RU Okay? Understanding the Regulatory Landscape for Diagnostic Tests in the US, UK and EU

Sharon Lamb focuses her practice on transactional and regulatory advice in the health and life sciences sector and leads McDermott’s UK Health and Life Sciences Practice Group.

Sharon advises on global transactional mandates, including mergers and acquisitions and joint ventures in health services, pharma and life sciences, digital health and health technologies. Sharon also provides strategic, regulatory and commercial support to UK and international clients on UK health and life sciences with a focus on health services, pharmaceuticals, medical devices, digital health and health data.

Sharon is widely recognized for her expertise on NHS and public law procurement, regulatory and contracting matters, including payment and reimbursement and market access. She has particular experience advising strategic and private equity investors in transactions and investments in health and life sciences.

Sharon is also well-versed in health care services governance and regulatory matters, NHS public private partnerships, procurements, joint ventures and shared working arrangements, mergers, acquisitions, health data and competition issues.

Sharon has practiced health and life sciences law in the UK since 2002 and is recognized in Chambers and Legal 500. Sharon has written and lectures widely on health and life sciences issues and has a wealth of experience with NHS law and policy, having worked on a 4-year part time secondment with the NHS and national health bodies in London.

Michael (Mike) Ryan advises manufacturers, healthcare providers, and investors on the legal, regulatory, and reimbursement/market access issues that arise during the development and commercialization of medical devices, clinical laboratory testing services, biological products, and drugs. He helps clinical laboratories and life sciences companies maintain regulatory compliance and evaluate, develop, and implement strategies to optimize coding, coverage, and payment for novel technologies.

Additionally, Mike helps innovative companies identify and navigate applicable Food and Drug Administration (FDA) regulatory requirements for new technologies, particularly in vitro diagnostics and digital health products. He regularly advises clients on the FDA’s evolving requirements for laboratory developed tests (LDTs) and reviews promotional and marketing materials for FDA-regulated medical products.

Mike also counsels clinical laboratories on state and federal compliance issues, including those under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), state laboratory licensure laws, and billing and reimbursement rules.

Jana Grieb has been advising pharmaceutical and medical technology companies on all aspects of health law for over 20 years. She accompanies pharmaceuticals, medical devices, and in vitro diagnostics throughout their entire life cycle - from research and development to market access, advertising and distribution. One main area of her work is providing legal and strategic advice on market entry and reimbursement paths in the European Union, with a particular focus on the EU regulations on medical devices and in vitro diagnostics and the law governing statutory health insurance in Germany. In this context, Jana also advises on research and distribution collaborations.

Besides her regulatory focus, Jana provides comprehensive advice on compliance issues in the healthcare market, including aspects of competition and medical advertising law, cooperation with professionals under anti-corruption and association law requirements, as well as background advice on commercial criminal law. She supports her clients in the establishment and further development of their compliance management.

Finally, Jana advises with broad experience on the borderline of health markets to neighboring product markets, mainly food, cosmetics, wellness and electronic products.

Jana is a regular speaker and author of numerous publications on pharmaceutical and medical device law.