consent during registration or using the e-consent App menu later-on) and stores via proper Application Programming Interfaces (APIs) towards 3rd parties, tracking data related to your behaviour, which are used in order to assess the App usability, offer you a better App experience and provide you personalized treatment adapted to your needs. These data include device identifiers, session duration and connection details, operating system, first launch of the App, App updates and version, geographical data, App scroll behaviour, use of App input forms/data fields.
During initial registration, you can accept or not the collection and storage of the afore mentioned analytics and statistical data (you can visit MY CONSENTS menu of the App, see consent option: Tracking my App usage for analytics and aggregated statistics). After registration, you can disable or re-enable the collection and storage of these data types through the MY CONSENTS toggle in the e-consents menu of Impakt Health App (this feature is provided in the context of clinical studies conducted by affiliated sponsors).
Data hosting of Impakt Health App tracking and analytics data is utilizing the services of Mixpanel (https://mixpanel.com/legal/gdpr-resources) and Firebase-Google (https://firebase.google.com/support/privacy).
Impakt Health App uses push notifications that are triggered from the system to inform the user about questionnaires or other news. User can anytime deactivate the push notifications from the iOS/Android device settings.
10.Data Retention
AKTHealth will not retain data longer than necessary to fulfil the purposes for which it was collected or as required by applicable laws and regulations. The data you provide us may be archived and stored periodically and will only be retained for as long as it is required for the purposes it was collected, unless the law requires us to retain them for a longer period, or delete it sooner, or unless you exercise the right to erasure (where it applies), when we do not need to retain it in connection with any reasons permitted or required by law. For the purposes of long-term research, and/or clinical studies conducted by affiliated sponsors and/or self-reporting of health-related data, data will be retained for maximum 10 years after last data collection.
11.International Transfers
We may need to transfer your information to other companies or service providers in countries outside the European Economic Area (EEA). The EEA consists of countries in the European Union, Switzerland, Iceland, Liechtenstein, and Norway: they are considered to have equivalent laws when it comes to data protection and privacy. This kind of data transfer may happen if our servers (i.e., where we store data) or our suppliers and service providers are based outside the EEA, or if you use our services and products while visiting countries outside this area. If AKTHealth sends your information to a country that is not in the EEA, we will make sure that your information is properly protected. We will always ensure that there is a proper legal agreement that covers the data transfer. In addition, if the country is not considered to have laws that are equivalent to EU data protection standards then we will ask the 3rd party to enter into a legal agreement that reflects those standards. In such cases, specific privacy notices are made available.
Data hosting of Impakt Health is utilizing the services of Microsoft Azure in servers of European Union member states. Microsoft’s contractual commitments with regards to GDPR can be found in the Online Services Data Protection Addendum:
https://www.microsoftvolumelicensing.com/DocumentSearch.aspx?Mode=2&Keyword=DPA.
Data hosting of Impakt Health App tracking and analytics data is utilizing the services of Mixpanel and Firebase-Google, and their contractual commitments with regards to GDPR can be found in the Online Services Data Protection Addendums: https://mixpanel.com/legal/dpa/ and https://firebase.google.com/terms/data-processing-terms.
Video conferencing services are provided by «Vidyo Cloud Services» (the Vidyo cloud subscription service provides access to the Vidyo Cloud Applications enabling video collaboration among Subscriber’s Users using supported devices). A signed Data Processing Agreement has been signed between INNOVATION SPRINT SPRL and Vidyo (Enghouse). No transfer of data outside the EU/EEA area takes place in this case.
12.Your Rights
AKTHealth ensures that you can under specific circumstances exercise all relevant rights in relation to your personal data, such as the right of access to your data, right to rectification, right to erasure, right to data portability, right to restriction of processing, right to object, right not be subject to automated decision making if human intervention is not taken under consideration and the necessity of the processing is not granted, and finally right of lodging a complaint towards the supervisory authority (https://www.dataprotectionauthority.be/citizen).
You can exercise your rights at any time by contacting us here: info@akthealth.com. An identification stage might be required before proceeding towards fulfilling your request. In this case, we will reply within one month or up to three after informing for the reasons of delay. However, if you still have doubts about the information provided by us upon exercising your rights you also have the right to lodge a complaint with a supervisory authority.
13.Changes to this Privacy Policy
Use of the personal data collected is subject to the Privacy Policy in effect at the time such information is used. As AKTHealth evolves, we may need to update this Policy from time to time to keep pace with changes in the Service and laws applicable to us and to you; we will, however, always maintain our commitment to respect your privacy.
If we make material changes in the way we use personal data, we will notify you by posting an announcement on our website, and we may ask for your consent to such changes if required by the applicable law. If you disagree with any changes in this Policy and do not wish your information to be subject to the revised Policy, you will need to close your account (you can use the DELETE ACCOUNT option of the Impakt Health App menu).
14.How to contact us
If you have questions, comments or requests about this Policy and your Personal Data, please contact us by submitting a request at:info@akthealth.com