We are pleased to announce the Greenwall Faculty Scholars
Class of 2016-2019
Daniel B. Kramer, MD, MPH is an Assistant Professor of Medicine (Cardiology) at Harvard Medical School. His project is “Ethical Implications of Post-market Surveillance and Remote Monitoring of Medical Devices: The Case of Implantable Cardioverter-Defibrillators.”
Implantable cardioverter-defibrillators (ICDs) can prevent sudden cardiac death; approximately 150,000 US patients/year receive ICDs. Malfunction of these devices illustrates the need for comprehensive post-market surveillance of safety. A growing number of ICDs and other implantable devices now contain remote monitoring systems that connect patients to clinicians and manufacturers. In addition, large registries of patients with ICDs and other high-risk implanted devices are being organized to more quickly identify emerging safety issues, such as device malfunctions. However, intensive collection of personal data through continuous remote monitoring and device registries implicates patients’ privacy interests, may not involve meaningful informed consent, and can alter patient-physician relationships. Dr. Kramer will define and evaluate the ethical challenges facing medical device patients related to information sharing and digital connectivity. This evaluation will support the development of normative frameworks that balance patients’ rights to privacy with public health goals protecting the public, in the context of new technologies.
Brownsyne Tucker Edmonds MD, MPH, MS is an Assistant Professor of Obstetrics and Gynecology at Indiana University School of Medicine. Her project is “Parental Perspectives on Periviable Birth: Exploring Values, Attitudes, and Coping Strategies.”
Periviable birth—an extreme degree of prematurity—is among the leading causes of infant death and childhood disability. These births disproportionately impact minority communities. When periviable delivery is threatened, pregnant women, with their families and physicians, must make ‘end-of-life decisions’ about resuscitation and palliation at the very beginning of life. Little is known about how parents make these high-stakes, value-laden decisions—particularly their attitudes, perceptions, and coping mechanisms related to death or long-term disability, which may inform their decisions. Additionally, we do not know if these attitudes, perceptions, and coping mechanisms differ across racially and ethnically diverse populations. The proposed study will address these knowledge gaps and provide the research team with data to: 1) develop a subsequent decision-support intervention that will assist parents and their physicians in making more informed, shared decisions about periviable delivery management, and 2) help determine if and how this intervention should be culturally-tailored.