Legal Aspects in Life Sciences 3

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

Unberechtigte Zugriffe auf Patientendaten -  Datenschutzcompliance im Spital (Deutsch)
Corinne Berger
  • Verletzung des Patientengeheimnisses – Beispiele aus der Praxis
  • Datenschutzcompliance im Spital (oder Umgang mit unberechtigten Zugriffen auf Patientendaten) 
  • Herausforderungen bei der Umsetzung datenschutzrechtlicher Vorgaben
Wie setzt ein öffentliches Spital datenschutzrechtliche Vorgaben um und welche Herausforderungen stellen sich dabei? Wo beginnt die Verletzung des Patientengeheimnisses und mit welchen Konsequenzen ist zu rechnen?
 

Real World Data – lawful use, access and sharing of personal data (English)
Florian Zabel
  • 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
Novartis International

Maria Chiara Atzori joined Novartis in 2009. She is currently Head Group Data Privacy Policies and member of the Data Privacy Leadership Team at Novartis. In her current position Maria Chiara leads the team of senior privacy professionals that defines group wide data privacy standards for the responsible use of data and provide guidance across all business functions on the interpretation and implementation of privacy provisions. Maria Chiara is qualified Italian attorney, holds an MBA from the Edinburgh Business School and is certified member of the IAPP.

 

Corinne Berger
lic. iur., Compliance Beauftragte
Universitätsspital Basel

Corinne Berger ist eine ausgewiesene Compliance Expertin mit über 20 Jahren Erfahrung in verschiedenen Branchen. Die Juristin mit Fokus war sowohl in der Privatwirtschaft als auch in der Bundesverwaltung tätig. Sie hält regelmässig Vorträge und Fortbildungen, u.a. im Bereich der Wirtschaftskriminalität. 
Im Oktober 2020 wechselte sie vom Beratungsunternehmen PricewaterhouseCoopers AG ans Universitätsspital Basel. 

 

Florian Zabel
Attorney at Law, Chief Privacy Officer
F. Hoffmann-La Roche Ltd

After studied laws in Germany and passing the bar exam in Frankfurt/Main, Florian Zabel worked for three years in the Legal Department of a multinational pharmaceutical company in Frankfurt/Main before joining Roche in Mannheim/Germany in 2002. Following that, he worked in several legal functions in Basel and Singapore before returning to Basel in 2011. Currently, Florian Zabel is Chief Privacy Officer of the Roche Group heading Roche's Global Privacy Office.

 

Claudia Seitz
Prof. Dr. iur., M.A. (King´s College London), Attorney-at-Law
University of Ghent
Chair

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  Introduction: Legal Issues of Data Protection in an Innovative Environment and Legal Challenges of AI and Big Data, Claudia Seitz (English)
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

Anmeldung für den 17. November 2021

 

Legal Aspects in Life Sciences 2
Integrität und Transparenz im Pharmabereich (Deutsch)
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Legal Aspects in Life Sciences 4
Data Protection in International Research Cooperations (Englisch)
01.12.2021

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