California Expands Privacy and Security Requirements for Genetic Data
With health-related data and how to protect it at the forefront of discussion since the start of the COVID-19 pandemic, this week California Governor Gavin Newsom signed into law two bills related to genetic data. First, AB 825, will expand the definition of personal information to include genetic data, for data breach notification requirements for businesses and government agencies, as well as reasonable safeguard requirements for businesses. Second, SB 41, will establish the Genetic Information Privacy Act, requiring a direct-to-consumer genetic testing company to provide a consumer with notice and consent regarding its genetic data collection, use and disclosure policies.
Below is a breakdown of each law:
AB 825 – Unanimously approved by the Senate on September 8th, and Assembly back in May, AB 825, will expand the definition of personal information to include genetic data and define genetic data to mean any data, regardless of its format, that results from the analysis of a biological sample of an individual, or other source, and concerns genetic material, as specified. This expanded definition of personal information will apply to three existing laws: 1) the Information Practices Act of 1977 which requires an agency that owns or licenses computerized data that includes personal information to disclose any breach of the security of the system following discovery or notification of the breach in the security of the data to any resident of California whose unencrypted personal information was compromised, 2) Civil Code 1798.81.5 which requires a business that owns, licenses, or maintains personal information about a California resident to implement and maintain reasonable security procedures and practices, and 3) Civil Code Section 1798.82 which requires a person or business that conducts business in California, and that owns or licenses computerized data that includes personal information, to disclose a breach of the security of the system following discovery or notification of the breach.
SB 41 – Also passed unanimously by both the Senate and Assembly in September, SB 41 will establish the Genetic Information Privacy Act, which will require a direct-to-consumer genetic testing company to provide a consumer with certain information regarding the company’s policies and procedures for the collection, use, maintenance, and disclosure, as applicable, of genetic data, and to obtain a consumer’s express consent for collection, use, or disclosure of the consumer’s genetic data. In particular, the new law will provide consumers with the right to revoke consent in accordance with certain procedures, and a requirement for companies to destroy a consumer’s biological sample within 30 days of revocation of consent. The bill will further require a direct-to-consumer genetic testing company to comply with all applicable laws for disclosing genetic data to law enforcement without a consumer’s express consent, implement and maintain reasonable security procedures and practices to protect a consumer’s genetic data against unauthorized access, destruction, use, modification, or disclosure, and develop procedures and practices to enable a consumer to access their genetic data, and to delete their account and genetic data. The law will impose civil penalties for violations of the law, and enforcement of such actions will be exclusive to the Attorney General, district attorney, county counsel, city attorney, or city prosecutor.
Both laws will take effect January 1, 2022. Whether an organization is a health care provider, a genetic testing company, an employer, or other company that potentially collects genetic data, it should review its policies and practices concerning genetic tests and genetic information.