AHLA The Law of Digital Health (Non-Members)

Bernadette M. Broccolo (Editor), is a partner in the Chicago office of McDermott Will & Emery LLP and has been counseling health industry organizations for more than 38 years on complex health industry innovation strategies, most recently including provider networks and big data strategies for transitioning to value-based care, development and deployment of digital health solutions, formation of electronic health information networks and exchanges to support improvements health care quality and accountability, and collaborations for streamlining and accelerating innovations in digital health, translational research and precision medicine. Her specialties include the full scope of legal and regulatory compliance in the areas of federal taxation of exempt organizations and not-for-profit corporate governance, privacy, human subject protection, and technology contracting. Bernadette is a frequent speaker and author on topics in her areas of practice.

She is co-author of Tax-Exempt Status of Health Care Organizations, which is part of BNA’s Health Law & Business Series. She has served in numerous leadership positions for organizations serving the health industry and the legal profession, including the Board of Directors of the American Health Lawyers Association (AHLA) and she is an AHLA Fellow. She has been selected by her peers to be included in The Best Lawyers in America for her expertise in health care law and was named Best Lawyers’ Chicago Health Care Lawyer of the Year for 2010. Bernadette is listed as a leading individual in health care in Chambers USA: America’s Leading Lawyers for Business, US Healthcare Expert Guide (EuroMoney Legal Media Group), Illinois Super Lawyer, and Leading Lawyers Network.

Lisa Schmitz Mazur (Editor), a partner in the law firm of McDermott Will & Emery LLP, advises health care providers, payers, investors, associations, and technology companies on the legal, regulatory, and compliance matters touching digital health, including telehealth, telemedicine, mobile health, and consumer wellness tools, and develops practical, forward-thinking solutions and strategies that meet the complex and still-evolving digital health regulatory landscape. She has helped numerous clients to build and implement revenue and reimbursement strategies that comply with laws and regulations and contemplate the shift to value-based reimbursement and future policy changes. Lisa is a co-leader of the McDermott Digital Health Practice, the editor of the Of Digital Interest blog, a proud board member of and mentor to cutting-edge health care organizations, and a prolific speaker and author in the area of digital health

Shelby, an associate in the law firm of McDermott Will & Emery LLP, advises pharmaceutical, medical device manufacturers, health care technology companies, and health care providers on health care and U.S. Food and Drug Administration (FDA) legal, regulatory, and compliance matters. She regularly counsels clients on related considerations associated with mobile medical technology, telehealth, telemedicine, digital health, and clinical research. Shelby also has experience providing guidance concerning the Open Payments provisions of the Patient Protection and Affordable Care Act and state “sunshine” laws.

Vanessa, an associate in the law firm of McDermott Will & Emery LLP, counsels health care entities, FDA-regulated entities, and their contractors on health care transactions, regulatory compliance, and reimbursement issues in connection with product development, marketing, data sharing, licensing, enforcement, and public health matters. Her broad-expertise includes compliance with FDA laws, regulations, executive orders, and guidance, and, as a former HIPAA privacy officer, compliance with HIPAA/HITECH’s privacy, security, and data breach response requirements and standards.

Jiayan, a partner in the law firm of McDermott Will & Emery LLP, counsels a wide range of clients on complex regulatory and strategic issues arising in biomedical innovation and data sharing initiatives. In her regulatory and transactional practice, Jiayan advises health systems, professional associations, and digital health and life sciences companies in connection with the development of innovative research collaborations, data sharing initiatives, quality improvement endeavors, and biospecimen and data repositories. Jiayan has particular expertise advising on such issues in the context of precision medicine and secondary use.

Amanda, a partner in the law firm of McDermott Will & Emery LLP, advises health care industry clients in all aspects of software licensing and other transactions involving the acquisition and deployment of electronic health record systems, software development and maintenance, outsourced cloud-computing and other hosting and service arrangements, and arrangements for other mission critical health information technology needs. Amanda provides guidance on regulatory issues in telehealth in particular and, in a broad range of health industry contexts, on Medicare and Medicaid reimbursement, and compliance with the federal Stark Law and Anti-Kickback Statute and state fraud and abuse laws.

Ryan, a partner in the law firm of McDermott Will & Emery LLP, focuses his practice on representing hospitals, health systems, private equity firms and platform companies, and other health care organizations in corporate and transactional matters, including mergers, acquisitions, joint ventures, and management arrangements. He also devotes a significant portion of his practice to representing health care organizations in matters involving health information privacy, security and data breach compliance.

Sarah, a partner in the law firm of McDermott Will & Emery LLP, represents companies in the life sciences and digital health industries on structuring and negotiating intellectual property licenses, strategic collaborations, and other complex commercial transactions – helping her clients leverage intellectual property assets and collaborate to develop, deliver, and implement innovative solutions that improve health and health care. Sarah uses her science background and in-depth life sciences and digital health industry knowledge as an asset to understand critical business concerns and effectively manage complex issues.

Marshall E. Jackson, Jr. is an Associate with McDermott Will & Emery LLP. He focuses his practice on transactional and regulatory counseling for clients in the health care industry, as well as advises clients on the legal, regulatory, and compliance aspects of digital health. Prior to joining McDermott, Marshall was an Associate in the health care and life sciences practice group of a national law firm. He earned his law degree with a health law concentration and, while in law school at the University of Maryland Francis King Carey School of Law, served as senior articles editor of the Journal of Healthcare Law and Policy and as captain of the National Trial Team.

Ryan, an associate in the law firm of McDermott Will & Emery LLP, advises hospitals, health systems, digital health, and a broad range of health industry clients on a variety of regulatory compliance and transactional matters. Ryan has assisted clients on a variety of health care transactions, ranging from asset purchases to strategic affiliations, and works with clients to identify the regulatory and transactional matters that are essential to the transaction and operations of the parties post-closing.