The Digital Health sector is booming. New health technologies and device innovation seek to address the demand for efficient delivery of health services and data collection. The role of technology in digital health has been described as the super-convergence of wireless, sensors and devices, genomics, social networking, mobile connectivity, imaging, health information systems, the internet, computing power and data.
We are working with clients and innovators, applying our digital technology and life sciences expertise to help businesses commercialise their intellectual property and comply with regulatory requirements in order to bring new products and services to market.
Digital Health crosses international borders as our clients seek to realise the fundamental economies of scale offered by the use of technology. Our international teams are able to resolve inevitable cross-border multi-jurisdictional issues.
A selection of our experiences
Patent & Technical Disputes
Advised ViCentra BV, leading early stage medical devices company, on contractual and copyright issues involving software for an insulin pump device.
Advised an orthopaedic medical devices specialist in respect of various contractual disputes and a complaint to a competition authority.
Advised an AIM-quoted medical device company on various contentious matters, including successfully defeating a shareholder's petition to the court for unfair prejudice.
Advised a well-known connected devices company, on a product safety issue that involved charging plugs catching fire, working through a product safety risk assessment and devised a strategy for the company to deal with customers, the supplier and regulators.
Advising ViCentra BV, leading early stage medical devices company, on contractual and copyright issues involving software for an insulin pump device.
Advising an AIM-quoted medical device company on various contentious matters, including successfully defeating a shareholder's petition to the court for unfair prejudice.
Advising a diagnostic laboratory client on a dispute relating to the supply of defective diagnostic equipment.
Advising a life sciences software provider on a potential breach of data.
Advising a medical devices company, on contractual and copyright issues involving software for an insulin pump device.
Advising an orthopaedic medical devices specialist in respect of various contractual disputes and a complaint to a competition authority.
Advising an innovative and rapidly growing US artificial intelligence company on biotech and pharmaceutical patent litigation in Poland.
Regulatory & Compliance
Advised Thriva, world's first preventative health tracking service, on contractual, regulatory and health data issues.
Advised a leader in telemedicine, on remote practice of medicine, free movement of doctors in the EU, cross-borders medical prescriptions and coverage by Health Insurance Programs.
Advised a US based child neurodevelopment technology company, as to whether a connected product and app would fall within the classification of Medical Device under the Directive/Regulations and whether claims made would increase risk of that.
Advised a global medical technology company, on anti-bribery and corruption compliance.
Advising Alpha, Telefonica's long term innovation facility, as to whether an algorithm to be included in an app constituted a medical device.
Advising Clinomic on several matters especially on regulatory data protection and IT law support for product development the product development.
Advising Engie Italia S.p.A., a major international energy company, on data processing relating to a special telemedicine project managed by a subsidiary.
Advising SevenVentures as part of the due diligence process for the investment in the Wellster Healthtech Group on regulatory issues (in particular § 9 HWG, prohibition of advertising for remote treatments) in relation to a health platform with online medical treatment.
Advising a foreign medical devices distributor in multiple good distribution practice (GDP) inspections led by the Belgian regulator.
Advising a leading multinational internet technology company on the requirements for advertising, through its global social media ad entertainment platform, of self-medication and non-prescription medicines.
Advising a medical device company on the interpretation of regulations and an internal compliance review in relation to one of its infection prevention products.
Advising on transparency ('sunshine') requirements applicable to foreign (non-Dutch) medical devices distributors interacting with hospitals and KOLs based in the Netherlands.
Providing medical regulatory advice to a PE house in respect of a potential investment into a company producing a novel medical device.
Assisting a US listed medical device business on its reporting (sunshine) obligations under Belgian medical devices regulations.
Advisory
Advised Babylon, a leading UK-based healthcare technology and services company, on various matters including health data, collaborations with Prudential Corporation in Asia-Pacific and TELUS Health in Canada.
Advised Intelligent Ultrasound Group, an ultrasound software and simulation company, on a long-term licence and co-development agreement for its AI software.
Advised a British healthcare technology company, on multiple health data matters including the development of a COVID-19 app for use in Germany and for NHSx.
Advised a healthcare technology company, on various health data matters including arrangements with the Kenyan Health Department.
Advised a leading provider of medical cosmetic treatments on various employment tribunal matters and other day-to-day employment issues.
Advising Baxter Healthcare on general employment matters.
Extensive consulting to Clinomic on many IT projects, product development and product rollout, as well as joint ventures and grant agreements.
Advising Koa Health on numerous commercial matters, including leading in various collaborations including with Doctor Care Anywhere.
Advising Nipro Medical France on the negotiation of the commercial lease of a mix-use (industrial/offices) property (approx.. 5,000 sq.m) in Clermont Ferrand.
Assisting in the due diligence and providing employment support to Visiomed, a French group, on their acquisition of a branch of activity in Omega Pharma (Perrigo).
Advising a developer of smart sensor technology for various IoT applications on the international distribution of the innovative "Floor Sense" technology, which can be used, for example, in retirement and nursing homes to determine (anonymously) whether a resident has fallen and needs help or whether the movement patterns indicate illnesses, in compliance with data protection regulations.
Transactional
Advised Creo Medical Group, an AIM-quoted medical device company focused on the emerging field of surgical endoscopy, on a successful fundraising to raise £52m by way of a placing and open offer.
Advised Sensyne Health, a British healthcare technology company, in connection with its successful AIM market IPO and associated restructuring.
Advised Inotec AMD, a fast-growing medtech business that has developed a new device to heal complex chronic wounds, in relation to a £7m funding round.
Advised Nuformix, a standard listed pharmaceutical development company, on its placing and corporate governance matters.
Advising Advent Life Sciences, one of the leading transatlantic venture investors building innovative life sciences businesses, on its lead investment in global health technology platform, Proximie's US$80m Series C equity financing.
Advising Dottori.it on the acquisition of dottori.it by Doctolib, leader on the European market for digital health.
Advising KMS Klinik Management Systeme on the sale of the shares of KMS Vertrieb und Services AG and the software "eisTik" to CompuGroup Medical.
Assisting OncoDNA, a precision medicine diagnostic company, in the framework of its due diligence and acquisition of Integragen, a French genomic testing company listed on Euronext Growth and one of their Spanish distributors BioSequence.
Assisting Sunrise, a medical device sleep apnea company, on their due diligence and €14m series A financing round lead by Kurma Partners and European Innovation Council Fund.
Advising Turbine, a company developing a cell behaviour simulation platform, on its €20m Series A financing round. Our team provided corporate and tax advice.
Advising TriCares on a €22m B round lead by Wellington Partners, Andera Partners and BioMed Partners.
Advising a Digital Health Platform in the context of the acquisition of DGG (Digital Health Group incl. medulife and DITG) from the founder including advice on subsequent various post-M&A disputes.
Advised a Venture Capital fund with Health-Tech specific expertise in an investment which operates mainly in the field of home and remote care of people's health outside clinical settings. This includes software solutions for cloud-based sharing and management of medical data among patients, caregivers, physicians and institutions and through the integration of medical devices, software and applications to securely collect and store health data.
© Osborne Clarke 2023