architecture, specification, and cost-benefit analysis #47
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…s to the incident response plan, data dictionary, glossary of terms, API specifications, and architectural diagrams. This update improves the accessibility and clarity of critical resources, supporting a comprehensive understanding of the platform's structure and functionality for decentralized clinical trials.
…ers, units, sources, consents, and trials. This enhancement provides a comprehensive overview of the database schema, supporting better understanding and management of data within the platform. Additionally, a new Ingest API specification is introduced, detailing endpoints for data submission and job tracking, which improves the API documentation and facilitates integration with external systems. Architectural diagrams have also been expanded to illustrate system interactions and components more clearly.
…tailing endpoints for querying health data. This new documentation includes authentication requirements, query parameters, and response structures, enhancing the API's usability and integration potential for developers.
…etailing endpoints for user profiles and consent management. This documentation enhances the API's usability by providing clear descriptions of authentication requirements, request/response structures, and consent processes, supporting better integration and user experience on the platform.
…defining endpoints for data mapping and analysis plugins. This documentation enhances modularity and extensibility, allowing third-party integrations to improve functionality within the Core Platform.
…ng a new C4 Container Diagram for the FDA.gov v2 Platform. This diagram details the main logical containers, their interactions, and enhances understanding of the platform's architecture and data flow.
…OI, cost per QALY, and QALYs gained. This improves accessibility and clarity of economic models, supporting better understanding of the dFDA platform's value proposition.
…ble to include visual representation. The new chart visualizes health interventions by QALYs gained per $1M, enhancing the analysis of the dFDA platform's effectiveness.
…o reflect revised QALY estimates and operational cost scenarios. The document now includes a range of QALY gains from 150,000 to 600,000 per year, enhancing the economic model's clarity and supporting the dFDA platform's value proposition.
…e cost-benefit analysis documentation for clarity. The lower bound for the dFDA Platform's cost is revised to 3750, and hyperlinks in the analysis are improved for better navigation.
…y updating hyperlinks for clarity and consistency. The document now references the 'Costs of Building and Operating the Global Decentralized FDA ROM Estimate' section more explicitly, enhancing the transparency of the ROI calculations and overall analysis.
…timates, increasing the projected annual QALYs from 300,000 to 330,000. Additionally, the daily opportunity cost of inaction is updated to reflect a loss of 904 QALYs, enhancing the clarity and accuracy of the economic model's impact assessment.
…timates and hyperlink improvements. The incremental cost-effectiveness ratio (ICER) is adjusted to approximately -$151,394 per QALY gained, and various cost scenarios are clarified with updated hyperlinks for better navigation and understanding of the economic model's implications.
…sistency in cost estimates and QALY projections. The document now reflects updated figures for the dFDA platform's operational costs, emphasizing the potential for significant cost reductions and improved health outcomes, while ensuring all monetary values are formatted correctly for better readability.
…n-table.md to reflect revised QALY estimates and cost metrics. The projected annual QALYs have been increased from 330,000 to 840,000, and the daily opportunity cost of inaction is updated to 2,301 QALYs lost. Additionally, the intervention comparison table now shows a broader range of QALYs gained per $1M for the dFDA platform, enhancing clarity and supporting the economic model's implications.
…summarizing key financial and health impacts. Added comparative cost-effectiveness analysis of the dFDA platform against other public health interventions, highlighting its dominant status and significant potential savings and health gains.
… version upgrades, including @types/node, typescript, gray-matter, markdown-it, and markdown-it-anchor. Additionally, enhance create_chart.py for improved QALY estimates and visualization, and update dfda-cost-benefit-analysis.md for clarity in cost-effectiveness comparisons and QALY ranges across health interventions.
…ect changes in file paths and enhance hyperlink references. The path for the Disease Eradication Act document has been simplified, and all related references have been updated accordingly to ensure consistency across the documentation.
…and markdownlint-cli for improved markdown linting capabilities. Also, include new scripts for linting markdown files.
…n linting rules, disabling specific checks for improved flexibility in markdown formatting.
…and detail across the documentation. Key changes include the addition of new sections in act.md, specification.md, and benefits-related documents, as well as improvements in the economic models and regulatory recommendations. These updates aim to provide clearer insights into the dFDA framework and its implications for healthcare.
…ore list, enhancing markdown linting configuration for improved usability.
…rkdown linting, streamlining the linting process.
…ferences and enhancing clarity in QALY projections and cost-effectiveness metrics. Key updates include adjustments to section links and improved formatting for better readability, supporting the overall economic model narrative.
…s for clarity and consistency. Changes include removing colons from section titles to enhance readability and maintain a uniform format throughout the document.
…ences and improve clarity in key sections. Changes include adjustments to citation links and formatting enhancements for better readability, supporting the overall narrative of the economic model.
…ences for improved accuracy and clarity. Changes include updating citation links to ensure they direct to the correct sources, enhancing the document's overall reliability and readability.
…ences and improve clarity in cost comparison section. Adjustments include refining citation links for accuracy and enhancing readability of the QALY projections.
…ence to the platform technical specification, ensuring accurate navigation and enhancing document reliability.
Contributor
Reviewer's GuideThis PR overhauls multiple documentation and specification files to improve data accuracy, formatting consistency, and cross-reference integrity. Key updates include refined economic-model metrics, restructured regulatory guidance lists, clarified technical specs and licensing, harmonized legislative texts, and standardized example and strategy documents. File-Level Changes
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Voting is closed Vote Summary: Acceptance Criteria:
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Hey @mikepsinn - I've reviewed your changes - here's some feedback:
- This PR is extremely large and spans multiple domains (cost-benefit analysis, spec, act text, regs); consider splitting it into smaller, focused PRs so each change can be reviewed in isolation.
- The baseline QALY estimate was updated to 840k but some sections still mention 300k—please ensure all references (Executive Summary, TL;DR, parameterization) are consistent.
- Several sections (especially in the cost-benefit analysis) appear duplicated or contain minor markdown formatting issues—please consolidate repeated content and clean up formatting for clarity.
Here's what I looked at during the review
- 🟡 General issues: 4 issues found
- 🟢 Security: all looks good
- 🟢 Testing: all looks good
- 🟢 Documentation: all looks good
Help me be more useful! Please click 👍 or 👎 on each comment and I'll use the feedback to improve your reviews.
| - name: Analysis | ||
| description: Endpoints for data analysis plugins. | ||
| paths: | ||
| /v1/map: |
Contributor
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🚨 issue (security): Missing security definitions on plugin endpoints
Please add security requirements (such as bearer tokens or mTLS) to these endpoints if they require protection.
| (b) **Subsidy Fund.** \$2 billion FY 2026‑30, released quarterly upon NIH certification that the subsidy‑allocation algorithm achieved or exceeded its projected QALY gain in the preceding quarter. | ||
| (c) **Regulatory‑Science Grants.** \$150 million FY 2026‑30. | ||
| (d) **Direct‑Hire Authority.** For FY 2026‑30 the Secretary may hire up to **200 technical employees** for the Platform under 5 U.S.C. § 9803 (critical‑need direct hire). | ||
| (e) **Agile Acquisition Pilot.** All contracts for the Platform are designated "modular IT acquisitions" under FITARA; FAR Part 15 documentation requirements are waived in favour of the **US Digital Service Playbook\[10]** incremental‑delivery model.\*\* \$150 million FY 2026‑30. |
Contributor
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issue (typo): Potential typo with double asterisks after 'model.'.
Double asterisks after 'model.' may be an unintended typo or misplaced Markdown. Please verify and correct if necessary.
Suggested change
| (e) **Agile Acquisition Pilot.** All contracts for the Platform are designated "modular IT acquisitions" under FITARA; FAR Part 15 documentation requirements are waived in favour of the **US Digital Service Playbook\[10]** incremental‑delivery model.\*\* \$150 million FY 2026‑30. | |
| (e) **Agile Acquisition Pilot.** All contracts for the Platform are designated "modular IT acquisitions" under FITARA; FAR Part 15 documentation requirements are waived in favour of the **US Digital Service Playbook\[10]** incremental‑delivery model. \$150 million FY 2026‑30. |
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| ### Tell me what it actually does (i.e. what are the its impact, intentional or unintentional - details and numbers are helpful here even if estimates). If both good and bad impacts exist, address both. | ||
| ### Tell me what it actually does (i.e. what are the its impact, intentional or unintentional - details and numbers are helpful here even if estimates). If both good and bad impacts exist, address both |
Contributor
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issue (typo): Grammatical error in heading
Please correct the heading to "what its impact is" or "what its impacts are" for grammatical accuracy.
… cost-effectiveness section by visualizing the dFDA platform's impact against other public health interventions. Key changes include the addition of a chart illustrating QALYs gained per $1 million of spending and a detailed table supporting the data, improving clarity and context for the analysis.
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Voting is closed Vote Summary: Acceptance Criteria:
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Co-authored-by: sourcery-ai[bot] <58596630+sourcery-ai[bot]@users.noreply.github.com>
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Voting is closed Vote Summary: Acceptance Criteria:
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Co-authored-by: sourcery-ai[bot] <58596630+sourcery-ai[bot]@users.noreply.github.com>
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Current Voting Result Vote Summary: Acceptance Criteria:
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mikepsinn
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architecture, specification, and cost-benefit analysis
mikepsinn
added a commit
to mikepsinn/dfda-wiki
that referenced
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Jun 24, 2025
architecture, specification, and cost-benefit analysis
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Summary by Sourcery
Revise and enrich economic models, specifications, regulatory, and legislative markdown to improve clarity, consistency, and accuracy across the dFDA documentation and Act proposal
Enhancements:
Documentation:
Chores: