Company: BIAF
Filing Date: 2025-04-11
Form Type: S-1
Source: 0001641172-25-003892
Chunk: 34

Company: bioAffinity Technologies, Inc.
Filing Date: 2025-04-11
Form: S-1
Chunk 34
---
, 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.

| 15 |

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. Recently, there has been an increase in public awareness of privacy
issues in the wake of revelations about the data collection activities of various government agencies and in the number of private privacy-related
lawsuits filed against companies. Concerns about our practices with regard to the collection, use, retention, disclosure, or security
of personal information or other privacy-related matters, even if unfounded and even if we are in compliance with applicable laws, could
damage our reputation and harm our business.

If we are unable to obtain adequate reimbursement from third-party payors or governmental agencies for CyPath ®Lung or other diagnostic tests or therapeutic products under development or if new restrictive legislation is adopted, market acceptance of our tests or products may be limited, and we may not achieve expected revenues.

The continuing efforts of government and insurance
companies, health maintenance organizations (“HMOs”), and other pay