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
FTC settles with payment processor Nuvei for $4.85 million over facilitated merchant fraud and tech support scams
The FTC filed a complaint and proposed settlement order against Nuvei Corporation and four subsidiaries on September 4, 2026, for opening payment processing accounts for merchants engaged in deception. The $4.85 million …
Read a full sample brief →CISA adds Google Chromium V8 type confusion vulnerability to Known Exploited Vulnerabilities catalog with federal remediation deadline of September 18 2026
CISA added CVE-2026-85046, a type confusion vulnerability in Google Chromium V8, to its Known Exploited Vulnerabilities catalog on September 4, 2026. Federal agencies face a mandatory remediation deadline of September 18…
Read a full sample brief →DOJ files proposed final judgment against KKR in antitrust consent decree proceeding
The Department of Justice filed a proposed final judgment and competitive impact statement in United States v. KKR & Co. Inc., et al., published in the Federal Register on September 4, 2026. This filing opens the Tunney …
Read a full sample brief →European Commission adopts final guidelines on exclusionary abuses of dominance, replacing 2009 enforcement priorities
The European Commission's Directorate-General for Competition published final guidelines on exclusionary abuses of dominance on September 3, 2026. The guidelines replace the 2009 enforcement priorities paper and establis…
Read a full sample brief →China's SAMR publishes second batch of administrative monopoly enforcement cases targeting local protectionism in pharmaceuticals, internet services, and coal
China's State Administration for Market Regulation (SAMR) released the second batch of cases under its national campaign to eliminate barriers to unified market competition, published September 4, 2026. All three cases i…
Read a full sample brief →FTC extends personalized pricing policy comment period by seven days to September 25, 2026
The FTC extended the public comment deadline on its proposed enforcement policy statement on personalized pricing from September 18 to September 25, 2026. The proposed statement addresses the use of personal data to set …
Read a full sample brief →FCC issues technical correction to broadband data collection final rule effective July 24, 2026
On September 3, 2026, the FCC published a correcting amendment to its final rule on the Digital Opportunity Data Collection and modernized Form 477 broadband data program. The correction restores a defined term that was …
Read a full sample brief →CMA finalizes revised merger efficiencies guidance, replacing existing assessment framework under its 4Ps reform programme
The Competition and Markets Authority published final revised guidance on rivalry-enhancing efficiencies in mergers on September 3, 2026. The guidance replaces the existing text in the Merger Assessment Guidelines and co…
Read a full sample brief →CNIL fines Hôpital Privé de la Loire €500,000 for inadequate patient data security under GDPR
The CNIL sanctioned Hôpital Privé de la Loire €500,000 on September 3, 2026, for failing to implement adequate security measures protecting patient and related-party health data. The decision sets an enforcement benchmar…
Read a full sample brief →CISA adds SonicWall SMA1000 OS command injection flaw to Known Exploited Vulnerabilities catalog with September 5 federal remediation deadline
CISA added CVE-2026-83549, an OS command injection vulnerability in SonicWall SMA1000 Appliances, to its Known Exploited Vulnerabilities catalog on September 2, 2026. The addition imposes a federal remediation deadline o…
Read a full sample brief →