Company: BIAF
Filing Date: 2025-03-31
Form Type: 10-K
Source: 0001641172-25-001840
Chunk: 56

Company: bioAffinity Technologies, Inc.
Filing Date: 2025-03-31
Form: 10-K
Item: Item 1
Chunk 56
---
Path® Lung as a commercialized LDT to be sold by our CAP-accredited, CLIA-certified clinical pathology laboratory PPLS,
in the future we may not be able to obtain or maintain adequate product liability insurance, when needed, on acceptable terms, if at all,
or such insurance may not provide adequate coverage against our potential liabilities. Furthermore, potential partners with whom we intend
to have collaborative or strategic agreements or our future licensees may not be willing to indemnify us against these types of liabilities
and may not themselves be sufficiently insured or have sufficient liquidity to satisfy any product liability claims. Claims or losses
in excess of any product liability insurance coverage that we may obtain could have a material adverse effect on our business, financial
condition, and results of operations.

In
addition, we may be unable to obtain or to maintain clinical trial liability insurance on acceptable terms, if at all. Any inability
to obtain and/or maintain insurance coverage on acceptable terms could prevent or limit the commercialization of any tests or products
we develop.

Our
collection, use, and disclosure of personal information, including health and employee information, is subject to U.S. state and federal
privacy and security regulations, and our failure to comply with those regulations or to adequately secure the information we hold could
result in significant liability or reputational harm.

The
privacy and security of personal information stored, maintained, received, or transmitted, including electronically, is a major issue
in the U.S. and abroad. Numerous federal and state laws and regulations, including state privacy, data security and breach notification
laws, federal and state consumer protection and employment laws, the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”),
as amended by the Health Information Technology for Economic and Clinical Health Act of 2009, and the Genetic Information Nondiscrimination
Act of 2008, govern the collection, dissemination, use, and confidentiality of personal information, including genetic, biometric, and
health information. These laws and regulations are increasing in complexity and number, may change frequently, and sometimes conflict.
Penalties for violations of these laws vary but can be severe.

While
we strive to comply with all applicable privacy and security laws and regulations, including our own posted privacy policies, these laws
and regulations continue to evolve, and any failure or perceived failure to comply may result in proceedings or actions against us by
government entities or others or could cause us to lose customers, which could have a material adverse effect on our business