Marylana Saadeh Helou

Attorney Marylana Saadeh Helou focuses her practice on advising academic medical centers, hospitals, universities, pharmaceutical and medical device companies, digital health companies, and other health care technology companies and research organizations on issues related to human subjects research and data privacy.

She assists clients in navigating requirements under the Common Rule, HIPAA, and other federal, state, and international human subject protection requirements and data protection and privacy laws, including the GDPR.

She counsels clients on the structure of research agreements for multi-site global industry-sponsored clinical trials, investigator-initiated studies, and strategic research collaborations.

She advises clients on the complex and evolving regulatory issues related to structuring decentralized clinical trials, mobile app/device research, internet research, and repositories for health data, genomic, and biospecimen research.

https://www.ebglaw.com/people/marylana-saadeh-helou