A Survey of mHealth and Cardiac Rhythm Management

Valerie Fenster DePaul University, School of CDM 1 East Jackson Boulevard, Chicago, IL 60604 vmfenster@aol.com Jason Friedlander DePaul University, School of CDM 1 East Jackson Boulevard, Chicago, IL 60604 jfrites@gmail.com

ABSTRACT

Mobile medical, or mHealth, devices can range from anywhere from tablet PCs that wirelessly program implantable pacemakers, to credit card sized hand-held glucose monitoring devices for diabetes management, to pocket-sized Smartphones that sense and display electrocardiograms (EKGs). With this project we investigated how mobile technology advancements, couple with wireless and Internet technology can help to augment traditional tools for cardiac rhythm management (CRM) while freeing physicians from their desks and exam rooms. We explored how both clinicians and patients can readily monitor disease states using mHealth mobile devices, and do so remotely from the convenience of home or while on vacation.
Author Keywords

How do patients interact with their current nonmHealth devices? How do doctors interact with their patients and their -mHealth devices? What is the environment that these devices are used in? Are there hazards to the patient if the device is misused? What are the overall benefits from using an mHealth device?

The following steps were taken to find answers to our objectives: Literature search and review past of usability studies for current solutions Expert Analysis of current solutions Requirements gathering for new solution Develop Happy Path with context scenario Low-fidelity prototype Mid-fidelity prototype Test new design Report findings and recommendations

mHealth; portable; pacemakers; defibrillators; smartphones; mobile technology; cardiac rhythm management; CRM
INTRODUCTION

Practicing medicine with the aid of portable mobile devices is called mHealth. Medical mobile devices can range from anywhere from tablet PCs that wirelessly program implantable pacemakers, to credit card sized hand-held glucose monitoring devices for diabetes management, to pocket-sized Smartphones that sense and display electrocardiograms (EKGs). With this project we investigated how mobile technology advancements can help to augment traditional tools for cardiac rhythm management (CRM), exploring how both clinicians and patients can readily monitor disease states using mHealth mobile devices. Our target audience was patients with heart disease who either have, or are candidates for, implantable pacemakers and defibrillators, and who might be either treated by a clinician using an mHealth device or personally prescribed one.
OBJECTIVES

The healthcare sector has never been known for being an early adopter of information technology. However, wireless devicesalong with wireless broadband data networks and mobile software applicationsare being recognized as fundamental components in the quest to expand and improve patient care, control costs and comply with government and industry mandates. [3] The above referenced quote is a problem the medical profession has had a history of struggling with. In addition to skyrocketing costs for malpractice insurance and the lower Medicare reimbursements for chronic patient disease, healthcare practitioners have consistently faced dwindling funding for purchasing cost-prohibitive hospital equipment and technology. A solution to these adaptation issues seems to be the growth of wireless networks and devices. Clinicians no longer have to be constrained by large-scale computer systems anchored to power outlets that make it difficult to sync between the exam room and a largely mobile world. With the influx of mobile devices and the

The research objectives were to find out: What type of functionality is currently available to patients & doctors? Is there an opportunity for device innovation within the current market?

scale of mobile networks, doctors are no longer chained to their desks. They can monitor and interact with patients on the fly, either from their hospital or the golf course. There are many moving parts that make up the connected mHealth world, with each of those parts having to be connected and in sync to deliver high quality and safe healthcare to patients. The roles within the current Healthcare system include patients, physicians, nurses, and healthcare providers. Each of the roles represents a person that uses a mobile device such as a mobile phone to communicate with the server setup in the care center such that he or she can go around without restrictions. [4] A great example of a hospital embracing mHealth is in Florida. A series of cardiac professionals made a pitch to the hospital, suggesting that specialty trained physicians having the ability to monitor, and even adjust, a patients cardiac device from a distance would lead to fewer team hours in the hospital. Remote programming, as opposed to the overhead of the doctor being present and the patient visiting the clinic, takes a fraction of the time. In order to deliver the proper care, this hospital has developed a system for wireless real-time monitoring and reprogramming of cardiac devices, including pacemakers and defibrillators, using an iPad. It is as simple as a doctor suggesting changes to a cardiac devices settings, and then relaying the information for a nurse in the hospital to execute using a touchscreen laptop. [5] Remote adjustments to the patients cardiac device from afar is still highly controversial; therefore, a nurse is still present with the patient to follow the physicians orders and to monitor for adverse cardiac reactions should an error occur. With all of the great advancements in technology and patient care there are concerns that come along with it as well. Many believe that a larger population of people using mHealth devices will lead to hackers attempting to override the system and cause damage or even death to patients, but others see risks in different places. Jim Keller of the ECRI Institute in Plymouth Meeting, Pennsylvania said, I have not seen that [wireless medical devices] is a high-profile target for the hacking community, One of the perspectives I have is the general proliferation of wireless signals is more of a concern than hacking, with interference from a variety of electronic devices. [1] The Federal Communications Commission (FCC) reserves varying frequency (Wireless Medical Telemetry Service WMTS) bands for health care wireless transmission. [2] and the Food and Drug Administration (FDA) publishes strict guidelines regarding use of RFID and wireless technology. The FDA cites that rather than hacking, there exists more danger from the co-existence of medical devices completing for the same band usage within the confines of a practical hospital environment. The literary research we have done clearly states a desire and need for the continual growth and development of safe

and secure mHealth devices. These type of devices will not only help save lives but save time and money on a grand scale for the doctors, hospitals and patients who use them.
ANALYSIS OF CURRENT SOLUTIONS & FUNCTIONAL REQUIREMENTS

EKGs provide a seven to twelve second running picture of the hearts electrical activity. The activity is captured using a series of external electrodes placed on the skins surface in twelve strategic positions that allow the physician to study a panoramic and cross-section view of the heart muscle. The hearts electrical activity is then traced allowing the physician to view their patients heart rate and rhythm.

Figure 1. Standard 12 Lead EKG

EKG machines are generally stationary and kept on a cart in a clinicians office or exam room and placed near a bedside or examination table to easily connect the leads or electrodes to the patients torso and limbs.

Figure 2. Standard 12 Lead EKG bedside monitoring device

Remotely programming patients with pacemakers and defibrillators is now possible using a product set consisting of a home transmitter that wirelessly captures heart rate and rhythm and uploads it to a central web site server where clinicians can triage data to determine if patients need to

visit the clinic. Patients with heart failure symptoms can use hand-held mHealth devices to enter weight gain or loss, and blood pressure. This is then transmitted along with patient entered information regarding fatigue, shortness of breath and trouble walking up stairs.

Figure 1. AliveCors Lead I EKG sleeve attaches to the back of a Smartphone. Against the skin, or over clothing, it can display the users heart rate and rhythm.

This mHealth device is an amazing achievement; however, there are still issues that need to be resolved before the FDA and other countrys regulatory bodies will approve this as a medical device for human use.
Pros

Eliminates need for wires or jack attachments, and need to attach sensor electrodes to the body, but requires use of a case or sleeve to be attached to back of iPhone that acts as EKG lead electrode for the positive and negative poles of Lead I between the right and left arms. Can be used over clothing, and on an animal, on top of fur. EKG data is transmitted to a cloud where it can be pulled down from the cloud and immediately read by the clinician. Only shows one channel EKG, whereas, traditional EKG devices can administer a12 lead views of the heart and display multiple channel views of the heart. Use error can occur if electrodes on the case get scratched. Not yet approved by the FDA for human use, no human trials yet scheduled, however currently being used in veterinary trials Is also being sold as an novel app to sense biorhythms and mood, so could detract from corporate brand Contains no other functionality in the app beside the EKG recording and sending. There is no other functionality such as reading of symptoms, preferences / clinic-doctor information. No direction how a novice user would read and understand the detail. Could be misunderstood by the laymen. Typical non-clinical user would not understand heart rhythms being relayed by the device. Simply a recording/transmission tool, rather than an emergency reporting tool.

Cons

Figure 3. St. Jude Medicals CRM product suite include Merlin.net remote care transmission web site (top left), Merlin@home patient home transmitter (top-right) and the PAM (Patient Activated Monitor-lower right) heart failure reporting device.

We reviewed AliveCor (www.AliveCor.com), a real-time Smartphone app that reads a surface EKG by attaching a slip-on case to the back of the phone. The case contains two electrodes that measure the bipolar Lead I between the left and right limbs, thereby capturing a view of electrical activity in the heart. The ability to have your phone tie to your healthcare record and track medical metrics will have vast repercussions. Though some arent cleared for sale in US yet, devices like the AliveCor electrocardiogram can monitor your heart in real time, send the data to the cloud, and allow your cardiologist to look at it instantly. Other devices are turning phones into otoscopes for looking in your ears, or glucometers for monitoring blood sugar. [6]

CARDIOCARE CONTEXT SCENARIO

We added to current cardio mHealth systems by, in addition to reading, displaying and transmitting real-time EKGs, including symptomatic heart failure reporting, 911 calling and clinician supervised set-up to ensure patient safety via identification of timely, triaged data. The following images represent design sketches and a context scenario making up the Happy Path through an

application we developed called CardioCare. This application is designed to allow users to read, display and upload an EKG to their clinicians office using a telemetry wand placed over a patients pacemaker or defibrillator. It also allows them to report heart failure related symptoms, such as fatigue, shortness of breath, and fainting, calling 911 and clinician-enabled smartphone set-up.

Figure 4. CardioCare is loading on his iPhone

Figure 2. CardioCare User

Figure 5. Simple easy-to-remember steps are always displayed

Figure 3. CardioCare User decides to check his EKG and transmit to clinic while on vacation

Figure 6. CardioCare reads, transmits and lets user know hes successfully sent his EKG to his clinic

Figure 7. CardioCare users can transmit symptomatic data such as shortness of breath, dizziness and fatigue

Figure 10. CardioCare provides users and their physicians a sense of well being at home and on the road

CARDIOCARE ANNOTATED SCREENS

We later improved upon our concept by developing fully annotated screens and detail for development.

Figure 8. Users can report light, moderate, severe or no symptoms

Figure 11. Home Application Launch

Figure 12. EKG Start Menu Figure 9. Symptomatic data is sent directly to the clinic to alert his physician in the event hes feeling ill

Figure 13. EKG Reading

Figure 17. Symptoms - Stairs

Figure 14. EKG Confirmation

Figure 18. Symptoms - Faint

Figure 15. Symptoms - Breath

Figure 19. Symptoms - Confirmation

Figure 16. Symptoms

Figure 20. 911 Call Screen

Settings Button:

Users understood the meaning of the Settings button, and that only clinicians should be allowed to modify these settings. They felt that under settings, there should be the doctors phone number, personal information, the type of pacemaker, and also suggested there should be a calendar function indicating these measurements should be taken on a basis prescribed by the physician. Users also indicated it would be very useful to show medications being taken, indicating this is a comprehensive applications for measuring heart complications, medications, and tests.
Figure 21. Settings

When asked why they thought the User ID and Password was present under settings, the user said it was there so only the doctor could make changes. He said your doctor would have a prescribed regimen or protocols the user needed to follow and wouldnt want the patient to be messing around with the type of device or medications. This wouldnt be something youd want the layman to be changing.
Recommendations: Consider adding a calendar function

Please note that not all options are selectable so all interactions may not be reflected when making selections within the prototype. Please follow the link to view the interactive prototype: http://share.axure.com/N66X95/Home.html
EVALUATION

and area for indicating medications, turning on and off symptomatic reporting and transmission reminders.
Call 911 Button:

A small sample was used to step through tasks using the mid-fidelity prototype. Participants accessed the application at the above website and were asked to comment about sending and EKG, entering symptoms, what they thought the Settings and Call 911 buttons were for. The following represents our observations and findings:
Sending an EKG and Symptoms

When asked how to make an emergency call, the user correctly chose the button for Call 911. However, when encountering a telephone keypad rather than seeing an indication the phone was dialing, users felt that if the button says Call 911, it should immediately call 911. Users indicated there should also be a Call Doctor that both Call 911 and Call Doctor should be hot buttons. Users also felt the Call 911 button should have a symbol more indicative of an emergency, and not just a phone symbol.
Recommendation: Make the Call 911 immediately dial

Users indicated theyd follow the instructions to plug in the jack and to place the round wand over his heart to measure his EKG. They said instructions were clear and easy to understand. However, they felt symptoms should appear first on the navigation bar, and then sending an EKG would be next. However, unbeknownst to users who are not required to send heart failure monitoring symptoms (this disease state monitors weight, blood pressure and fatigue), a cardiologist can read an EKG and determine the symptoms a patient is feeling. Inputting symptomatic data is secondary in the event of a life or death situation, and it is most important to send the EKG as soon as possible.
Recommendations: Make the EKG start process more

911. Perhaps this can be stored as an auto dial in the app. Consider adding a Call Doctor button.
CONCLUSIONS

prominent on the screen. To avoid patient confusion, symptoms should only be present for monitoring heart failure (not heart attack), and programmed to display / not display in device under Settings category

Based on our literature search, Smartphones and Tablet PCs provide an opportunity to create and improve upon traditional technology found in cardiac rhythm management. mHealth devices can create mobile portable platforms so physicians are no longer tied to power cords and exam rooms. Additionally, using wireless technology coupled with radio frequency (RF) allows clinicians to move freely between exam rooms and patient bedsides. Computer networking and todays improved telephony communications coupled with the internet allows for healthcare remote practice to take place, as long as patients are observed while changes are made, ensuring no patient harm is resulting due to the loss proximity between patient and physician.

REFERENCES

[1] Baum, S. (2012). Wireless device signal interference poses greater risk than hacking. Retrieved from http://www.medcitynews.com/2012/04/wirelessmedical-device-signal-interference-poses-greater-riskthan-hacking/ [2] Food and Drug Administration. (2011). RadioFrequency Wireless Technology in Medical Devices Draft Guidance. Retrieved from http://www.fda.gov/MedicalDevices/DeviceRegulation andGuidance/GuidanceDocuments/ucm077210.htm#4 [3] Frost & Sullivan. (n.d.). Mobile Devices and Healthcare: Whats New, What Fits and How do you Decide? [White paper] . Retrieved from Frost & Sullivan: http://www.gilglobal.com/je/fs_wp_mobile_devices_hc.pdf [4] Guey-Lee, R., Tseng, C., Hsiao, C., & Chen, K. (2007, September 2007). A Mobile Care System With Alert Mechanism. IEEE Transactions on Information Technology in Biomedicine, 11, 507 - 517. Retrieved from http://ieeexplore.ieee.org/xpl/login.jsp?tp=&arnumber= 4300837&url=http%3A%2F%2Fieeexplore.ieee.org%2 Fxpls%2Fabs_all.jsp%3Farnumber%3D4300837 [5] Gullo, C. (2011). Doctor uses iPad to re-program implanted cardiac devices. Retrieved from http://mobihealthnews.com/15199/doctor-uses-ipad-tore-program-implanted-cardiac-devices/ [6] Healthcare News Review, (2012). Alivecor Electrocardiogram Can Monitor Your Heart In Realtime. Retrieved May 24, 2012, from http://healthcare-news-review.blogspot.com/2012/01/blogpost.html
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IEMBS 04. 26th Annual International Conference of the IEEE, 2, 5384 - 5387. Retrieved from http://ieeexplore.ieee.org/xpl/login.jsp?tp=&arnumber=140 4503&url=http%3A%2F%2Fieeexplore.ieee.org%2Fxpls% 2Fabs_all.jsp%3Farnumber%3D1404503 Medical Connectivity. (2012). Retrieved from http://medicalconnectivity.com/about/ Parmar, A. (2011). Medtronic builds a healthcare mobile app for cardiac medical devices. Retrieved from http://www.medcitynews.com/2011/06/medtronic-builds-ahealthcare-mobile-app-for-cardiac-medical-devices/ Schultz, C. (2012). Boston Scientific pacemakers and cardiac devices to sync with AT&Ts wireless network. Retrieved from http://www.imedicalapps.com/2012/03/boston-scientificpacemakers-att-wireless/ Versel, N. (2011). Medical Devices Get Wireless, Smart, Secure. Retrieved from http://www.informationweek.com/news/healthcare/mobilewireless/232300861 Why Cardiac Rhythm Device Patient Portals Will Start the Digital Health Revolution. (2012). Retrieved from http://davidleescher.com/2012/02/03/why-cardiac-rhythmdevice-patient-portals-will-start-the-digital-healthrevolution/

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