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Publications

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    • All HBS Web  (1,378)
      • Faculty Publications  (383)

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      • 2022
      • Working Paper

      Post-market Surveillance of Software Medical Devices: Evidence from Regulatory Data

      By: Alexander O. Everhart and Ariel D. Stern
      Medical devices increasingly include software components, which facilitate remote patient monitoring. The introduction of software into previously analog medical devices as well as innovation in software-driven devices may introduce new safety concerns—all the more so...  View Details
      Keywords: Technological Innovation; Safety; Governing Rules, Regulations, and Reforms; Health Care and Treatment; Medical Devices and Supplies Industry
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      Everhart, Alexander O., and Ariel D. Stern. "Post-market Surveillance of Software Medical Devices: Evidence from Regulatory Data." Harvard Business School Working Paper, No. 23-035, November 2022.
      • 2022
      • Working Paper

      The Regulation of Medical AI: Policy Approaches, Data, and Innovation Incentives

      By: Ariel Dora Stern
      For those who follow health and technology news, it is difficult to go more than a few days without reading about a compelling new application of Artificial Intelligence (AI) to health care. AI has myriad applications in medicine and its adjacent industries, with...  View Details
      Keywords: AI and Machine Learning; Health Care and Treatment; Governing Rules, Regulations, and Reforms; Technological Innovation; Medical Devices and Supplies Industry
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      Stern, Ariel Dora. "The Regulation of Medical AI: Policy Approaches, Data, and Innovation Incentives." NBER Working Paper Series, No. 30639, December 2022.
      • November 2022
      • Teaching Note

      Proximie: Using XR Technology to Create Borderless Operating Rooms

      By: Ariel D. Stern, Alpana Thapar and Menna Hassan
      Founded by Nadine Hachach-Haram in 2016, Proximie was a digital medicine platform that used mixed reality and a host of digital audio and visual tools to enable clinicians, proctors, and medical device company personnel to be virtually present in operating rooms (ORs),...  View Details
      Keywords: Technological Innovation; Business Growth and Maturation; Growth and Development Strategy; Corporate Social Responsibility and Impact; Decision Making; Medical Devices and Supplies Industry; Medical Devices and Supplies Industry
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      Stern, Ariel D., Alpana Thapar, and Menna Hassan. "Proximie: Using XR Technology to Create Borderless Operating Rooms." Harvard Business School Teaching Note 623-034, November 2022.
      • November 2022 (Revised November 2022)
      • Case

      Martine Rothblatt and United Therapeutics: A Series of Implausible Dreams

      By: Debora L. Spar and Julia M. Comeau
      In 1990, satellite expert and Sirius XM founder Martine Rothblatt was determined to save the life of her seven-year-old daughter, Jenesis, who was diagnosed with a terminal illness called Pulmonary Arterial Hypertension (PAH). At the time, there was little medication...  View Details
      Keywords: Pharmaceutical Companies; Technological And Scientific Innovation; Organ Donation; Health Care and Treatment; Health Disorders; Innovation and Invention; Medical Devices and Supplies Industry; Medical Devices and Supplies Industry; United States; District of Columbia
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      Spar, Debora L., and Julia M. Comeau. "Martine Rothblatt and United Therapeutics: A Series of Implausible Dreams." Harvard Business School Case 323-039, November 2022. (Revised November 2022.)
      • October 2022
      • Case

      Cost Plus Drugs

      By: Alexander MacKay and James Barnett
      In September 2022, Mark Cuban Cost Plus Drugs Company CEO Alex Oshmyansky considered the future of the company. Cost Plus Drugs was a retailer for more than 340 generic oral medications, selling their drugs at significantly lower prices than typical pharmacies....  View Details
      Keywords: Business Ventures; Decision Making; Entrepreneurship; Ethics; Health; Markets; Social Enterprise; Society; Strategy; Health Care and Treatment; Business Divisions; Factories, Labs, and Plants; Health Industry; Pharmaceutical Industry; United States; Texas
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      MacKay, Alexander, and James Barnett. "Cost Plus Drugs." Harvard Business School Case 723-362, October 2022.
      • October 2022
      • Case

      Podimetrics: Next Steps for Diabetes Cases

      By: Regina E. Herzlinger and Ben Creo
      Podimetrics, a virtual care management company treating adults with acute diabetes, sat at the intersection of medical device technology, data, and health services. Their leadership team considered the best next step for the company to take—would it be expanding the...  View Details
      Keywords: Health Care; Health Care Delivery; Health Care Entrepreneurship; Health Care Outcomes; Diabetes; Chronic Disease; Chronic Illness; Health Care and Treatment; Health Disorders; Medical Specialties; Technological Innovation; Innovation Strategy; Product Development; Business Model; Customer Focus and Relationships; Medical Devices and Supplies Industry; Medical Devices and Supplies Industry
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      Herzlinger, Regina E., and Ben Creo. "Podimetrics: Next Steps for Diabetes Cases." Harvard Business School Case 323-015, October 2022.
      • Working Paper

      Representation and Extrapolation: Evidence from Clinical Trials

      By: Marcella Alsan, Maya Durvasula, Harsh Gupta, Joshua Schwartzstein and Heidi L. Williams
      This article examines the consequences and causes of low enrollment of Black patients in clinical trials. We develop a simple model of similarity-based extrapolation that predicts that evidence is more relevant for decision-making by physicians and patients when it...  View Details
      Keywords: Representation; Racial Disparity; Health Testing and Trials; Race; Equality and Inequality; Innovation and Invention; Pharmaceutical Industry
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      Alsan, Marcella, Maya Durvasula, Harsh Gupta, Joshua Schwartzstein, and Heidi L. Williams. "Representation and Extrapolation: Evidence from Clinical Trials." NBER Working Paper Series, No. 30575, October 2022. (Revise and resubmit, Quarterly Journal of Economics.)
      • September 2022
      • Technical Note

      Addressing Social Determinants of Health in the American Landscape

      By: Susanna Gallani and Jacob Riegler
      Social determinants of health (SDOH) have gained significant attention in recent years. A growing body of research shows that a person’s health is influenced by a large number of non-genetic factors, most of which operate outside the realm of health care and are...  View Details
      Keywords: Socioeconomic Determinants Of Health; Social Determinants Of Health; Population Health; Health; Health Care and Treatment; Social Issues; Medical Devices and Supplies Industry; Medical Devices and Supplies Industry; Medical Devices and Supplies Industry; United States
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      Gallani, Susanna, and Jacob Riegler. "Addressing Social Determinants of Health in the American Landscape." Harvard Business School Technical Note 123-023, September 2022.
      • September 2022
      • Case

      Proactive for Her

      By: Rembrand Koning and Kairavi Dey
      Proactive for Her began amid the COVID-19 pandemic, in August 2020 as a digital platform to provide accessible, evidence-based, primary, preventive non-judgmental healthcare services for Indian women, who were often dissuaded from seeking help as premarital sex and...  View Details
      Keywords: Women's Health; Healthcare; India; Start-up; Telehealth; Digital Platforms; Health Care and Treatment; Customer Focus and Relationships; Business Startups; Health Industry; Asia; South Asia; India
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      Koning, Rembrand, and Kairavi Dey. "Proactive for Her." Harvard Business School Case 723-351, September 2022.
      • September 2022
      • Case

      HPP: Tapping the Netherlands’ Potential

      By: Brian Trelstad and Idelès Kaandorp
      Stichting Het Potentieel Pakken (HPP) was launched to solve a systemic problem in the Dutch Labor Market: gender inequity that was leading to a large number of women to work part-time in fields that were in desperately short supply of labor, like health care, child...  View Details
      Keywords: COVID-19 Pandemic; Grants; Scaling And Growth; Nonprofit Organizations; Opportunities; Gender; Income; Employment; Health Care and Treatment; Human Capital; Mission and Purpose; Motivation and Incentives; Growth and Development Strategy; Employment Industry; Health Industry; Education Industry; Consulting Industry; Europe; Netherlands
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      Trelstad, Brian, and Idelès Kaandorp. "HPP: Tapping the Netherlands’ Potential." Harvard Business School Case 323-024, September 2022.
      • September 2022
      • Article

      Giving a Buck or Making a Buck? Donations by Pharmaceutical Manufacturers to Independent Patient Assistance Charities

      By: Leemore Dafny, Christopher Ody and Teresa Rokos
      The federal Anti-Kickback Statute prohibits biopharmaceutical manufacturers from directly covering Medicare enrollees’ out-of-pocket spending for the drugs they manufacture, but manufacturers may donate to independent patient assistance charities and earmark donations...  View Details
      Keywords: Cost Sharing; Prescription Drugs; Drug Spending; Medicare; Dual Eligibility; Cost; Health Care and Treatment; Philanthropy and Charitable Giving; Pharmaceutical Industry
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      Dafny, Leemore, Christopher Ody, and Teresa Rokos. "Giving a Buck or Making a Buck? Donations by Pharmaceutical Manufacturers to Independent Patient Assistance Charities." Health Affairs 41, no. 9 (September 2022).
      • 2022
      • Article

      Rapid Growth of Remote Patient Monitoring Is Driven by a Small Number of Primary Care Providers

      By: Mitchell Tang, Ateev Mehrotra and Ariel Dora Stern
      Growing enthusiasm for remote patient monitoring has been motivated by the hope that it can improve care for patients with poorly controlled chronic illness. In a national commercially insured population in the U.S., we found that billing for remote patient monitoring...  View Details
      Keywords: Remote Monitoring; Medical Billing; Health Care Costs; Telehealth; Diabetes; Chronic Disease; Insurance Claims; Diseases; Primary Care Providers; COVID-19 Pandemic; Health Care and Treatment; Insurance; Cost; Health Industry; United States
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      Tang, Mitchell, Ateev Mehrotra, and Ariel Dora Stern. "Rapid Growth of Remote Patient Monitoring Is Driven by a Small Number of Primary Care Providers." Health Affairs 41, no. 9 (2022): 1248–1254.
      • August 2022
      • Case

      NOW PT (A): Should We Invest?

      By: George A Riedel, Amy Klopfenstein and Mel Martin
      In fall 2021, a team of students from the HBS Impact Investing Fund considered Neurologic Optimal Wellness Physical Therapy (NOW PT) for a potential investment. Dr. Banks, the founder of NOW PT, drove to visit patients. She sought an investment from the fund to open a...  View Details
      Keywords: Entrepreneurship; Social Entrepreneurship; Finance; Investment; Health; Health Care and Treatment; Medical Specialties; Buildings and Facilities; Health Industry; Financial Services Industry; North and Central America; United States; Massachusetts
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      Riedel, George A., Amy Klopfenstein, and Mel Martin. "NOW PT (A): Should We Invest?" Harvard Business School Case 323-009, August 2022.
      • August 2022
      • Supplement

      NOW PT (B): Should We Invest?

      By: George A. Riedel, Amy Klopfenstein and Mel Martin
      This (B) case examines the results of the HBS Impact Investment Fund student team’s diligence on Neurologic Optimal Wellness Physical Therapy (NOW PT). After examining Springfield’s demographics, anticipated PT demand, local competition, and NOW PT’s financial...  View Details
      Keywords: Entrepreneurship; Social Entrepreneurship; Finance; Investment; Health; Health Care and Treatment; Medical Specialties; Buildings and Facilities; Health Industry; Financial Services Industry; North and Central America; United States; Massachusetts
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      Riedel, George A., Amy Klopfenstein, and Mel Martin. "NOW PT (B): Should We Invest?" Harvard Business School Supplement 323-014, August 2022.
      • August 3, 2022
      • Article

      How Will Amazon Approach U.S. Primary Care?

      By: Robert S. Huckman and Bradley Staats
      Amazon has a playbook for reinventing businesses that it enters. It includes simplifying processes, experimenting to determine which new approaches work best, and continuously recombining its existing assets to come up with a better way to do things. It is likely to...  View Details
      Keywords: Amazon; Health Care; Technology; Primary Care; Health Care and Treatment; Information Infrastructure; Health Industry; Technology Industry; United States
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      Huckman, Robert S., and Bradley Staats. "How Will Amazon Approach U.S. Primary Care?" Harvard Business Review (website) (August 3, 2022).
      • July 2022
      • Teaching Note

      The DivaCup: Navigating Distribution and Growth

      By: Ayelet Israeli
      Teaching Note for HBS Case No. 519-055. When the mother-daughter founders of DivaCup set out with a mission to disrupt the menstrual care industry with an innovative product form, they initially struggled to gain legitimacy and convince retailers to carry their unique...  View Details
      Keywords: Female; Female Ceo; Female Entrepreneur; Female Protagonist; Health & Wellness; Healthcare; Price Policies; Minimum Advertised Price; Differentiation; Positioning; Growth; Health; Health Care and Treatment; Price; Disruption; Distribution; Distribution Channels; Competitive Strategy; Competition; Growth Management; Mission and Purpose; Product Development; Product Marketing; Product Launch; Product Positioning; Advertising; Business Startups; Internet and the Web; Entrepreneurship; Social Entrepreneurship; Social Issues; Social Enterprise; Medical Devices and Supplies Industry; Medical Devices and Supplies Industry; Medical Devices and Supplies Industry; Medical Devices and Supplies Industry; Medical Devices and Supplies Industry; Medical Devices and Supplies Industry; Medical Devices and Supplies Industry; Medical Devices and Supplies Industry; Canada; United States; United Kingdom
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      Israeli, Ayelet. "The DivaCup: Navigating Distribution and Growth." Harvard Business School Teaching Note 523-008, July 2022.
      • June 2022
      • Teaching Plan

      Lifebank Nigeria

      By: Brian Trelstad, Pippa Tubman Armerding and Wale Lawal
      The aspiration of addressing maternal deaths in Nigeria, which were mostly caused by blood shortages, led Temie Giwa-Tubosun to found LifeBank in 2015. LifeBank developed an online platform that enabled hospitals to connect and purchase blood from local blood banks and...  View Details
      Keywords: Systems Design; Social Business; Business At The Base Of The Pyramid; Health Care; Blood; Social Enterprise; Health Care and Treatment; Growth and Development Strategy; Finance; Health Industry; Transportation Industry; Africa; Nigeria
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      Trelstad, Brian, Pippa Tubman Armerding, and Wale Lawal. "Lifebank Nigeria." Harvard Business School Teaching Plan 322-090, June 2022.
      • 2022
      • Working Paper

      Causal Inference During A Pandemic: Evidence on the Effectiveness of Nebulized Ibuprofen as an Unproven Treatment for COVID-19 in Argentina

      By: Sebastian Calonico, Rafael Di Tella and Juan Cruz Lopez Del Valle
      Many medical decisions during the pandemic were made without the support of causal evidence obtained in clinical trials. We study the case of nebulized ibuprofen (NaIHS), a drug that was extensively used on COVID-19 patients in Argentina amidst wild claims about its...  View Details
      Keywords: COVID-19; Drug Treatment; Health Pandemics; Health Care and Treatment; Decision Making; Outcome or Result; Argentina
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      Calonico, Sebastian, Rafael Di Tella, and Juan Cruz Lopez Del Valle. "Causal Inference During A Pandemic: Evidence on the Effectiveness of Nebulized Ibuprofen as an Unproven Treatment for COVID-19 in Argentina." NBER Working Paper Series, No. 30084, May 2022.
      • Article

      A Career Life-Cycle Perspective on Women's Health and Safety

      By: Robert S. Kaplan, Chizoba L. Chukwura, Gregory H. Gorman, Vivian S. Lee, Chester B. Good, Kathleen L. Martin, Gregory A. Ator and Michael D. Parkinson
      Women's health has demanded more attention from employers as women integrated into the workforce. Traditionally male-dominant fields and occupations require special attention to workplace design, physical standards for entry, employment practices, equipment, and health...  View Details
      Keywords: Women's Health; Healthcare Access; Workplace Design; Military Health System; Occupational Health; Medical Equipment & Devices; Employees; Gender; Personal Development and Career
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      Kaplan, Robert S., Chizoba L. Chukwura, Gregory H. Gorman, Vivian S. Lee, Chester B. Good, Kathleen L. Martin, Gregory A. Ator, and Michael D. Parkinson. "A Career Life-Cycle Perspective on Women's Health and Safety." Journal of Occupational and Environmental Medicine 64, no. 4 (April 2022): 267–270.
      • April 2022
      • Article

      AI Insurance: How Liability Insurance Can Drive the Responsible Adoption of Artificial Intelligence in Health Care

      By: Ariel Dora Stern, Avi Goldfarb, Timo Minssen and W. Nicholson Price II
      Despite enthusiasm about the potential to apply artificial intelligence (AI) to medicine and health care delivery, adoption remains tepid, even for the most compelling technologies. In this article, the authors focus on one set of challenges to AI adoption: those...  View Details
      Keywords: Artificial Intelligence; Medicine; Health Care and Treatment; Legal Liability; Insurance; Technology Adoption; AI and Machine Learning
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      Stern, Ariel Dora, Avi Goldfarb, Timo Minssen, and W. Nicholson Price II. "AI Insurance: How Liability Insurance Can Drive the Responsible Adoption of Artificial Intelligence in Health Care." NEJM Catalyst Innovations in Care Delivery 3, no. 4 (April 2022).
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