Medical device cybersecurity
Medical device cybersecurity is now a direct compliance obligation for Technology, AI and Competition sector firms that develop, integrate, or distribute connected health technologies. The U.S. Food and Drug Administration finalized its cybersecurity requirements for premarket submissions under Section 524B of the FD&C Act, and the European Commission's European Medicines Agency is aligning device security expectations with the EU Cyber Resilience Act, creating a dual-jurisdiction burden that legal and risk teams are actively mapping. Compliance officers in this sector are not waiting for enforcement: they are auditing third-party software bills of materials and vendor patch-management commitments now.
Watch
- FDA Section 524B premarket cybersecurity submission requirements, effective March 2023
- EU Cyber Resilience Act obligations as applied to connected medical devices and SDKs
- Software Bill of Materials mandates: which vendor contracts need updated disclosure terms
- U.S. Federal Trade Commission scrutiny of health data security practices in AI-enabled devices
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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