The emergence of integrated health information systems, mobile apps and software-based medical devices presents significant opportunities for diagnosing illnesses, engaging in preventative medicine, managing healthcare costs and achieving better outcomes. This technological innovation has given rise to new legal, regulatory and commercial challenges.

Many companies are developing integrated, software-based applications to optimise traditional medical devices. In May 2008, a European Commission (“Commission”) consultation on medical devices was launched. As a result, medical device manufacturers have developed and are in the process of developing wireless-enabled medical devices and mobile apps that allow healthcare providers to access and evaluate patient vital signs and other information through remote monitoring or cloud-based data-sharing systems. The telecommunications industry, software developers and internet service providers are also providing wireless solutions, technical support and healthcare solutions to healthcare providers, consumers and health systems.

Among other things, this has raised questions in relation to:

  • The regulation of these products as medical devices
  • Privacy and movement of personal information
  • The impact of Directive 2000/31/EC on certain legal aspects of information society services, in particular electronic commerce, in the Internal Market (“Electronic Commerce Directive”)

We have recently published an overview in Practical Law covering:

  • EU policy on eHealth and mHealth
  • EU regulation of medical devices
  • Stand-alone medical software and medical software in devices
  • 2012 Commission guidance on stand-alone software
  • Standard for conformity assessment of medical software
  • New regulatory framework
  • Data Protection
  • EU Framework
    • Article 29 Working Party
    • Apps on Smart Devices
    • mHealth and eHealth and “Big Data”
    • General data protection regulation
    • Interplay with Electronic Commerce Directive and other EU legal instruments
  • Consumer Law considerations
  • Differences and developments in key European markets
    • Belgium
    • Germany
    • Ireland
    • Italy
    • Spain
    • United Kingdom
  • Future regulation

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