pms-vigilance-intake

纯文档型提示技能：接收结构化不良事件要素或报告摘要，按 TH-MED-002 规则库匹配，返回含推荐路径代码、条款与判定依据的 JSON IR；声明无本地脚本、runtime 为 none，并提示结果仅为决策支持，需对照官方文本核验，未做独立安全扫描。

zhaoxinghua09-cell

热度 61.55

最近更新 2026-10-17 07:32:09

分类：知识依赖：内部调用大模型 / 读写文件应用场景：工作流 / 报告撰写

安装技能

复制下面的话术发给你的 Agent，它会通过 secure-skills 检索并安装该技能。

执行命令安装此 skill： npx secure-skills-cli add pms-vigilance-intake

Metadata

name: pms-vigilance-intake
title: Medical Device Vigilance Reporting Pathway Intake
slug: pms-vigilance-intake
display_name: 医疗器械不良事件报告路径判定器
display_name_en: Medical Device Vigilance Reporting Pathway Intake
version: 1.0.1
category: medtech-reg
author: SynomosAI
license: MIT
allowed-tools: Read, Glob, Grep, Bash, Write, WebFetch
description: 医疗器械不良事件报告路径判定器——基于官方规则源的零依赖决策支持工具，JSON IR 输出，覆盖 TH-MED-002 域（医疗器械全链路）。
description_zh: 医疗器械不良事件报告路径判定器——基于官方规则源的零依赖决策支持工具，JSON IR 输出，覆盖 TH-MED-002 域（医疗器械全链路）。
description_en: Medical device adverse-event reporting pathway determination tool: zero-dependency decision support with JSON IR output (domain TH-MED-002, full device chain).
tags: ["医疗器械","合规","判定器","TH-MED-002","pms-vigilance-intake","medtech-reg","不良事件"]
classification: {"skillhub":["medtech-reg","medical-device","pharmacovigilance"],"clawhub":["productivity","development"],"iso_25010":["Functional suitability"]}
read_when: ["收到新提交的不良事件数据需自动判定法定报告路径","多部门管辖的复杂事件初筛需按官方规则库合规分类","需生成符合 JSON IR 标准、可被后续步骤直接解析的决策建议"]
risk_tier: medium
risk_rationale: 调用 API/读写文件/本地执行，最小权限，密钥走 Secret；若实际涉对外代执行(push/发布/发送/上架)须人工复评，改 high 并走负责人批准。
platforms: ["windows","macos","linux"]
platform_compatibility: ["windows","macos","linux"]
ai_protocol: true
spec: usk/1.0
interface: {"type":"prompt","entry_point":"SKILL.md","runtime":"none","call_pattern":"prompt"}
output_schema: {"stdout":"structured JSON IR","exit_code":"rc=0 ok / rc=1 warning / rc=2 bad input"}
changelog: 1.0.1: Bilingual rewrite (EN-first) + read_when; risk_rationale ref neutralized; 1.0.0 initial

凡自治之物 · LGD 治理学 · 创造术家族｜评测协议：skill-quality-gate

English

Medical Device Vigilance Reporting Pathway Intake

When to use

When newly submitted adverse-event data arrives and its statutory reporting pathway must be determined.
For triaging complex events involving multi-department jurisdiction, classifying them against the official rule library.
When an automated flow needs JSON-IR-standard decisions parseable by downstream steps.

How to use

Pure documentation tool; no local scripts. Pass structured adverse-event elements or a full report summary as input; the interface returns JSON IR with the recommended pathway and rationale.

Workflow

Confirm the adverse-event data has been basic-validated and formatted.
Wrap the structured text as input into the skill node.
Trigger execution; the backend matches TH-MED-002 regulatory rules.
Inspect the returned JSON IR for the recommended pathway code and clauses.
Close the business loop or route for manual review.

Evidence & safety

Evidence: TBD; Version: 1.0.1; Security: no independent scan (TBD).

中文

医疗器械不良事件报告路径判定器

何时用

收到新提交的不良事件数据，需自动判定其法定报告路径。
涉及多部门管辖的复杂事件初筛，需按官方规则库合规分类。
自动化流程需生成符合 JSON IR 标准、可被后续步骤直接解析的决策建议。

用法

纯文档型工具，无需本地执行脚本。以结构化不良事件要素列表或完整报告摘要为输入，返回含推荐路径与判定依据的 JSON IR。

流程

完成数据基础校验与格式化 → 封装为输入参数 → 触发执行并匹配 TH-MED-002 规则库 → 查看 JSON IR 中推荐路径代码与条款 → 闭环或转人工复核。

证据与安全声明

证据：TBD；版本：1.0.1；安全：未做独立安全扫描（TBD）。