Company: OCEA
Filing Date: 2025-04-08
Form Type: 10-K
Source: 0001641172-25-003155
Chunk: 2141

Company: Ocean Biomedical, Inc.
Filing Date: 2025-04-08
Form: 10-K
Item: Item 1A
Chunk 2141
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 or making any materially false,
fictitious or fraudulent statement in connection with the delivery of or payment for healthcare benefits, items or services. Like the
federal Anti-Kickback Statute, a person or entity does not need to have actual knowledge of the statute or specific intent to violate
it in order to have committed a violation.

The
Civil Monetary Penalties Statute imposes penalties against any person or entity that, among other things, is determined to have presented
or caused to be presented a claim to a federal health program that the person knows or should know is for an item or service that was
not provided as claimed or is false or fraudulent.

We
may be subject to data privacy and security regulations by both the federal government and the states in which we conduct our business.
HIPAA, as amended by HITECH, and their implementing regulations, mandates, among other things, the adoption of uniform standards for
the electronic exchange of information in common healthcare transactions, as well as standards relating to the privacy and security of
individually identifiable health information, which require the adoption of administrative, physical and technical safeguards to protect
such information. Among other things, HITECH makes HIPAA’s security standards directly applicable to business associates, defined
as independent contractors or agents of covered entities, which include certain health care providers, health plans, and healthcare clearinghouses,
that create, receive or obtain protected health information in connection with providing a service for or on behalf of a covered entity
and their covered subcontractors. HITECH also increased the civil and criminal penalties that may be imposed against covered entities
and 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 attorney’s fees and costs associated with pursuing federal civil actions. In addition,
certain state laws govern the privacy and security of health information in certain circumstances, some of which are more stringent than
HIPAA and many of which differ from each other in significant ways and may not have the same effect, thus complicating compliance efforts.
Failure to comply with these laws, where applicable, can result in the imposition of significant civil and criminal penalties.

Additionally,
the federal Physician Payments Sunshine Act, or the Sunshine Act, within the ACA, and its implementing regulations, require that certain
manufacturers of drugs, devices, biological and medical supplies for which payment is available under Medicare, Medicaid or the Children’s
Health Insurance Program (with certain exceptions) report annually to CMS