Company: BIAF
Filing Date: 2025-03-31
Form Type: 10-K
Source: 0001641172-25-001840
Chunk: 67

Company: bioAffinity Technologies, Inc.
Filing Date: 2025-03-31
Form: 10-K
Item: Item 1
Chunk 67
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 impact our ability to generate revenue.

PPLS
relies on commercial courier delivery services to transport sputum samples for processing the CyPath® Lung test in a timely
and cost-efficient manner, and if these delivery services are disrupted, its business will be harmed.

PPLS’
business depends on its ability to quickly and reliably deliver test results to its customers. Sputum samples are received overnight
within the U.S. for analysis at the laboratory facility located in San Antonio, Texas. Disruptions in delivery service, whether due to
bad weather, natural disaster, terrorist acts or threats, or for other reasons could adversely affect specimen integrity and its ability
to process samples in a timely manner and to service its customers, and ultimately its reputation and its business. In addition, if PPLS
is unable to continue to obtain expedited delivery services on commercially reasonable terms, its operating results may be adversely
affected.

 34 

Security
breaches, loss of data, and other disruptions could compromise sensitive information related to PPLS’ business or prevent it from
accessing critical information and expose it to liability, which could adversely affect its business and reputation.

In
the ordinary course of its business, PPLS collects and stores sensitive data, including legally protected health information, credit
card information, and personally identifiable information, such as data collected in connection with the CyPath® Lung
laboratory test results. PPLS also stores sensitive intellectual property and other proprietary business information, including that
of its customers, payors, and collaboration partners. PPLS manages and maintains its applications and data utilizing a combination of
on-site systems, managed data center systems, and cloud-based data center systems. These applications and data encompass a wide variety
of business-critical information, including research and development information, commercial information, and business and financial
information. PPLS is highly dependent on information technology networks and systems, including the internet, to securely process, transmit,
and store this critical information. Although its policies and practices adhere to the requirements of HIPAA and PPLS employs measures
to protect sensitive information from unauthorized access or disclosure, its information technology and infrastructure, and that of its
third-party billing and collections provider, may be vulnerable to attacks by hackers or viruses or breached due to employee error, malfeasance,
or other disruptions.

A
security breach or privacy violation that leads to disclosure or modification of or prevents access to patient information, including
personally identifiable information or protected