Company: APM
Filing Date: 2025-11-17
Form Type: F-1
Source: 0001213900-25-111548
Chunk: 169

Company: Aptorum Group Ltd
Filing Date: 2025-11-17
Form: F-1
Chunk 169
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 HIPAA impose criminal liability                                                                        
 for, among other things, knowingly and willfully (i) executing (or attempting to execute) a scheme to defraud any health care benefit       
 program, including private payers, or (ii) falsifying, concealing or covering up a material fact or making any materially false,            
 fictitious or fraudulent statement in connection with the delivery of or payment for items or services under a health care benefit program. |

| ● | HIPAA, as amended by the Health Information Technology for Economic                                                                      
 and Clinical Health Act of 2009, which also restricts the use and disclosure of protected health information, mandates the               
 adoption of standards relating to the privacy and security of protected health information, and requires us to report certain security   
 breaches to health care provider customers with respect to such information where DiamiR is acting as a HIPAA business associate to that 
 customer.                                                                                                                                |

| ● | The federal Physician Payment Sunshine Act, which requires applicable                                                                    
 manufacturers of certain medical devices that may be reimbursed by Medicare, Medicaid, or the Children’s Health Insurance Program,       
 among others, to annually track and report payments or other transfers of value provided to U.S. licensed physicians, physician          
 assistants, nurse practitioners, clinical nurse specialists, certified nurse anesthetists, anesthesiologist assistants and certified     
 nurse-midwives, and U.S. teaching hospitals, as well as certain ownership and investment interest held in the manufacturer by physicians 
 and their immediate family members.                                                                                                      |

Similar requirements have been adopted by many states and foreign countries. Violations of any of these laws can lead to additional legal risk such as risk of plaintiff class actions, state Attorney General actions, and investigations by the Federal Trade Commission, among others. Failure to comply with applicable requirements, or later discovery of previously unknown problems with DiamiR’s products or manufacturing processes, including DiamiR’s failure or the failure of one of DiamiR’s contract manufacturers to take satisfactory corrective action in response to an adverse inspection, can result in, among other things:

| ● | administrative or judicially imposed sanctions; |

| ● | injunctions or the imposition of civil penalties; |

| ● | recall or seizure of DiamiR’s products; |

| ● | corrective field actions for DiamiR’s products; |

| ● | submission of reports to FDA or other regulatory authorities; |

| ● | total or partial suspension of production or distribution; |

93

| ● | withdrawal or suspension of marketing clearances or