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E
Explicit consent
F
Fairness and transparency
F
FDPIC (Swiss Federal Data Protection and Information Commissioner)
F
Federated learning
F
Filing system
F
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F
First-in-human (FIH) trial
F
Food and Drug Administration (FDA)
F
Fundamental rights impact assessment (FRIA)
G
General Data Protection Regulation (GDPR)
G
General-purpose AI model (GPAI)
G
Genetically modified organism (GMO)
G
Genetic data
G
Global public health security
G
Good clinical practice (GCP)
H
HDS certification (Hébergeur de Données de Santé)
H
Health data access body (HDAB)
H
Health data warehouse (HDW)
H
HHS Office for Civil Rights (OCR)
H
High-risk AI system
H
HIPAA (Health Insurance Portability and Accountability Act)
H
Homomorphic encryption
H
Human oversight (AI Act)
H
Human subjects protection review board
I
ICH E6(R3)
I
Incapacitated subject
I
Information Commissioner's Office (ICO)
I
Informed consent
I
Inspection
I
Institutional Review Board (IRB)
I
Interactive response technology (IRT)
I
Interactive voice response system (IVRS / IxRS)
I
Interactive web response system (IWRS)
I
International data transfer
I
Investigational Medicinal Product Dossier (IMPD)
I
Investigational medicinal product (IMP)
I
Investigational New Drug (IND) application
I
Investigator
I
Investigator's brochure (IB)
I
Investigator site file (ISF)
I
In Vitro Diagnostic Regulation (IVDR)
I
ISO/IEC 27001 (information security management)
I
ISO/IEC 42001 (AI management system)
J
Joint controllers
K
k-anonymity
K
Key-coded data (coded data)
K
Key (cryptographic key and pseudonymisation key)
K
Kinetics (pharmacokinetics and pharmacodynamics)
L
Large language model (LLM)
L
Lawfulness
L
Lay summary
L
Legal basis for processing
L
Legally designated representative
L
Legitimate interest
L
Legitimate interest assessment (LIA)
L
LGPD (Brazil's General Data Protection Law)
L
Limited data set (HIPAA)
L
Local site investigator
M
Main establishment
M
MedDRA
M
Medical Device Regulation (MDR)
M
Membership inference attack
M
Me-too drug
M
MHRA (Medicines and Healthcare products Regulatory Agency)
N
Natural history study
N
New drug application (NDA)
N
NIS2 Directive
N
Notified body
O
Observational study
O
Observer-reported outcome (ObsRO)
O
One-stop-shop mechanism and lead supervisory authority
O
Orphan drug designation (ODD)
P
Patient-reported outcome (PRO)
P
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P
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P
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P
Pharmacokinetics (PK)
P
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P
Population pharmacokinetics (pop PK)
P
Post-market surveillance (PMS)
P
Predetermined change control plan (PCCP)
P
Principal investigator (PI)
P
Principles of data protection
P
Privacy
P
Privacy by design
P
Privacy-enhancing technologies (PETs)
P
Privacy notice (information notice)
P
Processing
P
Processor
P
Profiling
P
Protected health information (PHI)
P
Protocol
P
Provider and deployer (AI Act roles)
P
Pseudonymisation
P
Purpose limitation
Q
Qualified Person for Pharmacovigilance (QPPV)
Q
Quality management system (QMS)
Q
Quasi-identifier
Q
Query (clinical data query)
R
Randomisation and trial supply management (RTSM)
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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