--- title: "Datasheets for Datasets, Definition | MedTech Terms" description: "Structured documentation describing a dataset's motivation, composition, collection process, preprocessing, uses, and maintenance, the dataset equivalent of a…" lang: en json-ld: | { "@context": "https://schema.org", "@graph": [ { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/datasheets-for-datasets#term", "name": "Datasheets for Datasets", "description": "Datasheets for Datasets is a documentation framework, introduced by Gebru et al. (2018), that prescribes a structured set of questions every dataset should answer: motivation for creation, composition (instances, labels, splits), collection process (who, how, when, consent), preprocessing/cleaning/labeling, uses (recommended, discouraged), distribution, and maintenance. 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[Home](/) 2. / 3. [Terms](/terms) 4. / 5. [Software & AI](/terms?cat=Software%20%26%20AI) 6. / 7. Datasheets for Datasets [All terms](/terms) Software & AI [AI / ML in Devices](/ecosystems/ai-ml)[Software Lifecycle](/ecosystems/software-lifecycle) # Datasheets for Datasets Structured documentation describing a dataset's motivation, composition, collection process, preprocessing, uses, and maintenance, the dataset equivalent of a model card. Reviewed by [Christian Espinosa, Founder, Blue Goat Cyber](/authors/christian-espinosa) Last reviewed June 20, 2026 ## Definition Datasheets for Datasets is a documentation framework, introduced by Gebru et al. (2018), that prescribes a structured set of questions every dataset should answer: motivation for creation, composition (instances, labels, splits), collection process (who, how, when, consent), preprocessing/cleaning/ [labeling](/terms/labeling), uses (recommended, discouraged), distribution, and maintenance. The intent is to surface biases, gaps, and limitations of a dataset before it is used to train or evaluate a model, and to make those properties auditable downstream by model consumers and regulators. What the regulation says FDA's [Good Machine Learning Practice](/terms/good-machine-learning-practice) Guiding Principles (joint with Health Canada and MHRA) call for representative data and transparency. [EU AI Act](/terms/eu-ai-act) Article 10 mandates data governance and management practices including documentation. Not yet specifically cited by name in FDA guidance, but the structure is widely used in [PCCP](/terms/ai-ml-pccp) submissions. ## What this means in practice For AI/ML medical devices, dataset documentation is rapidly becoming a regulatory expectation alongside model cards. FDA's [Good Machine Learning Practice](/terms/good-machine-learning-practice) (GMLP) principles call for transparency about the data used to train and test devices. [EU AI Act](/terms/eu-ai-act) Article 10 explicitly requires training, validation, and testing dataset documentation for high-risk AI systems, including demographic representativeness and bias analyses. Datasheets are the most widely adopted structure for meeting those requirements. Common pitfalls - • Documenting only the training set, validation and test set datasheets are equally important for evaluating generalization claims. - • Glossing over consent and source legitimacy, these are increasingly material under GDPR, HIPAA, and AI Act scrutiny. - • Treating datasheets as static, the document must be updated when datasets are augmented or relabeled. ## Related terms Grouped by theme ### Editor's picks · Hand-selected related concepts [ Software & AI AI/ML-Enabled Medical Device Medical device that uses artificial intelligence or machine learning to perform its intended use. ](/terms/ai-ml-device)[ Software & AI Algorithmic Bias and Fairness Systematic differences in model performance across demographic or clinical subgroups. ](/terms/ai-bias-fairness)[ Software & AI Data Governance (AI/ML) Policies, controls, and documentation for the data used to train, tune, and validate medical AI models. ](/terms/data-governance)[ Software & AI EU AI Act EU regulation establishing risk-based requirements for AI systems, including most medical AI. ](/terms/eu-ai-act) ### More in Software & AI · Same category [ Software & AI Good Machine Learning Practice(GMLP) Guiding principles for the development of AI/ML-enabled medical devices. ](/terms/good-machine-learning-practice)[ Software & AI Model Card Structured documentation of a machine learning model's intended use, performance, and limitations. ](/terms/model-card)[ Software & AI Predetermined Change Control Plan(PCCP) FDA mechanism to pre-authorize specific modifications to AI/ML-enabled devices. ](/terms/ai-ml-pccp)[ Software & AI Synthetic Data Artificially generated data used to augment training, validation, or stress-testing of medical AI. ](/terms/synthetic-data) Cited by Where this term appears across MedTech Terms. Ecosystems (2) - [AI / ML in Devices](/ecosystems/ai-ml) - [Software Lifecycle](/ecosystems/software-lifecycle) ## Primary references 3 sources Link health: 3 verified · last checked 2026-06-20 arXiv· 1 FDA· 1 IMDRF· 1 1. [1 Datasheets for Datasets (Gebru et al.) Verified arXiv · arxiv.org ](https://arxiv.org/abs/1803.09010) 2. [2 GMLP Guiding Principles Verified FDA · fda.gov ](https://www.fda.gov/medical-devices/software-medical-device-samd/good-machine-learning-practice-medical-device-development-guiding-principles) 3. [3 IMDRF - Software as a Medical Device Verified IMDRF · imdrf.org ](https://www.imdrf.org/working-groups/software-medical-device-samd) Inline markers like \[1\] jump to the matching reference above. Sponsor note ### Building software-as-a-medical-device? We help SaMD and AI/ML device teams meet IEC 62304 and the FDA's evolving expectations for software cybersecurity. [Book a 30-minute discovery session](https://go.bluegoatcyber.com/meetings/blue-goat-cyber/discovery-session) - No obligation - Expert-led from minute one - NDA available on request MedTech Terms is a community resource sponsored by [Blue Goat Cyber](https://bluegoatcyber.com). Definitions are independent of any vendor. On this term Category Software & AI Sources 3 Updated 6/20/2026 [Compare with another term](/compare?a=datasheets-for-datasets) Learn in 60 seconds Card Lesson Quiz Structured documentation describing a dataset's motivation, composition, collection process, preprocessing, uses, and maintenance, the dataset equivalent of a model card. - · For AI/ML medical devices, dataset documentation is rapidly becoming a regulatory expectation alongside model cards. - · FDA's Good Machine Learning Practice (GMLP) principles call for transparency about the data used to train and test devices. - · EU AI Act Article 10 explicitly requires training, validation, and testing dataset documentation for high-risk AI systems, including demographic representativeness and bias analyses. Remember this Watch out: Documenting only the training set, validation and test set datasheets are equally important for evaluating generalization claims. Related terms - [Good Machine Learning Practice(GMLP) ](/terms/good-machine-learning-practice) - [AI/ML-Enabled Medical Device ](/terms/ai-ml-device) - [Algorithmic Bias and Fairness ](/terms/ai-bias-fairness) - [Model Card ](/terms/model-card) - [EU AI Act ](/terms/eu-ai-act) - [Data Governance (AI/ML) ](/terms/data-governance) - [Synthetic Data ](/terms/synthetic-data) - [Predetermined Change Control Plan(PCCP) ](/terms/ai-ml-pccp) You may also need Auto-suggested from Software & AI and shared keywords. - [AAMI TIR45(TIR45) ](/terms/aami-tir45) - [Foundation Model (Healthcare) ](/terms/foundation-model-health) - [Premarket Cybersecurity Submission ](/terms/premarket-cybersecurity) - [STRIDE Threat Model(STRIDE) ](/terms/stride) - [Trial Master File(TMF) ](/terms/trial-master-file) - [Locked vs. Adaptive Algorithm ](/terms/locked-vs-adaptive) [All Software & AI terms](/terms?cat=Software%20%26%20AI) From the Blue Goat network Related resources and services on this topic. - [ AI SaMD Insights How AI is changing SaMD - risk, regulation, and good machine-learning practice. ](https://ai-samd.com) - [ Med Device Cyber Podcast Conversations with medical device cybersecurity practitioners. ](https://mdcpodcast.com) MedTech Terms An authoritative, plain-language reference for the regulatory, quality, cybersecurity, and software terms that shape modern medical devices. 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