Company: PTHS
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001753926-25-000503
Chunk: 83

Company: Pelthos Therapeutics Inc.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1
Chunk 83
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 program, regardless of the payor (e.g., public or private);

    ●
    HIPAA, as amended
    by HITECH, and its implementing regulations, and as amended again by the final HIPAA omnibus rule, Modifications to the HIPAA
    Privacy, Security, Enforcement, and Breach Notification Rules under HITECH and the Genetic Information Nondiscrimination Act;

    ●
    other modifications
    to HIPAA, which imposes certain requirements relating to the privacy, security and transmission of individually identifiable
    health information without appropriate authorization by entities subject to the rule, such as health plans, health care clearinghouses
    and health care providers.

    ●
    federal transparency
    laws, including the federal Physician Payment Sunshine Act, that require certain manufacturers of drugs, devices, biologics
    and medical supplies for which payment is available under Medicare, Medicaid or the Children’s Health Insurance Program,
    with specific exceptions, to report annually to the CMS information related to: (i) payments or other “transfers of
    value” made to physicians and teaching hospitals and (ii) ownership and investment interests held by physicians and
    their immediate family members;

48 

    ●
    state and foreign
    law equivalents of each of the above federal laws, state laws that require drug manufacturers to report information related
    to payments and other transfers of value to physicians and other healthcare providers or marketing expenditures and state
    laws governing the privacy and security of health information in certain circumstances, many of which differ from each other
    in significant ways and may not have the same effect, thus complicating compliance efforts in certain circumstances, such
    as specific disease states; and

    ●
    state and foreign
    laws that govern the privacy and security of health information in some circumstances, many of which differ from each other
    in significant ways and often are not enrollment by HIPAA, thus complicating compliance efforts.

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. If our operations are found to be in
violation of any of the laws described above or any other government 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