Melissa L. Markey, CISSP
Attorney | Denver
Phone: (248) 740-7505 | Fax: (248) 740-7501
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About Melissa
Melissa Markey is a health care operations attorney who focuses on FDA and clinical research matters affecting health care organizations, in addition to data privacy and security.
She leads Hall Render’s FDA team and advises hospitals, health systems, research institutions and innovators on complex regulatory and operational challenges. Melissa counsels clients across the lifecycle of clinical research and medical device development, from regulatory compliance through commercialization. She also regularly advises health care organizations on data privacy and cybersecurity risks, including preparing for and responding to cyber incidents.
Melissa’s practice includes:
- Advising on FDA regulatory compliance for medical devices, mobile medical applications and consumer-facing health technologies;
- Counseling on clinical research, including human subject protections, research misconduct and regulatory compliance;
- Supporting hospitals, health systems and research institutions in structuring and managing research programs;
- Guiding clients on data privacy and cybersecurity preparedness, including breach response; and
- Advising on technology-related issues, including electronic health records and data rights management.
A Certified Information Systems Security Professional (“CISSP”) and member of Hall Render’s data breach response team, Melissa is a recognized author and national speaker on cybersecurity, FDA law and research compliance. Prior to practicing law, she served as a paramedic.
