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Digital Health

Our lawyers have extensive experience and a deep understanding of the specific business issues and complex market conditions of the digital world. We provide specialist advice, integrated across a range of legal disciplines, and a global full-service offering.

Digital technology is revolutionising the healthcare industry. From robotic surgeons and wearable devices that measure and record vital signs, to smartphone Apps that detect diseases and new platforms for analysing medical data, things are changing fast. In order to reap the benefits of this revolution it is becoming increasingly important for industry players to navigate a myriad of legal issues. These include issues relating to data protection, regulatory requirements, liability and, more generally, corporate and commercial transactions. The team at Linklaters has the industry knowledge, technical expertise and global footprint that is necessary for advising on these legal issues.

Big Data

Data is at the core of successful digital health products. What is done with that data is not only pivotal to enhancing patient outcomes, but also to winning consumers’ trust and remaining competitive. Our global privacy team has been advising on data issues for more than 25 years. We help clients to understand the complex, strictly enforced and sometimes conflicting data laws around the world and share our deep market experience and knowledge gained from our strong relationships with regulators.

Technology

A deep understanding of technology is key to being part of the digital health ecosystem. Our global technology team is well-known for its presence at the cutting-edge of the technology market. We have worked on some of the most complex projects seen to date, from inception and through life. We understand the importance of getting to the heart of a project – helping to put in place arrangements that allow agile working, and which incentivise innovation and collaboration, while protecting our clients’ interests.

Intellectual Property

Intellectual property rights (IPRs) play a crucial role in protecting the innovations that lie at the heart of digital health. Our IP specialists have worked closely with a range of healthcare, medical device and technology companies for years, on a range of commercial, litigious and corporate matters. We have significant expertise in advising industry players on protecting and leveraging value from their IPRs and avoiding the risks of infringing third party IPRs.

Regulatory

The ever-changing regulatory landscape applicable to digital health can seem daunting. It includes medical device regulation, communications regulation, broader healthcare regulation, data/cyber regulation, e-commerce regulation, professional ethics, anti-bribery regulation, competition regulation and more. One of our key strengths is assisting clients with simplifying complex webs of local regulations and preparing clear global strategies. We leverage our own extensive global footprint and our relationships with subject matter experts to deliver seamless advice.

Commercialisation and portfolio management

Securing the right funding, alliance, supply chain and commercialisation structures is crucial for the growth of any digital health business - as is proper portfolio management. Some of the largest healthcare clients in the world trust us to advise them on all aspects of these issues. For example, we regularly advise on strategic partnering and JVs, portfolio M&A, licensing and other commercialisation arrangements, all aspects of manufacturing and distribution agreements, outsourcings and more.

Liability, Disputes and Investigations

Product liability is a key concern for any digital health business. We have experience of advising on class actions and investigations, regulatory actions and disputes arising from supply chain issues and in helping clients to calibrate and manage the risks associated with claims for defective products.

Work highlights

Multi-jurisdictional regulatory advice

  • Providing multi-jurisdictional regulatory advice to a global healthcare manufacturer on the regulatory frameworks governing the treatment of “well-being” and “health” data, the transfer of health data internationally, the use of certified hosting facilities for storing health data and the advertising of medical equipment
  • Providing multi-jurisdictional advice to a global healthcare manufacturer on the commercialisation of a tele-monitoring and patient management application designed to monitor and optimise the treatment of patients who suffer from sleeping disorders

McKesson

Advising McKesson on the sale of its European healthcare technology operations, which provide information technology systems that manage the flow of information between departments and organizations to assist health and social care practitioners in delivering improved outcomes to patients

A number of NGOs

Advising a number of NGOs on the regulatory issues affecting the collection and centralised electronic storage of medical information obtained by doctors from their work in emerging markets, and in relation to the data centre solution for the same

Elsevier Limited

Advising Elsevier Limited on its acquisition of 100% of InferMed Limited, a clinical decision support (CDS) technology company that is a leader in providing software and services to the healthcare, pharmaceutical, and clinical research sectors

A pharmaceutical company

Advising a pharmaceutical company on the tailoring of its contractual arrangements with technology providers to cater for digital health projects

Johnson & Johnson

Advising Johnson & Johnson on the competition law issues relating to its JV with Google for the creation of a comprehensive surgical solutions platform that will incorporate leading-edge robotic capabilities and best-in-class medical device technology

Wyeth

Advising Wyeth (now Pfizer) on a joint venture with Mobistar (Orange Group) for the commercialisation of an application for haemophiliac patients

Learn more about our Healthcare and Technology sector capabilities

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