Addressing the Data Protection and Ethical Challenges posed by AI in Health – Part 2

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Executive Order: Preventing Access to Americans' Bulk Sensitive Personal Data
The Biden Administration issued an executive order authorizing the Department of Justice (DOJ) and other federal agencies to take steps to prevent “the large-scale transfer of Americans’ personal data to countries of concern.” It represents an effort by the administration to put more safeguards on the data broker industry and limit the ability of US adversaries to purchase granular data on American citizens.
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EU Poised to Enact Sweeping AI Rules
The European Parliament is scheduled to vote on the legislation March 13, and one of the lawmakers leading the legislation said he expects it to pass easily. Under the current timeline the law would largely take effect in 2026, although some provisions would kick in this year.

Importance of Data Mapping and Data Flow in Clinical Trials
Data mapping and data flow are crucial components in the management of data, especially in the context of clinical trials. These processes not only ensure compliance with data protection regulations but also enhance the integrity and security of data handling. Here's a breakdown of the key points from your text, specifically tailored to emphasize their significance in clinical trials.

Opening of the Belgian Health Data Agency
On January 17, 2024, Belgium inaugurated its new Health Data Agency, a project approved a year earlier. The agency is designed to improve the accessibility and reusability of health data for secondary purposes. This enhancement of data availability will be executed in a manner that ensures both security and adherence to privacy regulations.

New Concerns For The Life Sciences Industry: Data Sovereignty and Data Hosting
The concept of data sovereignty is currently a hot topic in Europe. This relatively new idea originated from a series of events and geopolitical changes that began in the early 2000s.The issue of data control is emerging as a significant consideration, especially for companies strategizing future data management. This is especially relevant for life sciences companies with global operations, such as clinical trial sponsors managing international multi centric sites or AI health techs building models on international data sources.

EU Regulation Act Officially Adopted
Following 3-day ‘marathon’ talks, the Council presidency and the European Parliament’s negotiators have reached a provisional agreement on the proposal on harmonised rules on artificial intelligence (AI), the so-called artificial intelligence act. The draft regulation aims to ensure that AI systems placed on the European market and used in the EU are safe and respect fundamental rights and EU values. This