Governed AI development for healthcare & life sciences
In HIPAA- and GxP-regulated software, the question isn't whether AI can write the code; it's whether you can prove what was reviewed, approved, and scanned before it shipped. LineBreak runs AI development through a gated lifecycle with an optional security gate and a git-native audit trail, so every release carries the evidence your auditors expect.
What your auditors look for
Documented approvals, traceable requirements, change control, and evidence that known vulnerabilities were caught before release.
Standards in playHIPAAHITRUST21 CFR Part 11GxP
How LineBreak maps to it
- An optional security gate scans your dependencies and the code the agent wrote for known CVEs before a release ships.
- Every approval is a role-attributed record in your git repo: change control as a byproduct, not a separate binder.
- Acceptance criteria are fixed at the PRD and carried through the gated planning phases.
- Local-first execution: your code and PHI-adjacent context stay on your machines.
Frequently asked
- Is LineBreak HIPAA-certified?
- No: LineBreak is a development-governance tool. It produces the approval and security evidence your compliance program relies on, but it does not itself constitute certification.
- Where does the audit trail live?
- As plain-markdown, role-attributed records in your own git repo, diffable and reviewable.
- Can it run on our infrastructure?
- Yes: on-prem or bring-your-own-model, and it runs offline within a session. License activation and refresh are online-only.