Company: BLRX
Filing Date: 2025-03-31
Form Type: 20-F
Source: 0001178913-25-001123
Chunk: 209

Company: BioLineRx Ltd.
Filing Date: 2025-03-31
Form: 20-F
Item: Item 4
Chunk 209
---
 Portability and Accountability                                        
    Act of 1996, or HIPAA, which created additional federal criminal laws that prohibit, among other things, knowingly and willingly executing,
       or attempting to execute, a scheme or making false statements in connection with the delivery of or payment for health care benefits,   
                                                                items, or services;                                                            
-----------------------------------------------------------------------------------------------------------------------------------------------

•                                           HIPAA, as amended by the Health Information Technology for                                        
    Economic and Clinical Health Act and its implementing regulations, which also imposes obligations, including mandatory contractual terms, 
     with respect to safeguarding the privacy, security and transmission of individually identifiable health information on covered entities  
    and their business associates that associates that perform certain functions or activities that involve the use or disclosure of protected
                                                       health information on their behalf;                                                    
----------------------------------------------------------------------------------------------------------------------------------------------

•                                         the Foreign Corrupt Practices Act, or FCPA, which prohibits                                       
    companies and their intermediaries from making, or offering or promising to make improper payments to non-U.S. officials for the purpose
                                  of obtaining or retaining business or otherwise seeking favorable treatment;                              
--------------------------------------------------------------------------------------------------------------------------------------------

•                                             the federal transparency requirements known as the federal                                         
    Physician Payments Sunshine Act, under the Patient Protection and Affordable Care Act, as amended by the Health Care Education Reconciliation
        Act, or collectively the ACA, which requires certain manufacturers of drugs, devices, biologics and medical supplies for which payment   
           is available under Medicare, Medicaid, or the Children’s Health Insurance Program, with specific exceptions, to report annually       
        to the Centers for Medicare &amp; Medicaid Services, or CMS, within HHS, information related to payments and other transfers of value    
        to certain healthcare providers and teaching hospitals and information regarding ownership and investment interests held by physicians   
                                                       and their immediate family members; and                                                   
-------------------------------------------------------------------------------------------------------------------------------------------------

•                                       analogous state and foreign laws and regulations, such as state                                     
    anti-kickback and false claims laws, which may apply to healthcare items or services that are reimbursed by non-governmental third-party
                                                      payors, including private insurers.                                                   
--------------------------------------------------------------------------------------------------------------------------------------------
 
Some state laws require pharmaceutical companies to comply with the pharmaceutical industry’s voluntary compliance guidelines and the relevant compliance guidance promulgated by the federal government in addition to requiring drug manufacturers to report information related to payments to physicians and other health care providers or marketing expenditures. State and foreign laws also govern the privacy and security of health information in some circumstances, many of which differ from each other in significant ways and often are not