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.
Marylana’s experience includes the following:
- Assisting 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
- Counseling on the structure of research agreements for multi-site global industry-sponsored clinical trials, investigator-initiated studies, and strategic research collaborations, and assisting clients in the drafting and negotiation of such agreements and related informed consent forms and authorizations
- Advising clients on complex and evolving regulatory issues and considerations related to structuring decentralized clinical trials, mobile app/device research, internet research, and repositories for health data, genomic, and biospecimen research, including navigating secondary uses of stored materials
- Advising on FDA requirements for clinical investigations, treatment with investigational products under FDA’s expanded access program and “Right to Try” laws, and FDA Part 11
- Counseling clients on issues related to research noncompliance and misconduct proceedings
- Counseling on matters related to individual and institutional conflicts of interest, and assisting clients in reviewing and updating their policies and procedures to appropriately identify and manage such conflicts
- Advising on compliance with federal grant standards and efforts to address undue foreign influence in federally-funded research
Before joining Epstein Becker Green, Marylana was an attorney in the Health Care & Life Sciences Group of a New England regional law firm. While attending law school, she interned at the Office of the General Counsel for a not-for-profit, integrated health care system in Boston; the Massachusetts U.S. Attorney’s Office as part of the Health Care Fraud Unit; and a public interest law firm whose mission is to provide pro bono legal representation. She also served as a judicial intern for the Honorable Magistrate Judge Judith G. Dein of the U.S. District Court for the District of Massachusetts.
Prior to entering law school, Marylana was a research assistant at Boston University School of Medicine’s Obesity and Diabetes Research Center, where she conducted NIH-funded research to determine how fuels generate signals to modulate insulin secretion from pancreatic cells. Her work is published and referenced in several scientific journals. Marylana has been selected by peers for inclusion on the New England Rising Stars list (2017-2020) in the area of Health Care and was recognized by the 2021 edition of The Best Lawyers in America©: “Ones to Watch,” in the category of Health Care Law. Since 2014, she has been a community member of the Brigham and Women’s Hospital Institutional Review Board.