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Academic medical centers, universities, hospitals, and clinical research organizations face unique legal challenges at the intersection of healthcare and research. Navigating complex privacy laws, FDA regulations, human subjects protections, and compliance with federal agencies requires focused legal guidance.
Dickinson Wright’s Healthcare Research & Academic Institutions team advises clients across all stages of research and clinical trials — from contract negotiation and compliance programs to government audits and regulatory investigations.
Who We Serve
Academic medical centers
Universities
Hospitals
Physician groups
Clinical research organizations (CROs)
Independent research sites
Our Services
Structuring and negotiating clinical trial and research affiliation agreements
Human and animal research compliance (FDA, NIH, CDC)
HIPAA, HITECH, and global privacy compliance (GDPR and other laws)
Guidance on FDA regulatory requirements for research and investigational products
Advising on transparency and fraud/abuse laws
Representation in audits and investigations by FDA, OHRP, OCR, and ORI
Sensitive data compliance (genetic, substance use, mental health data)
Our team helps clients reduce legal risk, maintain compliance, and advance cutting-edge healthcare and scientific research.
