Protecting Data in Digital Health and Connected Devices (US & Europe Privacy, IP, Transactions)

Alexander Roussanov

Partner, Arnold & Porter

Alexander Roussanov, a former senior legal adviser in the Legal Department of the European Medicines Agency (EMA), focuses his practice on a broad range of issues related to the life-cycle of medicinal products and medical devices. His experience includes product classification, authorization and conduct of clinical trials for medicinal products and clinical investigations for medical devices, marketing authorization for medicinal products and CE marking of medical devices, pharmacovigilance and device vigilance, marketing and promotion activities, privacy and data protection counseling, and interactions with health care professionals.

He is well-versed in certain EMA-specific regulations, including those surrounding advanced therapy medicinal products, marketing authorization procedures, referral procedures, GxP inspections, the Agency’s freedom of information policy and clinical data transparency. In addition, he has represented the EMA in litigation in the Court of Justice of the European Union.

He has extensive practical experience counseling organizations on data security and privacy matters. Mr. Roussanov has assisted clients with compliance requirements of Regulation (EU) 2016/679 (GDPR). He advises on many aspects of the GDPR that are of particular importance in the Life Sciences sector. These include the collection and processing of patients’ personal health data and genetic data, transfer of personal health data outside the EU and the territorial scope of the GDPR.

Jami Vibbert

Partner, Arnold & Porter

Jami Vibbert helps clients navigate global data protection, privacy, and cybersecurity concerns across a number of industries, including life sciences, healthcare, financial services, media, and technology. She counsels on compliance with the ever-growing number of data protection requirements and on how to create global data strategies designed to align with these requirements in an efficient, proactive, and operationalized way. Ms. Vibbert assists in program and policy creation, conducts privacy and data security risk assessments, advises on data risk management, negotiates privacy and data security provisions with customers and third parties, and engages in privacy and data security due diligence. In the aftermath of a security incident or data loss, she guides clients through breach response and crisis management. She uses her privacy and security knowledge to successfully defend clients in privacy and data security-focused investigations with relevant privacy and data security regulators, including the Department for Health and Human Services Office for Civil Rights, the Federal Trade Commission, and multiple state attorneys general, and in privacy and data security litigation. She also aids clients in developing digital health, artificial intelligence, and other technology solutions to augment consumer, customer, and patient engagement and in designing new data-driven technology, products, and services in a forward-looking, flexible, and ethical manner.

Dr. Beatriz San Martin

Partner, Arnold & Porter

Dr. Beatriz San Martin has extensive experience in intellectual property matters with a particular focus on innovative and emerging technologies, particularly within the life sciences sector, as well as technology enabled solutions. She robustly manages and resolves disputes, assists clients on challenging technical legal issues and provides strategic IP advice.

Her disputes practice is varied with significant and high-profile experience handling cases before the UK Courts and the Court of Justice of the European Union, as well as assisting in multinational arbitrations. Besides her patent and SPC experience, she has also handled disputes and matters covering the full breadth of intellectual property rights including trademarks, database rights, copyright, design rights and trade secrets.

Prior to pursuing a legal career, Dr. San Martin was a scientist with a degree, PhD and postdoc specialising in genetics, cellular and molecular biology. This interest and passion in science and technology has broadened during the course of her legal career through her varied work with clients and involvement in trade associations.

She have been privileged to work on matters concerning a wide range of technologies – from pharmaceuticals and biotech to insulation products, from fintech services to agrochemicals, from software based platforms to medical instrumentation, from mosquito nets to digital technology. Most recently she has developed niche expertise in matters relating to gene editing and GMOs, as well as the implementation of the Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilization.

Nadia Gracias

Senior Associate, Arnold & Porter

Nadia Gracias represents clients in the life-sciences, technology, and healthcare sectors on the commercialisation of cutting-edge technologies. She has extensive experience in advising on all aspects of IP commercialisation strategy including development, licensing, collaboration, R&D deals and university spin-offs. She counsels clients on regulatory risks in the life sciences and health-tech sectors in an M&A and early-stage financing context, across all stages of the drug/device development life cycle. In 2020 Nadia was involved in advising on several projects (prophylactic, therapeutic and diagnostic) that were critical to delivering Covid-19 healthcare solutions both in the UK and overseas.

Nadia has significant pharmaceutical industry experience gained during four years in-house with a global CRO, advising on regulatory and contractual aspects of all phases of clinical trials, with a particular focus on oncology and paediatric trials. She has advised on the IP, commercial and regulatory aspects of the purchase of the largest public sector clinical trials unit in the UK. Nadia also spent time in the public sector working with the global IP legal team for 15 international agricultural research institutes funded by the UN Food and Agriculture Organisation and the World Bank.

Nadia is a qualified as a Solicitor in England and an Advocate in India. She holds a degree in international commercial law from the University of Cambridge and a post graduate degree in intellectual property law from the University of Oxford. She was a Cambridge Commonwealth Scholar, as well as an incoming Pegasus scholar with the Inner Temple in London, and served as a judicial clerk with the Supreme Court of India. She also acts as a mentor to a number of early stage start-ups and accelerator programs.