What is it? Why is it important?
The Federal Act on Data Protection (FADP) aims to protect the privacy and fundamental rights of persons from whom data is being processed.
The FADP regulates data processing:
- That entails the collection, storage, use, revision, disclosure, archiving, or destruction of data
- By private and federal persons from natural and legal persons
The Federal Council designates a Federal Protection and Information Commissioner (FDPIC). He / she:
- Is a competent authority on data processing by federal bodies, private persons including enterprises
- Advises private citizens on how to gain access to official documents
- Advises administrative authorities and federal departments on FADP implementation
FDPIC tasks also include to:
- Supervise federal bodies
- Advise and supervise private bodies
- Assist federal and cantonal authorities on data protection
- Provide opinion on draft confederation legislation
- Cooperate with data protection authorities in Switzerland and abroad
- Inform the public on findings and recommendations
- Maintain and publish the Register for Data Files
As of 08-SEPT-2020, the FDPIC stated that the US-Swiss data protection shield is not adequately robust. Data transfers from Switzerland to the US should be avoided unless covered by additional protection measures.
What do I need to do?
When handling data from study participants, you are required to know and comply with the FADP act.
Additional data protection requirements, which are auxiliary to the FADP act, are in place, such as:
- The Ordinance on Data Protection Certification (DPCO)
- Explicit cantonal data protection laws, which regulate data handling in the respective Swiss cantons
Comparable to the federal level, each canton nominates a Protection and Information Commissioner (cantonal-PIC).
The General Data Protection Regulation (GDPR) is the privacy and security law of the EU. The GDPR applies:
- To EU residents at a Swiss study site, if the study was advertised in an EU country
- At EU study sites in a multi-centre Swiss / EU study
- When study data are process in an EU country
Read the FADP law and based on your study:
- Be familiar with the organisation of the various chapters and sections
- As applicable, tag relevant articles that need to be complied with in your study
- Check your cantonal data protection act
Where can I get help?
Your local CTU↧ can support you with experienced staff regarding this topic
Basel, Clinical Trials Unit, CTU, dkf.unibas.ch
Bellinzona, Clinical Trials Unit, CTU-EOC, www.ctueoc.ch
Bern, Clinical Trials Unit, CTU, www.ctu.unibe.ch
Geneva, Clinical Research Center, CRC, crc.hug.ch
Lausanne, Clinical Research Center, CRC, www.chuv.ch
St. Gallen, Clinical Trials Unit, CTU, www.kssg.ch
Zürich, Clinical Trials Center, CTC, www.ctc.usz.ch
- FDPIC – supervise and assist federal and cantonal authorities in the field of data protection
- GDPR.EU – The complete guide to GDPR compliance
FEDLEX – laws are available online under numbers
- 235.13 DPCO
- 235.1 FADP
FADP – see in particular articles
- Art. 1 Aim
- Art. 2 Scope