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Redefining clinical trials: Adopting AI for speed, volume and diversity

IBM Big Data Hub

The FDA, in its May 2023 draft guidance, backed the adoption of DCTs across drugs, biologics and medical devices , highlighting their merits such as enhanced patient convenience, diminished caregiver burden, broader access to varied demographics, amplified trial productivity, and support for research on rare or mobility-restricted patient groups.

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EU: NIS2 enters into force

DLA Piper Privacy Matters

On 16 January 2023, the Directive on measures for a high common level of cybersecurity across the Union (“ NIS2 ”) entered into force. NIS2 replaces this categorisation with ‘essential’ entities and ‘important’ entities – based on the sector and size of the operators.