Life sciences & healthcare legal cluster: Hub · Dawn raid · VBP · Hospital AR · Exclusive agency · HGR · Trial injury · CRO/CDMO · Device liability · Labeling · SaMD · Patent linkage · License · FDA WL · MDR/IVDR · Internet hospital · Trade secrets · Pharma ads · Device distribution · Sources · Checklist
Is it SaMD? Classification posture
Classification turns on intended use and risk claims—not your marketing preference to stay “wellness.” Higher-risk diagnostic support may face Class II/III device pathways with clinical evaluation expectations. Engage regulatory counsel/consultants early; legal teams should lock intended-use language before growth teams publish WeChat claims.
Algorithm, training data & change control
- Training data provenance: licences, patient consent, HGR/PIPL constraints if data originated in China.
- Model update policy: when does a software change require re-filing vs documented letter-to-file style control under device quality systems.
- Transparency to users: performance limitations, population coverage, and contraindicated use.
- Overlap with generative AI rules for non-device content features — AI business guide.
Liability after AI-assisted error
Hospital care remains central in medical damage claims; developers face product liability, contract, and regulatory narratives if the software defectively designs decision support or misrepresents performance. Allocation clauses in hospital licence agreements matter, but they do not bind patients. Preserve model version, input snapshot, and human override logs.
Privacy, RWE & continuous learning systems
Continuous learning loops that ship hospital data to cloud trainers are cross-border and sensitive-PI problems. See clinical data and transfer roadmap. Anonymisation claims need technical and legal validation—not sales decks.
Digital therapeutics (DTx) & advertising
DTx-like products that claim treatment effects face device and advertising overlays. Do not borrow pharma efficacy language without a regulatory home. Promotion limits: device advertising.
Build-vs-buy hospital procurement checklist
- Intended use locked in Chinese and English.
- Registration/filing status and scope matching deployed modules.
- Cybersecurity and PIPL DPAs with subprocessors listed.
- Human factors and clinical validation summary for ethics/medical affairs.
- Incident response: who notifies patients, regulators, and the other party.
Related
AI & robotics hub · Cluster hub
FAQ · 高频检索问题
Chinese long-tail intents mapped to this guide (orientation only).
AI 医疗软件是否三类器械？
AI 诊断错误谁负责？
数字疗法 DTx 如何合规推广？
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