Cardiology & Wearable Medical Devices
Medical-Legal Issues Related to Wearable Medical Devices & Cardiology
Wearable medical devices, remote monitoring, and telemedicine visits are becoming increasingly common aspects of clinical care.
Novel technology applications can enhance health outcomes, yet also present risks, raising interesting medical-legal questions.
As many remote monitoring devices involve vital signs such as heart rate and blood pressure, cardiologists are particularly concerned about prudent ways to incorporate wearable devices into patient health plans.
There are several potential sources of liability for doctors and the medical device manufacturer, and digital health companies.
Keywords
Wearable Medical Devices, Remote Monitoring, Expert Witness, Independent Medical Examination, Medical Malpractice, Liability, Insurance Companies
At a glance
Intro:
Wearable medical devices can provide valuable, detailed data related to diagnosis and treatment, however, they are also potential sources of medical-legal liability for physicians, device manufacturers, and digital health companies
Discussion:
- Popular Wearable Medical & Diagnostic Devices
- Health Data Transmission
- Product Liability
- Data privacy and cybersecurity
DISCLAIMER: Dr. Dalawari shares interesting and relevant medical-legal news in the press. He also shares case verdicts & settlements from the public record. He has no professional or personal relationship to the cases.
Popular Wearable Medical & Diagnostic Devices
A widely used example, the Fitbit product is one of many popular wearable devices, among a large array of consumer-grade heart rate monitors, blood pressure monitors, pedometers, glucose monitors, and other devices used by patients [1].
There are devices that track and improve health on metrics such as sleep, weight, treatment adherence, and other facets of personal health.
The use of wearable technology and consumer electronics can help patients with chronic disease management, physical rehabilitation, cardiovascular health management, and more.
Consumer-grade wearable medical devices and smartphone technology may collect and integrate important health data, such as heart rate and blood pressure, and potentially identify important cardiac issues such as arrhythmias (atrial fibrillation, paroxysmal supraventricular tachycardia)[2].
Remote monitoring devices offer specific opportunities for timely interventions, however, there are risks as well as benefits to their use. For example, Fitbit comes with a specific disclaimer that it is not to be used as a medical device [3].
Consumer-grade wearable devices do not fill the same role as traditional ambulatory electrocardiographic monitoring devices, and overreliance for diagnostic purposes is risky [4].
There are many potential bases of liability for physicians, and the standard of care in this rapidly evolving area may not be clear.
Health Data Transmission.
Wearable devices raise important questions of health data transmission and the manner in which the data was communicated from the patient to the physician.
There are many gray areas surrounding the obligation of clinical staff to review data, as well as clinical billing and compensation for such services.
In addition, it is unclear whether the entirety of such data should be incorporated into the patient's electronic health records [5].
- Is it reasonable to expect clinical staff to constantly review incoming digital data in real-time, and flag issues, and initiate an intervention for the patient?
- Do the doctor and patient have a shared understanding of whether, when, and how the data is being reviewed?
The use of the data by other clinicians involved in the patient's care should also be considered.
Many issues surround the clinician use of data from wearable cardiac monitoring in routine clinical care, including data overload and alert fatigue [6].
Only some aspects of the data were considered relevant, and clinical staff felt overburdened by an expectation they be responsible to assess all data transmitted [6].
Conversely, data does not always prompt a specific actionable step, such as a medication change, and clinical staff should be aware not to rely excessively upon such devices [6.].
Product Liability.
Medical devices such as implantable pacemakers, defibrillators, monitoring devices, such as Holter monitors, and cardiac ablation catheters typically receive FDA approval [7].
Such devices may be recalled due to defects, and the software, as well as the device itself, may be considered defective in a product liability lawsuit [7].
The consumer-grade wearable devices have come under scrutiny, with questions as to their reliability.
The Fitbit product has a heart rate tracking feature but provides an extensive disclaimer insisting that it is not intended for use in the diagnosis or treatment of any disease [3]
Notably, some devices, such as the AliveCor Kardia device, is FDA approved, while other wearable devices are not [5].
Clinicians and patients should be mindful regarding the extent to which devices are reliable, or may be prone to false negatives or false positives.
In addition to doctors and medical centers, device manufacturers, digital health IT providers, and telemedicine network providers could potentially be held liable [8].
Given the wide variety of wearable devices available to consumers, it may not be reasonable to expect doctors to be familiar with the advantages and drawbacks of each, particularly in the context of frequent innovation.
If a doctor uses and relies upon device data in providing clinical care, the doctor may be deemed to be approving of its use; on the other hand, if the doctor disregards such data because its reliability is unknown, the doctor could be deemed to be disregarding clinically relevant information.
Such decisions are particularly important in the context of cardiac care, where emergencies can be life-threatening.
Data Privacy & Cybersecurity.
Data breaches are common in health care settings, such breaches can result in liability if the patient's personal information or health information is exposed [9].
There are also cybersecurity issues because such devices may be hacked, interfering with their reliability, with potentially life-threatening consequences [10].
The risk is so well known that, the FDA has developed cybersecurity planning for health delivery systems [4].
There may be product liability issues in such cases, as well as liability exposure for clinicians if the doctor is deemed to have an obligation to advise the patient on product use.
Rapidly evolving innovations such as wearable medical devices present interesting medical-legal questions, as the standard of care may not be known.
Patients and doctors alike ideally seek good health outcomes, and wish to avoid medical malpractice. One hopes that any medical expert or independent medical examination (IME) would agree that the physicians and clinical staff provided appropriate medical treatment and met the standard of care.
It is valuable to assess the manner in which patients actually use remote monitoring for cardiac and other health issues, so that manufacturers can refine and create products in the future that produce data more useful to the clinician [6].
It is helpful for doctors, health care administrators, and insurance companies to examine this important area with the help of expert cardiology consultants who can advice on the potential pitfalls and benefits of wearable devices and innovative technologies
DISCLAIMER:Dr. Dalawari shares interesting and relevant medical-legal news in the press. He also shares case verdicts & settlements from the public record. He has no professional or personal relationship to the cases.
Do you have questions about a medical case or need help understanding treatment plans and options?
Cardio Med Legal Dr. Jasdeep Dalawari
(804) 991-4109 - info@cardiomedlegal.com
REFERENCES:
[1.] https://www.physicianspractice.com/view/wearables-empower-patients-and-physicians-actionable-data
[2.] Ip JE. Wearable Devices for Cardiac Rhythm Diagnosis and Management. JAMA. 2019;321(4):337–338. doi:10.1001/jama.2018.20437
[3.] https://www.fitbit.com/in/legal/safety-instructions
[4.] https://www.manatt.com/insights/newsletters/health-update/wearables-devices-and-cybersecurity-new
[6.] Ferguson C, Inglis SC, Breen PP, et al. Clinician Perspectives on the Design and Application of Wearable Cardiac Technologies for Older Adults: Qualitative Study. JMIR Aging. 2020;3(1):e17299. Published 2020 Jun 18. doi:10.2196/17299
[7.] https://www.bellottilaw.com/defective-medtronic-medical-devices.html
[8.] https://www.manatt.com/insights/newsletters/health-update/wearables-devices-and-cybersecurity-new