From Product Vision to Regulatory Reality Anthropic’s “Claude for Healthcare” is an AI tool designed to support clinical, administrative, and research workflows by integrating directly into existing healthcare systems. It is built to connect with electronic health records (EHRs) and other internal tools, allowing professionals to query, summarize, and analyze medical information within a… Continue reading AI in Healthcare and European Regulation: Anthropic under GDPR and the AI Act
Tag: Regulatory
Germany’s DiGA Programme: the Evolution of Digital Therapeutics Reimbursement
When Germany introduced reimbursement for prescription digital health applications in 2020, it became the first country to create a national pathway for digital therapeutics to enter routine healthcare. The policy, embedded in the Digital Healthcare Act (Digitale-Versorgung-Gesetz), allowed physicians to prescribe certified medical apps (known as Digital Health Applications, or DiGAs) and have them reimbursed… Continue reading Germany’s DiGA Programme: the Evolution of Digital Therapeutics Reimbursement
Opt-Out Health Data Governance: Comparing Germany’s and France’s Regulatory Model
The ability to reuse routinely collected healthcare data has become a central aspect of modern clinical research and real-world evidence (RWE) generation. Across Europe, governments are reforming their legal frameworks to enable large-scale health data analysis while maintaining strong protections for patient privacy and individual rights. Two particularly instructive examples are Germany and France. … Continue reading Opt-Out Health Data Governance: Comparing Germany’s and France’s Regulatory Model
Regulatory Insights from FDA Review of the External Control Arm in a Pediatric Rare Disease Trial
The approval of eflornithine (brand name Iwilfin) for pediatric high-risk neuroblastoma offers an interesting example of how the FDA evaluates single-arm trials supported by external control arms (ECAs). External controls are increasingly common in oncology and rare disease drug development, but they remain a source of careful regulatory scrutiny. In this case, the FDA’s assessment… Continue reading Regulatory Insights from FDA Review of the External Control Arm in a Pediatric Rare Disease Trial
EHDS Section 60: The Illusion of Neutral Data Sharing?
Reading the EHDS regulation carefully, and in particular Section 60, leaves a sense of discomfort that is not really about legal drafting, but about how knowledge is produced and legitimized. The text is cautious, layered with safeguards, and repeatedly reassures the reader that intellectual property, trade secrets, and commercial confidentiality remain protected. And yet, between… Continue reading EHDS Section 60: The Illusion of Neutral Data Sharing?