Company: OCEA
Filing Date: 2025-04-08
Form Type: 10-K
Source: 0001641172-25-003155
Chunk: 2546

Company: Ocean Biomedical, Inc.
Filing Date: 2025-04-08
Form: 10-K
Item: Item 1
Chunk 2546
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, state and third-party reimbursement for our products, and the sale and marketing of our product candidates, are subject to scrutiny
under this law.

56

HIPAA
created new federal criminal statutes that prohibit among other things, knowingly and willfully executing, or attempting to execute,
a scheme to defraud or to obtain, by means of false or fraudulent pretenses, representations or promises, any money or property owned
by, or under the control or custody of, any healthcare benefit program, including private third party payors, knowingly and willfully
embezzling or stealing from a healthcare benefit program, willfully obstructing a criminal investigation of a healthcare offense, and
knowingly and willfully falsifying, concealing or covering up by trick, scheme or device, a material fact 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