Lexology Webinar: Launching Your Health App in the EU – Key Considerations
20 January 2020
The popularity of health apps has soared over the last number of years, with apps on the market for a range of health-related issues. From dermatological mole analysis to afibrilation detection, prescribing assistants to fertility trackers, wellness bots to early alert apps – the health app industry is booming and innovation continues at a rapid rate.
With the merging of health-related services and technology comes a number of challenges and legal considerations. Whether you are a new app developer, or an existing app developer or owner already in the market, keeping apprised of regulatory obligations is paramount to ensure compliance and patient safety.
In this webinar, we will examine the following key issues which app developers need to consider, including:
The application of the EU Medical Devices Regulation regulatory framework – when does it apply to your app?
How to distinguish a health app/software medical devices from a wellness/fitness app.
Key IP considerations when preparing to market your app from both a protection and defence perspective.
The implications of using AI in your app.
Data issues and ensuring compliance with GDPR
Consumer protection obligations
This webinar is aimed at in-house counsel and those in private practice in the life sciences and products industries, and will be of particular interest to companies engaged or planning to engage in health app development.
Brian is a partner in our Intellectual Property law team.
He advises on complex IP and technology issues for clients from a range of sectors including digital health, pharma, food, beverage, energy and agriculture. He also advises on AI across those sectors and plays an active role in the National Strategy on AI for Ireland and with the AI Alliance at EU level. He works closely with clients on the formulation and implementation of effective IP development and protection strategies. This includes guiding international brand owners through complex IP protection and commercialisation issues and advising major technology companies on IP licensing and due diligence surrounding mergers, acquisitions, IPOs and foreign direct investment.
Brian is a registered Irish and EU trademark and design agent and has a wealth of experience of managing significant trade mark portfolios of major international clients. He is a former chair of the Licensing Executives Society of Ireland and the Irish branch of the Anti-Counterfeiting Group.
Brian is a partner in our Privacy and Data Security team.
Brian provides companies with solutions to their privacy and data protection problems. His focus is on helping some of the world’s leading technology companies to launch new and innovative technologies in Europe, including in the digital health sector. This includes helping companies to navigate the risks associated with the collection and use of health data, conducting health research and the anonymization and commercialisation of data. Brian also has particular expertise advising companies throughout their engagement with regulators and law enforcement agencies, including helping them to resolve complex investigations and enforcement action.
Prior to joining the firm, Brian gained much of his experience with a leading technology firm in London and in-house at Samsung as its European Data Protection Officer. He also gained valuable experience working in the Irish Data Protection Commission a number of years ago. This diverse and varied experience means Brian has a strong understanding of the privacy and data protection challenges companies face and the pragmatic and commercial advice they need.
Michaela is a partner in our Regulatory team.
Michaela Herron advises clients in the pharmaceutical, medical device (including software medical device), healthcare, digital health, cosmetic and general consumer produce sectors on various regulatory compliance matters, including regulatory approval, labelling, traceability, safety and liability issues. She has advised clients on enforcement action, including the defence of criminal prosecutions, the implementation and coordination of produce withdrawals and product recalls and rectification strategies in multiple jurisdictions. She has also acted on behalf of clients in significant commercial disputes, group product liability litigation, inquests, injunctive relief and judicial review proceedings.
John Farrell is a Partner on our Commercial team.
John practises as part of the Technology, Consumer Law and Privacy & Data Security teams. John works closely with some of the world’s largest companies solving complex technology law issues and providing practical and commercially focused solutions. He specialises in advising on large scale commercial arrangements, including multi-party structures involving various contractual agreements. John also provides strategic and contractual guidance on privacy and consumer law issues, including helping companies launch innovative products within the complex and highly regulated consumer facing realm.