Living regulatory intelligence for public health laboratories

Public health laboratories do not experience regulation as a PDF that arrives once a decade. They experience it as an assay that must be stood up for a new threat, a screening list that updates monthly, a fee schedule that moves, and a surveyor who asks for the version that was in force on the day the result was released. A static binder can be excellent on the day it is signed and wrong by the next quarter.

Living regulatory intelligence, as this site uses the phrase, is the practice of watching CMS CLIA, OIG exclusion rules, CDC and APHL guidance, state reportable lists, and court outcomes, then writing down what changed in operational language. The regulatory page is that log. Each entry has a source, an impact area, a summary, an implication for the laboratory, a primary link, and a reviewed date. The point is not to impress a reader with volume. The point is that a director can see the delta without rereading the entire quality manual.

Salus does not claim to have ingested every guidance document in public health. The public log is the set of changes the site is willing to stand behind. If a topic is absent, the honest statement is that it is absent, not that the laboratory has nothing to do.

On 31 March 2025 the Eastern District of Texas vacated the FDA final rule that had treated laboratory-developed tests as medical devices. The site records that the government did not appeal and that in September 2025 FDA implemented the vacatur and reverted the IVD definition. The operational implication the log draws is narrow and important. LDTs remain under CLIA, administered through the CLIA program, not under that vacated device pathway. Flexibility does not retire analytic validation, personnel competency, proficiency testing, or documentation. A laboratory that treats the vacatur as permission to stop writing packets will still have a survey finding.

In July 2026 CMS, working with CDC, issued a request for information on modernizing CLIA. The topics the log lists are AI in post-analytic work, next-generation sequencing performance characteristics, cybersecurity and operational resilience, emergency preparedness, biosafety, and specialty testing. A request for information is not a final rule. The log's advice is to document those topics now, because the questions are already a preview of what a quality system is expected to be able to explain. Name any model, what it may draft, and what it is forbidden to do. Version a bioinformatics pipeline the way you version an SOP. Write the surge and outage plan before the week you need it.

The LEIE entry is standing, not a news event. Under 42 CFR 1001.1901, no payment may be made under Medicare, Medicaid, or other federal health care programs for items or services furnished, ordered, or prescribed by an excluded individual or entity. The log says screening extends to employees, contractors, and certain vendors, that LEIE updates monthly, and that SAM is complementary rather than a substitute. A public health laboratory that touches federal program funds needs a repeatable workflow. Global Hands can support the workflow and the evidence package. It does not itself bill those programs or perform testing.

Two further entries keep the menu honest. PAMA data collection and the Clinical Laboratory Fee Schedule continue to create multi-year uncertainty. The log says that, absent congressional action, reductions on the order of 15 percent remain possible on hundreds of tests. That is a planning note, not a forecast Salus is guaranteeing. ELC and PHEP cooperative agreements still shape respiratory, antimicrobial resistance, foodborne, vector-borne, biothreat, and data-modernization work. A living menu should show which assays are grant-aligned, which are readiness plays, and which are isolate-submission obligations.

Intelligence that never reaches the bench is a newsletter. The workbench turns a catalog entry into a CLIA-shaped validation or verification outline and an SOP skeleton: principle, specimen, reagents, procedure, quality control, reporting, limitations, and a competency checklist keyed to the method. Jurisdictional mapping starts from a federal baseline and leaves an explicit placeholder for the state overlay, including reportable condition, isolate submission, and timing. The state overlay is the laboratory's to complete. The product does not pretend to have enacted your state's list.

The 'what changed this week' tool is a synthesis of the log into suggested actions. The workbench page says suggestions are not instructions. A director still decides. In the product, a draft is stored, queued, and accepted or rejected by a person. Nothing in that queue is an operational commitment until the human gate fires. The kill switch is a reject, written down, not a mood.

The same discipline applies when the change is about software rather than an assay. If a model is in the post-analytic path, the quality system should already be able to say what the model may draft and what a human must do before a result, a claim, or a notification leaves. The CLIA request for information is the reason to write that down. Salus surfaces the expectation. It does not certify that your laboratory met it.

It is not a legal opinion. Primary sources are linked so a director, counsel, or survey consultant can read the document itself. URLs move. A reviewed date on an entry is the date the note was checked, not a promise that the agency has frozen the page.

It is not a compliance warranty. The platform page lists 'guarantee compliance, readiness, or a clean survey' among the things Salus does not do. Exportable evidence can make a survey week less of a scramble. The survey outcome belongs to the laboratory and the surveyor.

It is not a medical-device determination about Salus. The LDT entry is about how laboratories regulate their own tests after the vacatur. It is not a claim that this software is a certified medical device, and it is not a claim that the software diagnoses a patient. Decision support only. Local CLIA certification, state law, and medical director judgment control.

It is not a feed from any other company's regulatory product. JIL Sovereign Technologies, Inc. operates this host. salusagentic.com is part of JIL Sovereign Technologies, Inc., a Delaware corporation. SalusAgentic is a trade name of that company. JIL Sovereign Holdings, LLC (WY) owns the SalusAgentic software. Global Hands, Inc. (TX) gave a grant to JIL Sovereign Holdings, LLC (WY) to build salusagentic.com under its public good initiative. The cost to build SalusAgentic was greater than what Global Hands paid. Global Hands may benefit from the software because it gave Holdings that money. JIL Sovereign Technologies, Inc. (DE) operates salusagentic.com. Holdings owns the rights, maintains the code, provides Level 1 support, and does not operate the code. Global Hands, Inc. does not operate this site. The change log is part of Salus Agentic, the public-health laboratory product. JIL Sovereign Technologies, Inc. operates this host and does not own the software.