Digital Health

From smartphone applications and “wearable” technology which we use to track our sleeping patterns or fitness or technology which is used to diagnose and treat illnesses or injuries to social media communities supporting patients suffering from the same conditions, digital health is already changing our lives and disrupting existing business models.

Organisations used to operating along traditional sector lines and within recognised industry norms are rethinking their business models to tap into the seemingly limitless potential offered by digital health. Organisations will need to consider new and unfamiliar issues to ensure that legal, regulatory and other risks associated with this innovation are mitigated appropriately.

Through our multi-disciplinary team of lawyers operating throughout our international network, we can offer organisations what they need: the best business-focused legal and regulatory advice in a fast-changing healthcare environment.

We provide assistance in the following fields:

• Culture: The fail-fast approach in technology businesses contrasts with the more cautious approach of healthcare and life sciences businesses. The cultural challenges when these companies collaborate need to be managed.
• Cybersecurity: Hacking presents an increasing threat, particularly for health data. We can advise on contracting around cybersecurity risks and implementing incident response processes.
• Data: Data underpins all digital health projects. Compliance with data protection laws such as GDPR, HIPAA and HITECH is critical.
• Intellectual Property: Healthcare and life sciences businesses have traditionally protected products and processes through patents, while technology companies rely on copyright and database rights to protect software and IT systems. As these sectors converge, you need to address how IP rights apply to innovative technologies.
• Regulatory compliance: You need to consider whether a digital product may be regulated as a medical device under the new EU Medical Device Regulation and, if so, its likely classification for market access. We can also help you engage with regulators to guide their understanding.
• Product liability: Digital health collaborations present new challenges for product liability, given the nature of the technologies and the range of of parties who could be liable (data providers, software developers, hardware developers, physicians).
• Tax: The creation of new intangible property, changes to business models and/or or the relocation of functions/assets have tax implications that need careful planning. Digitalisation may also create opportunities to improve your tax and transfer pricing structures.
• Transactions: Digital health collaborations, joint ventures, mergers & acquisitions and minority investments require a nimble approach. This includes due diligence which relies less on a desktop review and more on engaging with management teams on the risks above, underpinned with tailored warranties.

We have created a series of byte-sized TechNotes summarising the legal challenges posed by the disruptive technologies that are revolutionising business today.