Industry

Healthcare

Healthcare data carries the highest regulatory risk under GDPR. Article 9 special category data, clinical trial obligations, and increasingly complex multi-controller data environments require a level of compliance rigour that generic advisory firms rarely provide.

Art. 9 GDPR — health data is special category, requiring explicit consent or specific legal basis exceptions
Art. 35 DPIA mandatory for large-scale processing of special category data — including clinical trial systems
HDS French health data hosting requirements — relevant for operators serving French healthcare organisations

Health Data Carries Elevated Regulatory Risk

Article 9 GDPR defines health data as a special category — meaning the standard lawful basis provisions under Art. 6 are insufficient. You need either explicit consent from the data subject, or one of the specific exception bases in Art. 9(2): healthcare provision, public health, scientific research. Getting this wrong is not a minor procedural issue; it is a fundamental lawful basis failure that supervisory authorities treat seriously.

For healthcare SaaS platforms and health data processors, the complexity multiplies. You are typically processing special category data on behalf of multiple controllers — each with their own data subject relationships and lawful bases. Your sub-processor chain needs documentation; your DPAs need to reflect the actual data flows. Qala maps this complexity to a defensible documented structure.

Core areas we address

  • Art. 9 lawful basis analysis — which exception applies to each processing activity, documented per data category and purpose
  • Explicit consent architecture — when consent is the basis, it must meet Art. 7 standards: freely given, specific, informed, unambiguous, withdrawable
  • Clinical trial data management — GDPR Art. 89 research derogations, data subject rights limitations, retention under scientific necessity
  • Healthcare processor chain documentation — ROPA covering multiple controller relationships, sub-processor registration, DPA templates
  • Hospital data pipeline observability — pipeline monitoring for systems processing patient data, schema drift alerting for fields that capture health indicators
  • DPIA for large-scale health data processing — mandatory Art. 35 assessments with prior consultation framework where required
  • HDS certification awareness — for operators serving French market healthcare organisations, understanding hébergeur de données de santé requirements

Art. 9 Processing Basis Decision Tree

Identify: is this health data?

Art. 4(15): data related to physical or mental health, revealing health status

Select lawful basis under Art. 9(2)

Explicit consent / healthcare provision / public health / research with safeguards

Document in ROPA + DPIA

Art. 30 ROPA entry + mandatory Art. 35 DPIA for large-scale processing

Monitor for schema drift

New fields capturing health indicators trigger review workflow

Healthcare compliance built for the actual risk level

Art. 9 processing is not a standard compliance checkbox. We build documentation and processes that reflect the elevated obligations — and that hold up when a supervisory authority asks to see your DPIA.

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