Publications

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March 2015 (Revised December 2016)
Case

American Well: The DTC Decision

By: Elie Ofek and Natalie Kindred

In late 2013, telehealth company American Well, which developed a digital platform that allowed patients to conduct online medical consultations with physicians, is considering pursuing a direct-to-consumer (DTC) strategy. Founded in 2006, American Well had, to date,... View Details

28 Jun 2012
News

How Does the US Health Care Decision Affect Employers?

Keywords: Professor Bill George; Ambulatory Health Care Services; Ambulatory Health Care Services

March 2019 (Revised June 2021)
Case

HelloSelf: Foundation

By: John R. Wells and Benjamin Weinstock

On January 6, 2019, HelloSelf, a London-based “BrainTech” company, founded a year earlier by Charles Wells, soft launched. The proposition was simply to help its members “Be your Best Self.” The company provided its registered members with access to a clinical... View Details

April 2023 (Revised January 2024)
Background Note

Note on Healthcare in Ghana

By: Regina E. Herzlinger and Ben Creo

This note provides an overview of the healthcare system in Ghana. It discusses the public and private sector as well as traditional medical practice. It also discusses the country’s pharmaceutical industry. It is recommended as a companion to Professor Regina... View Details

Keywords: Africa; Pharmaceutical Companies; Pharmacy Benefit Manager; Health Care; Health Care Costs; Health Care Delivery; Health Care Entrepreneurship; Telehealth; Health Equity; Governing Rules, Regulations, and Reforms; Health Care and Treatment; Business and Government Relations; Health Industry; Health Industry; Ghana

August 2022
Article

Regulatory Considerations to Keep Pace with Innovation in Digital Health Products

By: John Torous, Ariel Dora Stern and Florence T. Bourgeois

Rapid innovation and proliferation of software as a medical device have accelerated the clinical use of digital technologies across a wide array of medical conditions. Current regulatory pathways were developed for traditional (hardware) medical devices and offer a... View Details

Keywords: Emerging Technologies; Governing Rules, Regulations, and Reforms; Innovation and Invention; Medical Devices and Supplies Industry

01 Mar 2009
News

An Excerpt from The Innovator’s Prescription: A Disruptive Solution for Health Care

that chicken-and-egg situation. Similarly, health-care systems will need to integrate so that they can wrap their arms around all the pieces of the system that must be interdependently reconfigured.” Related Links A New Approach to Health-Care View Details

Keywords: Health, Social Assistance

1995
Chapter

Contending Views of Quality Management in Health Care: Implications for Competition and Regulation

By: D. Blumenthal and Richard Bohmer

Keywords: Health Care and Treatment; Quality; Governing Rules, Regulations, and Reforms; Policy; Government and Politics; Health Industry

May 2024
Article

Tepid Uptake of Digital Health Technologies in Clinical Trials by Pharmaceutical and Medical Device Firms

By: Caroline Marra and Ariel D. Stern

Digital health technologies (DHTs) can enable more patient-centric therapeutic development by generating evidence that captures how patients feel and function, enabling decentralized trial designs that increase participant inclusivity and convenience, and collecting... View Details

Keywords: Health Care and Treatment; Technological Innovation; Product Development; Health Testing and Trials; Governing Rules, Regulations, and Reforms

November 2012 (Revised January 2013)
Case

Companion Diagnostics: Uncertainties for Approval and Reimbursement

By: Richard G. Hamermesh, Norman C. Selby and Phillip Andrews

The FDA approvals of novel therapeutics were seen as signs in the personalized medicine community of real progress in the growth of personalized medicine. The FDA's approval of such drugs, along with companion diagnostics, suggested a shift in thinking and regulatory... View Details

Keywords: Models Of Reimbursement; Personalized Medicine; Regulation; Healthcare Reform; Health Care and Treatment; Health Industry; United States

Article

Ten Year Sunset Rule for Healthcare Regulation Is a Nonstarter and Discouragement to Post-COVID-19 Investment

By: Regina E. Herzlinger and Eugene Schneller

U.S. healthcare delivery has not benefitted from the same productivity growth as many other service industries, such as bricks and mortar retailing, a loss that has gravely diminished cost control and access. Regulatory capture, which creates barriers to venture... View Details

Keywords: Health Care; COVID-19; Regulation; Health Care and Treatment; Health Pandemics; Governing Rules, Regulations, and Reforms; Investment

September 2020
Article

Regulatory Sandboxes: A Cure for mHealth Pilotitis?

By: Abhishek Bhatia, Rahul Matthan, Tarun Khanna and Satchit Balsari

Mobile health (mHealth) and related digital health interventions in the past decade have not always scaled globally as anticipated earlier despite large investments by governments and philanthropic foundations. The implementation of digital health tools has suffered... View Details

Keywords: COVID-19; mHealth; Digital Health; Design Thinking; Regulation; Intervention; Regulatory Sandbox; Health Care and Treatment; Technological Innovation; Design; Governing Rules, Regulations, and Reforms; India

Article

Value-based Healthcare: Implications for Thyroid Cancer

By: A.K. Ying, T.W. Feeley and M. E. Porter

Today's delivery of care to thyroid cancer patients is complex, and costly, with uneven outcomes that can be improved. The incidence of thyroid cancer is rising and requires coordinated, multidisciplinary care with high volume centers that is not always available in... View Details

Keywords: Bundled Reimbursement; Healthcare Reform; Integrated Practice Units; Outcomes; Patient-reported Outcomes; Thyroid Cancer; Health Care and Treatment; Cost; Information Technology; Value

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October 2013
Case

FasterCures: Removing Barriers to Treatments

By: Richard G. Hamermesh and James Weber

In mid-2013, as FasterCures celebrated its 10th anniversary as a center of the Milken Institute, Executive Director Margaret Anderson thought about what the organization should do to ensure it had even more impact in its next 10 years. FasterCures was a non-profit... View Details

July 2019
Article

Challenges and Opportunities in Software-Driven Medical Devices

By: 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. View Details

Keywords: Medical Devices; Healthcare; Health Care; Health Care and Treatment; Applications and Software; Governing Rules, Regulations, and Reforms; Medical Devices and Supplies Industry

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27 Jul 2011
News

A New Individual Market on the Horizon

November 2010 (Revised December 2010)
Background Note

HR 3509

By: David F. Hawkins

HR 3509 ("2010 Health Reform Bill") imposition of a fee in pharmaceutical sales and an excise tax on medical device sales raises accounting issues. View Details

Keywords: Accounting; Governing Rules, Regulations, and Reforms; Government Legislation; Taxation; Medical Devices and Supplies Industry; Pharmaceutical Industry; United States