Company: BFRG
Filing Date: 2025-03-14
Form Type: 10-K
Source: 0001493152-25-010367
Chunk: 87

Company: BullFrog AI Holdings, Inc.
Filing Date: 2025-03-14
Form: 10-K
Item: Item 1
Chunk 87
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 Office must
determine that approval of the drug covered by the patent for which a patent extension is being sought is likely. Interim patent extensions
are not available for a drug for which an NDA has not been submitted.

Other
Healthcare Laws

In
the United States, biotechnology company activities are subject to regulation by various federal, state and local authorities in addition
to the FDA, including but not limited to, the Centers for Medicare & Medicaid Services (“CMS”), other divisions of the U.S. Department
of Health and Human Services (e.g., the Office of Inspector General and the Office for Civil Rights), the U.S. Department of Justice
(“DOJ”) and individual U.S. Attorney offices within the DOJ, and state and local governments. For example, research, sales, marketing,
and scientific/educational grant programs have to comply with the anti-fraud and abuse provisions of the Social Security Act, the federal
false claims laws, the privacy and security provisions of the Health Insurance Portability and Accountability Act (“HIPAA”) and similar
state laws, each as amended, as applicable.

Also,
many states have similar fraud and abuse statutes or regulations that apply to items and services reimbursed under Medicaid and other
state programs, or, in several states, apply regardless of the payor.

Data
privacy and security regulations by both the federal government and the states in which business is conducted may also be applicable.
HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act, or HITECH, and its implementing regulations,
imposes requirements relating to the privacy, security and transmission of individually identifiable health information. HIPAA requires
covered entities to limit the use and disclosure of protected health information to specifically authorized situations and requires covered
entities to implement security measures to protect health information that they maintain in electronic form. Among other things, HITECH
made HIPAA’s security standards directly applicable to business associates, independent contractors or agents of covered entities
that receive or obtain protected health information in connection with providing a service on behalf of a covered entity. HITECH also
created four 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. In addition, state laws
govern the privacy and security of health information