Recent Submissions

  • The Impact Of Price Regulation On The Availability Of New Drugs In Germany 

    Stern, Ariel; Pietrulla, Felicitas; Herr, Annika; Kesselheim, Aaron S.; Sarpatwari, Ameet (Health Affairs (Project Hope), 2019-07)
    The 2011 German Pharmaceutical Market Restructuring Act (“AMNOG”) subjected branded, non-rare disease drugs to price regulation based on an assessment of their clinical benefit. Assessment outcomes range from “major added ...
  • Advancing Digital Health Applications: Priorities for Innovation in Real-World Evidence Generation 

    Stern, Ariel; Brönneke, Jan; Debatin, Jörg F; Hagen, Julia; Matthies, Henrik; Patel, Smit; Clay, Ieuan; Eskofier, Bjoern; Herr, Annika; Hoeller, Kurt; Jaksa, Ashley; Kramer, Daniel B; Kyhlstedt, Mattias; Lofgren, Katherine T; Mahendraratnam, Nirosha; Muehlan, Holger; Reif, Simon; Riedemann, Lars; Goldsack, Jennifer C (Elsevier BV, 2022-03)
    In 2019, Germany passed the Digital Healthcare Act, which, among other things, created a “Fast-Track” regulatory and reimbursement pathway for digital health applications in the German market. The pathway explicitly provides ...
  • Cybersecurity Features of Digital Medical Devices: An Analysis of FDA Product Summaries 

    Stern, Ariel; Gordon, William J; Landman, Adam B; Kramer, Daniel B (BMJ, 2019-06)
    Objectives: To more clearly define the landscape of digital medical devices subject to US Food and Drug Administration (FDA) oversight, this analysis leverages publicly available regulatory documents to characterise the ...

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