Healthcare Research & Academic Partners

Research and academic institutions drive advances in healthcare—from medical devices and AI-enabled diagnostics to gene therapies and clinical trials. Alongside innovation comes a complex landscape of regulations, privacy requirements, and compliance obligations. Dickinson Wright works with universities, academic medical centers, hospitals, and clinical research organizations to help projects move forward while navigating these legal and regulatory challenges.

We advise clients on matters ranging from clinical trial agreements and human subject protections to AI and digital health compliance, FDA oversight, and government audits, allowing researchers and institutions to remain focused on advancing patient care and scientific discovery.

Who We Serve

• Academic medical centers
• Universities and teaching hospitals
• Physician groups
• Clinical research organizations (CROs)
• Independent research sites
• Digital health companies and AI-driven research initiatives

Our Services

We provide practical legal guidance on:

• Structuring and negotiating clinical trial agreements and research collaborations, including multi-site and international studies
• Compliance with human and animal research requirements, including FDA, NIH, and CDC regulations
• HIPAA, HITECH, GDPR, and other privacy and data governance requirements
• FDA regulatory guidance for investigational products, including AI-enabled diagnostics and software as a medical device (SaMD)
• Research funding compliance, including fraud and abuse considerations
• Representation in government audits and investigations involving the FDA, OHRP, OCR, and ORI
• Privacy and compliance issues involving sensitive data, including genetic information, mental health, and substance use records
• Intellectual property strategies for research collaborations, technology commercialization, and AI licensing

Representative Matters

• Developed compliance programs for pharmaceutical manufacturers, academic medical centers, and AI-driven research initiatives.
• Represented clients in multi-site clinical trials involving medical devices, AI-enabled diagnostics, and digital health technologies.
• Counseled private foundations and academic institutions on Cooperative Research and Development Agreements (CRADAs).
• Advised clients on legal and regulatory considerations for incorporating AI into clinical trials and research protocols.
• Assisted universities and teaching hospitals in developing privacy and data security strategies for large-scale patient data initiatives.