Company: DRTSW
Filing Date: 2025-03-12
Form Type: 20-F
Source: 0001213900-25-023187
Chunk: 36

Company: Alpha Tau Medical Ltd.
Filing Date: 2025-03-12
Form: 20-F
Item: Item 3
Chunk 36
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 or state healthcare program beneficiary if th...  

  the U. S. federal Health Insurance Portability and Accountability Act of 1996, or HIPAA, which imposes criminal and civil liability for, among other things, knowingly and willfully executing, o...  

  the FDCA, which prohibits, among other things, the adulteration or misbranding of drugs, biologics and medical devices;  

  the U. S. Physician Payments Sunshine Act and its implementing regulations, which require certain manufacturers of drugs, devices, biologics and medical supplies that are reimbursable under Med...  

  federal consumer protection and unfair competition laws, which broadly regulate marketplace activities and activities that potentially harm consumers;  

  analogous U. S. state laws and regulations, including: state anti-kickback and false claims laws, which may apply to our business practices, including but not limited to, research, distribution...  
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  similar healthcare laws and regulations in the EU and other jurisdictions, including reporting requirements detailing interactions with and payments to healthcare providers.  

Ensuring that our internal
operations and future business arrangements with third parties comply with applicable healthcare laws and regulations will involve substantial
costs. It is possible that governmental authorities will conclude that our business practices, including our relationships with physicians
and other healthcare providers, some of whom are compensated in the form of monetary payments and/or stock options for consulting services
provided, may not comply with current or future statutes, regulations, agency guidance or case law involving applicable fraud and abuse
or other healthcare laws and regulations.

If our operations are found
to be in violation of any of the laws described above or any other governmental laws and regulations that may apply to us, we may be subject
to significant penalties, including civil, criminal and administrative penalties, damages, fines, exclusion from government-funded healthcare
programs, such as Medicare and Medicaid or similar programs in other countries or jurisdictions, integrity oversight and reporting obligations
to resolve allegations of non-compliance, disgorgement, individual imprisonment, contractual damages, reputational harm, diminished profits
and the curtailment or restructuring of our operations. If any of the physicians or other providers or entities with whom we expect to
do business are found to not be in compliance with applicable laws, they may be subject to criminal, civil or administrative sanctions,
including exclusions from government funded healthcare programs and imprisonment,