Nadia

de la Houssaye

With experience in virtually all areas of healthcare law and regulation, Nadia now focuses her practice on three key areas: development, testing, and rollout of new drugs, medical devices, and other treatment modalities; telehealth and innovative care-delivery platforms; and general corporate, transactional, and regulatory counsel.

New-product development, clinical trials, and rollout

She represents pharmaceutical and medical device manufacturers, as well as clinical research institutions, in complex regulatory and compliance matters spanning clinical development, US Food and Drug Administration (FDA) approval, postmarket oversight, and commercialization strategy. Nadia guides clients through each phase of the drug and device development process, from the preparation of investigational new drug applications and new drug applications to 505(b)(2) submissions and accelerated approval pathways. She works closely with manufacturers, universities, institutional review boards, and other parties to structure compliant clinical programs, optimize regulatory engagement, and align scientific, operational, and commercial objectives to reduce time to market.

Nadia also advises on the evolving regulatory frameworks governing off-label communication, expanded access, compassionate use, label expansion initiatives, adaptive research strategies, and postmarket data collection designed to strengthen product positioning and support life cycle management. Known for her innovative and entrepreneurial experience building healthcare delivery modalities and biotechnology designs, Nadia collaborates with multidisciplinary client teams — including regulatory affairs, medical, legal, and commercial — to translate complex FDA guidance into straightforward, compliant strategies that advance innovation and market growth.

Among recent matters, she helped a major university system perform internal research audits, consolidate its multicampus research entities under a unified umbrella, and respond to and resolve regulatory concerns, enabling the institutions to continue their critical research activities.

Telehealth and innovative care-delivery platforms

Nadia has long been a pioneer in the expansion and growth of telemedicine. In 1997, she cocreated and helped launch one of Louisiana’s first teleradiology networks. In 2004, the company merged with another teleradiology network, creating NightHawk, the nation’s largest telehealth organization of its kind at the time, with headquarters and offices in the United States, Australia, Germany, and Switzerland. Since NightHawk Radiology went public in 2006, Nadia has continued to provide strategic counsel to other venture-backed entrepreneurs, healthcare providers, and hospital systems on digital health and telehealth service lines, including international telehealth arrangements involving multistate and international licensure and scope-of-practice issues, and on data security, storage, and usage.

She regularly provides guidance on the structuring of scalable national and international telehealth companies, including with respect to strategic growth, entry markets, acceptable telehealth modalities and practice standards, privacy and data usage, corporate practice of medicine prohibitions, FDA applications, Centers for Medicare & Medicaid Services waivers, and a wide range of regulatory changes in response to evolving needs and challenges.

Corporate, transactional, and other regulatory counsel

Nadia leverages the firm’s integrated capabilities in healthcare regulation, corporate structuring, and intellectual property to deliver comprehensive counsel that empowers healthcare entities and innovators to bring transformative therapies to market. Over the course of her career, she has advised on traditional healthcare issues, including major mergers, acquisitions, and joint ventures; medical malpractice defense and hospital-physician relations, including exclusive contracts and medical privileges and credentialing; certificates of need and licensure; medical coding and reimbursement; and fraud and abuse laws, including federal and state Emergency Medical Treatment & Labor Act actions, Stark Law and Anti-Kickback Statute violations, and False Claims Act violations.

She also has an in-depth understanding of medical staff bylaws, rules, regulations, and compliance protocols; board and senior management involvement and supervision; the proper roles for risk managers and risk management committees; and implementation of Medicare secondary payer reporting requirements.