Recent Submissions

  • Regulatory, Legal, and Market Aspects of Smart Wearables for Cardiac Monitoring 

    Brönneke, Jan Benedikt; Müller, Jennifer; Mouratis, Konstantinos; Hagen, Julia; Stern, Ariel (MDPI AG, 2021-07-20)
    In the area of cardiac monitoring, the use of digitally driven technologies is on the rise. While the development of medical products is advancing rapidly, allowing for new use-cases in cardiac monitoring and other areas, ...
  • 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 ...

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