Newsletter #25

‍

Regulations & Guidelines

­­

EU Moves to Loosen GDPR Rules for Small Businesses Amid Innovation Fears

­The European Commission is drafting reforms to lighten GDPR obligations for small and medium-sized businesses, aiming to cut red tape while safeguarding core privacy rights. Facing mounting pressure over Europe’s lagging competitiveness and the chilling effect of fragmented enforcement, Brussels is expected to unveil its proposal by May 21, setting the stage for a major shift in the continent’s data protection landscape.

­ Click to read more­

FDA Opens Door to AI and Real-World Data, Boosting the Future of Health Data Reuse

­The FDA is shifting away from mandatory animal testing, encouraging the use of AI models, organ-on-a-chip systems, and real-world safety data in drug development, beginning with monoclonal antibodies. This paradigm shift not only promises faster, more human-relevant drug evaluation but also signals that previously collected health data will become increasingly critical for research and regulatory submissions.

­ Click to read more­

Stricter Mobile Data Rules: CNIL Raises the Bar for Health and Medtech Apps

­The CNIL’s new guidelines tighten requirements for apps handling sensitive data, especially in healthcare, biotech, and medtech. Developers must strengthen privacy safeguards, secure explicit consent, and apply strict data minimization to stay GDPR-compliant, emphasizing transparency and security for health-related apps.

­ Click to read more­

CTIS Designated as WHO Primary Registry for Clinical Trials

­The Clinical Trials Information System (CTIS) has been designated as a primary registry by the WHO, confirming its compliance with global transparency and data quality standards. This designation will impact clinical trial sponsors submitting in Europe, as new public data sharing obligations and earlier disclosure requirements are being introduced under broader EU transparency efforts.

­ Click to read more­

BioTech, Healthtech and Healthcare

­­

India Completes Genome Mapping of 10,000 Individuals

­India has completed the Genome India Project, sequencing the genomes of 10,000 healthy individuals across 83 population groups. The data, now housed at the Indian Biological Data Centre, aims to boost precision medicine, enable targeted therapies, and improve understanding of genetic diseases within the Indian population.

­ Click to read more­

New Blood Test Redefines Early Alzheimer’s Detection

­Recent advances show that the p-Tau217 blood biomarker can detect Alzheimer’s disease risk over 20 years before symptoms appear, outperforming traditional CSF and PET scans. With its ability to track disease progression, respond to interventions like exercise or amyloid-reducing therapies, and guide personalized prevention strategies, p-Tau217 is redefining early Alzheimer’s detection — though debates continue on how and when it should be used for screening.

­ Click to read more­

AI & Techbio

­­

AI in Healthcare: Fast Pilots, Real Stakes

­

AI adoption in healthcare is accelerating rapidly, with organizations moving from experimentation to strategic implementation across care delivery, pharma, and payer sectors. While most AI projects are still in pilot phases, leaders are prioritizing co-development, real ROI, and C-suite-driven strategies, setting the stage for startups and healthcare players to fundamentally reshape workflows and innovation paths.

­ Click to read more­

Bridge2AI-Voice: Building the Future of AI-Driven Voice Biomarkers in Healthcare

­The Bridge2AI-Voice consortium piloted a new mobile health app to collect standardized voice and health data for training future AI models in disease detection and monitoring. While the concept showed strong promise, early testing revealed challenges around user experience, task clarity, and recording quality that must be addressed before large-scale rollout.

­ Click to read more­

Data Breach and Cybersecurity

­­

EU Launches Cybersecurity Action Plan to Shield Healthcare Systems

­The European Commission unveiled a Cybersecurity Action Plan focused on protecting hospitals and healthcare providers from the rising tide of ransomware attacks and cyber threats, emphasizing prevention, rapid response, and resilience. The plan includes creating a European Cybersecurity Support Centre within ENISA, fostering collaboration between Member States, healthcare providers, and cybersecurity experts, and implementing new measures around data protection, medical device security, and health data sharing, all of which will impact clinical sponsors operating in Europe

­ Click to read more ­

Data Breaches 2025: External Risks and Faster Attack

­The 2025 Data Breach Investigations Report from Verizon highlights a sharp rise in third-party-related breaches, ransomware attacks, and exploitation of edge device vulnerabilities, with small and medium businesses facing disproportionate risks. Despite some improvements in breach detection and remediation, the evolving threat landscape — including AI-driven threats and supply chain vulnerabilities — demands stronger collaboration, faster patching, and better third-party risk management.

­ Click to read more­

Podcasts

‍

‍ 

­­