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Privacy in Research: Highlights and Developments

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Description: Presenter Bio:
Linda A. Malek is a partner at Moses & Singer and Chair of the firm’s Healthcare and Privacy & Cybersecurity practice groups.  Her practice concentrates on regulatory, technology and business matters in the healthcare industry. Recognized by New York Metro Super Lawyers® in five consecutive editions, and by Chambers USA as a leader in her field, the Chambers ranking describes Linda as "well versed in transactional and regulatory matters, with particular insight into privacy issues relating to electronic and personal health records.”
Linda counsels a wide range of organizations and financial institutions on health law, such as national and regional managed care organizations, financial institutions, IRBs, government agencies, hospitals and hospital systems, genetic and biotechnology companies, medical device companies, international scientific organizations, pharmaceutical companies, and research foundations.  Providing expertise in the application of Federal and state healthcare laws and regulations to her clients’ businesses comprise a focal point of Linda’s practice.  She works closely with them to ensure compliance with health care anti-fraud, state, national and international privacy laws, Medicare/Medicaid regulations, False Claims Act, human subject research, genetic testing, Affordable Care Act initiatives and other regulatory matters.  The depth of her expertise in transactional matters includes advice regarding mergers and acquisitions, organizing start-up ventures, joint ventures, and negotiating complex agreements among various industry stakeholders.
In the life sciences context, Linda advises clients on cutting-edge legal issues with respect to translational and biomedical research and technology, genomics and gene studies, genetic privacy, regenerative medicine, clinical trials, and tissue banking.  Her work has also included counseling on privacy and security issues, strategizing and implementing clinical research policies and programs, and drafting and negotiating complex and time-sensitive grant and clinical research agreements.
Linda advises clients on compliance with federal, state and international privacy and security laws concerning the transfer of identifiable health information, the provision of health care and medical research.  This includes analyzing their privacy and security practices under state laws, federal laws such as the Health Insurance Portability and Accountability Act ("HIPAA") and under the Health Information Technology for Economic and Clinical Health Act (“HITECH”)., and international laws such as the recently enacted General Data Protection Regulation (GDPR) legislation.
Linda serves as Chair of the Health Law and Policy Coordinating Committee of the Health Law Section of the American Bar Association.  She has also been appointed to the Founding Board of the newest division of the NBTA (National Board of Trial Advocacy), called the National Board of Health Lawyers. She was nominated from the ABA Health Law Section based on her nationally recognized expertise in healthcare privacy law.
Prior to joining Moses & Singer, Linda spent nearly six years as a healthcare attorney for the Office of the Corporation Counsel, Division of Legal Counsel, where she was named Outstanding Assistant Corporation Counsel by the Association of the Bar of the City of New York.
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.
Program Description:
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 wearables in research, and vetting vendors in the context of privacy laws, such as those providing cloud or artificial intelligence support.

Practice Areas: Healthcare & Pharmaceutical Law
Online Media Type: Audio
Production Date: 06/10/2020
Level: Intermediate
Category: Standard
Duration: 1 Hours, 5 Minutes
Online Format: On Demand

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Total Credits: 1
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Status: Reciprocal Credit Available
Expiration: 06/09/2023
Training Type: Online

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Linda Malek - Moses & Singer LLP
Nora Schmitt - Moses & Singer LLP
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