Company: CERO
Filing Date: 2025-04-15
Form Type: 10-K
Source: 0001213900-25-032134
Chunk: 1656

Company: CERO THERAPEUTICS HOLDINGS, INC.
Filing Date: 2025-04-15
Form: 10-K
Item: Item 1A
Chunk 1656
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ly, we are, or may become, subject to numerous federal, state, local and international data privacy and data security laws, regulations,
guidance, and industry standards as well as external and internal privacy and data security policies, contracts and other obligations
that apply to our processing of personal data and the processing of personal data on our behalf.

In the United States, federal,
state, and local governments have enacted numerous data privacy and security laws, including data breach notification laws, personal data
privacy laws, consumer protection laws and other similar laws (e.g., unfair or deceptive acts or practices pursuant to Section 5(a) of
the Federal Trade Commission Act). For example, HIPAA, as amended by the Health Information Technology for Economic and Clinical Health
Act (“HITECH”), and their respective implementing regulations, imposes requirements relating to the privacy, security and
transmission of protected health information. Among other things, HITECH, through its implementing regulations, makes certain of HIPAA’s
privacy and security standards directly applicable to business associates, defined as a person or organization, other than a member of
a covered entity’s workforce, that creates, receives, maintains or transmits protected health information for or on behalf of a
covered entity for a function or activity regulated by HIPAA as well as their covered subcontractors.

In addition, the California Consumer Privacy Act (“CCPA”),
as amended by the California Privacy Rights Act, applies to personal information of consumers, business representatives, and employees,
and creates individual privacy rights and places increased privacy and security obligations on entities handling personal data of consumers
or households. The CCPA requires covered companies to provide disclosures to California consumers, affords California residents certain
rights related to their personal data, including the right to opt-out of certain sales of personal data, and allow for a private cause
of action for certain data breaches. The CCPA also created a new state regulatory agency to implement and enforce the law. Although there
are limited exemptions for clinical trial data under the CCPA, as our business progresses, the CCPA may become applicable and significantly
impact our business activities and exemplifies the vulnerability of our business to evolving regulatory environment related to personal
data and protected health information. In addition, several other states have also passed comprehensive privacy laws, and similar laws
are being considered in additional states, as well as at the federal and local levels. While these states, like the CCPA, also exempt
some data processed in the context of clinical trials, these developments further complicate