Digital health is an umbrella term for healthcare being provided or enhanced through the use of 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 aspects we have been involved with in this area include transactions between digital technology companies and healthcare providers, advice on liability issues associated with the development of mobile and other software applications, and advice under privacy law associated with digital health provision.
In the current “fourth industrial revolution”, studies have shown a marked shift in consumer habits towards embracing new digital health 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 respect of the use and protection of sensitive personal data relating to healthcare provision in the digital age? To what extent will “big data” issues lead to 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 within 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 issues addressed above, businesses should ensure that they are keenly aware of both the risks and the opportunities presented by the rapid digital evolution of healthcare provision.
Gustaf Duhs