Glossary

How does GDPR apply to health data?

Under the GDPR, health data is a special category of personal data subject to stricter conditions for lawful processing.

The General Data Protection Regulation, Regulation (EU) 2016/679, is the EU's core data protection law. It treats data concerning health as a special category of personal data, which is prohibited from processing unless a specific condition applies, such as explicit consent, the provision of health or social care, or reasons of substantial public interest set out in EU or national law. Organisations processing health data must identify a lawful basis and a special category condition, apply data minimisation and security safeguards, and often carry out a data protection impact assessment. National laws add further conditions for health and research data, so requirements vary across member states. The GDPR underpins other health data initiatives, including the European Health Data Space, which builds sector-specific rules on top of it rather than replacing it.

Frequently asked

Is health data special category data under GDPR?

Yes. Data concerning health is a special category under Article 9 of the GDPR, and processing it requires both a lawful basis and a specific special category condition.

Latest Health Data & Privacy updates
Regulation Category Impact Date

AMENDMENTS 2802 - 2985 - Draft report Establishing a framework of measures for strengthening Union’s biotechnology and biomanufacturing sectors particularly in the area of health and amending Regulations (EC) No 178/2002, (EC) No 1394/2007, (EU) No 536/2014, (EU) 2019/6, (EU) 2024/795 and (EU) 2024/1938 (European Biotech Act) - PE790.953v01-00

AMENDMENTS 2802 - 2985 - Draft report Establishing a framework of measures for strengthening Union’s biotechnology and biomanufacturing sectors particularly in the area of health and amending Regulations (EC) No 178/2...

European Parliament - SANT Subcommittee (Public Health)
Digital Health & AIClinical Trials
Medium

AMENDMENTS 2522 - 2801 - Draft report Establishing a framework of measures for strengthening Union’s biotechnology and biomanufacturing sectors particularly in the area of health and amending Regulations (EC) No 178/2002, (EC) No 1394/2007, (EU) No 536/2014, (EU) 2019/6, (EU) 2024/795 and (EU) 2024/1938 (European Biotech Act) - PE790.939v01-00

AMENDMENTS 2522 - 2801 - Draft report Establishing a framework of measures for strengthening Union’s biotechnology and biomanufacturing sectors particularly in the area of health and amending Regulations (EC) No 178/2...

European Parliament - SANT Subcommittee (Public Health)
Digital Health & AIClinical Trials
Medium

DRAFT REPORT on the proposal for a Directive of the European Parliament and of the Council amending Directives 2001/18/EC and 2010/53/EU as regards the placing on the market of genetically modified micro-organisms and the processing of organs - PE789.094v01-00

DRAFT REPORT on the proposal for a Directive of the European Parliament and of the Council amending Directives 2001/18/EC and 2010/53/EU as regards the placing on the market of genetically modified micro-organisms and...

European Parliament - SANT Subcommittee (Public Health)
General RegulatoryHealth Data & Privacy
Low