Compliance with Data Privacy Laws Representation and Warranty
(Underwriting Agreement)

Summary

This data privacy representation and warranty clause may be included in an underwriting agreement for a registered offering of securities by an issuer in the healthcare industry. This clause includes practical guidance and drafting notes. The United States, members of the European Union, and other countries have adopted various data privacy and security laws and regulations that apply to companies handling protected medical and health-related information. In the United States, the Health Insurance Portability and Accountability Act of 1996 (HIPAA) (104 P.L. 191) and various rules enacted thereunder create a privacy and security framework for protected health information. Similarly, the General Data Protection Regulation (GDPR), published by the European Union in 2016, created a sweeping data privacy framework that applies to many forms of personal information, including medical and health-related information. Other countries, such as Australia, Canada, New Zealand, and the United Kingdom, among others, also have privacy laws for healthcare-related data. Because of the importance of data privacy laws to healthcare-related companies, the underwriters for an offering may ask for a specific representation and warranty confirming the issuer's compliance with all applicable data privacy laws. This form representation and warranty incorporates the standard representations of the issuer and can be customized to the particular facts and circumstances of the issuer and the underwriting agreement. For a form of underwriting agreement that this clause may be used with, see Underwriting Agreement (Primary Offering). For more resources on registered offerings and underwriting agreements, see Initial Public Offerings Resource Kit. For more information on data privacy regulations for healthcare companies, see HIPAA Resource Kit and General Data Protection Regulation Fundamentals (EU GDPR) in Practical Guidance's Data Security & Privacy practice area.