הצהרת פרטיות בנושא עיבוד מידע אישי למטרות בטיחות תרופתית, מידע רפואי והבטחת איכות
הצהרת פרטיות זו מיועדת עבור: אנשים אשר מדווחים או מעורבים בתופעת לוואי או אירוע חריג, מוסרים מידע על בטיחות מטופלים המתייחס למוצרים שלנו, מבקשים מידע רפואי או מגישים תלונות בנושא איכות. נוברטיס מחויבת להגנה על מידע אישי ולשקיפות לגבי איסוף ושימוש במידע אישי. הצהרה זאת מספקת לך מידע לגבי האופן שבו נוברטיס ישראל בע"מ או החברות הקשורות לה ("נוברטיס", "אנו") מעבדת מידע אישי. אנו מזמינים אותך לקרוא הצהרת פרטיות זו בעיון, מאחר שהיא מכילה מידע חשוב. אם יש לך שאלות נוספות, את.ה מוזמנ.ת לפנות ל- [email protected] או ל[email protected].
מדוע אנו אוספים מידע אישי?
הצהרת פרטיות זו מיועדת עבור: אנשים אשר מדווחים או מעורבים בתופעת לוואי או אירוע חריג, אנו מעבדים מידע אישי למטרות שלהלן, ואיננו מעבדים מידע אישי אלא אם כן הדבר מוצדק על פי חוק.
- ניטור הבטיחות של תכשירים רפואיים ומכשירים רפואיים, לרבות איתור, הערכה, מעקב ומניעה של תופעות לוואי ודיווח עליהן לרשויות הבריאות
- מתן מענה לשאלות בנושא מידע רפואי, כגון זמינות מוצרים, מידע קליני, קביעת מינון ומתן, פורמולציה ותנאי יציבות, אינטראקציות עם תרופות אחרות ומוצרי מזון.
- מתן מענה לתלונות על איכות לגבי המוצרים שלנו, כגון ליקוי כלשהו באיכות ו/או ביעילות, ביציבות, באמינות, בבטיחות, בביצוע או בשימוש.
- ביצוע מחקרים שאינם התערבותיים באמצעות נתוני ניטור הבטיחות להערכת הסיכון לרעילות לרבייה, כאשר ייתכן שימוש במוצר במהלך היריון. לשם כך, אנו עשויים לקבל עדכונים תקופתיים מאנשי צוות רפואי רלוונטיים לצורך איסוף מידע על תוצאת ההיריון והתפתחות הילד לאחר הלידה.
- מתן מענה לשאלות או לבקשות נוספות ושיפור המוצרים והשירותים שלנו.
- עמידה בנהלי המדיניות שלנו ובדרישות חוקיות, רגולטוריות ובדרישות להיענות וכן ביצוע ביקורות וליטיגציה.
לתשומת לבך, במדינות מסוימות, הסכמה היא הבסיס לעיבוד מידע אישי.
איזה מידע אישי שלך נאסף?
אנו אוספים ומשתמשים בקטגוריות הבאות של מידע אישי למטרות שפורטו מעלה:
- מידע על אנשים המדווחים על תופעת לוואי או על אירוע חריג בנוגע לאחד המוצרים שלנו (כגון חשיפה לתרופה במהלך היריון, הנקה, מינון יתר, חוסר יעילות וכו') או פונים לגבי מידע רפואי או מגישים תלונות על איכות המוצר, לרבות אנשי ונשות צוות רפואי ומטפלים.ות. הדבר מאפשר לנו לתת מענה לבקשות ולחפש מידע נוסף לפי הצורך. הנתונים הנאספים על ידנו עשויים לכלול את שמך, כתובת דוא"ל ו/או כתובת למשלוח דואר, מספר טלפון ומקום עבודה (עבור אנשי ונשות צוות רפואי). אם את.ה איש.אשת צוות רפואי, אנו עשויים לאסוף גם מידע המיועד לאשר שאת.ה איש.אשת צוות רפואי;
- פרטי המטופלים, לרבות שם, , גיל או תאריך לידה, מין, משקל, גובה, גזע, האם בהיריון ו/או מניקה, מוצא אתני (כאשר סיכום מאפייני המוצר מכיל מידע המתייחס למוצא אתני), ונתונים תעסוקתיים (כאשר נדרש לצורך ביצוע הערכה לדיווח תופעת לוואי);
- כאשר נדרש לצורך ביצוע הערכה לדיווח תופעת לוואי ולמטרות המתוארות בהצהרת פרטיות זו, מידע על בריאותו ואורח חייו של המטופל.ת, לרבות, בין היתר, אופיין של תופעות הלוואי, תוצאות בדיקות, היסטוריה רפואית אישית או משפחתית, מחלות או אירועים נלווים, גורמי סיכון, מידע על שימוש בתרופות וניהול הטיפול, פעילות גופנית, תזונה והרגלי אכילה, חיי מין/ אמצעי מניעה וצריכת טבק, אלכוהול וסמים.
למי יש גישה למידע אישי?
איננו חושפים ואיננו מעבירים מידע אישי בכל דרך אחרת לצדדים שלישיים מלבד אלה המצוינים בהצהרת פרטיות זו. ייתכן כי לגורמים הבאים תהיה גישה למידע אישי או ייתכן שהמידע האישי יועברו לגורמים הבאים, והכל במסגרת תפקידם.ן:
- עובדי.ות מחלקות בטיחות המטופלים, מידע רפואי, הבטחת איכות והמחלקה המשפטית, וראשי המחלקות הללו בחברות אחרות מקבוצת נוברטיס;
- חברות תרופות ומכשור רפואי אחרות, אם הדיווח, בקשת המידע או התלונה מתייחסים לאחד המוצרים שלהן;
- ספקי שירותים הפועלים מטעם החברות של נוברטיס, כגון ספקי מערכות מידע ואחסון נתונים, וספקי שירות של עיבוד דיווח תופעות לוואי (לרבות ספקי מוקדים טלפוניים). צדדים שלישיים אלה מחויבים בחוזה להגנה על הסודיות ואבטחת המידע האישי, בהתאם לדין החל.
כמו כן, ייתכן כי מידע אישי ייחשף בפני:
- אנשי ונשות צוות רפואי המעורבים.ות בתופעת הלוואי, בבקשת מידע או בתלונה;
- רשויות בריאות, לרבות רשות התרופות האירופית (EMA) המפקחת על מאגר הנתוניםEU EudraVigilance (https://www.ema.europa.eu) וכן רשות התרופות הפדרלית האמריקאית (FDA);
- גוף רגולטורי, רשות ציבורית או בית משפט אם נידרש לכך על פי הדין החל על פי בקשתם.
היכן מאוחסן המידע האישי?
מידע אישי עשוי להיות מעובד, מאוחסן ועשויה להיות אליו גישה מחוץ לישראל, במדינה שייתכן כי אינה מציעה רמה זהה של הגנה על מידע אישי. אם נעביר מידע אישי לחברות חיצוניות באזורי שיפוט אחרים, אנו נגן על המידע האישי באמצעות (1) יישום רמת ההגנה הדרושה על פי דין הפרטיות החל על נוברטיס; (2) פעולה בהתאם לנהלי המדיניות ולתקנים שלנו; עבור העברות מידע אישי בתוך קבוצת החברות של נוברטיס, קבוצת נוברטיס אימצה 'כללי תאגיד מחייבים (Binding Corporate Rules)', מערכת של עקרונות, כללים וכלים המופיעים בדין האירופי, במטרה להבטיח רמת הגנת מידע גבוהה בהקשר להעברת מידע אישי מחוץ ל- EEA ושוויץ. ניתן לקרוא מידע נוסף ב- www.novartis.com/privacy
למשך איזו תקופה אנו מאחסנים מידע אישי?
מידע אישי, למעט פרטי קשר פשוטים של המדווח, יישמרו כל עוד אנחנו רואים בהם צורך באופן סביר להשגת המטרות שהוגדרו בהצהרת פרטיות זו, וכל עוד הדבר נדרש או מותר על פי הדין החל. פרטי קשר של המדווח יישמרו ללא הגבלת זמן, אם המדווח אינו נושא המידע האישי.
מהן זכויותיך וכיצד תוכל לממש אותן?
הזכויות שלך הן:
- לקבל גישה למידע האישי שלך כפי שעובד על ידנו, ואם את.ה מאמינ.ה שהוא שגוי, לא עדכני או חלקי, לבקש שהמידע יתוקן או יעודכן;
- לבקש מחיקה של המידע האישי שלך או הגבלת השימוש בו;
אנו עשויים ליישם חריגים לזכויות אלו לפי העניין ובהתאם לדין.
אם יש לך שאלה או אם ברצונך לממש את הזכויות המפורטות לעיל, ניתן להיכנס ללינק - www.novartis.com/privacy
בכל מקרה, יש לך זכות גם להגיש תלונה לרשות הגנת הפרטיות בנוסף לזכויותיך המפורטות לעיל.
כיצד תוכל לפנות אלינו?
אם ברצונך לפנות לממונה על הגנת הפרטיות בחברתנו, אנא שלח דוא"ל אל [email protected] או למייל [email protected].
כל שינוי או תוספות עתידיות להצהרה זאת יפורסמו באתר האינטרנט שלנו.
Novartis – General Privacy Notice for Health Care Professionals
This Privacy Notice is addressed to:
- the healthcare professionals with whom we create or maintain a relationship;
- our customers or prospects who are natural persons (such as self-employed pharmacists);
- the representatives or contact persons of our customers or prospects who are legal entities (such as wholesale pharmacists).
You are receiving this Privacy Notice because Novartis Israel Ltd. located at 6 Tozeret Haaretz Street, P.O.B. 7126, Tel Aviv, Israel and its affiliates (“Novartis”) is processing information about you which constitutes personal data and Novartis considers the protection of your personal data and privacy a very important matter.
Novartis is responsible for the processing of your personal data as it decides why and how it is processed, thereby acting as the controller. In this Privacy Notice, “we” or “us” refers to Novartis.
We invite you to carefully read this Privacy Notice, which sets out in which context we are processing your personal data and explains your rights and our obligations when doing so.
Should you have any further question in relation to the processing of your personal data, we invite you to contact Novartis Data Privacy Department at [email protected].
- What information do we have about you?
This information may either be directly provided by you, by our business partners (i.e. the legal entity for whom you work), by third parties (e.g. medical companies) or be obtained through trusted publicly available sources (such as PubMed, Clinical Trials.gov, congress websites or university websites), having obtained your consent to provide us with such personal data where necessary under applicable law. We collect various types of personal data about you, including:
- your general and identification information (e.g. full name, gender, email and/or postal address, fixed and/or mobile phone number);
- your function (e.g. title, position, name of company, as well as, for healthcare professionals, first specialty, second specialty, professional experience, education);
- Payment information (e.g., bank account details), photo ID, number of licensed dealer (as relevant), C.V. – all are collected for health care professionals who provide services to Novartis, such as lectures or consultancy;
- Novartis unique business partner ID and profile;
- your electronic identification data where required for the purpose of delivering products or services to our company (e.g. login, access right, passwords, badge number, IP address, online identifiers/cookies, logs, access and connexion times, image recording or sound such as badge pictures, CCTV or voice recordings);
- information regarding your interaction with us and with the content we send you to improve our services and tailor the communications we send you.
- information regarding your preferences including in terms of channels of communication and frequency;
- data you provide to us for example when you fill in forms or during events you attend, or when you answer questions in a survey;
- data which relate to our products and services; and
- information about the scientific and medical activities/interactions you have with us, including potential future interactions.
If you intend to provide us with personal data about other individuals (e.g. your colleagues), please refer them to this Privacy Notice.
- For which purposes do we use your personal data and why is this justified?
We always process your personal data for a specific purpose and only process the personal data which is relevant to achieve that purpose. In particular, we process your personal data for the following purposes:
- manage our relationship with you (e.g. through our databases);
- implement tasks in preparation of or to perform existing contracts;
- evidence transactions, when applicable;
- provide you with adequate and updated information about disease, drugs as well as our products and services;
- improve the quality of our services by adapting our offering to your specific needs;
- answer your requests and provide you with efficient support;
- send you surveys (e.g. to help us improve your future interactions with us);
- send you communications regarding products or services that we promote;
- manage communications and interactions with you (e.g. through the operation of a database keeping records of interactions with healthcare professionals or managing call planning as well as call reporting);
- track our activities (e.g. measuring interactions or sales, number and quality of appointments/calls);
- invite you to events or promotional meetings sponsored by us (e.g. medical events, speaker events, conferences);
- grant you access to our training modules allowing you to provide us with certain services;
- manage our IT resources, including infrastructure management and business continuity;
- preserve the company’s economic interests and ensure compliance and reporting (such as complying with our policies and local legal requirements, adverse event reporting, tax and deductions, managing alleged cases of misconduct or fraud; conducting audits and defending litigation);
- manage mergers and acquisitions involving our company;
- archiving and record keeping;
- billing and invoicing; and
- any other purposes imposed by law and authorities.
- Who has access to your personal data and to whom are they transferred?
We will not sell, share, or otherwise transfer your personal data to third parties other than those indicated in this Privacy Notice.
In the course of our activities and for the same purposes as those listed in this Privacy Notice, your personal data can be accessed by or transferred to the following categories of recipients, on a need to know basis to achieve such purposes:
- our personnel (including personnel, departments or other companies of the Novartis group);
- our independent agents or brokers (if any);
- our suppliers and services providers that provide services and products to us;
- our IT systems providers, cloud service providers, database providers and consultants;
- our business partners who offer products or services jointly with us or with our subsidiaries or affiliates;
- any third party to whom we assign or novate any of our rights or obligations; and
- our advisors and external lawyers.
The above third parties are contractually obliged to protect the confidentiality and security of your personal data, in compliance with applicable law.
Your personal data can also be accessed by or transferred to any national and/or international regulatory, enforcement, public body or court, where we are required to do so by applicable law or regulation or at their request.
The personal data we collect from you may also be processed, accessed or stored in a country outside of Israel, which may not offer the same level of protection of personal data. However. If we transfer your personal data to external companies in other jurisdictions, we will make sure to protect your personal data by (i) applying the level of protection required under the local data protection laws applicable in Israel, and (ii) acting in accordance with our policies and standards.
For intra-group transfers of personal data to our group companies, the Novartis Group has adopted Binding Corporate Rules, a system of principles, rules and tools, provided by European law, in an effort to ensure effective levels of data protection relating to transfers of personal data outside the European Economic Area.
- How do we protect your personal data?
We have implemented appropriate technical and organisational measures to provide an adequate level of security and confidentiality to your personal data. There are some risks which cannot be completely prevented, and can only be minimized by implementing these kind of measures, which take into account:
- the state of the art of the technology;
- the costs of its implementation;
- the nature of the data; and
- the risk of the processing.
The purpose thereof is to protect it against accidental or unlawful destruction or alteration, accidental loss, unauthorized disclosure or access and against other unlawful forms of processing.
Moreover, when handling your personal data, we:
- only collect and process personal data which is adequate, relevant and not excessive, as required to meet the above purposes; and
- aspire to keep your personal data up to date and accurate.
For the latter, we may request you to confirm the personal data we hold about you. You are also invited to spontaneously inform us whenever there is a change in your personal circumstances so we can ensure your personal data is kept up-to-date.
- How long do we store your personal data?
We will only retain your personal data for as long as necessary to fulfil the purpose for which it was collected or to comply with legal or regulatory requirements.
For contracts, the retention period is the term of your (or your company’s) contract with us, plus the period of time until the legal claims under this contract become time-barred, unless overriding legal or regulatory schedules require a longer or shorter retention period. When this period expires, your personal data is removed from our active systems.
- What are your rights and how can you exercise them?
You may exercise the following rights under the conditions and within the limits set forth in the law:
- the right to access your personal data as processed by us, and, if you believe that any information relating to you is incorrect, obsolete or incomplete, to request its correction or updating;
- the right to request the erasure of your personal data or the restriction thereof to specific categories of processing;
- the right to withdraw your consent at any time, without affecting the lawfulness of the processing before such withdrawal;
- the right to object, in whole or in part, to the processing of your personal data;
- the right to object to a channel of communication used for direct marketing purposes; and
If you have a question or want to exercise the above rights, you may send an email [email protected] with a scan of your identity card for identification purpose, it being understood that we shall only use such data to verify your identity and shall not retain the scan after completion of the verification. When sending us such a scan, please make sure to redact your picture and identification number or equivalent on the scan.
If you are not satisfied with how we process your personal data, please address your request to our data protection officer at [email protected], who will investigate your concern.
Please note that you are under no legal obligation to provide us with any personal data, and the provision of personal data is subject to your consent. However, in the event you do not consent to provide us with certain personal data, as well as your consent to the processing of such personal data in accordance with this notice, we will not be able to cooperate with you or provide you with some of our services.
- How will you be informed of the changes to our Privacy Notice?
Any future changes or additions to the processing of your personal data as described in this Privacy Notice will be notified to you in advance through an individual notice through our usual communication channels (e.g. by email or via our internet websites).
- Miscellaneous
This Privacy Notice (i) complements any data protection policy or a similar document introduced within Novartis before the date of this Privacy Notice and (ii) applies to any consent form signed by any data subject for Novartis on, before and after the date of this Privacy Notice
Novartis – General Privacy Notice for Suppliers
This Privacy Notice is addressed to:
- our suppliers and service providers who are natural persons (such as self-employed persons);
- the representatives or contact persons of our suppliers and service providers who are legal entities.
You are receiving this Privacy Notice because Novartis Israel Ltd. located at 36 Shacham St., Petach Tikva, Israel and its affiliates (“Novartis”) is processing information about you which constitutes “personal data” and the Novartis considers the protection of your personal data and privacy a very important matter.
Novartis is responsible for the processing of your personal data as it decides why and how it is processed, thereby acting as the “controller”. In this Privacy Notice, “we” or “us” refers to Novartis.
We invite you to carefully read this Privacy Notice, which sets out in which context we are processing your personal data and explains your rights and our obligations when doing so.
Should you have any further question in relation to the processing of your personal data, we invite you to contact Novartis Data Privacy Department at [email protected].
- What information do we have about you?
This information may either be directly provided by you or provided by our supplier or service provider (i.e. the legal entity for whom you work)./p>
We may collect various types of personal data about you, including:
- your general and identification information (e.g. full name, gender, date and place of birth, , ID or passport number, email and postal address, fixed and mobile phone number);
- your function (e.g. title, position and name of company); and
- for natural persons acting as suppliers or service providers, financial information (e.g. bank account details), photo of ID, professional experience, education;
If you intend to provide us with personal data about other individuals (e.g. your colleagues), you must provide a copy of this Privacy Notice to the relevant individuals, directly or through your employer.
- For which purposes do we use your personal data and why is this justified?
We always process your personal data for a specific purpose and only process the personal data which is relevant to achieve that purpose. In particular, we process your personal data for the following purposes:
- manage our suppliers and service providers throughout the supply chain;
- organise tender-offers, implement tasks in preparation of or to perform existing contracts;
- monitor activities at our facilities, including compliance with applicable policies as well as health and safety rules in place;
- grant you access to our training modules allowing you to provide us with certain services;
- manage our IT resources, including infrastructure management and business continuity;
- preserve the company’s economic interests and ensure compliance and reporting (such as complying with our policies and local legal requirements, tax and deductions, managing alleged cases of misconduct or fraud, conducting audits and defending litigation);
- manage mergers and acquisitions involving our company;
- archiving and record-keeping;
- billing and invoicing; and
- any other purposes imposed by law and authorities.
- Who has access to your personal data and to whom are they transferred?
We will not sell, share, or otherwise transfer your personal data to third parties other than those indicated in this Privacy Notice.
In the course of our activities and for the same purposes as those listed in this Privacy Notice, your personal data can be accessed by or transferred to the following categories of recipients on a need to know basis to achieve such purposes:
- our personnel (including personnel, departments or other companies of the Novartis group);
- our independent agents or brokers (if any);
- our other suppliers and services providers that provide services and products to us;
- our IT systems providers, cloud service providers, database providers and consultants;
- any third party to whom we assign or novate any of our rights or obligations; and
- our advisors and external lawyers.
The above third parties are contractually obliged to protect the confidentiality and security of your personal data, in compliance with applicable law.
Your personal data can also be accessed by or transferred to any national and/or international regulatory, enforcement, public body or court, where we are required to do so by applicable law or regulation or at their request.
The personal data we collect from you may also be processed, accessed or stored in a country outside of Israel, which may not offer the same level of protection of personal data.
However, If we transfer your personal data to external companies in other jurisdictions , we will make sure to protect your personal data by (i) applying the level of protection required under the local data protection laws applicable in Israel, and (ii) acting in accordance with our policies and standards.
For intra-group transfers of personal data to our group companies, the Novartis Group has adopted Binding Corporate Rules, a system of principles, rules and tools, provided by European law, in an effort to ensure effective levels of data protection relating to transfers of personal data outside the European Economic Area.
- How do we protect your personal data?
We have implemented appropriate technical and organisational measures to provide an adequate level of security and confidentiality to your personal data.
There are some risks which cannot be completely prevented, and can only be minimized by implementing these kind of measures, which take into account:
- the state of the art of the technology;
- the costs of its implementation;
- the nature of the data; and
- the risk of the processing.
The purpose thereof is to protect it against accidental or unlawful destruction or alteration, accidental loss, unauthorized disclosure or access and against other unlawful forms of processing.
Moreover, when handling your personal data, we:
- only collect and process personal data which is adequate, relevant and not excessive, as required to meet the above purposes; and
- aspire to keep your personal data up to date and accurate.
For the latter, we may request you to confirm the personal data we hold about you. You are also invited to spontaneously inform us whenever there is a change in your personal circumstances so we can ensure your personal data is kept up-to-date.
- How long do we store your personal data?
We will only retain your personal data for as long as necessary to fulfil the purpose for which it was collected or to comply with legal or regulatory requirements.
The retention period is the term of your (or your company’s) supply or service contract, plus the period of time until the legal claims under this contract become time-barred, unless overriding legal or regulatory schedules require a longer or shorter retention period. When this period expires, your personal data is removed from our active systems.
- What are your rights and how can you exercise them?
You may exercise the following rights under the conditions and within the limits set forth in the law:
- the right to access your personal data as processed by us and, if you believe that any information relating to you is incorrect, obsolete or incomplete, to request its correction or updating;
- the right to request the erasure of your personal data or the restriction thereof to specific categories of processing;
- the right to withdraw your consent at any time, without affecting the lawfulness of the processing before such withdrawal;
- the right to object, in whole or in part, to the processing of your personal data; and
If you have a question or want to exercise the above rights, you may send an email to [email protected]with a scan of your identity card for identification purpose, it being understood that we shall only use such data to verify your identity and shall not retain the scan after completion of the verification. When sending us such a scan, please make sure to redact your picture and national identification number or equivalent on the scan.
If you are not satisfied with how we process your personal data, please address your request to our data protection officer at [email protected], who will investigate your concern.
Please note that you are under no legal obligation to provide us with any personal data, and the provision of personal data is subject to your consent. However, in the event you do not consent to provide us with certain personal data, as well as your consent to the processing of such personal data in accordance with this notice, we will not be able receive any services from you.
- How will you be informed of the changes to our Privacy Notice?
Any future changes or additions to the processing of your personal data as described in this Privacy Notice will be notified to you in advance through an individual notice through our usual communication channels (e.g. by email or via our internet websites).
- Miscellaneous
This Privacy Notice (i) complements any data protection policy or a similar document introduced within Novartis before the date of this Privacy Notice and (ii) applies to any consent form signed by any data subject for Novartis on, before and after the date of this Privacy Notice