It's time to talk about the elephant in the room. This dichotomy is at the heart of most, if not all the misunderstandings around the regulation of health data. As a result, we find that many innovators (and even NHS organisations) veer between two extremes: being far too risk-averse with their use of health data, sitting on rich datasets which harbour huge possibilities, but perceiving that the regulatory environment is too prohibitive to permit them to use that dataset to its full potential; and being far too cavalier, inviting significant risk and regulatory scrutiny. There is huge potential for regulatory guidance in this space to clarify this intersection between these two regimes. Such guidance would need to involve multiple stakeholders, given the interplay of regulatory regimes, including the National Data Guardian, the Information Commissioner's Office, NHSX, the Medicines and Healthcare products Regulatory Agency, and the Health Research Authority. The volume of soft guidance is growing exponentially in the health data sphere, but we urge policymakers to focus on streamli...

https://insightplus.bakermckenzie.com/bm/healthcare-life-sciences/united-kingdom-an-open-letter-to-policymakers-we-need-to-talk-about-the-real-issue-with-health-data-regulation