Artificial Intelligence in Pharmacovigilance: Eight Action Items for Life Sciences Companies
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.
Medicare Reimbursement Pathway for AI-Enabled Medical Devices Considered in Senate’s Health Tech Investment Act
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.
New Pathway of Regulating Artificial Intelligence in Switzerland: Competitive Edge or Challenge?
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. (more…)
U.S. HHS Office of General Counsel Statement of Organization Suggests Potential Consolidation, Expansion of Authority
On March 14, 2025, the U.S. Department of Health and Human Services (HHS) issued a revised Statement of Organization for the Office of the General Counsel (HHS-OGC).1 Changes include a return to an organizational structure more like the early days of the first Trump administration for the lawyers advising the Food and Drug Administration (FDA), as well as the closing of certain regional HHS-OGC offices. Additional changes could potentially signal an effort to consolidate and expand HHS-OGC’s authority, especially with respect to matters currently opined upon by lawyers advising the HHS Office of Inspector General (HHS-OIG). Stakeholders should consider opportunities to engage with HHS in light of the changes announced in the March 2025 Statement of Organization.
European Health Data Space Regulation Adopted: What’s Next for Life Sciences Companies?
On January 21, 2025, the European Health Data Space Regulation (EHDS) was formally adopted by the Council of the European Union. This marks the near-final step in the adoption process, and will enter into force in the coming weeks. Importantly for life sciences companies (pharma, biotech, and medtech), the EHDS’ so-called secondary use provisions will become applicable in 2029, leaving companies four years to consider, adapt to, and implement these wide-ranging requirements.
Top Trends in the European Digital Health/AI Market
Digital health AI technologies are transforming the advancement of drug development and healthcare delivery at an unprecedented speed, backed by governments facilitating the momentum to improve healthcare for their growing populations. Sidley’s European life sciences lawyers Josefine Sommer, Eva von Mühlenen, and Francesca Blythe share a timely take on the top 5 life sciences industry trends being shaped by pioneering digital technologies. We are delighted to present a series of insightful interviews with leaders from a diverse digital health ecosystem giving their perspectives from Roche, Origen Genetics, FemTech Insights, Verge, Steto, and Clario.
Pharma Companies in Beijing Free Trade Zone to Benefit from Relaxed Data Transfer Rules
On August 30, 2024, the Beijing Municipal Cyberspace Administration, Beijing Municipal Commerce Bureau and Beijing Municipal Government Services and Data Administration Bureau jointly released the “Administrative Measures for the Data Exit Negative List of the China (Beijing) Pilot Free Trade Zone (Trial)” (Administrative Measures) and the “Data Exit Administration List (Negative List) of the China (Beijing) Pilot Free Trade Zone (2024 Edition)” (Negative List) to facilitate the export of important industry data and personal information out of the country by companies operating in the Beijing free trade zone (FTZ). (more…)
In a Win for Defendants, Illinois Supreme Court Holds That Health Care Exemption Under BIPA Is Not Limited to Patients’ Biometric Information
For the third time in 2023, the Illinois Supreme Court addressed the scope of the Illinois Biometric Information Privacy Act (BIPA) — this time in Mosby v. Ingalls Memorial Hospital. In a unanimous decision, the court held that BIPA’s “health care exemption” is not limited to patients’ biometric information (such as fingerprint scans), but also extends to biometric information collected, used, or stored for healthcare treatment, payment, or operations — regardless of its source.1 This decision also marks the Illinois Supreme Court’s first BIPA-related decision where it adopted the defendants’ proposed interpretation of the statute. (more…)
AI Use in Drug Discovery
Artificial Intelligence (AI) has the potential to revolutionize how we find, develop, and deliver new life-saving therapies.
Join “State of the Art” host and Sidley partner Stephen Abreu as he speaks with Colin Hill, CEO and Co-Founder of Aitia. Together, they discuss the challenges and opportunities AI presents for the pharmaceutical industry, particularly how AI is accelerating the pace of drug discovery and its implications for the future of medicine.
Digital Health and Artificial Intelligence: New Developments From President Biden’s Executive Order
The Biden administration’s executive order issued on October 30, 2023, includes a number of initiatives relating to the development and use of artificial intelligence (AI), including in healthcare. As AI becomes a pivotal point of innovation for the healthcare industry, digital health healthcare technology developers, private equity sponsors, and other key industry stakeholders should track the regulatory frameworks certain to be developed following this executive order to better inform strategies for developing drugs and devices and assessing deals involving AI.
