“HEART FAILURE PATIENT MANAGEMENT AND INTERVENTIONS USING CONTINUOUS PATIENT MONITORING OUTSIDE HOSPITALS AND REAL-WORLD DATA”
As of January 2, 2023
Who we are, what we do, and our values
RETENTION is a Horizon 2020 Project (GA 965343, Research and Innovation Action H2020-SC1-BHC-2018-2020), conceived to support clinical monitoring and data-driven interventions for diagnosed heart failure patients, patients with ventricular assist devices (VAD) and patients who received a heart transplant.
RETENTION exploits and integrates state-of-the-art technologies to develop an innovative platform supporting clinical decision-making and evidence-based personalised interventions aimed at improving the clinical management of patients with chronic Heart Failure, reducing their mortality and hospitalisation rates and improving their quality of life, safety, and well-being.
The ‘RETENTION platform’ is the total system, consisting of:
- the Global insights Cloud (the web AI subsystem for the clinical and technical personnel),
- the Clinical Side Backend (the web application for the clinical personnel) and
- the EDGE (consisting of a mobile application and a local gateway on the patient’s premises).
To support the operation of the RETENTION solution, we have developed the RETENTION Mobile Application (“Application” or “App”), which enables the collection of data from its users and features a user-friendly interface supporting our remote patient management and monitoring services.
Our App is currently being made available as part of the RETENTION multicentred clinical study, taking place in 5 clinical sites located in Greece, Italy, Germany, and Spain. Any personal information collected and processed through the App will be done in accordance with your agreement to participate in the RETENTION clinical study and the privacy notices provided to you in this context.
You may access our Website and read more about RETENTION and the 14 partners that constitute our consortium here.
Any personal data collection and processing activity carried out by RETENTION shall be in compliance with the applicable laws of the European Union -and especially the Regulation (EU) 2016/679 of the European Parliament and of the Council (‘GDPR’)- and the provisions of the RETENTION consortium’s national data protection laws in effect.
To help you understand the key terms used in this policy, please take a look in the following definitions, as determined by the GDPR:
‘personal data’: shall mean any information relating to an identified or identifiable natural person (‘data subject’); an identifiable natural person is one who can be identified, directly or indirectly, in particular by reference to an identifier such as a name, an identification number, location data, an online identifier or to one or more factors specific to the physical, physiological, genetic, mental, economic, cultural or social identity of that natural person;
‘data processing’: shall mean any operation or set of operations which is performed on personal data or sets of personal data, whether or not by automated means, such as collection, recording, organisation, structuring, storage, adaptation or alteration, retrieval, consultation, use, disclosure by transmission, dissemination or otherwise making available, alignment or combination, restriction, erasure or destruction;
‘usage data’: refers to data collected automatically, either generated by the use of our Website or the use of our Application and their infrastructures (for example, the duration of a page visit);
‘consent’: shall mean any freely given, specific, informed and unambiguous indication of the will of the Data Subject by which he or she, by a statement or by clear affirmative action, signifies agreement to the processing of personal data relating to him or her;
‘data controller’: shall mean the natural or legal person, public authority, agency or other body which, alone or jointly with others, determines the purposes and means of the processing of personal data; where the purposes and means of such processing are determined by European Union or Member State law, the controller or the specific criteria for its nomination may be provided for by Union or Member State law;
‘data processor’: shall mean a natural or legal person, public authority, agency or other body which processes personal data on behalf of the controller;
‘third-party’: shall mean a natural or legal person, public authority, agency or body other than the data subject, controller, processor and persons who, under the direct authority of the controller or processor, are authorised to process personal data;
‘recipient’: shall mean a natural or legal person, public authority, agency, or another body, to which the personal data are disclosed, whether a third party or not. However, public authorities which may receive personal data in the framework of a particular inquiry in accordance with European Union or Member State law shall not be regarded as recipients; the processing of those data by those public authorities shall be in compliance with the applicable data protection rules according to the purposes of the processing;
‘pseudonymisation’: means the processing of personal data in such a manner that the personal data can no longer be attributed to a specific data subject without the use of additional information, provided that such additional information is kept separately and is subject to technical and organisational measures to ensure that the personal data are not attributed to an identified or identifiable natural person.
What personal data we collect and how we obtain it
We collect and process personal data from you when you visit and navigate our Website, when you choose to subscribe to our Newsletter, or when you use our Application.
Please note that we are not responsible for any data collected and processed during the download of the App from an app store, e.g., Google’s Google Play Store. You may check the privacy note of the respective app store for further information.
You may read below in detail the types of personal data that we collect and the ways in which we obtain it.
Personal data we collect through our website:
When you visit our Website we receive, record and analyse certain information using Cookies (see ‘Cookies’ section below) and other services (see next section). This includes, but is not limited to:
- Information about your computer, such as your IP address, browser type and version, operating system, device characteristics, and language preferences
- Information about your visits to and use of our Website including time and length of visit, page views, and Website navigation paths.
Moreover, If you choose to contact us through our Website, you will be asked to provide us with your first name, last name and email address.
If you wish to subscribe to the RETENTION newsletter, we will ask you to provide us with your first name, last name and email address.
Personal data we collect through the Application:
To enable the patient monitoring and management features of the RETENTION platform, our Application will be gathering certain personal data about you and data regarding your home environment (i.e., medical, clinical, physiological, behavioural, psychosocial, and real-world data).
This information can be either manually entered by you (or by your caregiver on your behalf), automatically collected from devices connected to the App, or it may be collected and inserted into the App by the RETENTION clinical team with which you are related while using the App. The types of devices and sensors that will be paired to our App to gather data are: i) a Smartphone, ii) a Weight Scale, iii) a Smartwatch, iv) a Blood Pressure Monitor, v) an Oximeter, via Bluetooth Low Energy (BLE), and vi) the Local gateway supporting a home temperature sensor, a humidity sensor.
In particular, we process:
- Data provided directly from you by manually inputting it into the App. Such information may include your name, responses to our questionnaires, health result data, demographic data, information on health condition/symptoms, medication and nutrition intake, and requests or correspondence.
If you have previously indicated specific persons that assist you as caregivers to act on your behalf in this regard, those caregivers may also insert this information directly into the App for you, as well as complete questionnaires intended for caregivers.
- Data you provide to us when registering to RETENTION research study, inserted to the App by the RETENTION clinical team that attends to you. This information may include your date of birth, age, sex, race, marital status, height, home address, level of education, employment status, caregiver data (if available), ABO blood group, cardiovascular history, non-cardiovascular history, blood tests, and cardio-pulmonary exercise testing.
- Data you provide to us during planned follow-up visits (medical examinations) to your attending medical team in the context of the RETENTION study, inserted to the App by the latter. This shall include information such as: weight, vital signs (blood pressure, heart rate, peripheral capillary oxygen saturation, temperature), electrocardiography, echocardiography, and blood test, questionnaire responses (depression score PHQ-9, Kansas City Cardiomyopathy Questionnaire), interrogation of defibrillator data, and cardio-pulmonary exercise testing/six minutes’ walk test.
- Data automatically recorded from the smartphone on which your App is running or from your RETENTION devices that are paired with your App, depending on the enabled features. Such data may include: weight, blood pressure – excluding patients with VAD, heart rate, peripheral capillary oxygen saturation, deep and light sleep phases, sleep interruptions, steps, distance covered, floors climbed. And from the local gateway, patient living space data (temperature and humidity, approximate GPS coordinates) and patient living environment data (extreme temperatures and weather conditions, pollutants obtained from external services).
- Data collected (manually from users with VAD devices, including: controller parameters, Alarms, RPMs, power consumption, flow, pulsatility index, coagulation values (INR) – through point of care devices, and driveline exit site evaluation (photographic evidence) as early signs of infection.
- Data collected whenever you use the Application (i.e., usage data). This information may include your IP address, unique device identifiers and other system settings, device characteristics, operating system type, language preferences, actions taken, dates and times of Application visits, user performance in the Application.
Note that the specific types of personal data we gather and process through our App vary depending on the application features you are using, or the specifics of the treatment regime being applied.
How we use your data and relevant legal bases
We will only collect and process personal data that is relevant to the purposes for which the data is intended, and we will not use it in a way that is incompatible with such purposes unless such use has been previously authorised by you. We will take reasonable steps to ensure that personal data is reliable for its intended use, accurate, complete, and current. We may occasionally contact you to determine that your data is still accurate and current.
You may read below the purposes for which we collect and process your personal data and the legal basis of the processing in the context of each of our Services:
We analyse the information we collect from Website visits -using Google Analytics and Yoast SEO- in order to gain useful insights for maintaining and improving our Website, as well as for communicating better our research activities and outcomes. When you first visit our Website, you will be asked to provide us or not with your consent to process your Website usage data.
The personal data that you voluntarily submit for subscribing to our Newsletter will be used for sending you our Newsletter via email. Remember that withdrawing your subscription can be easily done by clicking “Unsubscribe” underneath any Newsletter-mail.
Personal data gathered through our App will be processed for the research purposes related to the conduction of the RETENTION study and the provision of the services offered to you in the context of your participation in it. Your explicit and informed consent will be the legal basis for the processing of your personal data when using the App and its functionalities.
In brief, the overall purpose of data processing within the scope of the RETENTION research study includes: (i) continually monitoring the collected medical, clinical, physiological, behavioural, psychosocial, and real-world data, (ii) analysing these data in a pseudonymized form -or anonymized when possible- using innovative model-driven big data analytics, statistical, artificial intelligence and machine learning techniques to provide evidence-based and personalized interventions, (iii) detecting patterns in the HF disease progression and the quality of life of patients, and (iv) cross-checking and validating them against the clinical literature, and (v) (e) offering transparent, explainable and verifiable decision-making capabilities that leverage the evidence produced by the underlying data analysis and augment clinical studies targeting HF and other cardiovascular diseases.
We will also be processing your personal data as necessary to create anonymous, aggregated, and de-identified data, prior to any AI-assisted data analysis. We will only use fully anonymised data to support publications of research outcomes in scientific journals and conferences. Under no circumstances will any scientific publication of the RETENTION project include any information that could lead to your identification.
Moreover, we may process your App usage data on the basis of our legitimate interest when necessary for analysing the performance of the Application, in order to improve its features, fix bugs, troubleshoot user queries, and generally ensure its high and secure performance. However, such data processing will take place only after your personal data are pseudonymized or anonymized if possible.
Please note that your personal data might be also processed if it is reasonably necessary to comply with any legal obligations, meet any regulatory requirements, resolve any disputes or litigation, or as otherwise needed to enforce any applicable legislation, and prevent fraud and abuse.
Who has access to your data
Any personal data we receive when you visit and navigate through our Website or any data collected when subscribing to our Newsletter will be managed by RETENTION consortium partners, and in particular by our website administration partner (i.e., Innovation to Grow S.R.L. – ‘i2grow’, based in Via Mascheroni 31, 20121 Milano & Via Matteotti 21, 40128, Bologna, Italy). Please note that for collecting the above-mentioned data and making statistics and analysis, we use Google Analytics (Google LLC., with a registered seat at 1600 Amphitheatre Parkway Mountain View, CA 94043, United States), and Yoast SEO (with a registered seat at Yoast BV Don Emanuelstraat 3 6602 GX Wijchen, The Netherlands).
The personal data collected through the use of our Application may be accessed by the following categories of recipients, always in a strictly confidential manner:
- RETENTION clinicians: Your identity will be known only by the authorised clinical team responsible for your treatment within the context of your participation in the RETENTION study. These clinicians shall have full access to all of your personal data gathered in the App. The RETENTION clinical partners are: (i) the Onaseio Kardiocheirourgiko Kedro (‘OCSC’), established at 356 Syggrou Avenue, GR-17674 Kallithea, Athens, Greece; (ii) the ALMA MATER STUDIORUM – Università di Bologna (‘UNIBO’), established at via Zamboni 33 40126, Bologna, Italy; (iii) the Universitaetsklinikum Essen (UKESSEN), established in Hufelandstr. 55, 45147, Essen, Germany; (iv) the Servicio Madrileño de Salud (SERMAS), established at Plaza Carlos Trias Bertran 7, 28020, Madrid, Spain; and (v) the Ethniko Kai Kapodistriako Panepistimio Athinon (NKUA), established at 6 Christou Lada Str 10561, Athens, Greece.
- Administrators and GDPR Auditors: in order to manage your App account (e.g., activate/lock/suspend/delete) and answer any questions or GDPR-related requests you might raise regarding your participation in the RETENTION study and use of the App, personnel designated by our clinical partners will access the necessary information related to you for carrying out such App administration tasks, pseudonymised or anonymised where possible. Any GDPR-related requests will be directed to our Data Protection Officer (‘DPO’) or the DPO of the clinical partner with which you are related.
- Technical support/Help desk operators: in case you require technical support for using the App and the technical equipment supporting its function, you may come into contact with authorized technical support/help desk operators, designated by our clinical partners. However, your identity will not be disclosed to said technical support/help desk operators nor any personal data collected throughout the study will be accessible to them by any manner. Any personal information disclosed in this case will be strictly limited to what is necessary for helping you with the technical issues you need assistance with (e.g., IP address, device system settings, etc.).
Please note that your personal data might also be shared with government authorities and/or law enforcement officials if mandated by law or if required for the legal protection of the data controller(s) legitimate interests in compliance with applicable laws.
Your personal data will not be disclosed or transferred to other third parties. To enable the collection of data from the devices connected to the App (e.g., from the smartwatch) in a direct manner and prevent third parties from having access to such data, we will be using SDKs.
Keeping your data safe and secure
Data collected through our Website or Newsletter subscriptions will be kept in a confidential, safe and secure manner by our website administrator (i.e., i2grow).
The RETENTION platform, and of its all sub-components, are being hosted on a private cloud infrastructure at a controlled and secure computer room located in the premises of the RETENTION consortium partner Institute of Communication and Computer Systems (‘ICCS’), based in Greece, part of the School of Electrical and Computer Engineering at the National Technical University of Athens (NTUA). All technical and organizational measures are taken to ensure maximum system safety and all provisions are put into place, to guarantee the security of personal data.
We place great importance on the security of all personal data that we collect and process for operating the RETENTION solution. In this direction, we have adopted appropriate data collection, storage and processing practices and security measures to protect your data against unauthorised access, alteration, disclosure or destruction. The implemented technical and organisational measures include, but are not limited to: data encryption, pseudonymization, authorisation mechanisms ensuring limited access, auditing of access logs, the appointment of a DPO and confirmation of DPO designation by all RETENTION clinical partners within their institution, the establishment of an Ethics & Privacy Committee, etc.
Overall, security constitutes an integral part of the RETENTION solution infrastructure deployment. The RETENTION platform supports state of the art controls and processes to ensure the security and privacy of the data held in the platform (and hence, the Applications) and the protection of the platform itself, including periodic vulnerability analyses and penetration testing. Continuous monitoring of the implemented security and privacy control mechanisms of the platform ensure auditability. Moreover, RETENTION has adopted a layered architecture for the operation of the whole system, in which non-anonymised personal patient data will only be stored at the components of the platform operating at the secure clinical backend of the project and be accessible only to a restricted number of researchers (e.g., clinicians having responsibility for the follow-ups of patients). These personal data will be transmitted only in a fully anonymised form to the cloud of the platform for analysis using AI techniques (data mining and machine learning).
We highlight that, If in the unlikely event of malicious access/leak of data to any component of the platform is achieved, the identification of the individuals will not be possible since the association between participants’ pseudonymisation codes is stored in an encrypted fashion in separate storages.
Automated decision making and profiling
The RETENTION App does not provide to patients any kind of alerts/indications for interventions enabled solely by automated decision-making functionalities. Any AI-driven data analysis outcomes provided by the system will be at the medical professionals’ disposal to evaluate, validate, and possibly deduce “informed clinical decision-making”. This means that any kind of decision for recommending an intervention will be taken only by your attending physician.
Please consider carefully that the AI-driven functionalities of the RETENTION platform do not support any kind of alert mechanism for medical emergency situations and that the RETENTION App will not alert you or your clinicians about any sign that indicates a need for urgent medical attention.
How long we keep your data
Personal data collected for Newsletter subscription will be retained until you choose to unsubscribe from our emailing list.
All personal data collected and processed for the purposes of the RETENTION research project will be retained for the whole duration of the project (considering any potential extension to the initial project duration in case of a GA amendment) or for a shorter period as long as their data are required to fulfil the purposes of the research. After such a period participants’ personal data may be archived, where possible in an anonymised format, in accordance with applicable legal requirements. To carry out activities relating to the dissemination and exploitation of the project’s results, all data will be kept anonymised for up to 3 years after the end of the project. Participants’ personal data may also be retained for a longer period if it is reasonably necessary to comply with any legal obligations, meet any regulatory requirements, resolve any disputes or litigation, or as otherwise needed to enforce the data protection legislation, and prevent fraud and abuse.
Your rights under the GDPR
We are committed to facilitating the management of your personal data and the exercise of your personal data protection rights. You may read below your relevant rights, in accordance to the GDPR:
- Right to access: You have the right to be informed whether we process and maintain your personal data. If the answer you receive is affirmative, you may submit a request to obtain information about the processing, its purpose, the type of data, the recipients of your data, the period of retention, the existence of automated decision-making, as well as the possibility of exercising your other rights as described below
- Right to rectification: You have the right request the correction of errors or inaccuracies in the personal data that we hold about you
- Right to restrict the processing: of your personal data if either the accuracy of said data is contested or the processing is unlawful or the purpose of the processing was eliminated, and provided that there is no legitimate reason to retain them.
- Right to object or to restrict the processing: under certain circumstances provisioned by the applicable data protection legislation, you may ask for a restriction of processing or object to the processing of your personal data.
- Right to data portability: under certain circumstances described in the applicable data protection legislation, you have the right to receive the personal data processed in a format that is structured, commonly used, and machine-readable and to transmit this data to another service provider.
- Right to withdraw your consent: In the event that your data is processed on the legal basis of your consent, you can revoke it at any time in order to stop the processing of data carried out on the basis of it.
You may initiate a GDPR request by sending an email to the RETENTION DPO or the DPO of the RETENTION healthcare provider you are related to when using our App (see contact details in the relevant section below). We will respond to you without undue delay and in any event within one month of receipt of your request. That period may be extended by two further months only where necessary, taking into account the complexity and number of the requests. If for any reason we cannot comply with your request, we will provide you with a detailed and reasoned response.
If you have unresolved concerns, you have the right to lodge a complaint with an EU Data Protection Authority (DPA) where you live, work, or where you believe a breach may have occurred.
Links to other websites
Processing related to children
Note also that our Website and Newsletter are not directed at children under the age of 13. We do not consciously collect or solicit data from subjects under the age of 13 via these services. In the event that we learn that we have gathered personal information from anyone under the age of 13 without the consent of a parent or guardian, we will delete that information as soon as possible.
Data Controllers and Data Processors
We act as data controllers of any personal data uploaded and collected when using the Application or the Website or when subscribing to our Newsletter.
If you have consented to allow your data to be collected and processed in the context of your participation in the RETENTION research study, the RETENTION clinical partners act as a Data Controllers for that data and will only process that data for the purposes of conducting our research project. RETENTION partners may also act as a Data Processors on behalf of the RETENTON healthcare providers in the provision of particular services they provide, such as in the case of our server host (ICCS).
We also act as a Data Controller in the context of data processing activities carried out for the purposes of product and service improvement and product research and development. However, data used for these purposes is de-identified and anonymised.
If you have any questions about our privacy practices or wish to raise relevant complaints and exercise your rights, please contact us by sending an email to Christina Nanou (RETENTION Data Protection Officer – “DPO”), at firstname.lastname@example.org or to the DPO’s of the RETENTION clinical partners’ institutions, as noted below:
- OCSC DPO: Mr. Panagiotis Tampoureas, email@example.com
- UNIBO DPO: Dr. Manuela Zecca, firstname.lastname@example.org
- UKESSEN DPO: Mr. Christian Hecke, email@example.com
- SERMAS DPO: ALARO AVANT SL, firstname.lastname@example.org
- NKUA DPO: Mr. Andreas Rodakos, email@example.com