Company: OCEA
Filing Date: 2025-04-08
Form Type: 10-K
Source: 0001641172-25-003155
Chunk: 3544

Company: Ocean Biomedical, Inc.
Filing Date: 2025-04-08
Form: 10-K
Item: Item 1A
Chunk 3544
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 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 payors, including private insurers, and
    may be broader in scope than their federal equivalents; state and foreign laws that require biopharmaceutical companies to comply
    with the biopharmaceutical industry’s voluntary compliance guidelines and the relevant compliance guidance promulgated by the
    federal government or otherwise restrict payments that may be made to healthcare providers and other potential referral sources;
    state and foreign laws that require drug manufacturers to report information related to payments and other transfers of value to
    physicians and other healthcare providers, marketing expenditures or drug pricing; state and local laws that require the registration
    of biopharmaceutical sales representatives; and state and foreign laws governing the privacy and security of health information in
    certain circumstances, many of which differ from each other in significant ways and