Oliver Mobasser

Solicitor, Latham & Watkins

Oliver Mobasser is a Senior Associate in the Healthcare and Life Sciences group of the London office of Latham & Watkins. He advises clients in the healthcare and life sciences industry on a range of technology, intellectual property, and data-focused transactions and matters.

Mr Mobasser helps emerging and established multinational pharmaceutical, biotechnology, digital health, and medical technology companies as well as their investors navigate:

• Strategic licenses and collaborations

• Product acquisitions, divestments, and carve-outs

• Manufacturing, supply, distribution, and other commercial agreements

• Data protection, as well as data use, re-use, and exploitation

• Research and development and clinical trials

He has particular expertise and has contributed to a number of publications and conferences in complex data protection matters in the life sciences sector, including matters related to use of data in the context of clinical trials and other research, anonymisation, pseudonymisation, digital health and AI solutions.

Prior to joining Latham, Mr. Mobasser practised at a leading law firm in Dublin, Ireland, and completed a secondment as in-house counsel for Shire Pharmaceuticals. He brings a multifaceted, multijurisdictional perspective to his work for clients across Europe and North America. He regularly writes about topics at the intersection of healthcare, technology, and regulation.

Contributed to

3

Digital health—data protection and privacy case studies

Practice Notes

This Practice Note examines data protection considerations in relation to digital health. It first explains the general concept of digital health, which encompasses mHealth, mobile apps, telemedicine, machine learning, etc, and provides some background on the increasing use of digital health solutions in the life sciences sector. It also provides an overview of the regulatory authorities and key stakeholders in different jurisdictions: EU, UK, France and Germany. This Practice Note then analyses the data protection challenges posed by digital health through three different case studies, covering a wide range of digital health technology applications: wearables (ie devices that remotely monitor patients in real time in non-clinical environments to improve patient care and medical diagnosis), artificial intelligence (AI) diagnostic tools (ie AI tool which analyses mammograms and radiology images to predict diagnosis) and digital health records (ie medical software). Key concepts of applicable data protection laws, including the General Data Protection Regulation (GDPR), are examined through these case studies: role of the relevant parties (controller, processor or joint controller of personal data), applicable legal basis, transparency, accuracy, anonymisation, special category data, secondary use of personal data, security, data transfers, data hosting, data subject rights, and cookies.

Life Sciences

EU Pharmacovigilance

Practice Notes

This Practice Note deals with pharmacovigilance. It sets out the EU regulatory framework and discusses the role of the Pharmacovigilance Risk Assessment Committee (PRAC), EudraVigilance and the guidelines on good pharmacovigilance practices (GVPs). It then takes a more detailed look at the pharmacovigilance processes and requirements set out in the GVP modules, including: how to establish a pharmacovigilance system, the qualified person responsible for pharmacovigilance (QPPV), the pharmacovigilance system master file (PSMF), pharmacovigilance inspections, pharmacovigilance audits, periodic safety update reports (PSURs), and post-authorisation safety studies (PASS). The Practice Note then considers non-compliance with pharmacovigilance requirements, data protection considerations, and outsourcing pharmacovigilance activities.

EU Law

Pharmacovigilance

Practice Notes

This Practice Note deals with pharmacovigilance. It sets out the EU and UK regulatory framework and discusses the role of the Pharmacovigilance Risk Assessment Committee (PRAC), EudraVigilance and the guidelines on good pharmacovigilance practices (GVPs). It then takes a more detailed look at the pharmacovigilance processes and requirements set out in the GVP modules, including: how to establish a pharmacovigilance system, the qualified person responsible for pharmacovigilance (QPPV), the pharmacovigilance system master file (PSMF), pharmacovigilance inspections, pharmacovigilance audits, periodic safety update reports (PSURs), and post-authorisation safety studies (PASS). The Practice Note then considers non-compliance with pharmacovigilance requirements, data protection considerations, and outsourcing pharmacovigilance activities. Finally, it discusses pharmacovigilance in the UK and the role of the Medicines and Healthcare products Regulatory Agency (MHRA).

Life Sciences