Harvard Business School
Recent Submissions
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The Impact Of Price Regulation On The Availability Of New Drugs In Germany
(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
(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
(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 ...