Company: BWAY
Filing Date: 2025-04-22
Form Type: 20-F
Source: 0001171843-25-002347
Chunk: 52

Company: Brainsway Ltd.
Filing Date: 2025-04-22
Form: 20-F
Item: Item 5
Chunk 52
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; state laws that require medical device companies to comply with the industry’s voluntary compliance guidelines            
  and the applicable compliance guidance promulgated by the federal government or otherwise restrict payments that may be made to healthcare      
  providers and other potential referral sources; state and local laws that require the licensure of sales representatives; state laws that       
  require medical device manufacturers to report information related to payments and other transfers of value to physicians and other healthcare  
  providers or marketing expenditures and pricing information; data privacy and security laws and regulations in foreign jurisdictions that       
  may be more stringent than those applicable to us in the United States; state laws governing the privacy and security of health information     
  in certain circumstances, many of which differ from each other in significant ways and may not have the same effect, thus complicating          
  compliance efforts; and state laws related to insurance fraud in the case of claims involving private insurers.                                 
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These laws and regulations, among other things, constrain
our business, marketing, and other promotional activities by limiting the kinds of financial arrangements, including sales programs, we
may have with physicians or other potential purchasers of our products. We also entered into consulting agreements with physicians, which
are subject to these laws. Further, while we do not submit claims and our customers will make the ultimate decision on how to submit claims,
we may provide reimbursement guidance and support regarding our products. Due to the breadth of these laws, the narrowness of statutory
exceptions and regulatory safe harbors available, and the range of interpretations to which they are subject, it is possible that some
of our current or future practices might be challenged under one or more of these laws.

To enforce compliance with healthcare regulatory
laws, certain enforcement bodies have recently increased their scrutiny of interactions between healthcare companies and healthcare providers,
which has led to a number of investigations, prosecutions, convictions and settlements in the healthcare industry. For example, U. S. federal
and state regulatory and enforcement agencies continue to actively investigate violations of healthcare laws and regulations, including
pursuing novel theories of liability under these laws. These government agencies have recently increased regulatory scrutiny and enforcement
activity with respect to manufacturer reimbursement support activities and patient support programs, including bringing criminal charges
or civil enforcement actions under the federal healthcare Anti-Kickback statute, federal civil False Claims Act, the healthcare fraud
statute, and the HIPAA privacy provisions. Responding