Company: RGNT
Filing Date: 2025-01-27
Form Type: DRS/A
Source: 0001213900-25-006676
Chunk: 63

Company: REGENTIS BIOMATERIALS LTD.
Filing Date: 2025-01-27
Form: DRS/A
Chunk 63
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 adverse effect on our business.

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HIPAA requires Covered Entities
(like many of our potential customers) and business associates, like us, to develop and maintain policies and procedures with respect
to protected health information that is used or disclosed, including the adoption of administrative, physical and technical safeguards
to protect such information HITECH expands the notification requirement for breaches of patient-identifiable health information, restricts
certain disclosures and sales of patient-identifiable health information and provides for civil monetary penalties for HIPAA violations.
HITECH also increased the civil and criminal penalties that may be imposed against Covered Entities and business associates and gave state
attorneys general new authority to file civil actions for damages or injunctions in federal courts to enforce HIPAA and its implementing
regulations and seek attorney’s fees and costs associated with pursuing federal civil actions. Additionally, certain states have
adopted comparable privacy and security laws and regulations, some of which may be more stringent than HIPAA.

Internationally, many jurisdictions
have or are considering enacting privacy or data protection laws or regulations relating to the collection, use, storage, transfer, disclosure
and/or other processing of personal data, as well as certification requirements for the hosting of health data specifically. Such laws
and regulations may include data hosting, data residency or data localization requirements (which generally require that certain types
of data collected within a certain country be stored and processed within that country), data export restrictions, international transfer
laws (which prohibit or impose conditions upon the transfer of such data from one country to another), or may require companies to implement
privacy or data protection and security policies, enable users to access, correct and delete personal data stored or maintained by such
companies, inform individuals of security breaches that affect their personal data or obtain individuals’ consent to use their personal
data. For example, European legislators adopted the EU’s General Data Protection Regulation (2016/679), or the GDPR, which became
effective on May 25, 2018, and are now in the process of finalizing the ePrivacy Regulation to replace the European ePrivacy Directive
(Directive 2002/58/EC as amended by Directive 2009/136/EC). The GDPR, supplemented by national laws and further implemented through binding
guidance from the European Data Protection Board, imposes more stringent EU data protection requirements and provides for significant
penalties for noncompliance.

Further, the United Kingdom’s
initiating a process to leave the