Company: BWAY
Filing Date: 2025-04-22
Form Type: 20-F
Source: 0001171843-25-002347
Chunk: 51

Company: Brainsway Ltd.
Filing Date: 2025-04-22
Form: 20-F
Item: Item 5
Chunk 51
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 or service          
  for which payment may be made, in whole or in part, by Medicare or a State healthcare program;                                             
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  HIPAA created additional federal criminal statutes that prohibit, among other things,                                                         

  the federal Physician Payments Sunshine Act under the Patient Protection and Affordable                                                       
  Care Act (PPACA), which requires certain manufacturers of drugs, medical devices, biologics and medical supplies for which payment is         
  available under Medicare, Medicaid or the Children’s Health Insurance Program (with certain exceptions) to report annually to the             
  United States Department of Health and Human Services, Centers for Medicare and Medicaid Services, information related to payments and        
  other transfers of value to physicians (defined to include doctors, dentists, optometrists, podiatrists and chiropractors) and teaching       
  hospitals, and applicable manufacturers and group purchasing organizations, as well as ownership and investment interests held by physicians  
  and their immediate family members. Since January 2022, applicable manufacturers are also required to report information regarding payments   
  and transfers of value provided to physician assistants, nurse practitioners, clinical nurse specialists, certified nurse anesthetists,       
  and certified nurse-midwives;                                                                                                                 
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  HIPAA, as amended by HITECH, and their respective implementing regulations, impose                                                              
  privacy, security, and breach reporting obligations with respect to PHI upon entities subject to the law, such as health plans, healthcare      
  clearinghouses and certain healthcare providers and their respective business associates that perform services on their behalf that involve     
  PHI. HITECH also created new tiers of civil monetary penalties, amended HIPAA to make HIPAA compliance as well as 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 HIPAA laws and seek attorneys’ fees and costs associated with pursuing federal civil actions; and              
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  analogous state and foreign law equivalents of each of the above federal laws, such                                                             
  as anti-kickback and false claims laws which may apply to items or services reimbursed by any third-party payor, including commercial           
  insurers or patients