More from the Author

• 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

  CiteView DetailsFind at Harvard

  Related

• 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

  CiteView DetailsFind at Harvard

  Related

• Supplement | HBS Case Collection | March 2019 (Revised June 2019)

  Gender and Free Speech at Google (C)

  Nien-hê Hsieh and Sarah Mehta

  This case reveals Google’s response to a list of employee demands aiming to combat sexual misconduct in the workplace. This case should accompany the (A) and (B) cases, “Gender and Free Speech at Google” (318-085) and (319-085).

  Keywords: Free Speech; Ethnicity; Gender; Race; Employees; Employee Relationship Management; Recruitment; Labor; Employment; Lawsuits and Litigation; Technology Industry; United States; California;

  Citation:

  Hsieh, Nien-hê, and Sarah Mehta. "Gender and Free Speech at Google (C)." Harvard Business School Supplement 319-097, March 2019. (Revised June 2019.)  View Details

  CiteView DetailsPurchase

  Related