Trust and status

Topic	Where it stands	Status
Patient data	LMOS is designed to hold none, in either deployment. The rule is enforced and tested as the system is built.	Design rule
Clinical role	LMOS enforces the lab's own SOPs and paperwork. It makes no clinical decisions.	Design rule
Isolation	The on-premise tier is designed to run isolated from the public internet, with controlled, authenticated integration points. The cloud tier separates each laboratory as its own tenant.	Design rule
SOC 2 Type 2	Examination in progress. No report has been issued yet.	In progress
21 CFR Part 11	Designed to support its requirements: attributable signatures, an append-only audit trail. A design target; no validation has been run.	Design target
Validation	Installation, operational and performance qualification will be executed with each customer's quality team.	Planned
HIPAA, ISO 27001	Planned for the cloud tier.	Planned
Public regulations	21 CFR 606, 610, 640, 600, 607 and Part 11; 42 CFR 493 and 482; FDA guidance on blood establishment computer software validation; OSHA bloodborne pathogens.	In design
Licensed standards	AABB, CAP, The Joint Commission, ISO 15189, COLA and CLSI come from the customer's own license. LMOS does not bundle them or copy them between laboratories.	Design rule
Customers	Built with input from an informal network of laboratory directors. The first pilot cohort is forming.	Forming

Topic

Where it stands

Status

Patient data

LMOS is designed to hold none, in either deployment. The rule is enforced and tested as the system is built.

Design rule

Clinical role

LMOS enforces the lab's own SOPs and paperwork. It makes no clinical decisions.

Design rule

Isolation

The on-premise tier is designed to run isolated from the public internet, with controlled, authenticated integration points. The cloud tier separates each laboratory as its own tenant.

Design rule

SOC 2 Type 2

Examination in progress. No report has been issued yet.

In progress

21 CFR Part 11

Designed to support its requirements: attributable signatures, an append-only audit trail. A design target; no validation has been run.

Design target

Validation

Installation, operational and performance qualification will be executed with each customer's quality team.

Planned

HIPAA, ISO 27001

Planned for the cloud tier.

Planned

Public regulations

21 CFR 606, 610, 640, 600, 607 and Part 11; 42 CFR 493 and 482; FDA guidance on blood establishment computer software validation; OSHA bloodborne pathogens.

In design

Licensed standards

AABB, CAP, The Joint Commission, ISO 15189, COLA and CLSI come from the customer's own license. LMOS does not bundle them or copy them between laboratories.

Design rule

Customers

Built with input from an informal network of laboratory directors. The first pilot cohort is forming.

Forming

How we word claims

We say designed to when something is a design intent, planned when it has not started, and in progress when work is under way. We do not describe anything as certified, approved or validated until the document that proves it exists. If you spot a statement on this site that runs ahead of that standard, tell us at hello@lmos.bio.

What is true today, and what is not yet.

How we word claims

Ask us the hard questions.