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Telehealth: Lessons from the Future

Speaker(s): Jason E. Johnson, Laurel Pickering, Linda A. Malek, William A. Tanenbaum
Recorded on: Feb. 24, 2021
PLI Program #: 320403

Jason Johnson is a Partner in Moses & Singer’s Healthcare, Privacy & Cybersecurity, and Intellectual Property practices. Jason counsels his clients on the complicated regulatory and compliance issues related to the privacy and security of data under US and European laws (including HIPAA, HITECH and GDPR) and complex transactional matters related to product development, marketing, clinical research and business matters.

Jason has experience as a bench top research scientist in the academic and pharmaceutical environments. Additionally, as a clinical research monitor, Jason trained physicians and clients on FDA laws and regulations regarding the proper conduct of clinical studies. Jason uses this practical experience to guide his clients through all aspects of healthcare privacy and research and development, such as drafting and negotiating research and clinical trial agreements, licensing and manufacturing agreements, assisting clients with regulatory submissions, mergers and acquisitions, and related transactions. Jason’s clients in this area include academic medical centers, healthcare technology companies, emerging to late stage biotechnology companies, pharmaceutical and medical device companies and other healthcare and research related organizations.

Jason’s practice also includes counseling and educating hospitals, home health agencies and other health care providers on state and federal fraud and abuse issues including the Stark Law and the Anti-Kickback Statute. Jason has also managed litigations and liquidation proceedings for health maintenance organization.

Prior to joining Moses & Singer’s healthcare practice, Jason was a patent litigator in Hatch-Waxman Act litigations in the chemical and pharmaceutical areas for over 11 years and has substantial experience in counseling clients regarding patent portfolio management, including reviewing patent portfolios, providing advice on the strength or weakness of those portfolios and what actions should be taken, if any, to best protect the company’s products and assets. Jason helps his clients understand the competitive space and the relevant IP landscape, enabling them to evaluate and implement the best strategic business strategy for their needs. Jason has led the research and preparation of due diligence and freedom to operate opinions for both small and large biotechnology and pharmaceutical companies. Jason is a registered agent with the United States Patent and Trademark Office and he acts as lead attorney for both offensive and defensive Inter Partes Reviews.

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.

As Welldoc’s Executive Vice President, Enterprise Solutions, is responsible for broadening relationships with key stakeholders to expand use of Welldoc’s FDA-cleared, proven BlueStar® digital therapeutic.

Laurel is a leader and visionary, devoted to transforming healthcare at both regional and national levels. Before joining Welldoc, Laurel served as president & CEO of Northeast Business Group on Health (NEBGH) for nearly 25 years. There, she built an employer-led coalition of healthcare leaders and other stakeholders with the mission of empowering members to drive excellence and value in healthcare and the patient experience. NEBGH currently has 170 members comprised of national and global self-insured employers based in New York, New Jersey, Connecticut and Massachusetts; plus national health plans, major consulting organizations, regional hospital systems and other key stakeholders.

Under Laurel’s leadership, NEBGH became one of the most active and influential healthcare-focused business coalitions in the country, focused on moving toward a value-based delivery system. NEBGH delivers educational and training programs for benefits executives, user groups designed to help them improve health plan and PBM performance, and guidance on private exchanges via the Private Exchange Evaluation Collaborative (PEEC), of which Laurel is a founder.

On the national level, Laurel serves as Chair of the Board of Directors of The Leapfrog Group and on the Board of the National Quality Forum. She previously served on the Board of the National Alliance of Health Care Purchaser Coalitions. Laurel received her BA in Anthropology from SUNY Albany and MPH from Emory University.

William A. Tanenbaum is ranked in top tiers by Chambers: America’s Leading Lawyers for Business and in its Global Edition, Who's Who Legal, and Best Lawyers in America in technology, outsourcing, IP, AI and Data Law and recognized for his strength in healthcare technology.  He works closely with clients to bring actionable, industry-informed solutions to their business needs.

Bill has “expertise in technology transactions that puts him at the very top of the market” (Who's Who Legal) and "his technology approach and understanding of healthcare - his domain expertise - is a winning combination.” (Chambers)  According to Chambers, Bill “brings extremely high integrity, a deep intellect, fearlessness and a practical, real-world mindset to every problem.”  Bill is recognized as one of the “leading names” in AI and as a “go-to expert [on] data.” (Who's Who Legal/Global Data Review)  He was named as the “Lawyer of the Year” in IT in New York in 2013 by US News & World Report and one of the Top 30 IT lawyers in the U.S. (Best of the Best/Expert Legal Guide), and as one of the “IAM Strategy 300 - The World's Leading IP Strategists,” as an “IP Star” and as a “Life Sciences Star.” (Managing IP; LMG Life Sciences) Bill was President of the International Technology Association and is the Contributing Editor of the International Comparative Legal Guide to Digital Health 2020

Chambers also finds that Bill has a “solid national reputation,” “is a “prominent figure in technology and outsourcing,” “provides savvy representation,” and “uses his expertise to help [clients] successfully navigate negotiations.”  Bill also “has strong litigation experience” with patent victories in the Court of Appeals for the Federal Circuit (Who's Who Legal).  He was appointed by peer review to the “List of the World’s Leading Neutrals [Arbitrators]” and is Board Member of the Silicon Valley Arbitration and Mediation Center.  He is also a past Vice President of the Society for Information Management, an  industry CIO association (New York Chapter). 

Prior to joining Moses & Singer, Bill was the Chair of IP and Technology Transactions at a Wall Street firm, a partner in an international IP firm, and the Practice Co-Chair of Healthcare Technology Transactions at an Am Law 100 firm.