Company: BIAF
Filing Date: 2025-04-11
Form Type: S-1
Source: 0001641172-25-003892
Chunk: 36

Company: bioAffinity Technologies, Inc.
Filing Date: 2025-04-11
Form: S-1
Chunk 36
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, complete,
and accurate information to the FDA or foreign health authorities; (3) comply with manufacturing standards we have established; (4) comply
with healthcare fraud and abuse laws in the U.S. and similar foreign fraudulent misconduct laws; or (5) report financial information or
data accurately or to disclose unauthorized activities to us.

Our business operations and current and future relationships with investigators, healthcare professionals, consultants, third-party payors, and customers are subject, directly or indirectly, to federal and state healthcare fraud and abuse laws, transparency laws, and other healthcare laws and regulations. If we are unable to comply, or have not fully complied, with such laws, we could face substantial penalties.

Healthcare providers and others play a primary role
in the recommendation, ordering, and prescription of any diagnostic tests or therapeutic products for which we obtain marketing approval.
Our operations and current and future arrangements with investigators, healthcare professionals, customers, and third-party payors are
subject to various U.S. federal and state healthcare laws and regulations, including, without limitation, U.S. federal Anti-Kickback Statute,
the U.S. federal civil and criminal false claims laws, and the Physician Payments Sunshine Act and regulations. These laws may impact,
among other things, our current business operations, including our clinical research activities, and proposed sales, marketing, and education
programs and constrain the business of financial arrangements and relationships with healthcare providers and other parties through which
we may market, sell, and distribute our diagnostic tests or therapeutic products for which we obtain marketing approval. In addition,
we may be subject to additional healthcare, statutory, and regulatory requirements and enforcement by foreign regulatory authorities in
jurisdictions in which we conduct our business.

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Ensuring that our internal operations and future business
arrangements with third parties comply with applicable healthcare laws and regulations will involve substantial costs. It is possible
that governmental authorities will conclude that our business practices, including certain arrangements with physicians who receive stock,
warrants, or stock options as compensation for services provided to us, do not comply with current or future statutes, regulations, agency
guidance, or case law involving applicable fraud and abuse or other healthcare laws and regulations. If our operations are found to be
in violation of any of the laws described above or any other governmental laws and regulations that may apply to us, we may be subject
to significant penalties, including civil, criminal, and administrative penalties, damages, fines, exclusion from U.S. government-funded
healthcare programs,