Digital Health is an umbrella term for healthcare being provided or enhanced through the use digital technology, and covers everything from telediagnostics, wearable medical devices, use of mobile software and applications, machine learning and artificial intelligence (AI).

This is a rapid growth area in the life sciences sector. There is considerable investment in this space as well as M&A activity. Legal activity we have been involved in this area includes transactions between digital technology companies and healthcare providers, advice on liability issues associated with development of mobile and other software applications, and advice under privacy law associated with digital health provision.

In many ways, the Digital Healthcare aspects of this fourth industrial revolution has led to a change in consumer behaviour, with studies showing a marked shift in consumer habits towards embracing new technologies such as wearable technology and AI diagnosis.

From a legal perspective, digital health raises a number of interesting and challenging issues, including:

Regulation

To what extent is the ‘traditional’ life sciences regulatory framework appropriate to regulate digital health? For example, does national regulation still function where healthcare can be delivered globally through digital means? How do you attribute liability for issues arising in respect of AI? To what extent can regulators effectively police opaque technological solutions?

Data-related issues

What issues arise in the use and protection of sensitive personal data relating to healthcare provision in the digital age? To what extent will ‘big data’ issues lead dominance that can be exploited by those with first-mover advantage?

Platform issues

What is the correct treatment of liabilities in peer-to-peer technologies in a digital space, and what is the impact of removing the healthcare ‘expert’ from health treatment?

Industry expansion and consolidation

As with other areas of digital expansion, expect to see innovation, growth and then industry consolidation. These will be busy times for M&A and other related areas (for example merger control).

In light of the development of digital health related issues businesses should ensure that they are keenly aware of both the risks and the opportunities presented by the rapid digital evolution of healthcare provision.