Top Life Sciences and Healthcare Updates
Welcome to your daily digest of the top regulatory and compliance news impacting the life sciences and healthcare industries.
Today, we’re bringing you the five most critical updates from the last 24 hours, specifically for 2025, that you need to know.
1. FDA Intensifies Scrutiny on Drug Advertising
The FDA is increasing its focus on drug advertising, particularly within Direct-to-Consumer (DTC) channels.
The Office of Prescription Drug Promotion has issued a high volume of warning letters, signaling a crackdown on misleading claims, especially from compounding pharmacies and telehealth companies.
This aggressive stance, aiming to return to a “1990s paradigm” of frequent enforcement, emphasizes strict adherence to regulatory standards for all promotional practices.
For GRC professionals, this means reassessing all labeling, promotional statements, and social media content to ensure transparency and avoid enforcement risks.
2. FDA Releases Updated Cybersecurity Guidance for Medical Devices
Issued in June 2025, the FDA’s new guidance makes cybersecurity a lifecycle obligation for medical device manufacturers, expanding the definition of a “cyber device” to include more connected devices.
It mandates third-party component transparency through SBOMs and requires demonstrating how security objectives are addressed based on intended use and potential for harm.
Manufacturers must now prioritize cybersecurity from design to decommissioning, adopting a Secure Product Development Framework and robust risk management practices.
3. Increased Enforcement of the False Claims Act
The Department of Justice and HHS have formed a new False Claims Act enforcement task force targeting pharmaceutical, medical device, and healthcare industries.
This task force will prioritize investigations into violations of the Food, Drug, and Cosmetic Act, intervening in whistleblower suits and suspending payments based on fraud allegations.
Companies in these sectors should expect heightened scrutiny and must strengthen compliance programs, perform proactive risk assessments, and conduct thorough internal audits.
4. Focus on AI and Machine Learning in Medical Devices
The FDA is seeking public input on regulating AI-enabled medical devices, especially those with evolving machine learning algorithms.
With over 1,200 AI applications expected to be certified by July 2025, the FDA’s December 2024 guidance on Predetermined Change Control Plans is a key regulatory milestone.
Innovators must understand this evolving AI regulatory landscape, build robust data infrastructure, and focus on continuous monitoring for AI-based devices.
5. HIPAA Enforcement and Penalty Updates
As of 2025, the HHS has implemented updated civil monetary penalties, significantly increasing consequences for HIPAA noncompliance.
The OCR is ramping up privacy and security enforcement, elevating all implementation specifications to required status and reducing the breach notification timeframe from 60 days to just 24 hours.
Healthcare organizations must conduct updated risk assessments, revise policies, and train staff regularly to maintain full compliance and prepare for potential breaches.
Thank you for joining us for today’s regulatory and compliance news digest.
Stay tuned for tomorrow’s updates to stay informed and ahead in the dynamic world of life sciences and healthcare regulations.
