Avoiding Privacy Violations During Clinical Trial Mergers

Clinical trial site mergers promise efficiency but often bring chaos—especially with data privacy. HIPAA and GDPR compliance can be lost in the shuffle if privacy assessments and consent updates are ignored.

Where Mergers Go Wrong:

• Poor Data Integration: Inconsistent record-keeping can create unauthorized access points.
• Outdated Consents: Patients must know who controls their data—mergers change that.
• Vendor Risks: Third-party vendors may mishandle sensitive data.
• Not Considering all Privacy Risks: Consider state privacy laws. Also consider marketing laws including issues related to CANSPAM, TCPA, state wiretapping laws, disease specific laws and more.

The Solution:

1. Conduct Privacy Impact Assessments (PIAs): Identify and address data privacy risks before merging.
2. Update Data Sharing Agreements (DSAs): Clearly define data ownership and sharing rules.
3. Secure Patient Consents: Notify patients and obtain consent for new data controllers.

Why It Matters:

Beyond regulatory penalties, privacy failures erode patient trust—something no sponsor can afford.

Get Guidance:

The Kulkarni Law Firm, P.C. advises pharmaceutical sponsors on protecting patient data during mergers. Contact us to safeguard your next clinical trial site acquisition.