Clinical trial disclosure
Clinical trial disclosure obligations are arriving in Technology, AI and Competition through two channels at once: direct regulatory pressure from the U.S. Food and Drug Administration on AI-assisted trial design and data integrity, and competition scrutiny from the U.S. Federal Trade Commission over proprietary health datasets used to train commercial models. The European Medicines Agency has also signaled that AI-generated evidence packages submitted under its clinical data transparency framework will face heightened documentation requirements. Compliance teams are not waiting for final rules; they are auditing data-sharing agreements and model documentation practices now.
Watch
- FDA draft guidance on AI/ML-assisted clinical trial design: comment period status
- FTC enforcement pattern targeting health data acquisitions by large technology platforms
- EMA Clinical Data Publication Policy revision: scope expansion to AI-generated datasets
- ClinicalTrials.gov results disclosure deadlines for trials using algorithmic endpoints
Recent material activity in Technology, AI & Competition
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FCC proposes routine national security conditions for submarine cable landing licensees and SLTE owners
The FCC adopted a Second Further Notice of Proposed Rulemaking on July 27, 2026, seeking comment on standardized conditions for submarine cable landing licensees. The proceeding designates submarine line terminal equipme…
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FCC adopts Second Report and Order creating new licensing regime for submarine cable terminal equipment operators
The FCC adopted a Second Report and Order on July 27, 2026, establishing a licensing framework for submarine line terminal equipment owners and operators. The order introduces blanket licenses, routine and national secur…
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European Commission opens Phase II investigation into proposed Saipem and Subsea7 merger in offshore energy services
The European Commission has opened a Phase II in-depth investigation into the proposed merger between Saipem S.p.A. and Subsea 7 S.A., citing serious competition concerns. The preliminary review identified potential harm…
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European Commission approves €54 million Luxembourg State aid scheme for transport operators facing elevated fuel costs
The European Commission has approved a €54 million Luxembourg State aid scheme supporting road and rail transport firms affected by increased fuel prices. The approval confirms compatibility with EU State aid rules under…
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CMA opens Phase 1 merger inquiry into nexfibre's anticipated acquisition of Substantial, including Netomnia, Brsk, and YouFibre
The Competition and Markets Authority launched a merger inquiry on July 24, 2026 into the anticipated acquisition of Substantial and its subsidiaries by the joint venture nexfibre, owned by Liberty Global, Telefónica, an…
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DOJ files proposed final judgment against OhioHealth Corporation in hospital merger antitrust action
The Department of Justice, joined by state co-plaintiffs, filed a proposed final judgment and competitive impact statement against OhioHealth Corporation on July 23, 2026. The filing opens the Tunney Act public-comment p…
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CMA serves initial enforcement order on Co-operative Group acquisition of Southern Co-operative as Phase 1 review opens
The Competition and Markets Authority served an initial enforcement order on July 23, 2026 on Co-operative Group Limited and Siena Co-operative Limited under the Enterprise Act 2002. The order takes effect at the pre-not…
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European Commission approves €300 million Irish State aid scheme providing temporary electricity price relief to energy-intensive industries
The European Commission has approved a €300 million Irish State aid scheme under the EU State aid Temporary Crisis and Transition Framework, providing temporary electricity cost relief to energy-intensive companies opera…
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CMA opens pre-notification comment period on Sky UK's anticipated acquisition of ITV ahead of formal Phase 1 investigation
The Competition and Markets Authority published an invitation to comment on 23 July 2026 on Sky UK Limited's anticipated acquisition of ITV M&E Holdings Limited. The comment window closes 6 August 2026, before formal Pha…
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FTC distributes $672,000 in redress checks to 9,419 consumers harmed by Trend Deploy deceptive marketing
The FTC announced on July 22, 2026 that it is mailing 9,419 checks totaling more than $672,000 to consumers deceived by Trend Deploy operator Frank Romero. JND Legal Administration is administering the redress program. C…
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