Data Protection Compliance in the Health and Pharmaceutical Sector
Der Schutz von Patienten- und Forschungsdaten unterliegt nicht zuletzt auf Grund der rasanten Entwicklung in der medizinischen und biotechnologischen Forschung zunehmenden Herausforderungen. Die Erhebung, Bearbeitung und Weitergabe von Personendaten, Gesundheitsdaten und genetische Daten sind Bestandteil der medizinischen Behandlung und Forschung unterliegen diversen datenschutzrechtlichen Vorgaben.
The protection of patient and research data is subject to increasing challenges, not least due to the rapid developments in medical and biotechnological research. The compilation, processing and transfer of personal data, health data and genetic data are an inherent part of medical treatment and research and are subject to various data protection regulations.
Schwerpunkte / Focus
- Verletzung des Patientengeheimnisses – Beispiele aus der Praxis
- Datenschutzcompliance im Spital (oder Umgang mit unberechtigten Zugriffen auf Patientendaten)
- Herausforderungen bei der Umsetzung datenschutzrechtlicher Vorgaben
Real World Data – lawful use, access and sharing of personal data (English)
- RWD is a valuable source that allows insights to advance scientific research and develop new medical diagnosis and treatments
- Processed with appropriate technical and organizational data protection measures, the use of RWD does not interfere with the personal rights and freedoms of patients
- Prerequisite for the use of RWD is the respect of highest ethical standards under which data is obtained
Clinical trials – lawful use, access and sharing of personal data (English)
Maria Chiara Atzori
- Internationally well-established ethical standards have been developed and applied over the last decades to ensure the protection of patients as trial participants.
- In combination with data protection laws and provisions, this framework still works well even considering the latest technological developments and the new capabilities with respect to data processing and analytics
- Challenges exist due to lack of harmonization of data protection laws and their implementation, and the interplay of sector specific legislation in particular regarding the question to what extent and which purposes data can be used and shared
Referierende / Speakers
Maria Chiara Atzori
LLM, Advocat, MBA, CIPP/E, Head Data Privacy CH
lic. iur., Compliance Beauftragte
Attorney at Law, Chief Privacy Officer
F. Hoffmann-La Roche Ltd
Prof. Dr. iur., M.A. (King´s College London), Attorney-at-Law
University of Ghent
Claudia Seitz is visiting professor at the University of Ghent, Faculty of Law and Criminology. Additionally, she is lecturer at the Faculties of Law of the Universities of Basel and Bonn, as well as director of the »CAS Medical Law: Law of Human Research, Pharmaceuticals and Genomics« at the Faculty of Law of the Private University in the Principality of Liechtenstein (UFL). She is also partner at the law firm Seitz & Riemer, founded in 1999, specialized in life sciences law, and has extensive scientific and practical experience in the life sciences sector. Previously, she was i.a. the Max Geldner assistant professor at the Faculty of Law of the University of Basel and in-house legal counsel at an international life sciences company in Basel. Claudia Seitz does advisory work as legal expert and is lecturer for international organisations and the European Commission as well as other institutions such as the Leibnitz Institute. She is a member of several advisory boards, such as the European Association for Health Law (EAHL) and the German Association for Synthetic Biology (GASB). She is also a board member of Ethics and Compliance Switzerland (ECS) as well as a member the editorial board of the European Pharmaceutical Law Review (EPLR) and the editorial advisory board of the Europäische Zeitschrift für Wirtschaftsrecht (EuZW). Her teaching, research and legal advisory activities focuses on life sciences, health, biotechnology, pharmaceutical, medical devices, data protection, IP and competition law as well as the regulation of new technologies.
Ablauf / Time Table
15:30 Einführung: Rechtsrahmen und offene Rechtsfragen zur Integrität und Transparenz, Claudia Seitz (Deutsch)
15:40 Unberechtigter Zugriff auf Patientendaten, Corinne Berger (Deutsch)
16:10 Real World Data – lawful use, access and sharing of personal data, Florian Zabel (English)
16:40 Clinical trials – lawful use, access and sharing of personal data, Maria Chiara Atzori (English)
17:10 Fragen und Austausch / Q&A
17:30 Fazit und Ende / Conclusion