Includes 5 documents
Healthcare Kit
Technical and clinical validation, DPIA for health data, clinician oversight, in-use monitoring and a model card for clinical AI tools.
USD 139USD 215
Complete kit · available to buyDiagnosis, triage or clinical support
AI that helps diagnose, prioritize patients, recommend treatments, read medical images or draft clinical notes. Errors affect health, so clinical validation, medical oversight, patient transparency and, if it is a medical device, sanitary registration are required.
Examples
- AI-assisted X-ray reading
- Algorithmic emergency triage
- Generative AI clinical note summaries
- Telehealth with an AI assistant
By country
We only list countries where an obligation in force or adopted mentions this use case.
How rules treat it, by jurisdiction
| Jurisdiction | Level | Date | Note |
|---|---|---|---|
| European Union | High risk | August 2, 2028 | AI medical devices: Annex I, integrated into the MDR/IVDR technical file (MDCG 2025-6 guidance). |
| European Union | High risk | December 2, 2027 | Annex III(5): emergency triage and eligibility for healthcare benefits. |
| Spain | Sector rules | — | Medical device regulation (AEMPS) and GDPR for health data. |
| Peru | High risk | September 10, 2026 | Access to health is high-risk and the health-sector deadline has passed: records, human oversight, transparency and training. |
| Colombia | Sector rules | September 7, 2026 | Ministry of Health Resolution 1644/2026 (telemedicine, Art. 23): prior patient notice, technical and clinical validation, traceability and INVIMA registration if it is a device. |
| Brazil | Sector rules | August 26, 2026 | CFM Resolution 2,454/2026: risk classification, continuous auditing, medical oversight committee and ban on delegating diagnosis communication to AI; ANVISA RDC 657/2022 for medical software. |
| Ecuador | Data protection | — | Sensitive health data: impact assessment required at scale; ARCSA registration if it is a device. |
| Mexico | Sector rules | — | Software that qualifies as a medical device requires COFEPRIS sanitary registration. |
| United States (federal) | Sector rules | — | FDA for AI-enabled device software; Section 1557 (45 CFR 92.210): identify and mitigate discrimination risk in clinical decision support tools since May 1, 2025. |
| Texas | Transparency | January 1, 2026 | TRAIGA: healthcare providers must disclose AI use in patient care. |
| California | Transparency | January 1, 2025 | AB 3030: disclaimer on AI-generated clinical communications to patients unless reviewed by a clinician. |
| Colorado | Consequential decision | January 1, 2027 | SB 26-189: health care is a consequential decision. |
Common base documents
- Clinical and Technical Validation Protocol for Healthcare AI
Protocol · USD 59 · Available to buy
- Algorithmic Impact Assessment (AIA)
Assessment template · USD 59 · Available to buy
- Human Oversight Procedure for AI Systems
Procedure · USD 39 · Available to buy
- AI Post-Deployment Monitoring Plan
Plan · USD 39 · Available to buy
- Model Card
Datasheet · USD 19 · Available to buy
- Data Protection Impact Assessment (DPIA) for AI
Assessment template · USD 59 · Available to buy
Depending on your situation
- If the software is a medical device
- If there are patients in Brazil
- If patients interact directly with the AI
- If it is trained on patient data