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

More

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

More

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

References

  • FDPIC – supervise and assist federal and cantonal authorities in the field of data protection
  • GDPR.EU – The complete guide to GDPR compliance

Swiss Law

FEDLEX – laws are available online under numbers

  • 235.13 DPCO
  • 235.1 FADP

FADP – see in particular articles

  • Art. 1 Aim
  • Art. 2 Scope
Abbreviations
  • CTU – Clinical Trials Unit
  • DPCO –Ordinance on Data Protection Certification
  • EU – European Union
  • FADP – Federal Act on Data Protection
  • FDPIC – Federal Data Protection and Information Commissioner
  • FEDLEX – Publication Platform for Federal Laws
  • GDPR – General Data Protection Regulation
  • PIC – Protection and Information Commissioner
Basic ↦ Ethics and Laws ↦ Swiss Law ↦ Data Protection Act
Study
Basic

Provides some background knowledge and basic definitions

Basic Protocol
Basic Statistics
Basic Monitoring
Basic Drug or Device
Basic Biobanking
Concept

Starts with a study idea

Ends after having assessed and evaluated study feasibility

Concept Protocol
Concept Statistics
Concept Drug or Device
Concept Biobanking
Development

Starts with confidence that the study is feasible

Ends after having received ethics and regulatory approval

Development Protocol
Development Statistics
Development Drug or Device
Development Biobanking
Set-Up

Starts with ethics and regulatory approval

Ends after successful study initiation

Set-Up Protocol
Set-Up Ethics and Laws
Set-Up Statistics
Set-Up Drug or Device
Set-Up Biobanking
Conduct

Starts with participant recruitment

Ends after the last participant has completed the last study visit

Conduct Protocol
Conduct Statistics
Conduct Drug or Device
Conduct Biobanking
Completion

Starts with last study visit completed

Ends after study publication and archiving

Completion Protocol
Completion Statistics
Completion Drug or Device
Completion Biobanking
Current Path (click to copy): Basic ↦ Ethics and Laws ↦ Swiss Law ↦ Data Protection Act

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