Company: XAIR
Filing Date: 2025-06-20
Form Type: 10-K
Source: 0001641172-25-015750
Chunk: 760

Company: Beyond Air, Inc.
Filing Date: 2025-06-20
Form: 10-K
Item: Item 1A
Chunk 760
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 parties will comply with applicable healthcare laws and regulations will involve substantial costs. Because of
the breadth of these laws and the narrowness of the statutory exceptions and safe harbors available, it is possible that some of our business
activities could be subject to challenge under one or more of such laws. The scope and enforcement of these laws is uncertain and subject
to change in the current environment of health care reform. We cannot predict the impact on our business of any changes in these laws.
Federal or state regulatory authorities may challenge our current or future activities under these laws. Any such challenge, even if we
are able to successfully defend against it, could have a material adverse effect on our reputation, business, results of operations, and
financial condition. Any state or federal regulatory review of us, regardless of the outcome, would be costly and time-consuming. If our
operations are found to be in violation of any of the laws described above or any other governmental regulations that apply to us, we
may be subject to penalties, including civil and criminal penalties, damages, fines, exclusion from participation in government health
care programs, such as Medicare and Medicaid, imprisonment and the curtailment or restructuring of our operations, any of which could
adversely affect our ability to operate our business and our results of operations.

39

If we fail to comply with
applicable privacy, data protection and data security laws and regulations, we could face substantial penalties, liability and adverse
publicity and our business, operations and financial condition could be adversely affected.

We are subject to various laws
and regulations globally regarding privacy and data protection, including laws and regulations relating to the collection, storage, handling,
use, disclosure, transfer and security of personal data. The restrictions under applicable privacy, data protection and data security
laws and regulations that may affect our ability to operate include but are not limited to:

    ●
    HIPAA governs the use, disclosure, and security of protected health information by HIPAA “covered entities” and their “business associates.” Covered entities are health plans, health care clearinghouses and health care providers that engage in specific types of electronic transactions. A business associate is any person or entity (other than members of a covered entity’s workforce) that performs a service for or on behalf of a covered entity involving the use or disclosure of protected health information. Most healthcare providers who prescribe our products and from whom we obtain patient health information are subject to privacy and security requirements under HIPAA, as are we in certain circumstances. The U