ARTICLE SUMMARY:
In this week’s Pathways Picks: The World Health Organization and European Commission addressed health technology assessment practices; EU Commission guidance documents on pending MDR/IVDR reforms and structured dialogue are coming; Medicare software payment details and debates; FDA hears input on advisory committees; and more on AI, digital health, and health spending.
Tech Assessment Picks
WHO and EU address HTAs:
Global HTA procedures proposed. The World Health Organization circulated a new guide for public consultation this week on conducting health technology assessments for medical devices. The goal of the document is to advance the use of HTAs and to strengthen evidence-based decision-making for devices, especially in low-to-middle-income countries. WHO lays out strategies for developing HTAs, including the prospect of “adapting” HTAs conducted by one country to the local context of another country. The draft guide includes a distinct chapter on “international collaboration in HTA” that outlines existing global and regional efforts to share HTA resources. That section in particular is in an “early stage of development” and needs more input from international organizations, WHO underscores. WHO defines HTA broadly, explaining that it bridges regulatory approval, policies around coverage and reimbursement, and management of day-to-day use of device technologies. Comments on the document, which would update a 2011 guide, are due July 17.
