Digital Health in the UK: MHRA Bold New (Regulatory) World?

In his statement to the House of Lords on September 16, Lord Frost announced that “we will use the provisions of the Medicines and Medical Devices Act 2021 to overhaul our clinical trial frameworks, based on outdated EU legislation, giving a major boost to the UK’s world-class R&D sector and getting patients access to new lifesaving medicines more quickly. The MHRA which is a world class regulator as we know, is already reforming the medical devices regulations to create a world-leading regime in this area.” This provided a timely back-drop to the MHRA’s new publications on medical device software, and part of a broader agenda for regulatory change in the UK.

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European Commission Releases Assessment of the EU Member States’ Rules on Health Data in Light of GDPR

On February 12, 2021, the European Commission (Commission) published an “Assessment of the EU Member States’ rules on health data in the light of GDPR” (the Assessment). The Assessment concludes, amongst other things, that there are variations in the implementation of the EU General Data Protection Regulation (GDPR) at a national level with regards to the processing of health data. In turn, this has led to a fragmented approach to the processing of health data for health and research purposes across the EU. To avoid further fragmentation, the Assessment proposes various future EU-level actions, including stakeholder-driven Codes of Conduct as well as new targeted and sector-specific legislation.

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Digital Health and Cyber Risk in the “New Normal”

Sidley partnered with Aon’s Cyber Solutions for an exclusive webinar for life sciences organizations to address developments in digital health and cybersecurity in light of some key trends affecting the industry today.

The speakers discussed the latest in digital health and how to better understand and mitigate cyber risk, as well as protect life sciences organizations’ highly valuable and sensitive data.

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