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R
Randomised clinical trial (RCT)
R
Real-world data (RWD)
R
Real-world evidence (RWE)
R
Recipient
R
Record of processing activities (RoPA)
R
Regulatory intelligence
R
Re-identification risk (motivated intruder test)
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
Right to object
R
Right to restriction of processing
S
Schrems II
S
Scientific research purposes (Art. 89 GDPR)
S
Secondary use of health data
S
Security breach (security incident)
S
Security of processing
S
Sensitive data
S
Serious adverse event (SAE)
S
Shadow AI
S
Site management organisation (SMO)
S
SNDS (Système National des Données de Santé)
S
Software as a Medical Device (SaMD)
S
Source data verification (SDV) and source documents
S
Special categories of personal data
S
Sponsor
S
Standard contractual clauses (SCC)
S
Start of a clinical trial
S
Storage limitation (limited storage periods)
S
Study Data Tabulation Model (SDTM)
S
Subject (clinical trial participant)
S
Sub-processor
S
Supervisory authority
S
Supplementary measures
S
Swiss Federal Act on Data Protection (FADP / revFADP)
S
Swissmedic
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)
T
Trusted research environment (TRE)
U
UK GDPR
U
Unexpected serious adverse reaction (SUSAR)
U
US CLOUD Act
V
Validation (computerised system validation, CSV)
V
Vendor assessment (third-party risk management)
V
Vital interests (Art. 6(1)(d) GDPR)
V
Vulnerable participants (vulnerable subjects)
W
Wearables and digital health technologies (DHT)
W
Withdrawal (of consent and from a clinical trial)
W
World Health Organization (WHO)
X
XAI (explainable artificial intelligence)
Y
Yellow Card scheme (UK)
Z
Zero-knowledge proof
Z
Zero trust architecture
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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.

N

Notified body

A notified body is an organisation designated by an EU country to perform specified conformity-assessment tasks under relevant EU legislation. In medical devices and certain AI assessment routes, it provides independent assessment within its authorised scope. It is not the manufacturer, and its designation does not automatically cover every product type or regulatory framework.

Key takeaways

  • Check designation and scope, not just the name.
  • Notified-body involvement depends on the applicable route.
  • The manufacturer retains its own responsibilities.

Role and Scope of Assessment

The EU conformity-assessment guidance distinguishes self-assessment from routes involving a notified body. The EMA device overview describes the role of designated bodies in assessing devices before CE marking.

FrameworkQuestion to check
MDR or IVDRIs the body designated for the relevant device scope?
AI ActDoes the applicable assessment route require its involvement?
Combined productDoes its competence cover the necessary assessment tasks?

Why It Matters for Data Protection

For life sciences procurement, we recommend checking the official designation record and the proposed assessment scope before contracting. Clarify what evidence the body needs and how confidential information will be shared. A request for technical documentation should prompt a review of whether identifiable patient material is necessary, who may access it and how the exchange will be controlled.

Hypothetical example: A manufacturer preparing an AI-enabled device selects potential assessment partners. It compares their designated scope against the product and proposed route, then confirms responsibilities for the AI-related evidence. The project plan records unresolved scope questions rather than assuming a familiar certification provider can assess every component.

Frequently Asked Questions

Is a notified body the same as a regulator?

No. It performs designated conformity-assessment tasks; designation and regulatory oversight are separate functions.

Does every product require a notified body?

No. Requirements depend on the legislation, classification and assessment route.

Can a device notified body assess the AI component?

For relevant product-related AI, AI Act Article 43 links this to the sectoral procedure and verification of the body’s necessary competence.

Related reading: Medical Device Regulation, high-risk AI systems. For practical support, see medical-device data protection support.

Updated: 27 October 2026