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Privacy policy

1. Preliminary provisions on personal data processing

1.1. The controller of personal data processed within the www.Hemolens.eu website is a company operating under the name of Hemolens Diagnostics sp. z o.o. with the seat in Wrocław (54-202), at ul. Legnicka 48, registered in the Register of Entrepreneurs kept by the District Court for Wrocław-Fabryczna in Wrocław, 6th Commercial Division of the National Court Register under no. 0000589648, with Tax ID [NIP] no: REGON: 521-371-43-87, 363139231, share capital as at 16.05.2022 of PLN 108,550 (hereinafter “Data Controller” or “Hemolens Diagnostics”). Contact with the Data Controller:

1.1.1. by e-mail at iod@hemolens.eu,

1.1.2. using the contact form provided on the website.

1.2. Hemolens Diagnostics processes personal data in accordance with the applicable data protection legislation, in particular Regulation (EU) No. 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data and repealing Directive 95/46/EC (General Data Protection Regulation, hereinafter referred to as GDPR).

1.3. This policy aims to, among other things, comply with the information obligation under the provisions of the GDPR.

1.4. Personal data shall be processed by Hemolens Diagnostics sp. z o.o. to the extent and for the purposes indicated in this policy, respecting the individual’s right to privacy and taking into account the individual’s rights and freedoms.

1.5. The Data Controller has appointed a Data Protection Officer, to be contacted by e-mail at iod@hemolens.eu.

2. The basis for personal data processing

2.1. Hemolens Diagnostics processes the personal data provided within the website in connection with the use of the said website, in order to contact its users, respond to queries made, as well as to provide a newsletter to its subscribers.

2.2. Hemolens Diagnostics processes the personal data on the basis of:

2.2.1. communication with the user – when answering questions asked via the contact form,

2.2.2. determination, investigation, and safeguarding of possible claims arising in connection with the services provided by the website – in relation to the user’s use of the website, 2.2.2. Article 6(1)(a) of the GDPR, i.e. on the basis of the Data Subject’s consent, when:

2.2.2.1. sending commercial information within the meaning of the provisions of the Act of 18 July 2002 on the provision of electronic services,

2.2.2.2. presenting an offer of services or products of Hemolens Diagnostics in connection with an enquiry or consent of the Data Subject,

2.2.3. Article 6(1)(a) of GDPR, i.e. the legitimate interest of the Data Controller in the form of:

2.2.3.1. carrying out direct marketing activities – in the case of newsletter subscribers,

2.2.4. Article 6(1)(c) and (f) of GDPR, i.e. in order to comply with a legal obligation of the Data Controller and his/her legitimate interest in case of exercising an individual’s rights under the law in the field of personal data protection.

3. Principles of personal data processing

3.1. Hemolens Diagnostics processes only those personal data that are necessary for the purposes indicated.

3.2. The website may ask you to provide the required personal data if you use part of its functionalities or if you wish to use certain services.

3.3. The provision of personal data is voluntary and of a contractual nature, but it may be necessary in order to use certain functionalities of the website. In particular, failure to provide personal data will make it impossible to send a contact form, answer questions, present an offer or send commercial information. Also, exercising the Data Subject’s rights cannot take place without providing the personal data necessary to exercise the said rights.

3.4. Hemolens Diagnostics may process personal data in the following scope:

3.4.1. full name, including the name of your business,

3.4.2. address,

3.4.3. e-mail addresses,

3.4.4. telephone numbers

3.4.5. official position,

3.4.6. place of work,

3.4.7. other which the individual discloses when using the site, and also when making an inquiry via the contact form, e.g. TAX ID [NIP] number.

3.5. The Data Controller shall process personal data for a period depending on the purpose of the processing, i.e:

3.5.1. in case of newsletter subscribers – for the period of providing the newsletter service, until the subscriber withdraws his/her consent to provide this service electronically, requests the deletion of personal data, or objects to their processing,

3.5.2. in case of contact with the service user, including answering a question sent through the contact form – for the period necessary for the contact, answering the question asked,

3.5.3. in case of sending commercial information or submitting an offer – until the withdrawal of consent or objection to data processing,

3.5.4. in case of determination, investigation, and safeguarding of possible claims arising in connection with the services provided by the service – for the period necessary to secure them, in accordance with generally applicable law.

3.6. After the expiry of the periods indicated in the paragraph above, the Data Controller will process the personal data for the time required by the applicable legislation.

3.7. Access to the personal data provided to Hemolens Diagnostics (data recipients) shall be granted to entities providing IT (including website hosting), legal, tax, financial, and accounting services to Hemolens Diagnostics, including on the basis of signed personal data processing agreements, moreover to persons cooperating with Hemolens Diagnostics, involved in the realization of the purposes for which the data were collected, as well as to public authorities entitled to access the data on the basis of the relevant legislation.

3.8. Hemolens Diagnostics:

3.8.1. shall not use personal data by automated processing, including profiling,

3.8.2. shall not transfer data to third parties not mentioned in the item above,

3.8.3. shall not transfer data to a third country or an international organization within the meaning of the provisions of the GDPR, except on the basis of the express consent of the Data Subject or if this is required by the applicable legislation.

4. Rights of the Data Subject

4.1. Individuals whose personal data is processed by Hemolens Diagnostics are entitled to:

4.1. 1. access their personal data,

4.1.2. rectify incorrect data,

4.1.3. supplement incomplete data,

4.1.4. delete their personal data in cases stipulated in Article 17 of GDPR,

4.1.5. restrict their processing in cases regulated in Article 18 of GDPR,

4.1.6. transfer their data pursuant to Article 20 of GDPR,

4.1.7. object to the processing of their personal data pursuant to Article 21 of GDPR,

4.1.8. lodge a complaint to the supervisory authority, i.e. the President of the Office for Personal Data Protection within the territory of the Republic of Poland. A complaint may be lodged if personal data is processed contrary to the law.

4.2. If the processing of personal data takes place on the basis of Article 6(1)(a) of GDPR, i.e. the consent of the individual, the Data Subject has the right to withdraw consent to the processing of their data at any time. This does not affect the compliance with law of the processing carried out on the basis of consent prior to its withdrawal.

4.3. The Data Subjects shall exercise their rights in accordance with the provisions of the GDPR, in particular – depending on the purpose and basis of the processing – these provisions may exclude or limit the exercising of certain rights indicated in 4.1 above.

4.4. Exercising the rights referred to in this item 4 shall take place by sending a request to that effect in writing or by email to the addresses indicated in clause 1.1. or 1.5. above.

5. Safety of personal data

5.1. Hemolens Diagnostics ensures appropriate technical and organizational measures to protect personal data, in particular securing it by implementing appropriate data storage procedures.

5.2. Hemolens Diagnostics shall protect the personal data against disclosure and interception by unauthorized persons, as well as against their destruction, loss, damage, or alteration and against the processing in violation of the law, including the GDPR.

5.3. The IT systems with the use of which Hemolens Diagnostics processes personal data are equipped with direct and remote tools to protect the data from unauthorized access (e.g. passwords, encryption).

This is a medical device. Use it in accordance with the instructions.

Intended Use:

Cardiolens FFR-CT Pro is a coronary physiologic simulation software for the clinical quantitative and qualitative analysis of previously acquired Coronary Computed Tomography Angiography (CCTA) and optionally with Continuous Non-invasive Blood Pressure (CNBP) data for assessment of patients with suspected Chronic Coronary Syndromes (CCS). It provides hemodynamic diagnostic factor FFR-CT (Fractional Flow Reserve with Computed Tomography), a mathematically derived quantity, computed from simulated pressure, velocity and blood flow information obtained from a 3D computer model generated from static coronary CT images and optionally from CNBP measurement. The factor FFR-CT at the output of Cardiolens FFR-CT Pro device is intended to support the functional evaluation of coronary artery disease. The Cardiolens FFR-CT Pro outputs are provided to support qualified clinicians to aid in the evaluation and assessment of coronary arteries. The results of Cardiolens FFR-CT Pro are intended to be used by qualified clinicians in conjunction with the patient’s clinical history, symptoms, and other diagnostic tests, as well as the clinician’s professional judgment.