Company: OCEA
Filing Date: 2025-04-08
Form Type: 10-K
Source: 0001641172-25-003155
Chunk: 2649

Company: Ocean Biomedical, Inc.
Filing Date: 2025-04-08
Form: 10-K
Item: Item 1
Chunk 2649
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 material fact or making any materially false statements in connection
    with the delivery of, or payment for, healthcare benefits, items or services relating to healthcare matters. Similar to the federal
    AKS, a person or entity can be found guilty of violating HIPAA without actual knowledge of the statute or specific intent to violate
    it;

    ●
    HIPAA,
    as amended by the Health Information Technology for Economic and Clinical Health Act of 2009, or HITECH, and their respective implementing
    regulations, which impose, among other things, requirements relating to the privacy, security and transmission of individually identifiable
    health information on certain covered healthcare providers, health plans, and healthcare clearinghouses, known as covered entities,
    as well as their respective “business associates,” those independent contractors or agents of covered entities that perform
    services for covered entities that involve the creation, use, receipt, maintenance or disclosure of individually identifiable health
    information. HITECH also created new tiers of civil monetary penalties, amended HIPAA to make civil and criminal penalties directly
    applicable to business associates, and gave state attorneys general new authority to file civil actions for damages or injunctions
    in federal courts to enforce the federal HIPAA laws and seek attorneys’ fees and costs associated with pursuing federal civil
    actions;

    ●
    the
    federal Physician Payments Sunshine Act, created under the ACA, and its implementing regulations, which require some manufacturers
    of drugs, devices, biologics and medical supplies for which payment is available under Medicare, Medicaid or the Children’s
    Health Insurance Program (with certain exceptions) to report annually to CMS information related to payments or other transfers of
    value made to physicians (defined to include doctors, dentists, optometrists, podiatrists and chiropractors) and teaching hospitals,
    as well as ownership and investment interests held by physicians and their immediate family members. Effective January 1, 2022, these
    reporting obligations will extend to include transfers of value made in the previous year to certain non-physician providers such
    as physician assistants and nurse practitioners;

    ●
    federal
    consumer protection and unfair competition laws, which broadly regulate marketplace activities and activities that potentially harm
    consumers; and

    ●
    analogous
    state and foreign laws and regulations, such as state anti-kickback and false claims laws, which may apply to sales or marketing
    arrangements and claims involving healthcare items or services reimbursed by third-party