European Local Regulations
In the EU the number of applicable laws and privacy frameworks can multiply, depending in which country the data processing is taking place. If you are considering conducting studies in the EU, the regional framework should be analyzed in coordination with local prerequisites.
iliomad Health Data has developed extensive expertise of the local prerequisites for companies conducting clinical studies.
Why do you need to be compliant ?
The variations in how the GDPR is applied require companies to exercise caution when initiating any data processing activities. Several considerations must be addressed to ensure that operations align with the region-specific nuances of the regulation.
The criteria for appointing a Data Protection Officer may vary among member states, which could affect life sciences companies' internal data governance structures.
DPIAs are crucial for life sciences companies, especially when processing might result in a high risk to data subjects' rights and freedoms. The criteria for when a DPIA is mandatory can differ between countries.
The GDPR permits the processing of health data under specific conditions, such as for reasons of public interest in the public health sector or ensuring high standards of healthcare and medicine. Individual member states may introduce more specific provisions.
Life sciences companies often handle special categories of personal data. Some member states may introduce further conditions, including limitations, concerning the processing of genetic, biometric, or health data.
While the GDPR states that personal data shouldn't be kept longer than necessary, some countries might have specific retention periods for medical data or clinical trial data.
Consent is a fundamental aspect of both clinical trials and GDPR. How consent for data processing under GDPR intersects with informed consent for trial participation can be approached differently in various countries.
How can iliomad Health Data help you ?
Iliomad Health Data has assisted its clients in managing clinical operations across the 27 European Union countries. With a profound understanding of local prerequisites and strong ties with local authorities, Iliomad stands out as the go-to partner for health data processing within this region.
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