Welcome to the latest update on digital health law trends and insights for Spring 2024. In this curated compilation, we provide you with key developments in the legal and regulatory landscape of digital health.
In the United States, the FDA has been making progress in regulating artificial intelligence and machine learning technologies in the healthcare sector. The agency has continued to refine its risk-based regulatory framework for AI/ML products, following guidelines from President Biden’s AI Executive Order and other initiatives. Recently, the FDA released a white paper outlining its focus areas for AI, including collaboration, regulatory approaches, standards development, and research support.
Furthermore, the DOJ in the U.S. has been actively prosecuting alleged telemedicine schemes, particularly focusing on cases involving durable medical equipment and prescription medication fraud. Several individuals have been charged with schemes that have cost Medicare millions of dollars due to fraudulent practices.
On the global front, the European Commission has been working on promoting vaccine-preventable cancers by recommending Member States to increase vaccination rates for HPV and HBV. Additionally, the Commission has proposed new measures to improve the life-cycle management of medicine authorizations and to amend the Medical Devices and IVD Regulations to address urgent issues.
In Belgium, the Federal Agency for Medicines and Health Products has updated its guidance on genetically modified organisms in clinical trials, providing a comprehensive overview of the legal procedures for submitting a dossier. Meanwhile, the Superior Health Council in Belgium has published a report on digital interventions for mental health, outlining recommendations to improve the use of digital tools in mental healthcare.
In Germany, the Federal Council has approved the Digital Act and the Health Data Use Act, which aim to simplify healthcare through digital solutions and facilitate the use of health data for research.
These are just a few highlights of the recent developments in the digital health law landscape. Stay tuned for more updates and insights on the evolving legal and regulatory trends in the digital health industry.