Data Matters In Cybersecurity

The Council for International Organizations of Medical Sciences Working Group XIV (CIOMS) Draft Report offers comprehensive principles and best practices, translating global artificial intelligence (AI) requirements — such as those in the EU Artificial Intelligence Act (EU AI Act) — into practical guidance for pharmacovigilance (PV). In the U.S., where no overarching AI legislation exists, the report can guide lawmakers, regulators, and other stakeholders as they develop approaches to using AI in PV. The consultation period for the draft report is currently open, and interested parties are encouraged to take advantage of this opportunity by providing comments on the draft report by June 6, 2025. The post Artificial Intelligence in Pharmacovigilance: Eight Action Items for Life Sciences Companies appeared first on Data Matters Privacy Blog.

On May 9, 2025, the U.S. Copyright Office released a “pre-publication” version of Part III of its highly anticipated Report on Copyright and Artificial Intelligence (AI) (Report). The Report provides a technical overview of how generative AI models are developed, trained, and deployed and how U.S. copyright law, particularly the fair use doctrine, should apply in the context of training generative AI models. The prepublication report states that it was released “in response to congressional inquiries and expressions of interest from stakeholders” and that “[a] final version will be published in the near future, without any substantive changes expected in the analysis or conclusions.” The post Generative AI Meets Copyright Scrutiny: Highlights from the Copyright Office’s Part III Report appeared first on Data Matters Privacy Blog.

On April 9, 2025, U.S. Sens. Mike Rounds, Republican of South Dakota, and Martin Heinrich, Democrat of New Mexico, introduced a bill titled the Health Tech Investment Act (S 1399). The proposed bill would amend Title XVIII of the Social Security Act to create a Medicare payment system for algorithm-based healthcare services (AHBS), defined in the proposed legislation as services delivered through FDA-cleared or -approved devices that use artificial intelligence (AI), machine learning, or similar software to yield clinical outcomes for use by healthcare professionals to diagnose and treat diseases. The post Medicare Reimbursement Pathway for AI-Enabled Medical Devices Considered in Senate’s Health Tech Investment Act appeared first on Data Matters Privacy Blog.

The National Association of Insurance Commissioners (NAIC) held its Spring 2025 National Meeting (Spring Meeting) March 23–26, 2026. This Sidley Update summarizes the highlights from this meeting in addition to interim meetings held in lieu of taking place during the Spring Meeting. Highlights include continued development of guidance on asset adequacy testing for reinsurance transactions, efforts to develop revisions to the Long-Term Care Insurance Multistate Rate Review Framework, and consideration of amendments to the NAIC’s Purposes and Procedures Manual regarding private letter rating rationale reports. The post Regulatory Update: National Association of Insurance Commissioners Spring 2025 National Meeting appeared first on Data Matters Privacy Blog.

The European Union’s (“EU”) Digital Operational Resilience Act (“DORA”) became effective on 17 January 2025. Since then, financial entities (such as banks, insurance companies and investment firms) and their ICT third-party service providers operating in the EU have been – directly or indirectly – subject to the new regime. One of the first key DORA compliance deadlines, for financial entities to register their ICT service providers with competent EU Member State authorities, is coming into effect across most of the member states this month. The post Financial Entities in the EU: Time to Register Your ICT Third-Party Service Providers under DORA appeared first on Data Matters Privacy Blog.

On April 9, 2025 the European Commission adopted a communication on the so-called AI Continent Action Plan – its strategy to shape the next phase of AI development in Europe, with consultation to follow. The Commission’s declared objective is to transform the EU into a global leader in AI by fostering innovation, ensuring trustworthy AI, and enhancing competitiveness while safeguarding democratic values and cultural diversity. Keep monitoring Data Matters for more on the Commission’s consultation, when available. The post EU Commission Publishes AI Continent Action Plan and Seeks Input appeared first on Data Matters Privacy Blog.

Consumer protection is rising to the top of the regulatory agenda worldwide. The UK consumer protection regime is undergoing a major shift: The Competition and Markets Authority (CMA) now has powerful new tools under the Digital Markets, Competition, and Consumers Act (DMCCA) (see our Sidley Update here), including the ability to directly enforce consumer law and fine companies up to 10% of global annual turnover for serious infringements. The post New UK Consumer Rules Herald Stricter Enforcement and Significant Fines appeared first on Data Matters Privacy Blog.

For Swiss companies, the next six months are critical for preparing to meet new Digital Data Law obligations. In this briefing, we outline the key timelines, compliance requirements, and practical steps to align with EU requirements. The post Meeting EU Data, Cybersecurity, and Artificial Intelligence Law Obligations: A Checklist for Swiss Life Sciences Companies appeared first on Data Matters Privacy Blog.

On February 12, 2025, the Swiss Federal Council unveiled its long-awaited approach to artificial intelligence (AI) regulation. Instead of adopting a comprehensive AI Act like the European Union, Switzerland has opted for a sector-specific framework, integrating AI considerations into existing laws rather than creating a standalone regulatory regime. The post New Pathway of Regulating Artificial Intelligence in Switzerland: Competitive Edge or Challenge? appeared first on Data Matters Privacy Blog.

The newest editions of the Chambers Global Practice Guides have been published. Sidley lawyers have contributed to: Cybersecurity 2025. The post Chambers 2025 Global Practice Guide for Cybersecurity appeared first on Data Matters Privacy Blog.