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 a partner with McDermott Will & Emery. He focuses his practice on transactional and regulatory counseling for clients in the health care industry as well as advising clients on the legal, regulatory, and compliance aspects of digital health. He provides counseling and advice to hospitals and health systems, private equity
firms and their portfolio companies, post/sub-acute providers, physician practices, and other public and private healthcare companies in a variety of complex transactions and health regulatory compliance matters. Marshall advises healthcare providers, private equity firms and their portfolio companies, and technology companies involved in “digital health”— the intersection of health software applications, analytical tools, medical technology and electronic data assets enabled by the Internet and mobile devices—on a variety of legal, regulatory and compliance matters with a particular focus on digital health topics, including telehealth, telemedicine, mobile health and consumer wellness.

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.

Anisa, an associate in the law firm of McDermott Will & Emery LLP, advises life sciences companies on regulatory, compliance, enforcement, policy, and legislative matters arising under the Federal Food, Drug, and Cosmetic Act. She counsels pharmaceutical, medical device, and consumer product companies and investors generally and in the context of complex transactions and government enforcement actions on regulatory compliance with regard to premarket pathways, advertising and promotion, current Good Manufacturing Practice and Quality System requirements, and FDA engagement strategies.

Amy, an associate in the law firm of McDermott Will & Emery LLP, focuses her practice on data privacy and cybersecurity. She assists clients in identifying, assessing and remediating privacy and data protection risks on an enterprise-level and global scale. She focuses on customized and pragmatic approaches to managing compliance risk and advising on best practices for achieving harmonization of international regulatory requirements. Amy also manages responses to large and complex cyber incidents by guiding clients through the phases of breach response preparation, incident management, and post-incident remediation.

Michael, a partner in the law firm of McDermott Will & Emery LLP, advises manufacturers, health care providers, developers, and investors on the legal, regulatory, and reimbursement issues that arise throughout the life cycle of the development and commercialization of FDA-regulated medical devices, drugs, biological products, and clinical laboratory testing services. He is particularly experienced in the review of promotional/marketing materials and compliance strategies for responding to evolving FDA policy and enforcement positions for mobile health and personal engagement tools, including mobile medical applications and clinical decision support software. Michael regularly counsels clinical laboratories on federal (CLIA) and state regulatory issues, as well as the FDA’s ongoing efforts to regulate laboratory-developed tests (LDTs).

Dale, a partner in the law firm of McDermott Will & Emery LLP, advises health industry clients on strategic transactions and the evolution of health care delivery models. He has extensive experience in health system affiliations and joint venture transactions. Dale also provides counseling on the development of technology in health care delivery, with a particular emphasis on telemedicine. Dale has been at the forefront of advising clients with respect to the globalization of the US health care industry. He advises US and non-US enterprises with respect to the formation of cross-border affiliations and international programs. Dale is a frequent author and speaker at conferences on the globalization of health care.

Christine, an associate in the law firm of McDermott Will & Emery LLP, focuses her practice on representing nonprofit and private companies, health systems, and research institutions in the digital health technology and life sciences industries in the structuring and negotiation of technology development and transfer agreements. Her transactional experience includes advising clients on intellectual property licensing transactions and strategic collaborations, technology development and services arrangements, outsourcing deals and other complex commercial transactions involving intellectual property assets. Christine also advises health, technology, and life science clients on privacy and data security matters related to the Health Insurance Portability and Accountability Act.

Scott, an associate in the law firm of McDermott Will & Emery LLP, provides legal counsel on health care regulatory compliance, contracting, and transactional due diligence, with a focus on health information privacy and security, Medicare and Medicaid health information technology and quality reporting requirements, and clinical research regulations. He also provides legal counsel on federal and state privacy and data protection laws, with a focus on privacy audits and the development of internal and externally facing privacy policies for websites and mobile applications.