AI Use in Clinical Trials: Privacy, Confidentiality, and Compliance Risks
Artificial Intelligence (AI) is becoming increasingly common in health care clinical trial operations. Sponsors, contract research organizations, research sites and vendors may use AI for many tasks such as patient recruitment, eligibility screening, and informed consent support among other things. While this can improve efficiency, these tools may also create privacy, confidentiality and compliance risks in an already highly regulated environment.
Clinical trials often involve sensitive patient information, confidential study data, and strict documentation obligations. This means that AI use in clinical research cannot be treated like traditional workplace software. Before deploying an AI tool, organizations should understand what data the tool will access, where that data will go, whether the vendor can use it to train models, and whether the output can be explained, reviewed, and preserved.
How is AI being used in clinical trials?
AI tools may be used throughout the clinical trial process. For example, AI can be used to help identify potential participants, screen patient eligibility, summarize medical records, draft study documents, monitor data and flag adverse events. Generative AI may also be used for other tasks in the clinical trial process such as summarizing meeting notes, clinical records or other trial related documents.
These uses can be helpful, but they also raise basic compliance questions. Before using an AI tool, organizations need to ask whether the tool fits within the trial’s legal and contractual framework. Clinical trial agreements and site agreements often control who may access trial data and how that data can be used, but those contracts may have been drafted without considering the use of AI in the trial. If an AI vendor is introduced without updating those agreements, contracts that are not AI-specific may create gaps in data access, confidentiality and regulatory accountability.
What legal obligations matter?
AI use in clinical trials must also fit within existing privacy, research and documentation obligations. HIPAA and its related rules may apply when AI vendors receive, store and analyze PHI. This means, organizations may need privacy and security safeguards before sharing their trial data with the AI vendor.
FDA electronic records requirements should also be considered as clinical trial records have to be reliable, auditable and traceable. If an AI tool creates a summary or other output without prompt logs or documented human review, it may create problems for recordkeeping and data integrity.
Consent for the use of AI in the clinical trial process is also a key factor, especially when AI is used in recruitment processes or eligibility screenings. In these situations, participants should receive clear information about how AI is involved and how their information may be used.
Finally, confidentiality should remain at the forefront. Clinical trials do not only involve patient data, but may also involve sensitive commercial information, such as investigational product data, interim results, safety signals, and proprietary research methods. If an AI tool takes in this information for transcription, summarization, or analysis without clear confidentiality restrictions, it may create risks for sponsor confidentiality, trade secret protection, or attorney-client privilege.
Why are AI vendors a risk?
AI vendors can be one source of risk in clinical trials because they may receive and process very sensitive trial data. Standard AI vendor terms may not be enough when clinical trials involve protected health information or FDA-regulated records. Before using a specific AI vendor, organizations should review whether the vendor can retain prompts or outputs, use trial data to train its models, allow employee access to uploaded data, or store information outside approved systems.
Vendor contracts should clearly address data retention, model training, confidentiality, audit rights, security controls and human oversight. Additionally, companies should not rely only on what the vendor promises in the contract. They should verify how the vendor actually handles trial data before using the AI tool.
What should companies take away?
For sponsors, meaning the organizations responsible for clinical trials, the main takeaway is that AI should be reviewed before it is used with clinical trial data. The organization should review what the AI tool will be used for, whether it will access PHI or confidential study information, whether the vendor can use trial data to train its models and if AI-generated outputs can become part of the trial record.
There are AI vendors that offer privacy-protective features like PHI redaction and de-identification. However, companies should not assume these features automatically make the tools compliant. Companies still need to verify how the vendor stores, processes, deletes and protects clinical trial data before deployment.
AI may help clinical trials become more efficient, but efficiency does not replace privacy, confidentiality, consent, or regulatory accountability. Companies should update agreements, limit data exposure, verify vendor practices, document human review, and clearly disclose AI involvement where appropriate.