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• Article | Nature Biomedical Engineering | July 2019

  Challenges and Opportunities in Software-Driven Medical Devices

  William J. Gordon and Ariel Dora Stern

  The safety and security of medical devices driven by software, the software-development processes, and the need for data collection and privacy, all offer challenges and opportunities for device regulation and clinical care.

  Keywords: medical devices; healthcare; health care; Health Care and Treatment; Software; Governing Rules, Regulations, and Reforms; Medical Devices and Supplies Industry;

  Citation:

  Gordon, William J., and Ariel Dora Stern. "Challenges and Opportunities in Software-Driven Medical Devices." Nature Biomedical Engineering 3, no. 7 (July 2019): 493–497.  View Details

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• Article | Health Affairs | July 2019

  The Impact of Price Regulation on the Availability of New Drugs in Germany

  Ariel Dora Stern, Felicitas Pietrulla, Annika Herr, Aaron S. Kesselheim and Ameet Sarpatwari

  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 benefit” to “less benefit than the appropriate comparator,” and impact price negotiations beyond the first year on the market. Using data on drugs that entered the market from 2012 to 2016, we evaluated benefit assessment findings, subsequent drug exits, and their correlates. We considered 171 drug-indication pairs, corresponding to 138 different drugs. Of these, 66 drug-indication pairs (55 different drugs) were found to have any additional benefit. Almost all drugs with any positive benefit assessment (98%) remained on the market, while drugs without a positive benefit assessment were over ten times more likely to exit (25% vs. 2%). U.S. policymakers considering how to address rapidly increasing drug costs may draw valuable lessons from the German experience.

  Keywords: regulation; Pharmaceuticals; healthcare; Health Care and Treatment; Price; Governing Rules, Regulations, and Reforms; Pharmaceutical Industry; Germany;

  Citation:

  Stern, Ariel Dora, Felicitas Pietrulla, Annika Herr, Aaron S. Kesselheim, and Ameet Sarpatwari. "The Impact of Price Regulation on the Availability of New Drugs in Germany." Health Affairs 38, no. 7 (July 2019): 1182–1187.  View Details

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• Case | HBS Case Collection | April 2019 (Revised June 2019)

  Ariadne Labs: Building Impactful Partnerships

  Ariel D. Stern and Sarah Mehta

  In September 2018, the executive team at Ariadne Labs (Ariadne), a Boston-based organization dedicated to improving health systems through the discovery and implementation of simple tools, faced a number of strategic decisions. Chief among them, the seven-year-old organization needed to determine how it might establish and shepherd successful partnerships with a wide range of diverse entities—ranging from major international public health organizations like the World Bank to small non-profit implementing organizations.

  Keywords: Health; Health Care and Treatment; Innovation and Invention; Social Enterprise; Nonprofit Organizations; Partners and Partnerships; Health Industry; Boston;

  Citation:

  Stern, Ariel D., and Sarah Mehta. "Ariadne Labs: Building Impactful Partnerships." Harvard Business School Case 619-017, April 2019. (Revised June 2019.)  View Details

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