This newsletter translates FDA and industry guidance on design controls and software regulation into practical structure for digital health teams. It covers how to organise a Design History File or Design and Development File, map agile work to regulatory expectations, and plan for audit readiness.
Website: https://productizing-compliance.ghost.io/
Dan Noyes writes about healthcare AI governance, covering accreditation frameworks like the Joint Commission and CHAI guidance, patient use of AI, and the effects of digital health tools on clinicians. Readers get practical governance guidance alongside a patient-informed perspective on healthcare technology.
Analysis and founder interviews on the GLP-1 and obesity drug market, focusing on business strategy, competition and customer retention. Readers get podcast-based takeaways, market estimates and practical lessons from operators and analysts.
A field guide and podcast for digital health founders, mixing in-depth playbooks on selling into managed Medicare and Medicaid with fundraising guidance and a monthly NYC digital health events roundup. Issues combine operator-sourced detail with the author's own commentary.
A weekly-ish essay newsletter by Bart de Witte of the Hippo AI Foundation, examining AI in healthcare through the lenses of open medicine, sovereignty and the economics of big tech. It offers a critical, experience-based view of announcements from AI labs and European health policy.
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