Running Head: HEALTH INFORMATION TECHNOLOGY PAPER

Health Information Technology Paper ________________________________________ Presented to Patricia A. Crane, PhD, RNC, MSN, WHNP THE UNIVERSITY OF TEXAS SCHOOL OF NURSING AT GALVESTON ________________________________________ In Partial Fulfillment Of the Requirements for the Course GNRS 5349: Informatics and Quality Improvement ________________________________________ By Lisa Baker RN, BSN William Byrd RN, BSN Aracelis Silva RN, BSN Hei Nam Wong RN, BSN Wei Zhu RN, BSN

February 17, 2014

HEALTH INFORMATION TECHNOLOGY PAPER Atrial fibrillation (AF) is the most common sustained heart arrhythmia that can increase the risk for heart disease and stroke, the leading and preventable causes of death in the United States (Heart Rhythm Society, 2014). Atrial fibrillation affects about three million American adults and is expected to double over the next 25 years (Hendrick, 2011). The traditional diagnostic methods used to detect AF are the electrocardiogram (ECG) or Holter monitor, but

both have limitations in capturing the paroxysmal atrial fibrillation which indicates that AF could be hard to diagnose or detect. With widespread adoption and use of mobile devices, the idea of self-monitoring arrhythmia applications on mobile devices such as the Apple iPhone 4s allows patients to monitor and record heart rhythms at their leisure. This ability will be beneficial to the patient and providers and will improve the health care delivered to the AF patient. The purpose of this paper is to investigate the upcoming trend of smartphone-based medical applications that are dedicated to monitoring and detecting AF and to analyze its impact on patient care and nursing practice. Description of the Technology The use of a smartphone-based application to detect irregular pulses in patients with atrial fibrillation has become a significant technological achievement. The application is user friendly and only requires an iPhone 4s with a camera to obtain rapid results. The participant simply has to place an iPhone 4s camera directly on the index finger for 2 minutes while the application is running. Pulse signals are formed by illuminating the fingertip using the standard iPhone lamp and recording a video signal. A color bar on the iPhone screen will turn red if the heartbeat is irregular indicating possible atrial fibrillation or green indicating normal sinus rhythm (McManus et al., 2012).

HEALTH INFORMATION TECHNOLOGY PAPER The iPhone 4s application to detect atrial fibrillation is based on the results of a recent study by McManus et al. (2012). In the study, seventy-six adult participants with persistent AF scheduled to have elective cardioversion agreed to use the iPhone App before and after the cardioversion. Participants who converted to normal sinus rhythm after the cardioversion were

asked to reapply their fingers to the iPhone 4s to get new readings. In those participants that did not convert to a normal sinus rhythm, heart rate and rhythm measurements showed pulse waveforms produced by the electrical activity of the AF rhythm. To analyze the pulses in real time, researchers used a root mean square of successive difference (RMSSD) to quantify RR variability and the Shannon entropy (ShE) statistical method to characterize its complexity. Study results demonstrated that the iPhone application accurately distinguished the participants pulse recordings during AF from normal sinus rhythm (McManus et al., 2012). Analysis Smartphone-based applications for detecting AF are a highly effective, accurate and costeffective way to screen and identify patients with AF and prevent strokes and heart attacks (Lechnologies Research Incorporated, 2012). These mobile applications are a digital revolution in healthcare and will change healthcare in many ways. Impact on Nursing Knowledge or Practice The use of AF applications will alter the ways nurses practice. First, it will facilitate communication between patients, physicians, and nurses (The University of Sydney, 2013). Traditional clinical work requires nurses to communicate with different individuals and move between different places. The use of the AF application will allow patients wirelessly forwarding their cardiac readings to nurses and cardiologists. Second, the use of the AF applications will speed the nurses response to patients condition. It will also reduce the nurses

HEALTH INFORMATION TECHNOLOGY PAPER workload by eliminating the need for the nurse to be the one solely responsible for relaying this

critical information. Third, the use of AF applications will improve nursing documentation upon standard paper documentation through facilitation of error prevention (Fierce Mobile Healthcare, 2013). However, the adoption of AF applications will present challenges on nursing knowledge and practice as well. In addition to mastering the medical knowledge about the disease and its management, nurses need to keep up with the latest technology of AF applications that are different from the traditional ECG or Holter monitors. Access to Care The prevalence of smartphones will enable patients to download the AF applications and take advantage of increasingly flexible access to healthcare by self-monitoring their cardiac rhythms. The iPhone 4s based AF application currently is under the approval process of the US Food and Drug Administration (U.S. FDA, 2011). The AF application is easy to use and the event recording is quick and accurate. The cardiac readings will be shown on the smartphone screen in real-time along with the summarized diagnostic implications (Lechnologies Research Incorporated, 2012). Data can be transmitted to a cloud server for remote diagnosis and management from the health providers. Thus, the use of the AF applications will facilitate the delivery of healthcare to any individual carrying a smartphone regardless of location. However, both the patient and healthcare provider have to possess a smartphone and know how to use the AF applications. Patient Safety The real-time communication between patients and healthcare providers using AF applications that track cardiac rhythms will contribute to improved patient safety. Patients with asymptomatic atrial fibrillation or a history of a coronary artery bypass graft (CABG), ablation,

HEALTH INFORMATION TECHNOLOGY PAPER cardiac abnormalities, or taking antiarrhythmic drugs will benefit from the instant identification of AF rhythms. It will allow those patients to measure their baseline and build a database of their cardiac rhythm to improve the detection of AF, speed the decision-making from the health providers, and possibly reduce the number of heart attacks and strokes (iMedicalApps, 2013). However, at present, most AF applications are developed by companies with commercial interests and the safety concerns remain. In order to protect patient safety, FDA has provided guidance that any mobile healthcare application used as medical device needs medical device certification first (U.S. FDA, 2011). Quality of Care The use of AF applications will improve the quality of healthcare significantly. It will enhance health providers responses to patients in a timely manner, promoting faster treatment through earlier notification, assessment, and interpretation. A study of one iPhone 4s based AF application showed high accuracy compared with a 12-lead ECG (ORiordan, 2012). The algorithms had excellent sensitivity (0.962), specificity (0.975), and accuracy (0.968) for the discrimination of an irregular pulse during atrial fibrillation from sinus rhythm (McManus et al, 2012). The use of AF applications will encourage patients self-motivation in monitoring their

cardiac function. It will also empower healthcare professionals and patients working together to improve patients outcomes. However, relying more on the technologies, AF applications could potentially decrease the physical bonds between patients and health professionals, thus, it may deviate from the patient-centered care to technology-focused care and seem to depersonalize the relationship and sabotage trust between patients and health providers (Jacques, 2012). Cost

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Cost-effectiveness is a potential advantage of AF applications. Atrial fibrillation places a huge economic burden on health care payers, patients, and the government. Treating people with AF added $26 billion to the nations health care bill in just one year (Hendrick, 2011). The implementation of AF applications has the potential to identify and manage AF at an earlier stage and to decrease disability and its associated life-long health care and other related costs (McManus et al, 2012). AF applications also can lower long-term health care costs through increased access to care. In addition, patients do not have to travel to the hospital or the doctor's office every time when they suspect they might be having an episode of AF, thereby saving the transportation costs. Nevertheless, the price of smart phone, AF applications and the service of remote healthcare access is a non-ignorable cost consideration. Ease of Use The AF application is relatively easy to use. It does not require special training of staff or patients beyond a simple demonstration that can be accomplished during an office visit. If the patient is having symptoms, they can open the AF application on their smartphone. He or she would simply place the camera of the iPhone 4s over their index finger for a one to two minutes period and it will detect whether you have a normal heart rhythm with a green indicator light on display, or a red light for an abnormal heart rhythm. Researchers have identified a very small, very large, or calloused index finger as a limitation of the device because it may not be able to properly transilluminate the fingertip (ORiordan, 2012). Further, ORiordan (2012) reported that extremes in temperature or using the application in bright ambient light might produce erroneous data. Another advantage to this application is beyond the initial cost of the smartphone, it does not require additional hardware like other AF devices. Availability

HEALTH INFORMATION TECHNOLOGY PAPER This AF application is currently being reviewed by the Federal and Drug Administration and is not yet available (ORiordan, 2012). Additionally, this technology is currently specific

only to the iPhone 4s or later models, but further development of this AF application is underway for other smartphone models. ORiordan (2012) estimates that 80% of the population has used a smartphone, with encouraging estimates of 66% of the population owning a smartphone by the year 2015. Supporting evidence by the FDA (2014) on the availability of health care applications for smartphones includes estimates of 500 million smartphone users worldwide that will be using a medical application by 2015. The future outlook of smartphone utilization by 2018 estimates that 50% of the more than 3.4 billion smartphone and tablet users will have downloaded a mobile health application (U.S. FDA, 2014). Interoperability The delivery of healthcare is being transformed with the development of medical devices in telemedicine. The National Institute of Standards and Technology (NIST) is in the process of developing guidelines for standards-based medical device interoperability and communication (2011). The challenge to interoperability with medical devices is how they will integrate into existing information systems infrastructure and how that information will be incorporated into patient health information (PHI). The development of a medical devices interoperability should be centered on the patients, who have rights to their own data that he/she can connect with (Gold, 2014). Privacy Privacy laws for PHI have been established through the Health Insurance Portability and Accountability Act (HIPPA), with subsequent laws specific to medical devices detailed by the Health Information Technology for Economic and Clinical Health Act (Rose, 2013). However, a

HEALTH INFORMATION TECHNOLOGY PAPER big challenge is ensuring privacy when utilizing a medical application on a smartphone. While the health care server and physician tablet or email system is covered by HIPPA, the patient owned device, i.e. smartphone, is not (Greene, 2013). In review of this specific AF application, the recorded data from the iPhone 4s is sent directly to the physician via email. The Office of Civil Rights (OCR) is tasked with ensuring privacy of PHI and developing best practice to

protect health information (Gold, 2013). The OCR is committed to building trust and confidence of the healthcare consumer to encourage the patient to engage and participate in managing their own healthcare (Gold, 2013). It is possible that the FDA will play a role in privacy because they were criticized for failing to ensure adequate privacy and security safeguards (Shah, 2013). Regulatory The FDA is responsible for regulating medical devices. The agency provides oversight on the functionality of such devices to ensure it is safe and effective and also assesses if it poses a risk to the patient (U.S. FDA, 2014). This AF application on the iPhone 4s qualifies as a medical device because the indicated use is to screen for arrhythmia utilizing a light emitting diode to diagnose the heart rhythm (U.S. FDA, 2014). Further, the FDA has the discretion to exercise enforcement when a mobile medical device helps the patient to self-manage their disease and/or condition without providing specific treatment interventions. According to the Mobile Medical Application Guidance (U.S. FDA, 2013), this specific AF application would follow Code of Federal Regulations 870.1025 regarding cardiovascular diagnostic devises and arrhythmia detectors and alarms. Potential Ethical Issues Medical applications can positively impact patient outcomes through detection, diagnosis, and management via electronic communication with health care personnel or through

HEALTH INFORMATION TECHNOLOGY PAPER patient self-management. Nevertheless, Project HealthDesign, raises complex questions about patient privacy, data security, and decision support, and legal and regulatory requirements when using medical devices (Cushman, Froomkin, Cava, Abril, & Goodman, 2014). Project

HealthDesign has identified abundant ethical issues including design of the device, functionality, release of information, around-the-clock monitoring, robust security, feedback and decisionmaking on patient input, patient capabilities of data interpretation, and automated decision support to name a few. Another interesting ethical issue raised is the selling of patient data for profit by the medical device business (Rose, 2014). Even after patient data is de-identified, the data may be sold to health systems or insurers that could use it to predict diseases and possibly lower their costs (Rose, 2014). While the FDA is regulating the function of the device, the OCR, operating under HIPPA must regulate the individual's PHI and ensure the user of the device receive full disclosure of data usage. Conclusion Technology plays a large role in todays healthcare system and small devices for point of care testing are creating new and innovative ways to improve healthcare delivery. There are already proven devices used at home for self-monitoring of an individuals health status including the automatic blood pressure cuff and the home based glucometer. With the high number of smartphones in use today, there is a lot of potential for utilizing them to be a tool in health maintenance. Available research has shown that the deployment of iPhone 4s based AF applications can be effective tools for evaluation of a patients heart rhythm. For patients with atrial fibrillation, the ability to check their heart rhythm at any time with a device in their pocket could be both lifesaving and convenient. In the inpatient setting, a smartphone based AF application could provide quicker results than doing an EKG. These applications could speed up

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the communication between the patients or nursing staff and the cardiologist. However, there are certainly hurdles that need to be overcome before this technology becomes readily available, such as the concerns of HIPPA, medical staff training, liability of health providers, cost, FDA approval and regulation. In summary, as a new technology, the iPhone 4s based AF application is a portable, efficient, inexpensive, and easy to use device and it has the potential to improve the care of patients with atrial fibrillation.

HEALTH INFORMATION TECHNOLOGY PAPER References Cushman, R., Froomkin, A., Cava, A., Abril, P., & Goodman, K. (2014). Ethical, Legal and Social Issues for personal health records and applications. Retrieved from http://www.rwjf.org/en/research-publications/find-rwjf-research/2010/10/projecthealthdesign-/ethical--legal-and-social-issues-for-personal-health-records-and.html Fierce Mobile Healthcare. (2013). ECG app on iPhone found effective in diagnosing atrial fibrillation; mobile health apps taking a bite out of weight watchers customer base. Retrieved from http://www.fiercemobilehealthcare.com/story/ecg-app-iphone-foundeffective-diagnosing-atrial-fibrillation-mobile-health/2013-08-11 Gold, A. (2014). Feds: Draft med device interoperability standards could come this spring. Retrieved from http://www.fiercehealthit.com/story/feds-draft-med-deviceinteroperability-standards-could-come-spring/2014-02-07#ixzz2sm0s7Pd6

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Greene, A. (2013). OCR/NIST 2013 Annual Conference: HIPPA requirements and mobile apps. Retrieved from http://csrc.nist.gov/news_events/hipaa2013/presentations/day1/greene_adam_day1_1115_ocr_nist_2013.pdf Grier, J. W. (2013). Comparison of handheld 1-lead ECG / EKG recorders. Retrieved from http://www.ndsu.edu/pubweb/~grier/Comparison-handheld-ECG-EKG.html Heart Rhythm Society. (2014). Atrial Fibrillation Fact Sheet. Retrieved from http://www.hrsonline.org/News/Fact-Sheets/AFib-Facts#axzz2stLXS74n Hendrick, B. (2011). Atrial fibrillation treatment costs, hospitalizations mount. Retrieved from http://www.webmd.com/heart-disease/atrial-fibrillation/news/20110503/atrialfibrillation-treatment-costs-hospitalizations-mount

HEALTH INFORMATION TECHNOLOGY PAPER iMedicalApps. (2013). iPhone app accurately detects atrial fibrillation. Retrieved from http://www.imedicalapps.com/2013/01/iphone-app-detects-atrial-fibrillation/ Jacques, E. (2012). Smart phone apps. Specialiving Magazine, 12(1), 2-7. Lechnologies Research Incorporated. (2012). Monitor your heart health anytime anywhere. Retrieved from http://www.afibalert.com/

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McManus, D., Lee, J., Maitas, O., Esa, N., Pidikiti, R., Carlucci, A., & Chon, K. (2013). A novel application for the detection of an irregular pulse using an iPhone 4S in patients with atrial fibrillation. Heart Rhythm, 10(3), 315-319. doi:10.1016/j.hrthm.2012.12.00 ORiordan, M. (2012). Think you might have AF? There is an app for that. Retrieved on January 31, 2014 from http://www.medscape.com/viewarticle/776171 Rose, R. (2013). How Does HIPAA and the HITECH Act impact medical device and Pharma Companies? Retrieved from http://www.beckershospitalreview.com/healthcareinformation-technology/how-does-hipaa-and-the-hitech-act-impact-medical-device-andpharma-companies.html Shah, A. (2012). Privacy and security are paramount when designing healthcare apps. Retrieved on from http://www.techhealthperspectives.com/2012/09/11/privacy-and-security-areparamount-when-designing-healthcareThe University of Sydney. (2013). iPhone device detects heart rhythm problem that can cause stroke. Retrieved from http://sydney.edu.au/news/84.html?newsstoryid=12106 U.S. Food and Drug Administration. (2011). FDA proposes health App guidelines. Retrieved from http://tinyurl.com/c3vob9v

HEALTH INFORMATION TECHNOLOGY PAPER U.S. Food and Drug Administration. (2013). CFR - code of federal regulations title 21. Retrieved from http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?fr=870.1025

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U.S. Food and Drug Administration. (2014). Mobile medical applications: guidance for industry and food drug administration. Retrieved from http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/Guidanc eDocuments/UCM263366.pdf Versel, N. (2012). Smartphone app for AFib detection awaits FDA clearance. Retrieved from http://mobihealthnews.com/17638/smarthphone-app-for-afib-detection-awaits-fdaclearance/