Company: BIAF
Filing Date: 2025-03-31
Form Type: 10-K
Source: 0001641172-25-001840
Chunk: 187

Company: bioAffinity Technologies, Inc.
Filing Date: 2025-03-31
Form: 10-K
Item: Item 1A
Chunk 187
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, which could control or significantly influence
the purchase of healthcare services, diagnostics, and drugs, as well as legislative proposals to reform healthcare or reduce government
insurance programs, may all result in lower prices for or rejection of our tests or products.

Our
employees, independent contractors, consultants, commercial partners, and vendors may engage in misconduct or other improper activities,
including noncompliance with regulatory standards and requirements.

Our
business operations and current and future relationships with investigators, healthcare professionals, consultants, third-party payors,
and customers will be subject, directly or indirectly, to federal and state healthcare fraud and abuse laws, false claims laws, health
information privacy and security 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. We are exposed to the risk of employee fraud or other illegal activity by our employees,
independent contractors, consultants, commercial partners, vendors, and agents acting on behalf of us or our affiliates. Misconduct by
these parties could include intentional, reckless, and/or negligent conduct that fails to (1) comply with the regulations of the FDA
or foreign health authorities; (2) provide true, 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.

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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