--- title: "ONC HTI-1 / HTI-2, Definition | MedTech Terms" description: "ONC certification rules adding transparency and risk-management requirements to certified health IT, including AI/predictive DSI." lang: en json-ld: | { "@context": "https://schema.org", "@graph": [ { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/onc-hti#term", "name": "ONC HTI-1 / HTI-2", "description": "HTI-1 (final 2024) introduced the Decision Support Intervention criterion requiring source attributes and intervention risk management for predictive models in certified EHRs. 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This is crucial for transparency and user understanding in clinical decision-making." } }, { "@type": "Question", "name": "How does ONC HTI-1 impact AI/ML in healthcare?", "acceptedAnswer": { "@type": "Answer", "text": "ONC HTI-1 directly impacts AI/ML by requiring that predictive models used in certified EHRs provide transparent source attributes and have associated intervention risk management. This means developers must design AI with explainability and safety in mind from the outset." } }, { "@type": "Question", "name": "Are there specific requirements for risk management under ONC HTI-1?", "acceptedAnswer": { "@type": "Answer", "text": "Yes, ONC HTI-1 mandates intervention risk management for decision support interventions. This implies a structured approach to identifying, analyzing, and mitigating risks associated with the use of predictive models in clinical practice." } }, { "@type": "Question", "name": "What is the importance of 'nutrition labels' for AI in healthcare?", "acceptedAnswer": { "@type": "Answer", "text": "Similar to food nutrition labels, AI 'nutrition labels' provide essential information about an AI model's characteristics, such as its intended use, performance, limitations, and data dependencies. This helps healthcare delivery organizations (HDOs) make informed procurement decisions and assess the suitability of AI tools for their specific needs, aligning with the transparency goals of ONC HTI-1." } } ] } ] } --- [ MedTech Terms The authoritative reference ](/) Browse Learn [Latest](/latest) About 1. [Home](/) 2. / 3. [Terms](/terms) 4. / 5. [Software & AI](/terms?cat=Software%20%26%20AI) 6. / 7. ONC HTI-1 / HTI-2 [All terms](/terms) Software & AI [AI / ML in Devices](/ecosystems/ai-ml)[Software Lifecycle](/ecosystems/software-lifecycle)[Quality System](/ecosystems/quality-system) # ONC HTI-1 / HTI-2 ONC certification rules adding transparency and risk-management requirements to certified health IT, including AI/predictive DSI. Reviewed by [Christian Espinosa, Founder, Blue Goat Cyber](/authors/christian-espinosa) Last reviewed May 5, 2026 ## Definition HTI-1 (final 2024) introduced the Decision Support Intervention criterion requiring source attributes and intervention risk management for predictive models in certified EHRs. HTI-2/HTI-3 extend transparency, [interoperability](/terms/interoperability), and information-blocking requirements. What the regulation says The ONC Health IT Certification Program, specifically the HTI-1 Final Rule, mandates new requirements for certified electronic health records (EHRs) regarding decision support interventions. These regulations aim to enhance patient safety and transparency when predictive algorithms are used in clinical settings. The rule requires that certified health IT modules identify source attributes for decision support interventions and implement intervention risk management, as detailed in 45 CFR Part 170. This directly impacts how AI and machine learning models integrated into EHRs must be developed, validated, and deployed. ## What this means in practice Even non-EHR vendors are affected: model 'nutrition labels' are increasingly expected by HDOs procuring AI-enabled tools. ## Examples - A developer integrating a diagnostic AI algorithm into a certified EHR must ensure the algorithm's training data, validation metrics, and known biases are clearly documented as source attributes. - A hospital procuring an AI-powered clinical decision support system requests explicit documentation of its intervention risk management plan, demonstrating compliance with ONC HTI-1 requirements. - A health IT vendor creates a mechanism within their EHR to display the source attributes of a predictive model whenever a clinician receives a decision support alert. Common pitfalls - • Misconception: These rules only apply to EHR vendors, but any developer whose software integrates with or provides data to certified EHRs may be indirectly affected. - • A common pitfall is failing to adequately document the 'source attributes' of predictive models, which can lead to non-compliance during certification. - • Overlooking the necessity of a robust intervention risk management plan for all decision support interventions is a frequent error. - • Assuming that existing risk management processes are sufficient without specifically addressing the unique risks of AI-driven interventions can lead to gaps. - • Failure to keep up with subsequent ONC rules, such as potential HTI-2 or HTI-3 updates, could lead to outdated compliance strategies. ## Frequently asked questions What are 'source attributes' in the context of ONC HTI-1? Source attributes refer to the information that explains the basis of a decision support intervention, including the algorithms, data sources, and evidence used. This is crucial for transparency and user understanding in clinical decision-making. How does ONC HTI-1 impact AI/ML in healthcare? Are there specific requirements for risk management under ONC HTI-1? What is the importance of 'nutrition labels' for AI in healthcare? ## Related terms Grouped by theme ### Editor's picks · Hand-selected related concepts [ Software & AI Interoperability Ability of devices and systems to exchange and use information. ](/terms/interoperability)[ Software & AI Model Card Structured documentation of a machine learning model's intended use, performance, and limitations. ](/terms/model-card) ### More in Software & AI · Same category [ Software & AI AAMI TIR45(TIR45) AAMI Technical Information Report providing guidance on applying Agile software development practices within an IEC 62304-compliant medical device software lifecycle. ](/terms/aami-tir45)[ Software & AI Adversarial Robustness Resilience of an ML model to inputs deliberately crafted to cause misclassification. ](/terms/adversarial-robustness)[ 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 Algorithm Change Protocol(ACP) The detailed procedural section of a PCCP that specifies how planned modifications to an AI/ML model will be developed, validated, and implemented. ](/terms/algorithm-change-protocol) Cited by Where this term appears across MedTech Terms. Ecosystems (3) - [AI / ML in Devices](/ecosystems/ai-ml) - [Software Lifecycle](/ecosystems/software-lifecycle) - [Quality System](/ecosystems/quality-system) ## Primary references 3 sources Link health: 3 verified · last checked 2026-06-20 ONC· 1 FDA· 2 1. [1 ONC HTI-1 Verified ONC · healthit.gov ](https://www.healthit.gov/topic/laws-regulation-and-policy/health-data-technology-and-interoperability-certification-program) 2. [2 FDA - Software as a Medical Device (SaMD) Verified FDA · fda.gov ](https://www.fda.gov/medical-devices/digital-health-center-excellence/software-medical-device-samd) 3. [3 FDA - AI/ML-Enabled Medical Devices Verified FDA · fda.gov ](https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-and-machine-learning-aiml-enabled-medical-devices) 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 5/5/2026 [Compare with another term](/compare?a=onc-hti) Learn in 60 seconds Card Lesson Quiz ONC certification rules adding transparency and risk-management requirements to certified health IT, including AI/predictive DSI. - · Even non-EHR vendors are affected: model 'nutrition labels' are increasingly expected by HDOs procuring AI-enabled tools. - · HTI-2/HTI-3 extend transparency, interoperability, and information-blocking requirements. Remember this Watch out: Misconception: These rules only apply to EHR vendors, but any developer whose software integrates with or provides data to certified EHRs may be indirectly affected. Related terms - [Model Card ](/terms/model-card) - [Interoperability ](/terms/interoperability) You may also need Auto-suggested from Software & AI and shared keywords. - [Algorithm Change Protocol(ACP) ](/terms/algorithm-change-protocol) - [EU AI Act ](/terms/eu-ai-act) - [MLOps for Medical Devices(MLOps) ](/terms/mlops-medical-device) - [Clinical Decision Support(CDS) ](/terms/cds) - [Class III Device ](/terms/class-iii) - [IEC 80001-1 ](/terms/iec-80001) [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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