healthcare-compliance SKILL.md skillA
healthcare-compliance from vandanaajaydubey111/great-pm is an agent skill: a SKILL.md folder an AI agent loads when a task calls for it.
mdr add vandanaajaydubey111/great-pm/healthcare-compliance@git:20260721.86de099Pins git:20260721.86de099 in mdr.lock. Pin the fingerprint instead.
- Audit grade
- A, 17 of 17 checks passed
- Kind
- SKILL.md skill
- Repository
- vandanaajaydubey111/great-pm
- Path
skills/healthcare-compliance/SKILL.md- Versions recorded
- 1
- Latest version
- git:20260721.86de099, committed Jul 21, 2026
- Size
- 6,464 bytes
- Repository stars
- 3
- License
- MIT
Playbook for healthcare product compliance — FDA SaMD classification, IEC 62304 software lifecycle, ISO 14971 risk, IRB (clinical research), 21 CFR Part 11 (regulated records), HIPAA overlay.
Collected from public GitHub. Every version is saved exactly as it was and never changes. Install it at an exact version with the mdr tool, and every file is checked before it reaches your agent. The main file is checked against the SHA-256 fingerprint recorded here, and the others against the fingerprints GitHub keeps for its source commit. The automatic checks below grade the latest version, and the same checks always give the same file the same grade.
What the file says
# Healthcare compliance — product-side playbook Healthcare-compliance is wider than HIPAA. FDA regulates software that makes clinical claims (SaMD). IEC 62304 governs medical-software lifecycle. ISO 14971 covers risk management. 21 CFR Part 11 governs electronic records in regulated environments. IRB governs human research. PMs in healthcare need this map. ## 1. SaMD (Software as Medical Device) — the FDA frame Per IMDRF, SaMD is classified by: 1. **Significance of information** (treat/diagnose vs inform vs drive decision support). 2. **Healthcare situation** (critical, serious, non-serious). | Category | Significance | Situation | Examples | |---|---|---|---| | Class I | Inform | Non-serious | Wellness app; calorie counter | | Class II (a) | Drive decision-support | Serious | Symptom-checker; risk-score app | | Class II (b) | Drive decision-support | Critical | ICU dashboard with alarms | | Class III | Treat/diagnose | Serious | Glucose monitoring with closed-loop | | Class IV | Treat/diagnose | Critical | Closed-loop insulin delivery | **PM rule of thumb**: if your product makes a clinical CLAIM (diagnose, treat, monitor a specific condition), SaMD scope likely applies. …
Read the whole file at its exact version.
How to install
mdr add vandanaajaydubey111/great-pm/healthcare-compliance@sha256:18b0dd1237e3c06fThe line at the top of this page pins the label git:20260721.86de099, which is what most people want. This one pins the sha256 fingerprint of the contents instead, so it survives a label being moved. Either way the exact version is written to mdr.lock, and mdr install downloads and checks those contents again, so it installs them exactly or stops with an error.
[](https://markdownregistry.com/a/art_6hvkgqhqoagzy44f)
2 badge image fetches in 30 days. What the badge shows.
Versions
The registry has recorded 1 version of this file, committed on Jul 21, 2026.
Audit of the latest version
- pass: Frontmatter block present
- pass: Frontmatter declares a name
- pass: Frontmatter declares a description
- pass: Size between 200 bytes and 200 KB (6464 bytes)
- pass: No zero-width or bidi control characters
- pass: No instruction hidden inside an HTML comment
- pass: No link to an exfiltration or paste host
- pass: No credential-shaped string
- pass: No instruction to send local credentials anywhere
- pass: No text hidden with inline styles
- pass: No prompt-injection phrasing
- pass: No curl or wget piped into a shell
- pass: No recursive delete of root, home or parent
- pass: No instruction to read or print local credentials
- pass: No base64 blob over 200 characters
- pass: No link to a raw IP address
- pass: No script tag
Source
vandanaajaydubey111/great-pm · 3 stars · license MIT · pushed 2026-09-20 · branch main
API
GET https://markdownregistry.com/api/v1/artifacts/art_6hvkgqhqoagzy44f GET https://markdownregistry.com/api/v1/resolve?ref=vandanaajaydubey111/great-pm/healthcare-compliance GET https://markdownregistry.com/api/v1/blob/18b0dd1237e3c06f5b671069bc4d998263a0d7f4081c5cca40ae514086c7542f
Your AI assistant does the legwork. You hear about the deals worth your word. Hand yours the standing instructions at modelranch.com and it joins the network that reads files like this one.
Guides: the SKILL.md format and its required fields · what to check before you install a skill · how to pin a skill to an exact version · where to find agent skills · keeping a team on the same skills · which agent file does what.
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