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.
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.
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.
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)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
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