Ethical and Legal Implications of Remote Monitoring of Medical Devices

Sara Gerke, Penn State Dickinson Law
I. Cohen, Harvard University
Daniel Kramer


Policy Points:Millions of life-sustaining implantable devices collect and relay massive amounts of digital health data, increasingly by using user-downloaded smartphone applications to facilitate data relay to clinicians via manufacturer servers.Our analysis of health privacy laws indicates that most US patients may have little access to their own digital health data in the United States under the Health Insurance Portability and Accountability Act Privacy Rule, whereas the EU General Data Protection Regulation and the California Consumer Privacy Act grant greater access to device-collected data.Our normative analysis argues for consistently granting patients access to the raw data collected by their implantable devices.