Research and academic institutions drive the future of healthcare — from cutting-edge medical devices to AI-powered diagnostics, gene therapies, and breakthrough clinical trials. But innovation exists alongside a web of regulations, privacy requirements, and compliance challenges. Dickinson Wright partners with universities, academic medical centers, hospitals, and clinical research organizations to keep projects moving while navigating the legal landscape.
We handle everything from clinical trial agreements and human subject protections to AI and digital health compliance, FDA oversight, and government audits — so our clients can focus on the discoveries that advance patient care and transform medicine.
Who We Serve
- Academic medical centers
- Universities and teaching hospitals
- Physician groups
- Clinical research organizations (CROs)
- Independent research sites
- Digital health startups and AI-driven research initiatives
Our Services
We provide practical, forward-looking legal guidance on:
- Structuring and negotiating clinical trial and research affiliation agreements, including multi-site and international studies
- Compliance for human and animal research (FDA, NIH, CDC)
- HIPAA, HITECH, and global privacy compliance (GDPR, AI data ethics, and other regulations)
- FDA and regulatory guidance for investigational products, including AI-enabled diagnostics and software as a medical device (SaMD)
- Transparency, fraud, and abuse compliance in research funding
- Representation in audits and investigations (FDA, OHRP, OCR, ORI)
- Sensitive data compliance, including genetic information, mental health, and substance use
- Intellectual property considerations for research collaborations and AI/technology licensing
Representative Matters
- Designed compliance programs for pharmaceutical manufacturers, academic centers, and AI-driven research initiatives.
- Represented clients in multi-site clinical trials for medical devices, AI-powered diagnostics, and digital health platforms.
- Counseled private foundations and academic institutions on cooperative research and development agreements (CRADAs).
- Advised on legal and regulatory strategy for AI integration in clinical trials and research protocols.
- Assisted universities and teaching hospitals with privacy and data security strategies for large-scale patient data sets.
