New California Data Privacy Law (AB 375) Continues to Pose Challenges for Life Sciences Industry
By Brett Johnson
August 21, 2018
The California Life Sciences Association (CLSA) joined a coalition, which includes fellow life sciences trade associations, providers, insurers, and a number of other key stakeholders, to address the concerns related to HIPAA preemption and clinical trials data in the recently enacted AB 375, “The California Consumer Privacy Act of 2018” (“Privacy Act”), which will become effective January 1, 2020.
Previously, CLSA was engaged in a broader coalition led by the California Chamber of Commerce (CalChamber) to propose technical fixes to the Privacy Act. The primary concern of CLSA as part of this coalition was the need to ensure clinical trial data was not adversely impacted. CLSA decided, however, that the size and disparate interests of the large CalChamber coalition made it difficult to have the complex policy discussions needed on healthcare data issues. Therefore, several healthcare-related industry associations and organizations impacted by AB 375 proposed to create a healthcare-specific coalition. The chair of the Senate Health Committee has been amenable to the healthcare coalition’s collective suggestions and approach, pending the consent of the authors and our ability to find a legislative vehicle for that approach.
Even if CLSA and our partner healthcare organizations are successful in addressing concerns around the transfer and use of clinical trial data, other issues for the life sciences industry may remain. For instance, some biopharmaceutical and medical device companies may use third party vendors to capture, consolidate, and report adverse events to the manufacturer and/or regulators, but such arrangements would arguably face significant hurdles under the Privacy Act. Furthermore, many patient and clinical decision-making software applications could face substantial challenges under the Privacy Act in its current form.
CLSA will continue working towards solutions that protect the life sciences industry’s ability to innovate in California. Any CLSA members who would like to provide input on the potential impact of the Privacy Act or would like further information on the issues discussed above are asked to reach out to Oliver Rocroi, Senior Dirctlr, State Government Relations (firstname.lastname@example.org) or Brett Johnson, Senior Director, Policy & Regulatory Affairs(email@example.com).