Telemedicine: The European Health Data Space
April 09, 2024
Telemedicine: The European Health Data SpaceApril 09, 2024 In May 2023, the EC unveiled a proposal for a regulation concerning the European Health Data Space, aiming to oversee and facilitate the accessibility and sharing of electronic health data within the EU. The primary objectives of this data space are to empower individuals with seamless access to and control over their electronic health data while also enabling researchers, innovators, and policymakers to utilize this data in a lawful, trusted, and secure manner. Given the sensitive nature of the EU member states' healthcare systems, the negotiations surrounding this proposal have proven challenging. Notably, the European Data Protection Board and the European Data Protection Supervisor have raised concerns about potential GDPR issues within the health data space and have made recommendations to clarify its relationship with existing data protection laws. Looking aheadThe UK’s approach to regulating telemedicine is therefore fragmented at present, drawing upon various pieces of legislation and supplemented by industry guidance in the absence of a single, unifying regulation. This is in contrast to some European jurisdictions which have a more developed regulatory system. Although there is still some residual caution around the use of telemedicine when compared against traditional face-to-face healthcare, attitudes are changing and it is possible that medical innovation, combined with effective government policy, could further normalise telemedicine and instil confidence in patients and healthcare professions. For businesses and organisations to avoid further legislative and regulatory requirements in this field, the best approach is to show that current requirements are already sufficient to safeguard data and patients. By complying with current obligations and thus avoiding and reducing the risk of harm arising in practice, bodies can provide supporting evidence for this conclusion.
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