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Highlights of our experience in eHealth

  • Major medical devices manufacturer on regulatory issues in respect of its remote monitoring, diagnostic and therapeutic suggestion services for implants, including consideration of confidentiality, consent and data protection issues.
  • A global software company in the ehealth field on the regulatory environment and likely supply and use restrictions for data software packages for healthcare use, including remote health monitoring intended for use in the healthcare provider sector, providing strategic advice on the borderline status of software products and the risk of their classification as a medical device. The advice was coordinated across the EEA, the US, LatAm and ASEAN countries.
  • UCL Business on the preparation of a standard agreement for use with NHS clinical commissioning groups in order to allow patients access to an online self-management programme for type II diabetes developed by HELP Digital CIC, a social enterprise incorporated by UCL Business. We also assisted with the preparation of HELP Digital CIC’s website terms and conditions, advising on key issues such as data protection compliance and exclusions of liability.
  • A healthcare company on the investment in a software development business together with advice relating to an agreement for the development, licensing and services for a health scoring software platform with that company.
  • The NHS in Scotland on the procurement of new systems to replace its existing electronic patient records and patient identification systems.
  • A major diagnostics company on the legal status of standalone, user design software supplied to enable laboratories to customise existing tests and protocols or to develop new ones using existing IVD laboratory systems.
  • A major software company on the use of its software products within a collaborative healthcare research programme, including advice on the legal status, supply and use of both developmental as well as finished products and applicable regulatory frameworks in each case.
  • A major global ICT company on the launch of its ehealth technology applications and associated infrastructure.
  • A leading private healthcare provider on the legal status of a smartphone health app designed to monitor glucose levels and on the significance of claims wording for the legal status of the product.  
  • University of Glasgow on all legal matters relevant to the establishment of the Stratified Medicine Scotland Innovation Centre ((SMS-IC) an initiative funded by the Scottish Funding Council). SMS-IC projects depend upon access to IP, data, human tissue samples, and electronic health records held by the core partners and involve use of state of the art genomic sequencing and bioinformatics technologies. Our role has included advising  on the structuring of and thereafter preparing template documentation for use to govern SMS-IC projects, including documenting complex IP and data sharing arrangements.