SSDataProtection object

Notification to DP Authority/ Ombudsmann is mandatory

Yes

Specific notification timelines before operations start

Latest 30 days before collecting and saving the data at issue

Notification fee required

No

Guidance on notification requirements

The ‘Notification to the Data Protection Ombudsman (letter)’ and the ‘Notification of Transfer of Personnel Data outside the EU or EEA form’ must be completed and submitted to the Data Protection Ombudsman ahead of time.

Further information and notification forms and letters are provided on the Data Protection Ombudsman website > Publications.

Data Protection Authority/ Agency - Contact Details

Office of the Data Protection Ombudsman

Phone

+358 29 56 66700 (exchange)

E-Mail

tietosuoja@om.fi

Web address

http://www.tietosuoja.fi/en/

Address

P.O. Box 800 (Visiting adress: Ratapihantie 9, 6rd floor- 00520 HELSINKI)

ZIP/City

00521 HELSINKI

Country

Finland (FI)

Additional Information

The collection and keeping of patient files in clinical trials are governed by the Personal Data Act No. 523/1999 (unofficial English translation).

Legal framework (on safeguarding the collection, handling, recording, keeping and/or processing of any clinical trial related data and patient files)

National Data Protection Act

National DP act

The collection and keeping of patient files in clinical trials are governed by the Personal Data Act No. 523/1999 (unofficial English translation).

This project (ECRIN Integrating Activity/ECRIN-IA) has received funding from the European Union’s Seventh Framework Programme for research, technological development and demonstration under grant agreement no 284395
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