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The Effect of GDPR on Health Research

by Robert Bergen MD in Blog 2019-09-11

Personal data is crucial to help ensure there is high-quality and reliable scientific research. The impact of GDPR on health research has been greatly felt. The new EU General Data Protection Regulation (GDPR) that repeals Directive 95/46/EC helps to strengthen and harmonize the rules that indicate people’s rights privacies are well protected and freedom with and under various conditions outside of the territory of EU.

The GDPR helps to fix both general rules that apply to any form of personal data processing and various regulations that apply to the processing of personal data’s special categories like health data that takes place in the form of scientific research in areas like translational and clinical fields.

The EU decided to adopt a new regulation to protect natural persons concerning personal data processing after a very long and intense reform. The GDPR applies to this protection since it aims to protect the freedoms and fundamental rights of individuals. It also aims to accelerate internal market achievement where the flow of personal data is vital for both non-commercial and commercial relationships.

The General Data Protection Regulation (GDPR) also aims to harmonize the Member States’ rules to help in the reduction of legal fragmentation, uncertainties, and complexities that exist between them under the directive of data protection, as well as the reinforcement of the rights of subjects in an evolutive environment that is well digitalized, to enable them to regain control of their data.

What the GDPR really aims to achieve is the creation of legal substantiality and certainty of the measures of data protection in a neutral and technological approach. However, the GDPR doesn’t want to change the field’s approach to what existed in the previous Directive of 1995 but strives to perform several updates and introduce new individual rights and important procedures that affect scientific research activities. The GDPR only aims to fix general principles that need to be observed in any personal data processing context.

It is essential to understand the definitions highlighted below.
•    Data that concern health means explicitly personal information related to both the mental and physical health of a person.
•    Genetic data –This means information related to acquired or inherited genetic characteristics of a person, and it also provides unique data about the health or physiology of a person.
•    Biometric data – Biometric data is information resulting from various technical processing related to the behavioral or physiological aspects of a person.
•    Pseudonymization – This is the processing of data so that personal information cannot be attributed to a specific person.
•    Anonymous data – It is data that doesn’t relate to an identified person.
•    Consent – It is data that is freely given by a person who grants permission, affirms, and signifies the action.

Conclusion
The impact of GDPR on health research has dramatically changed and impacted the scientific research, which people are yet to adapt to and navigate all the rules that have been put in place. Therefore, having this knowledge is essential and significantly benefit you in a major way.

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