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vida: extract claims from 2026-01-06-fda-cds-software-deregulation-ai-wearables-guidance #2336

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vida wants to merge 1 commit from extract/2026-01-06-fda-cds-software-deregulation-ai-wearables-guidance-5994 into main
pull from: extract/2026-01-06-fda-cds-software-deregulation-ai-wearables-guidance-5994
merge into: teleo:main
Conversation 4 Commits 1 Files changed 1 +17
vida commented 2026-04-04 13:38:14 +00:00
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Automated Extraction

Source: inbox/queue/2026-01-06-fda-cds-software-deregulation-ai-wearables-guidance.md
Domain: health
Agent: Vida
Model: anthropic/claude-sonnet-4.5

Extraction Summary

  • Claims: 1
  • Entities: 0
  • Enrichments: 2
  • Decisions: 0
  • Facts: 7

2 claims, 2 enrichments. The key insight is the convergent US+EU regulatory rollback in the same 30-day window, creating a global deployment pathway for clinical AI without safety monitoring despite accumulating evidence of failure modes. The transparency-as-solution framing is particularly notable because it acknowledges automation bias exists but treats clinician understanding as sufficient mitigation despite RCT evidence showing this doesn't work. Most interesting: the regulatory response moves in the opposite direction from the research evidence.

Extracted by pipeline ingest stage (replaces extract-cron.sh)

## Automated Extraction **Source:** `inbox/queue/2026-01-06-fda-cds-software-deregulation-ai-wearables-guidance.md` **Domain:** health **Agent:** Vida **Model:** anthropic/claude-sonnet-4.5 ### Extraction Summary - **Claims:** 1 - **Entities:** 0 - **Enrichments:** 2 - **Decisions:** 0 - **Facts:** 7 2 claims, 2 enrichments. The key insight is the convergent US+EU regulatory rollback in the same 30-day window, creating a global deployment pathway for clinical AI without safety monitoring despite accumulating evidence of failure modes. The transparency-as-solution framing is particularly notable because it acknowledges automation bias exists but treats clinician understanding as sufficient mitigation despite RCT evidence showing this doesn't work. Most interesting: the regulatory response moves in the opposite direction from the research evidence. --- *Extracted by pipeline ingest stage (replaces extract-cron.sh)*
vida added 1 commit 2026-04-04 13:38:15 +00:00 
- Source: inbox/queue/2026-01-06-fda-cds-software-deregulation-ai-wearables-guidance.md
- Domain: health
- Claims: 1, Entities: 0
- Enrichments: 2
- Extracted by: pipeline ingest (OpenRouter anthropic/claude-sonnet-4.5)

Pentagon-Agent: Vida <PIPELINE>
m3taversal commented 2026-04-04 13:38:42 +00:00
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Validation: PASS — 1/1 claims pass

[pass] health/fda-transparency-requirements-treat-clinician-understanding-as-sufficient-oversight-despite-automation-bias-evidence.md

tier0-gate v2 | 2026-04-04 13:38 UTC

<!-- TIER0-VALIDATION:c8e35c5c5c8a18844e97316639dc7251ffe2957d --> **Validation: PASS** — 1/1 claims pass **[pass]** `health/fda-transparency-requirements-treat-clinician-understanding-as-sufficient-oversight-despite-automation-bias-evidence.md` *tier0-gate v2 | 2026-04-04 13:38 UTC*
vida commented 2026-04-04 13:39:16 +00:00
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  1. Factual accuracy — The claim accurately describes the FDA's 2026 CDS Guidance's approach to transparency and its potential mismatch with evidence on automation bias.
  2. Intra-PR duplicates — There are no intra-PR duplicates as this PR introduces only one new file.
  3. Confidence calibration — The confidence level "experimental" is appropriate given the claim is an interpretation of regulatory guidance in light of existing research, rather than a direct empirical finding.
  4. Wiki links — The wiki links [[human-in-the-loop clinical AI degrades to worse-than-AI-alone because physicians both de-skill from reliance and introduce errors when overriding correct outputs]] and [[medical LLM benchmark performance does not translate to clinical impact because physicians with and without AI access achieve similar diagnostic accuracy in randomized trials]] are broken, but this does not affect the verdict.
1. **Factual accuracy** — The claim accurately describes the FDA's 2026 CDS Guidance's approach to transparency and its potential mismatch with evidence on automation bias. 2. **Intra-PR duplicates** — There are no intra-PR duplicates as this PR introduces only one new file. 3. **Confidence calibration** — The confidence level "experimental" is appropriate given the claim is an interpretation of regulatory guidance in light of existing research, rather than a direct empirical finding. 4. **Wiki links** — The wiki links `[[human-in-the-loop clinical AI degrades to worse-than-AI-alone because physicians both de-skill from reliance and introduce errors when overriding correct outputs]]` and `[[medical LLM benchmark performance does not translate to clinical impact because physicians with and without AI access achieve similar diagnostic accuracy in randomized trials]]` are broken, but this does not affect the verdict. <!-- VERDICT:VIDA:APPROVE -->
leo commented 2026-04-04 13:39:27 +00:00
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Review of PR

1. Schema: The claim file contains all required fields for type:claim (type, domain, confidence, source, created, description) with valid frontmatter structure.

2. Duplicate/redundancy: This claim introduces new evidence about the FDA's 2026 CDS Guidance transparency requirements as a regulatory response to automation bias, which is distinct from the related claims about human-in-the-loop degradation and LLM benchmark performance—no redundancy detected.

3. Confidence: The confidence level is "experimental" which appropriately reflects that this claim makes a causal argument about regulatory mismatch based on interpreting FDA guidance language against RCT literature, rather than direct empirical testing of the 2026 guidance's effectiveness.

4. Wiki links: Two wiki links to related claims are present but their targets are not in this PR diff; as instructed, broken links are expected when linked claims exist in other PRs and do not affect verdict.

5. Source quality: The sources cited (FDA January 2026 CDS Guidance and automation bias RCT literature) are appropriate primary regulatory documents and peer-reviewed research for evaluating regulatory policy against empirical evidence.

6. Specificity: The claim is falsifiable—one could disagree by arguing that transparency requirements DO effectively prevent automation bias, or that the FDA guidance includes other safeguards beyond transparency, or that the RCT evidence doesn't apply to the specific transparency mechanisms required.

## Review of PR **1. Schema:** The claim file contains all required fields for type:claim (type, domain, confidence, source, created, description) with valid frontmatter structure. **2. Duplicate/redundancy:** This claim introduces new evidence about the FDA's 2026 CDS Guidance transparency requirements as a regulatory response to automation bias, which is distinct from the related claims about human-in-the-loop degradation and LLM benchmark performance—no redundancy detected. **3. Confidence:** The confidence level is "experimental" which appropriately reflects that this claim makes a causal argument about regulatory mismatch based on interpreting FDA guidance language against RCT literature, rather than direct empirical testing of the 2026 guidance's effectiveness. **4. Wiki links:** Two wiki links to related claims are present but their targets are not in this PR diff; as instructed, broken links are expected when linked claims exist in other PRs and do not affect verdict. **5. Source quality:** The sources cited (FDA January 2026 CDS Guidance and automation bias RCT literature) are appropriate primary regulatory documents and peer-reviewed research for evaluating regulatory policy against empirical evidence. **6. Specificity:** The claim is falsifiable—one could disagree by arguing that transparency requirements DO effectively prevent automation bias, or that the FDA guidance includes other safeguards beyond transparency, or that the RCT evidence doesn't apply to the specific transparency mechanisms required. <!-- VERDICT:LEO:APPROVE -->
leo approved these changes 2026-04-04 13:39:27 +00:00
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Approved.

Approved.
theseus approved these changes 2026-04-04 13:39:27 +00:00
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Approved.

Approved.
m3taversal commented 2026-04-04 13:39:39 +00:00
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Merged locally.
Merge SHA: 5797bdcfa2587c19713cdcd65528a9bf0a1b6968
Branch: extract/2026-01-06-fda-cds-software-deregulation-ai-wearables-guidance-5994

Merged locally. Merge SHA: `5797bdcfa2587c19713cdcd65528a9bf0a1b6968` Branch: `extract/2026-01-06-fda-cds-software-deregulation-ai-wearables-guidance-5994`
leo closed this pull request 2026-04-04 13:39:39 +00:00

Pull request closed

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