On September 28, the governor of California signed into law AB 2089, which expands the scope of California’s Confidentiality of Medical Information Act (“CMIA”) to cover mental health services that are delivered through digital health solutions and the associated health information generated from these services. 

Specifically, AB 2089 amends the definition of “medical information” to include “mental health application information,” defined as “information related to a consumer’s inferred or diagnosed mental health or substance use disorder . . . collected by a mental health digital service.”  “Mental health digital service” is in turn defined to mean “a mobile-based application or internet website that collects mental health application information from a consumer, markets itself as facilitating mental health services to a consumer, and uses the information to facilitate mental health services to a consumer.”  

In addition to expanding the scope of “medical information,” AB 2089 also provides that “any business that offers mental health digital service to a consumer for the purpose of allowing the individual to manage the individual’s information, or for the diagnosis, treatment, or management of a medical condition of the individual” will be considered a provider of health care for purposes of the CMIA.  AB 2089 further requires that any business that partners with and provides a mental health digital service to a provider of health care must offer the provider of health care information related to data breaches that must be reported to the California Attorney General.

The legislature passed the law in response to the recent increase in consumer utilization of mobile applications to access mental health care.  While mental health information collected by a traditional health care provider, such as a psychologist, was clearly covered by the CMIA prior to the passage of AB 2089, there was ambiguity as to whether that same information collected by a mobile application or website, outside of a medical facility, fell within the scope of the CMIA.  With the passage of AB 2089, the state has clarified that digital health solutions providing mental health services are subject to the CMIA’s restrictions on the use, disclosure, and maintenance of medical information and could face increased legal exposure under the CMIA’s private right of action.

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Photo of Libbie Canter Libbie Canter

Libbie Canter represents a wide variety of multinational companies on privacy, cyber security, and technology transaction issues, including helping clients with their most complex privacy challenges and the development of governance frameworks and processes to comply with global privacy laws. She routinely supports…

Libbie Canter represents a wide variety of multinational companies on privacy, cyber security, and technology transaction issues, including helping clients with their most complex privacy challenges and the development of governance frameworks and processes to comply with global privacy laws. She routinely supports clients on their efforts to launch new products and services involving emerging technologies, and she has assisted dozens of clients with their efforts to prepare for and comply with federal and state privacy laws, including the California Consumer Privacy Act and California Privacy Rights Act.

Libbie represents clients across industries, but she also has deep expertise in advising clients in highly-regulated sectors, including financial services and digital health companies. She counsels these companies — and their technology and advertising partners — on how to address legacy regulatory issues and the cutting edge issues that have emerged with industry innovations and data collaborations.

As part of her practice, she also regularly represents clients in strategic transactions involving personal data and cybersecurity risk. She advises companies from all sectors on compliance with laws governing the handling of health-related data. Libbie is recognized as an Up and Coming lawyer in Chambers USA, Privacy & Data Security: Healthcare. Chambers USA notes, Libbie is “incredibly sharp and really thorough. She can do the nitty-gritty, in-the-weeds legal work incredibly well but she also can think of a bigger-picture business context and help to think through practical solutions.”

Photo of Anna D. Kraus Anna D. Kraus

Anna Durand Kraus advises on issues relating to the complex array of laws governing the health care industry. Her background as Deputy General Counsel to the U.S. Department of Health and Human Services (“HHS”) gives her broad experience with, and valuable insight into…

Anna Durand Kraus advises on issues relating to the complex array of laws governing the health care industry. Her background as Deputy General Counsel to the U.S. Department of Health and Human Services (“HHS”) gives her broad experience with, and valuable insight into, the programs and issues within the purview of HHS, including Medicare, Medicaid, fraud and abuse, and HIPAA privacy and security. Anna is co-chair of the firm’s Health Care Industry practice group.

Anna regularly advises clients on Medicare reimbursement matters, particularly those arising under Part B and the Part D prescription drug benefit. She also has extensive experience with the Medicaid Drug Rebate program. She assists numerous pharmaceutical and device manufacturers, health care providers, pharmacy benefit managers, and other health care industry stakeholders to navigate the challenges and opportunities presented by the Affordable Care Act.

Anna is a trusted adviser on health information privacy, security and breach notification issues, including those arising under the Health Insurance Portability and Accountability Act (“HIPAA”) and the Health Information Technology for Economic and Clinical Health (“HITECH”) Act. Her background in this area dates back to the issuance of the original HIPAA privacy regulations.

Anna’s clients depend on her to guide them through compliance with the Anti-Kickback statute, the Stark regulations, and other laws preventing fraud and abuse in the health care industry. Her deep knowledge of these laws has made her an important component of the firm’s representation of pharmaceutical companies and health care organizations under federal investigation or facing allegations under the False Claims Act. In addition, clients contemplating acquisitions in the health care sector rely on her to guide due diligence efforts.

Photo of Tara Carrier Tara Carrier

Tara Carrier is an associate in Covington’s Boston office, where she is a member of the Health Care and White Collar Defense and Investigations Practice Groups. Tara focuses her practice on representing clients in the life sciences and health care industries in a…

Tara Carrier is an associate in Covington’s Boston office, where she is a member of the Health Care and White Collar Defense and Investigations Practice Groups. Tara focuses her practice on representing clients in the life sciences and health care industries in a variety of regulatory and compliance matters, including fraud and abuse, health information privacy and compliance with HIPAA, promotion and advertising, market access, pricing and reimbursement activities, and other related areas. In addition, Tara has experience representing clients in government investigations and conducting targeted internal investigations covering a broad range of health care compliance issues. She also counsels clients on mitigating compliance risks and implementing and operating under HHS OIG Corporate Integrity Agreements.

Tara is an author of the U.S. chapter of a global treatise on drug pricing and reimbursement.

In addition to her life sciences practice, Tara maintains an active pro bono practice, with a particular focus on reproductive rights.

Photo of Olivia Vega Olivia Vega

Olivia Vega provides strategic advice to global companies on a broad range of privacy, health care, and technology issues, including in technology transactions, mergers and acquisitions, and regulatory compliance. Within her practice, Olivia counsels clients on navigating the complex web of federal and…

Olivia Vega provides strategic advice to global companies on a broad range of privacy, health care, and technology issues, including in technology transactions, mergers and acquisitions, and regulatory compliance. Within her practice, Olivia counsels clients on navigating the complex web of federal and state privacy and data security laws and regulations, including on topics such as HIPAA, California’s Confidentiality of Medical Information Act, and the California Consumer Privacy Act. In addition, Olivia maintains an active pro bono practice.

Photo of Elizabeth Brim Elizabeth Brim

Elizabeth Brim is an associate in the firm’s Washington, DC office, where she is a member of the Data Privacy and Cybersecurity and Health Care Practice Groups and advises clients on a broad range of regulatory and compliance issues related to privacy and…

Elizabeth Brim is an associate in the firm’s Washington, DC office, where she is a member of the Data Privacy and Cybersecurity and Health Care Practice Groups and advises clients on a broad range of regulatory and compliance issues related to privacy and health care.

Elizabeth’s practice includes counseling clients on compliance with the complex web of health information privacy laws and regulations, such as HIPAA, the FTC’s Health Breach Notification Rule, and state medical and consumer health privacy laws as well as state consumer privacy and genetic privacy laws. She also advises clients on health care compliance issues, such as fraud and abuse, market access, and pricing and reimbursement activities.

Elizabeth routinely advises on regulatory compliance as part of transactions, clinical trial programs, collaborations and other activities that involve genetic data, and the development and operation of digital health products. As part of her practice, Elizabeth routinely counsels clients on drafting and negotiating privacy and health care terms with vendors and third parties and developing privacy notices and consent forms. In addition, Elizabeth maintains an active pro bono practice.

Elizabeth is an author of the American Health Law Association treatise, Pricing, Market Access, and Reimbursement Principles: Drugs, Biologicals and Medical Devices and the U.S. chapter of the Global Legal Insights treatise, Pricing & Reimbursement Laws and Regulations.