Company: BDRX
Filing Date: 2025-01-17
Form Type: F-1
Source: 0001214659-25-000922
Chunk: 207

Company: Biodexa Pharmaceuticals Plc
Filing Date: 2025-01-17
Form: F-1
Chunk 207
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 federal or state governmental program;                                          |

| • | the federal Health Insurance Portability and Accountability Act of 1996, or HIPAA, imposes criminal and                                     
 civil liability for executing a scheme to defraud any healthcare benefit program or making false statements relating to healthcare matters; |

| • | HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act and its implementing                                  
 regulations, also imposes obligations, including mandatory contractual terms, with respect to safeguarding the privacy, security and transmission 
 of individually identifiable health information;                                                                                                  |

| • | the federal false statements statute prohibits knowingly and willfully falsifying, concealing or covering                                
 up a material fact or making any materially false statement in connection with the delivery of or payment for healthcare benefits, items 
 or services;                                                                                                                             |

| • | the federal transparency requirements of the Physician Payment Sunshine Act, which requires manufacturers                                    
 of drugs, devices, biologics and medical supplies covered by Medicare, Medicaid or a state plans under CHIPs to report to the Centers        
 for Medicaid Services, or CMS, information related to payments and other transfers of value to physicians, certain non-physician advanced    
 healthcare practitioners, and teaching hospitals or to entities or individuals at the request of, or designated on behalf of, the physicians 
 and teaching hospitals as well as certain ownership and investment interests held by physicians and their immediate family members; and      |

| 102 |

| • | analogous state and foreign laws and regulations, such as state anti-kickback and false claims laws, may                              
 apply to sales or marketing arrangements and claims involving healthcare items or services reimbursed by non-governmental third-party 
 payors, including private insurers.                                                                                                   |

Additionally, similar healthcare
laws and regulations in the European Union, United Kingdom and other jurisdictions, including reporting requirements detailing interactions
with and payments to healthcare providers and laws governing the privacy and security of certain protected information, such as GDPR and
UK GDPR, which imposes obligations and restrictions on the collection and use of personal data relating to individuals located in the
European Union (including health data).

Finally, the majority of states
also have statutes or regulations similar to the aforementioned federal laws, some of which are broader in scope and apply to items and
services reimbursed under Medicaid and other state programs, or, in several states, apply regardless of the payor. Some state laws require
pharmaceutical companies to comply with the pharmaceutical industry’s voluntary compliance guidelines and the relevant compliance
guidance promulgated by the federal government