Nora Lawrence Schmitt is an associate in Moses and Singer’s Healthcare and Privacy & Cybersecurity practices.
Nora advises academic medical centers, hospitals, pharmaceutical companies and physician organizations on the conduct and oversight of clinical research, including human subject protection and the privacy of research subjects’ information. She counsels academic medical centers and other research organizations on research affiliations and contracting matters and regularly advises on matters related to HIPAA, HITECH, and state privacy laws. Nora has particular experience in the field of genetic privacy and frequently advises clients on compliance with federal and state genetic privacy laws, including restrictions on the use of genetic information for secondary research purposes. She also has experience advising on IRB review arrangements, regulation of human tissue and data repositories, permitting and licensure of clinical laboratories, including state approval of laboratory developed tests, and state and federal informed consent requirements.
In addition to her research-focused work, Nora provides counsel regarding fraud and abuse laws, including the Stark Law and the Anti-Kickback Statute. She has supported healthcare providers in the field of managed care contracting, including in the formation and maintenance of accountable care organizations, physician hospital organizations, and independent practice associations. Nora has experience representing healthcare providers in Medicare and Medicaid payment disputes, including the handling of administrative appeals to the Provider Reimbursement Review Board. She also works with emerging to late stage biotechnology companies on various regulatory and compliance issues and has advised numerous clients on compliance with EU and other foreign data protection laws.
Prior to joining Moses & Singer, Nora practiced in the healthcare and academic and clinical research groups at Verrill Dana, LLP.
This webinar will provide participants with a comprehensive update on privacy issues related to clinical research, including updates to state and Federal genetic privacy laws, issues related to biorepositories and data banks, mobile apps and wearable...