Company: DRTSW
Filing Date: 2025-03-12
Form Type: 20-F
Source: 0001213900-25-023187
Chunk: 181

Company: Alpha Tau Medical Ltd.
Filing Date: 2025-03-12
Form: 20-F
Item: Item 4
Chunk 181
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 and services, which could result in reduced demand for our products or additional pricing
pressure.

For instance, on December
13, 2021, the EU Regulation No 2021/2282 on Health Technology Assessment, or HTA, amending Directive 2011/24/EU, was adopted. The Regulation
entered into force in January 2022 and has been applicable since January 2025, with phased implementation based on the type of product
i. e., certain high-risk medical devices as of 2026. The Regulation intends to boost cooperation among EU member states in assessing health
technologies, including certain high-risk medical devices, and providing the basis for cooperation at the EU level for joint clinical
assessments in these areas. It will permit EU member states to use common HTA tools, methodologies, and procedures across the EU, working
together in four main areas, including joint clinical assessment of the innovative health technologies with the highest potential impact
for patients, joint scientific consultations whereby developers can seek advice from HTA authorities, identification of emerging health
technologies to identify promising technologies early, and continuing voluntary cooperation in other areas. Individual EU member states
will continue to be responsible for assessing non-clinical (e. g., economic, social, ethical) aspects of health technologies, and making
decisions on pricing and reimbursement.

Data Privacy and Security Laws

Numerous state, federal and
foreign laws, regulations and standards govern the collection, use, access to, confidentiality and security of health-related and other
personal information, and could apply now or in the future to our operations or the operations of our partners. In the United States,
numerous federal and state laws and regulations, including data breach notification laws, health information privacy and security laws
and consumer protection laws and regulations govern the collection, use, disclosure, and protection of health-related and other personal
information. In addition, certain foreign laws govern the privacy and security of personal data, including health-related data. Privacy
and security laws, regulations, and other obligations are constantly evolving, may conflict with each other to complicate compliance efforts,
and can result in investigations, proceedings, or actions that lead to significant civil and/or criminal penalties and restrictions on
data processing.

  Organizational Structure  
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Alpha Tau Medical Ltd. was
incorporated in 2015 under the Israel Companies Law of the State of Israel and commenced operations on that date.

We have three wholly-owned
subsidi