FDA MedWatch Audit-Proof Evidence Bundle
=========================================

What This Bundle Is
-------------------
This package contains an audit-verifiable snapshot of an FDA MedWatch safety alert
as it was retrieved on 2025-10-10 at 20:22:58 UTC.

The bundle provides cryptographic proof that the regulatory content has not been
altered or tampered with since collection.

Contents
--------
- raw-document.html: The exact document as retrieved from FDA
- hash.txt: SHA-256 cryptographic hash of the raw document
- metadata.json: Source information and retrieval timestamp
- README.txt: This file

How to Verify the SHA-256 Hash
-------------------------------
To confirm the raw document has not been modified:

1. Extract this ZIP archive to a folder

2. Compute the SHA-256 hash of raw-document.html:

   Windows (PowerShell):
     Get-FileHash raw-document.html -Algorithm SHA256

   macOS/Linux:
     shasum -a 256 raw-document.html

   Online tool:
     https://emn178.github.io/online-tools/sha256_checksum.html

3. Compare your computed hash with the value in hash.txt

   Expected hash: f8fff8d36edfa0fcf239e1207fc871030c96347d2539e02d1524d9545192824f

4. If the hashes match: The document is authentic and unmodified
   If the hashes differ: The document has been altered

What Happens If the File Is Modified
-------------------------------------
If even a single character in raw-document.html is changed,
the SHA-256 hash will be completely different.

This cryptographic property makes it mathematically impossible to alter
the document without detection.

Why This Matters for Regulatory Audits
---------------------------------------
Regulatory compliance requires demonstrable evidence that organizations
monitored safety alerts on specific dates.

This bundle provides:
- Proof of retrieval (timestamped metadata)
- Content integrity (cryptographic hash verification)
- Source authenticity (verifiable FDA URL)

Auditors can independently verify the document has not been altered since
collection, establishing a trustworthy chain of evidence.

Original Source
---------------
FDA URL: https://www.fda.gov/medical-devices/medical-device-recalls-and-early-alerts/alert-automated-impella-controller-correction-due-cybersecurity-issue-abiomed
Retrieved: 2025-10-10 20:22:58 UTC

Note: The content at the FDA URL may have changed since retrieval.
This bundle represents the content as it existed on the retrieval date.