An introduction to key risks in digital health transactions
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We understand the challenges that established healthcare providers and life sciences companies and disrupters face in a fast-changing and highly regulated area where patient safety is critical and COVID-19 is placing unprecedented strains on healthcare systems and businesses. We can use our industry insight to deliver pragmatic advice on all aspects of digital health technology, on compliance and on investments and collaborations in this area.
The commercial questions
Established healthcare and life sciences organisations are seeking to develop new services and products, and harness data and transform business processes, using a range of innovative technologies such as artificial intelligence. They are often not as nimble as technology companies and start-ups in exploiting these technologies, but have a depth of understanding of patient needs and the regulatory framework that new entrants to the market may lack. This creates opportunities for consolidation in the market, including through mergers, acquisitions and joint ventures. The need for funding and scale on the part of start-ups and growth companies is also creating opportunities for strategic and/or financial investment in these companies.
The legal questions
The disruptive nature of these technologies demands an innovative approach to legal issues.
Greater collaboration and wider reliance on open source software requires new approaches to the protection of intellectual property reflecting collaboration across the industry and greater reliance on copyright and restrictive covenants in key employees’ service contracts rather than the patents on which the life sciences industry has traditionally depended.
Data, data protection and information security are also crucial areas of focus in this space. All healthcare involves the processing of sensitive, special category personal data, and regulators like the Information Commissioner’s Office are likely to take any breaches of data protection obligations by health and social care or life sciences businesses particularly seriously.
You will also need to consider other healthcare-specific regulatory issues, including the classification of your digital solution under the EU Medical Device Regulation.
Any transactions in this area are likely to involve detailed scrutiny, legal due diligence and negotiation of how risks should be allocated in relation to these issues and other matters such as the impact of COVID-19 and any liability to third parties for any defects in these new digital solutions.
Working with us
Our experience advising clients within the digital health space will enable us to pre-empt the commercial and legal challenges that you may face and deliver valuable solutions.
Get in touch if you have a project or question that we can assist with.
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