Digital Health

Our Practice

Digital health, in its various forms, is becoming an increasingly high profile area. From (i) mobile smartphone applications and “wearable” technology which we use to track our sleeping patterns or fitness to (ii) technology which is used to diagnose and treat illnesses or injuries to (iii) social media communities supporting patients suffering from the same conditions; it is ubiquitous and here to stay.

Organisations used to operating along traditional sector lines (such as telecommunications companies, pharmaceutical companies and software developers) and within recognised industry norms are broadening their service offerings to tap into the seemingly limitless potential offered by digital health. This expansion is not without risk. Organisations will need to consider new and unfamiliar issues to ensure that risks associated with this expansion 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 advice in a fast-moving sector.

Experience

Adherium

  • advising this digital health company on a ground-breaking long-term supply and development agreement to supply its ‘Smartinhaler’™ to AstraZeneca AB

Cegedim

  • advising this provider of digital data flow management systems for healthcare companies on various data protection compliance issues

Clinical Practice Research Datalink

  • in relation to the licensing of big data to an international pharmaceutical company for use in connection with clinical trials

Dutch National Institute for Public Health and Environment (RIVM)

  • legal issues in respect of the content and operation of the Kiesbeter.nl portal

GlaxoSmithKline on a number of data protection projects, including in respect of:

  • international data transfers
  • data protection issues in the context of outsourcing and cloud computing transactions
  • disclosure of data relating to payments to healthcare professionals
  • social media monitoring

 MHRA (UK Medicines and Healthcare Products Regulatory Agency)

  • on the procurement of a significant IT system from Accenture and Oracle
  • on the outsourcing of IT infrastructure and software development services to Accenture across two generations of outsourcing contracts

Private Healthcare Information Network (“PHIN”)

  • on its set-up, funding and governance

UK Health and Social Care Information Centre

  • in relation to its strategic review of the Dr Foster Intelligence joint venture and disposal of its 50% stake

Zephyr Health

  • advising this provider of data analytics and data management solutions to healthcare companies on data protection compliance issues in a number of EU countries

Further Expertise

Regulation & Data Protection

  •  a leading pharmaceutical company on regulatory, ethical and data protection relating to the establishment and operation of bio banks in Germany
  • a Japanese digital health apps designer on UK regulatory issues in relation to the commercialisation of a self-testing male fertility kit
  • a pharmaceutical company on the implementation of a cloud – based data management system, involving cross-border data transfer aspects

IT & E-commerce

  • a pharmaceutical company on the development of an iPad application for cancer patients
  • a Belgian pharmacy business with regard to e-commerce of OTC products
  •  a top 10 global pharmaceutical company on digital agency agreements for roll out of social media and internet analytics based campaigns
  • a North American software provider in contractual negotiations with a French public health authority on implementing the use of mobile technology to monitor patients
  • a US software provider in relation to an a end-user licence agreement (EULA) relating to cardiology system software for a French end-user
  • a healthcare group comprising 180 clinics in setting up an online communications platform for healthcare professionals and patients
  • an international pharmaceutical company on the structure of data flows and the applicable regulatory requirements on the implementation of a platform providing online assistance to patients during the course of their treatment
  • African Medical and Research Foundation on a 10 month pilot to develop a multi-channel (SMS, USSD, IVR, mobile web, etc.) training and productivity mobile platform to be used by approximately 300 health workers in Kenya

Advertising, promotion and social media

  • a European medical imaging business on multijurisdictional issues relating to online advertising and promotion
  • French association of advertisers – on its participation in the think tank/working group organised between the French Health Product Authority (ANSM) and other stakeholders for the creation of a Charter for the communication and the promotion of health products online
  • a top 10 global pharmaceutical company on a range of social media campaigns for the local Arabic language market in the United Arab Emirates
  • Australian manufacturer of products for the treatment of sleep disorders - on the setting up of a Facebook page presenting a medical device

Licensing and collaboration

  • a leading manufacturer and service provider for medical diagnostics on R&D collaboration relating to telemedicine services, funded by the German Federal Ministry of Education and Research
  • a life science company on a licensing agreement relating to individually developed software for specific use in the life sciences sector

Product liability

  • a medical devices manufacturer on liability and ethical aspects of a software tool to predict the mortality of patients with chronic medical conditions
  • a pharmaceutical and medical devices company on product liability and classification relating to an international project for decision support software, based on IBM Watson.