Clinical-grade AI: 21 CFR Part 11, HIPAA minimum-necessary, and the deferral floor.

In Lesson 5.1 of GROW Course 5 (Vertical Specialization), Doug Liles works through it with you. What 'clinical-grade' demands of an FDE deployment and where the deferral floor sits.

What you'll take away

- Clinical-grade defined

- 21 CFR Part 11

- HIPAA minimum-necessary

Chapters

(0:00) Cold open & the promise

(6:34) Clinical-grade defined

(13:09) 21 CFR Part 11

(19:43) HIPAA minimum-necessary

(26:18) The deferral floor

(32:52) Artifacts on the table

(39:27) The artifact & what to do Monday

Mentioned and cited

- 21 CFR Part 11

- HIPAA Minimum Necessary Standard

Study guide, slide deck, blog companion, infographic (free)

- https://fde.goodcombinator.ai/lessons/FDE_Lesson_5_1

Audio companion is AI-narrated using NotebookLM. Explainer video is human-produced.

Public release

This full FDE Certification audio lesson is available publicly as part of GROW by Good Combinator.

Continue in GROW Skills Library: https://goodcombinator.com/grow/library

Episode metadata

Show: GROW by Good Combinator

Course: Course 5 - Vertical Specialization

Lesson: 5.1

Season/Episode: 5/1

Runtime: 46:02

Access label: public-full-lesson

Source channel: spotify

Source audio: app/lessons/assets/course-5/5.1/5.1 Deep Dive Audio.m4a

Taxonomy: Domain=Vertical Specialization; Career stage=Senior FDE; Skill level=Advanced; Asset type=Lesson; Outcome=Deploy

CRM events: course_started, lesson_completed, cert_enrolled

Transcript and accessibility

Final transcript required before launch: https://goodcombinator.com/grow/courses/course-5/lesson-5.1/transcript

Accessibility requirement: reviewed audio, clear title, descriptive show notes, and transcript availability before launch.

Audio companion is AI-narrated using NotebookLM and disclosed here.

Credits

Host: Doug Liles

Producer: Good Combinator

Audio: NotebookLM AI narration (disclosed)