Navigating U.S. State Privacy Laws in Clinical Research: Exemptions and Applicability 

The landscape of data privacy is shifting rapidly in the United States, with numerous states enacting comprehensive privacy laws aimed at protecting consumer data. These laws, such as the California Consumer Privacy Act (CCPA) and Virginia Consumer Data Protection Act (VCDPA), are reshaping how organizations process personal data. However, for the pharmaceutical and clinical research sectors, the intersection of these laws with the strict regulatory frameworks already governing clinical trials presents a nuanced challenge. 

Applicability of U.S. State Privacy Laws to Pharmaceuticals 

U.S. state privacy laws often impose thresholds that many pharmaceutical companies, particularly smaller ones, do not meet. For example, under the CCPA, a business is only subject to the law if it satisfies one of the following conditions: 

• Has annual gross revenues exceeding $25 million. 

• Buys, receives, or sells the personal information of 100,000 or more California residents, households, or devices. 

• Derives 50% or more of its annual revenue from selling personal information. 

Similar thresholds exist in other state privacy laws, including the VCDPA and Colorado Privacy Act (CPA). Smaller pharmaceutical companies, especially those in early stages of development or focused on business-to-business (B2B) operations rather than direct consumer interaction, often do not meet these thresholds. As a result, they are frequently outside the scope of such laws. 

This reality provides a level of relief for many biopharmaceutical firms, enabling them to prioritize compliance with specialized regulations that govern their operations, such as those issued by the U.S. Food and Drug Administration (FDA) and international frameworks like the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use Good Clinical Practice (ICH-GCP) guidelines. 

Exemptions for Clinical Trial Data 

A key factor distinguishing clinical research from other sectors is the comprehensive regulatory oversight that governs the processing of personal data in clinical trials. Most U.S. state privacy laws recognize these existing frameworks and exempt data processed for research purposes under certain conditions. 

For instance: 

• CCPA/CPRA: Excludes personal data used exclusively for scientific, historical, or statistical research in the public interest, provided the research adheres to applicable ethics and privacy laws, such as the Common Rule (45 C.F.R. Part 46), and is overseen by an Institutional Review Board (IRB) or similar entity. 

• VCDPA and CPA: Offer similar exemptions for personal data processed for research purposes that are conducted in compliance with recognized ethical and legal standards. 

• Texas Data Privacy and Security Act (TDPSA): Explicitly exempts identifiable private information collected as part of human subjects research under FDA regulations, ICH-GCP, or the Common Rule. 

These exemptions ensure that data used in clinical trials is governed by a regulatory regime tailored to the unique requirements of clinical research, prioritizing participant safety, data accuracy, and ethical standards. 

A Nuanced Approach to Investigators’ Data 

While data collected about investigators and medical staff is crucial for clinical trial operations, its treatment under privacy laws depends on the context. If this data is processed strictly within the scope of the trial, in compliance with FDA regulations and ICH-GCP, it is typically exempt from U.S. state privacy laws. However, if the same data is used for purposes outside the trial—such as employment-related activities or marketing—and the threshold for application is met, it may fall under the purview of applicable privacy laws. 

Sponsors should exercise caution and limit the processing of investigators’ personal data to the purposes necessary for the trial. Misusing such data outside its intended scope could trigger compliance obligations under U.S. state privacy laws or other applicable regulations. 

Practical Recommendations for Compliance 

Pharmaceutical companies and clinical trial sponsors should take the following steps to ensure compliance: 

1. Assess Applicability: Determine whether state privacy laws apply based on thresholds, business operations, and data processing activities. 

2. Document Exemptions: Clearly document that data used in clinical trials complies with FDA regulations, ICH-GCP guidelines, and ethical standards, demonstrating its exemption from state privacy laws. 

3. Limit Data Use: Restrict the use of investigators’ and staff data to the purposes necessary for trial conduct, avoiding processing for unrelated purposes that could trigger privacy law obligations. 

4. Prepare for GDPR Compliance: For companies running trials in the EU, ensure full alignment with GDPR requirements, including appointing an EU data protection representative, is mandatory. 

Conclusion 

While the growing web of U.S. state privacy laws presents new compliance challenges for businesses, the pharmaceutical and clinical research sectors benefit from tailored exemptions recognizing the rigorous regulatory frameworks already in place. By ensuring that clinical trial data complies with FDA regulations, ICH-GCP, and other applicable laws, sponsors can maintain focus on advancing medical research while respecting data protection requirements, nonetheless, U.S. companies must be vigilant and if conducting trials in the EU, GDPR compliance must be ensured.  

In this evolving landscape, a proactive approach to compliance—rooted in understanding the scope and exemptions of privacy laws—can help pharmaceutical companies navigate complexities and continue driving innovation in clinical research.