Company: RGNT
Filing Date: 2025-07-07
Form Type: F-1/A
Source: 0001213900-25-061821
Chunk: 61

Company: REGENTIS BIOMATERIALS LTD.
Filing Date: 2025-07-07
Form: F-1/A
Chunk 61
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, or their interpretation, or any changes regarding the manner in which the consent of
relevant users for the collection, use, retention, or disclosure of such data must be obtained, could increase our costs and require
us to modify our services and candidate products, possibly in a material manner, which we may be unable to complete, and may limit our
ability to store and process patients’ data or develop new services and features.

In particular, we will be
subject to U.S. data protection laws and regulations (i.e., laws and regulations that address privacy and data security) at both the
federal and state levels. The legislative and regulatory landscape for data protection continues to evolve, and in recent years there
has been an increasing focus on privacy and data security issues. Numerous federal and state laws, including state data breach notification
laws, state health information privacy laws, and federal and state consumer protection laws, govern the collection, use, and disclosure
of health-related and other personal information. Failure to comply with such laws and regulations could result in government enforcement
actions and create liability for us (including the imposition of significant civil or criminal penalties), private litigation and/or
adverse publicity that could negatively affect our business. For instance, California enacted the California Consumer Privacy Act, or
the CCPA, on June 28, 2018, which took effect on January 1, 2020. The CCPA creates individual privacy rights for California consumers
and increases the privacy and security obligations of entities handling certain personal data. The CCPA provides for civil penalties
for violations, as well as a private right of action for data breaches that is expected to increase data breach litigation. The CCPA
may increase our compliance costs and potential liability, and many similar laws have been proposed at the federal level and in other
states.

In addition, we expect to
obtain health information that are subject to privacy and security requirements under HITECH and its implementing regulations. The Privacy
Standards and Security Standards under HIPAA establish a set of standards for the protection of individually identifiable health information
by health plans, health care clearinghouses and certain health care providers, referred to as Covered Entities, and the business associates
with whom Covered Entities enter into service relationships pursuant to which individually identifiable health information may be exchanged.
Notably, whereas HIPAA previously directly regulated only Covered Entities, HITECH makes certain of HIPAA’s privacy and security
standards also directly applicable to Covered Entities’ business associates. As a result, both