Digitalisation of Healthcare - Key IP, Contractual & Regulatory Changes

Introduction

The increasing digitalisation of healthcare - accelerated due to the pandemic - is transforming traditional models of patient care as well as diagnostic and treatment approaches.

This digitalisation trend, accompanied by increasing levels of investment and innovation in healthcare technologies (including in AI, wearables, telehealth, and smartphone integrations) presents new challenges for companies and gives rise to several unique issues.

These developments have prompted a number of important changes in the legal and regulatory landscape.

It also means that companies may need to rethink their strategies regarding path to market and approaches to commercialisation.

This new full day in-person course will explore the key IP, contractual and regulatory changes that are taking place and explore the various trends and approaches.

The session will be interactive and will engage directly with delegates by working through various case study examples.

The course assumes a working knowledge of IP law and practice, as well as some familiarity with the healthcare sector.

What You Will Learn

This course will cover the following:

• What is ‘digital health’?
• Digital health v traditional healthcare delivery
• Key recent developments and sector observations
• Protecting IP in the digital health space
• What technologies can attract protection, and how are these best protected?
• The role of AI in digital healthcare
• Dealing with infringements
• Regulation of digital health
• Clinical trials considerations
• The Medical Devices Regulation, product labelling and registration requirements
• Marketing approvals and the role of the MHRA
• Commercialising digital health technologies
• A strategic approach to each stage of development (through due diligence, the R&D process and licensing/supply)?
• Licensing structures and considerations - what should go into the contract?
• Privacy, big data, and digital health
• The impact of digitalisation and the rights of patients
• Data as an asset
• What if thing go wrong?
• The software-device interface and expansion of product liability risk - legal developments
• Vulnerabilities and challenges with increasing technological complexity
• Product liability risk - what’s the claim, how will it land and who picks up the tab?