Harvard Business School
Recent Submissions
-
Regulatory, Legal, and Market Aspects of Smart Wearables for Cardiac Monitoring
(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
(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 ...