Deaths, disclosure and a 24-hour clock that's already running
Hospital beds, liability rules and cyber incidents: today's stories share one thing. Someone will ask what happened, and want to see it.
- 01
FDA alerts on hospital beds after two deaths
Two deaths and sixteen serious injuries traced to Medline hospital beds. The FDA has issued an early alert, a reminder that medical device manufacturers must monitor safety post-market and report serious incidents.
Why it matters for evidence: Medical device makers must keep records of incidents and safety monitoring. A digital witness makes those records provably unchanged.
Source: MedTech Dive
- 02
New liability rules put burden of proof on makers
The new EU Product Liability Directive extends strict liability to software and AI, with reversed burden of proof. Companies must now prove what their systems did. Applies to products released after 9 December 2026.
Why it matters for evidence: When the burden of proof is on you, a sealed log of what your software did is no longer optional.
Source: metzler.law
- 03
CRA's 24-hour clock starts in September
ENISA's statement on refrigeration system breaches highlights the Cyber Resilience Act's reporting duties. From 11 September 2026, manufacturers must report severe incidents and actively exploited vulnerabilities within tight deadlines.
Why it matters for evidence: The 24-hour clock starts when you know, not when it suits you. A sealed record of when you knew is the receipt.
Source: enisa.europa.eu
- 04
US healthcare systems face AI audit burden
The American Medical Association's new liability framework puts the burden on healthcare systems to prove how AI is governed. CISOs and compliance leaders are now on the hook for audit evidence.
Source: kiteworks.com
- 05
Legal professionals fear fake orders and falsified evidence
A Thomson Reuters survey found that 43% of legal professionals worry most about AI hallucinations, and 32% about malicious AI use such as fake court orders or falsified evidence. Only 7% fear widespread job loss.
Source: legal.thomsonreuters.com
- 06
What log tampering is, and why it matters
Log tampering is the deliberate alteration, deletion or fabrication of logs to hide activity or mislead investigators. It directly threatens compliance with regulations requiring automatic logging and log protection for AI systems.
Source: nhimg.org