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Inspection
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Investigator's brochure (IB)
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ISO/IEC 27001 (information security management)
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ISO/IEC 42001 (AI management system)
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Joint controllers
K
k-anonymity
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Key-coded data (coded data)
K
Key (cryptographic key and pseudonymisation key)
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Kinetics (pharmacokinetics and pharmacodynamics)
L
Large language model (LLM)
L
Lawfulness
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Legal basis for processing
L
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L
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Legitimate interest assessment (LIA)
L
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M
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M
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N
Natural history study
N
NIS2 Directive
O
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O
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O
One-stop-shop mechanism and lead supervisory authority
O
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P
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Purpose limitation
Q
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Q
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Q
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R
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R
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R
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R
Restriction of processing
R
Right not to be subject to solely automated decision-making
R
Right of access
R
Right of information
R
Right of rectification
R
Rights of the data subject
R
Right to data portability
R
Right to erasure ("right to be forgotten")
R
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R
Right to restriction of processing
S
Scientific research purposes (Art. 89 GDPR)
S
Secondary use of health data
S
Security breach (security incident)
S
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Serious adverse event (SAE)
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Software as a Medical Device (SaMD)
S
Source data verification (SDV) and source documents
S
Special categories of personal data
S
Sponsor
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Standard contractual clauses (SCC)
S
Start of a clinical trial
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Storage limitation (limited storage periods)
S
Study Data Tabulation Model (SDTM)
S
Subject (clinical trial participant)
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Sub-processor
S
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S
Supplementary measures
S
Swiss Federal Act on Data Protection (FADP / revFADP)
S
Synthetic data
T
Technical and organisational measures (TOMs)
T
Temporary halt of a clinical trial
T
Third country
T
Third party
T
Transfer impact assessment (TIA)
T
Trial master file (TMF)
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Term of the Day

Natural history study

A natural history study is a preplanned observational study intended to track the course of a disease over time, identifying demographic, genetic, environmental and other variables that correlate with its development and outcomes in the absence of intervention, or under standard of care. Designs may be retrospective (chart review of existing records) or prospective (longitudinal follow-up of a cohort or registry).

Natural history data is particularly important in rare and paediatric diseases, where randomised placebo-controlled trials may be infeasible or unethical. The FDA (guidance on rare disease natural history studies, 2019) and the EMA accept well-designed natural history studies to define endpoints and biomarkers, identify patient subgroups, estimate sample sizes and, in some cases, serve as external or historical control arms for single-arm trials supporting orphan products.

Because they are non-interventional, natural history studies fall outside the CTR and are governed by national law (for example France's MR-003 or MR-004 reference methodologies) and by the GDPR. They typically involve secondary use of medical records, long-term follow-up, genetic data and small populations in which anonymisation is rarely achievable, so pseudonymisation, a DPIA and a robust research legal basis under Art. 9(2)(j) are essential. Registries maintained by patient organisations or academic consortia raise additional questions of joint controllership and data access governance.

S

Supervisory authority

A supervisory authority is an independent public authority established by a Member State pursuant to Art. 51 GDPR to monitor the application of the Regulation in order to protect the fundamental rights and freedoms of natural persons in relation to processing and to facilitate the free flow of personal data within the Union. It is the formal term for what is commonly called a data protection authority; each Member State has at least one (Germany has one federal and sixteen Länder authorities), and the EDPS fulfils the role for EU institutions.

Tasks under Art. 57 include monitoring and enforcing the GDPR, promoting awareness, advising national institutions, handling complaints, conducting investigations, approving codes of conduct, certification criteria, BCRs and standard clauses, drawing up DPIA lists, and contributing to the EDPB. Powers under Art. 58 are investigative (audits, access to premises), corrective (warnings, orders, bans, suspension of transfers, fines under Art. 83) and authorisation-related (prior consultation under Art. 36, approval of contractual clauses). Decisions can be appealed before national courts.

For organisations engaged in cross-border processing, the authority of the main establishment acts as lead supervisory authority under the one-stop-shop mechanism (Art. 56), cooperating with concerned authorities under Art. 60 and, in case of disagreement, through the EDPB's binding decision. Organisations without an EU establishment do not benefit from this and may face every concerned authority, acting through their Art. 27 representative. Life sciences companies deal with supervisory authorities when notifying breaches, when authorisation is required for health research under national law (CNIL, Garante), during inspections and when responding to complaints from participants or employees.