Beth Israel Deaconess Medical Center / Harvard Medical School
About
Scholar Project
Dr. Kramer is a cardiac electrophysiologist at Beth Israel Deaconess Medical Center where he directs the Pacemaker and ICD Service, and Assistant Professor of Medicine at Harvard Medical School. He is a founding faculty member of the Richard A. and Susan F. Smith Center for Outcomes Research in Cardiology, with affiliated faculty roles at the HMS Center for Bioethics, the Brigham and Women’s Hospital Program on Regulation, Therapeutics, and Law (PORTAL), and the Hinda and Arthur Marcus Institute for Aging Research. Dr. Kramer’s research focuses on clinical, ethical, and policy questions arising from the use of medical devices. This work includes comparative evaluation of medical device regulatory pathways, end-of-life care considerations for patients with pacemakers and implantable defibrillators, and projects evaluating ethical implications of remote monitoring and digital health data collection.
Ethical Implications of Post-market Surveillance and Remote Monitoring of Medical Devices: The Case of Implantable Cardioverter-Defibrillators
Grant Cycle: 2015 - 2016
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.
Daniel B. Kramer, David J. Cohen, and Efthimios Parasidis, Comparative Effectiveness Research and
Cardiovascular Device Registries: Aligning Policy and Methods, Cardiovascular Quality and Outcomes, July 2021.
Ariane M. Fraiche et al., Patient and Provider Perspectives on Remote Monitoring of Pacemakers and Implantable Cardioverter-Defibrillators, American Journal of Cardiology, Mar 2021.
Daniel B. Kramer and Efthimios Parasidis, Informed consent and compulsory medical device registries: ethics and opportunities, Journal of Medical Ethics, Feb 2021.
Jessica N. Holtzman et al., Trends in utilization and spending on remote monitoring of pacemakers and implantable cardioverter–defibrillators among Medicare beneficiaries, Heart Rhythm, June 8, 2020.
Christopher E. Knoepke et al., Medicare Mandates for Shared Decision Making in Cardiovascular Device Placement, Cardiovascular Quality and Outcomes, Jul 2019.
Jessica N. Holtzman and Daniel B. Kramer, Harmonizing Standards and Incentives in Medical Device Regulation: Lessons Learned from the Parallel Review Pathway, The Journal of Law, Medicine & Ethics, Jan 2019.
Daniel Wann, et al., Clinical and regulatory considerations for novel electrophysiology mapping systems: Lessons from FIRM, Pacing Clinical Electrophysiology, Dec 2018.
Daniel B. Kramer, et al., Regulation and Responsibility: Implications of the Medicare Coverage for Magnetic Resonance Imaging in Patients With Capped or Epicardial Leads, JAMA Cardiology, Nov 2018.
Daniel B. Kramer and Aaron S. Kesselheim, Coverage of Magnetic Resonance Imaging for Patients With Cardiac Devices: Improving the Coverage With Evidence Development Program, JAMA Cardiology, Jul 2017.
