Data Protection Statement for Vigilance

Data Protection Statement for Vigilance

Data protection information on processing personal data related to adverse reactions or events associated with the use of medicinal products and safety of medical devices (vigilance)

Last updated November 2020.

In our capacity as a manufacturer of pharmaceuticals and medical devices, Fresenius Kabi Deutschland GmbH (“we”) will collect, use and report personal data of patient using our products and reporters of adverse reactions or events.

This data protection statement informs you about the processing of personal data when making an adverse event report.

Please be aware that we also may process your personal data in other contexts, e.g. when you visit our website, when you are a business contact for products or services or when you interact with us in your capacity as a healthcare professional. Please see the specific information on the processing of your personal data in such situations.

Why We Collect and Use Your Data

What Data We Collect and How We Do That

We may collect and use your personal data in the following situation:

Information you provide to us

We collect and use the data you provide directly to us (e.g. via phone, letter or webform), as patient using our products or as reporter of adverse reactions or events.

The exact amount and kind of data depends on the information submitted to us or the information that is published, posted or shared. Such data includes:

Information identifying the patient (potentially including first and last name, date of birth, gender)
- Medical history and other characteristics including laboratory data, pregnancy, weight and height, age,
- Measures and treatment of adverse reaction(s)
Information identifying the reporter
- First and last name
- Contact and address information (including address, e-mail address, social media account name, phone number)
Information on the adverse event or other information on the safety of our products
- Description of the adverse reactions related data including start, stop, duration
- Drug/active substance related data including dosage, application, suspected causality indication and duration of treatment
- Medical device related data including application, and malfunctioning
- Seriousness criteria of reaction such as death, life threatening, hospitalization or prolonged hospitalization, permanent injury or disability, important medical event
- Outcome of reaction(s)

Information we collect from publicly available sources

We collect and use the data as reported and published on publicly available sources such as social media and internet forums, literature or other reports we became aware of.

The exact amount and kind of data depends on the information submitted to us or the information that is published, posted or shared. Such data includes:

Information identifying the patient (potentially including first and last name, date of birth, gender)
- Medical history and other characteristics
- Measures and treatment of adverse reaction(s)
Information on the primary source of the data for potential follow-up requests
- First and last name
- Contact and address information (including address, e-mail address, social media account name, phone number)
Information on the adverse event or other information on the safety of our products
- Description of the adverse reactions related data including start, stop, duration
- Drug/active substance related data including dosage, application, suspected causality indication and duration of treatment
- Medical device related data including application, and malfunctioning
- Seriousness criteria of reaction such as death, life threatening, hospitalization or prolonged hospitalization, permanent injury or disability, important medical event
- Outcome of reaction(s)

Information we collect from other organizations

We collect and use the data as provided to us by healthcare organizations or organizations otherwise involved in the provision of care such as hospitals, our distributors and resellers or universities.

The exact amount and kind of data depends on the information submitted to us such data includes:

Information identifying the patient (including Initials, date of birth, gender)
- Medical history and other characteristics including laboratory data, pregnancy, weight and height, age,
- Measures and treatment of adverse reaction(s)
Information identifying the reporter
- First and last name
- Contact and address information (including address, e-mail address, social media account name, phone number)
- Signature
Information on the adverse event or other information on the safety of our products
- Description of the adverse reactions related data including start, stop, duration
- Drug/active substance related data including dosage, application, suspected causality indication and duration of treatment
- Medical device related data including application, and malfunctioning
- Seriousness criteria of reaction such as death, life threatening, hospitalization or prolonged hospitalization, permanent injury or disability, important medical event
- Outcome of reaction(s)

Legal Basis for Processing Your Data

We Share Your Data

We collaborate with other organizations to fulfill or legal obligations. Therefore, we may send your personal data in parts or as a whole to other organizations. Such recipients are:

Other Fresenius Group companies if such a transfer of personal data is required for the specific purpose (Please refer to the overview of the locations in which Fresenius Kabi Group companies are active)
Service providers who process personal data on our behalf (e.g. for hosting or maintenance services) that have to follow our instructions on such processing; these service providers will not be allowed to use your personal data for other than our purposes
Health authorities, other pharmaceutical companies, other courts, parties in a litigation in case we are required to do so to meet any applicable laws, regulations, legal processes or enforceable governmental requests
Professional advisors or auditors, such as tax advisors, financial auditors, lawyers, insurers, banks and other external professional advisors in the countries in which we operate

International Data Transfers

We may send your personal data in parts or as a whole to Fresenius Group recipients in countries, which are not member states of the European Union or international organizations, for the purposes listed above. Please refer to the overview of the locations in which Fresenius Kabi is active.

We may send data to the following countries for which the European Commission has determined an adequate level of data protection to be in place that matches the level of data protection within the European Union in which Fresenius entities have been established: Argentina, Canada, Japan, New Zealand, Switzerland or Uruguay.

With regards to such international data transfers to third countries, for which the European Commission has not decided that an adequate level of data protection exists, we have provided appropriate safeguards in order to secure your personal data to a degree that equals the level of data protection in the European Union.

Safeguards used are:

Standard Contractual Clauses that have been issued by the European Commission
Participation in the EU-US-Privacy Shield

You can obtain a copy of these standard contractual clauses online, or upon request.