From assessing the performance of pacemakers to tracking a patient’s location and actions, modern technology is increasingly being used to monitor patient wellbeing. These remote monitoring devices provide extremely precise data on a patient’s health, which can improve their quality of care. Remote monitoring is particularly helpful for medically fragile patients. However, this data collection practice also creates serious moral and ethical risks. Bioethics experts are considering, for example, whether doctors invade a patient’s privacy via remote monitoring and whether it is inappropriate that patients often cannot access these data.
The Foundation has been at the forefront of supporting research on the ethics and policy implications of medical remote monitoring, both through Making a Difference grants and the Faculty Scholars Program.
Medication adherence after transplant surgery is incredibly important for patient health. Without near-perfect adherence to medication regimes, patients may experience organ rejection. Remote monitoring – via ‘smart pills,’ visual ingestion monitoring, and pill bottles that store data about when they are opened, for example – can assist physicians in assuring that patients are taking all of the medications they need to post-transplant. However, such practices may strike patients as invasive. Some patients feel that by monitoring when and how they take their medications, doctors and caregivers are questioning their ability to follow medication instructions on their own. Harald Schmidt, MD, is investigating the attitudes of patients, caregivers, and clinicians towards emerging monitoring technologies for anti-rejection medication through a Making a Difference grant. Dr. Schmidt’s work seeks to support the development of policies informed by all stakeholder perspectives.
Activity and Location
GPS devices, activity sensors, and monitoring cameras are sometimes used to ensure that older adults who require homecare are safe. But older adults sometimes feel that they are being over-monitored. Bioethics researchers have raised concerns that some older adults cannot give fully informed consent to monitoring because they may not fully understand the data being collected about them. Clara Berridge, PhD, studied the preferences of older adults and of their family members regarding remote monitoring in long-term elder care, funded by a Making a Difference grant. She published her findings in The Gerontologist. Most adult children were more in favor of remote monitoring than their parents. However, in justifying their position, adult children underestimated their parents’ ability to comprehend the function of the technologies involved. Despite this, adult children were confident that they could persuade their parents to consent to remote monitoring. Prof. Berridge and her coauthor argue that these findings highlight how important it is to include the opinions of older adults in making decisions about remote monitoring, and they make some suggestions for how to do so.
Performance of Implantable Medical Devices
Remote monitoring can also take place via medical devices such as pacemakers. As a Greenwall Faculty Scholar, Daniel B. Kramer, MD, MPH, examined many regulatory aspects of remote monitoring, focusing on pacemaker devices, which gather data on their own performance that patients generally cannot access. He has published a number of papers on these issues, including:
- Dr. Kramer co-authored a BMJ editorial with Faculty Scholar Alum Aaron Kesselheim, MD, JD, MPH, which examined the FDA’s monitoring of adverse reactions to these devices, arguing that the now-ended alternative summary reporting program, through which medical device manufacturers could report adverse reactions without making them public, was unethical.
- Along with Faculty Scholar Alum Efthimios Parasidis, JD MBE, Dr. Kramer also wrote about the evaluation of medical devices used for remote monitoring in the U.S. in the Journal of Medical Ethics. Their paper describes how surveillance of these devices for post market evaluation of safety might strengthen the U.S. regulatory process, but also points out that, currently, many registries do not require informed consent. Dr. Kramer and Prof. Paradisis question this practice and suggest there could be advantages in transparency and outcomes when a patient is fully informed on how their data are used.
- Writing for The Milbank Quarterly with Faculty Scholar Program Committee Member and Alum I. Glenn Cohen, JD, and Sara Gerke, JD, Dr. Kramer also examined the ethical and legal implications of the fact that most U.S. patients don’t have access to their own digital data.
Explore more Greenwall-funded work on bioethics issues raised by remote monitoring, big data, and AI here.