Embarking on a journey into the future of health care shaped by technological advances and the impact of the COVID-19 pandemic, we delve into the transformative landscape shaped by the integration of wearable technology, medically regulated devices, and advanced software. The ability to offer consumers unprecedented access to vital signs, advanced biomarkers, and environmental data enables a host of new capabilities to fill gaps in existing knowledge and permit individualized insights and education. Continuous monitoring enables individualized insights, emphasizing the need for a redefinition of health and human performance that is decentralized, dynamic, and personalized. The challenge lies in managing the massive amounts of continuous wearable data, necessitating new definitions of health data and secure practices. The COVID-19 pandemic has accelerated the adoption of digitalized consumer-facing diagnostics and software, transforming the traditional patient role. Consumers now have the tools to identify and understand an impending or existing disease state before they encounter traditional health care delivery health systems, making self-diagnosis commonplace. This shift empowers consumers to actively participate in their health, contributing to a new era where patients are in control of their well-being, from wellness to disease. Physicians in 2025 will engage with more informed and educated consumers, leveraging advanced analytic tools for diagnostics and streamlined patient management. Wearable devices play a pivotal role in enhancing patient engagement, while virtual reality and tailored software can be used by physicians to offer immersive learning experiences about conditions or upcoming procedures. Clinician decision support models and virtual care solutions will contribute to recruiting and maintaining health care providers amid a growing workforce shortage. Health care delivery organizations are transforming to improve outcomes at a lower cost, with partnerships with digital technology companies enabling innovative care models. This marks a historic moment where digital health and human performance solutions empower consumers to actively participate in their care. Physicians embrace digital tools, fostering richer patient partnerships, while health care organizations seize unprecedented opportunities for multilocation care delivery, addressing cost, workforce, and outcome challenges.

Embarking on a journey into the future of healthcare shaped by technological advances and the impact of the COVID-19 pandemic, we delve into the transformative landscape shaped by the integration of wearable technology, medically regulated devices, and advanced software. The ability to offer consumers unprecedented access to vital signs, advanced biomarkers, and environmental data enables a host of new capabilities to fill gaps in existing knowledge and permit individualized insights and education. Continuous monitoring enables individualized insights, emphasizing the need for a re-definition of health and human performance that is de-centralized, dynamic and personalized. The challenge lies in managing the massive amounts of continuous wearable data, necessitating new definitions of health data and secure practices. The COVID-19 pandemic has accelerated the adoption of digitized consumer-facing diagnostics and software, transforming the traditional patient role. Consumers now have the tools to identify and understand an impending or existing disease state before they encounter traditional healthcare delivery health systems, making self-diagnosis commonplace. This shift empowers consumers to actively participate in their health, contributing to a new era where patients are in control of their well-being, from wellness to disease. Physicians in 2024 will engage with more informed and educated consumers, leveraging advanced analytic tools for diagnostics and streamlined patient management. Wearable devices play a pivotal role in enhancing patient engagement, while virtual reality and tailored software can be utilized by physicians to offer immersive learning experiences about conditions or upcoming procedures. Clinician decision support models and virtual care solutions will contribute to recruiting and maintaining healthcare providers amidst a growing workforce shortage. Healthcare delivery organizations are transforming to improve outcomes at a lower cost, with partnerships with digital technology companies enabling innovative care models. 2024 marks a historic moment where digital health and human performance solutions empower consumers to actively participate in their care. Physicians embrace digital tools, fostering richer patient partnerships, while healthcare organizations seize unprecedented opportunities for multi-location care delivery, addressing cost, workforce, and outcome challenges.

The ability to obtain dynamic movement assessments using force plate technology holds the promise of providing more detailed knowledge of the strength, balance and forces generated by active-duty military personnel. To date, there are not well-defined use cases for implementation of force plate assessments in military training environments. We sought to determine if force plate technology assessments could provide additional insights, related to the likelihood of graduation, beyond that provided by traditional physical fitness tests (PFT’s), in an elite Marine training school. Serial force plate measures were also obtained on those Marines successfully completing training to determine if consistent measures reflecting the effects of training on muscle skeletal load-over-time could be accurately measured. A pre-training force plate assessment performed in 112 Marines did not predict graduation rates. For Marines who successfully completed the course, serial measures obtained throughout training were highly variable for each individual and no firm conclusions could be drawn related to load imposed or the fitness attained during training.

BACKGROUND:Continuous exposure to extreme and chronic stress from uncontrollable events has been linked to increased psychological and physiological reactivity. Prolonged, frequent deployments may test coping skills over time, ultimately rendering Servicemembers vulnerable to mental health problems and suicide. This study develops a methodology for accurately collecting holistic health measures from Servicemembers using digital tools, including custom-built phone software and body-worn sensors. METHODS:The secure research platform and mobile app continuously collect multiple health measures and, after data analysis, deliver continuously updated summary data back to the Servicemember. This system provides novel insights into the relationships between the measures while helping individuals track their progress toward self-established goals. Participants were given an iPhone (including the study app) and an Apple Watch. Participants tracked their data for more than 6 months and responded to baseline, daily, and weekly questions and assessments. Physiologic, psychologic, and cognitive assessment data across the Preservation of the Force and Family program (POTFF) domains were collected, displayed to the individual, and analyzed in aggregate. RESULTS:When coupled with custom-built software, this hardware can be elevated from a fitness tracker to a user-facing health monitoring, educational, and delivery system. CONCLUSION:This wearable system measured vital factors associated with the health and human performance of Servicemembers. In real-time, it engaged Servicemembers in health and human performance optimization practices to achieve a goal of prevention of physical or mental injury.

BACKGROUND:The impact of using direct-to-consumer wearable devices as a means to timely detect atrial fibrillation (AF) and to improve clinical outcomes is unknown. METHODS:Heartline is a pragmatic, randomized, and decentralized application-based trial of US participants aged ≥65 years. Two randomized cohorts include adults with possession of an iPhone and without a history of AF and those with a diagnosis of AF taking a direct oral anticoagulant (DOAC) for ≥30 days. Participants within each cohort are randomized (3:1) to either a core digital engagement program (CDEP) via iPhone application (Heartline application) and an Apple Watch (Apple Watch Group) or CDEP alone (iPhone-only Group). The Apple Watch Group has the watch irregular rhythm notification (IRN) feature enabled and access to the ECG application on the Apple Watch. If an IRN notification is issued for suspected AF then the study application instructs participants in the Apple Watch Group to seek medical care. All participants were "watch-naïve" at time of enrollment and have an option to either buy or loan an Apple Watch as part of this study. The primary end point is time from randomization to clinical diagnosis of AF, with confirmation by health care claims. Key secondary endpoint are claims-based incidence of a 6-component composite cardiovascular/systemic embolism/mortality event, DOAC medication use and adherence, costs/health resource utilization, and frequency of hospitalizations for bleeding. All study assessments, including patient-reported outcomes, are conducted through the study application. The target study enrollment is approximately 28,000 participants in total; at time of manuscript submission, a total of 26,485 participants have been enrolled into the study. CONCLUSION:The Heartline Study will assess if an Apple Watch with the IRN and ECG application, along with application-facilitated digital health engagement modules, improves time to AF diagnosis and cardiovascular outcomes in a real-world environment. TRIAL REGISTRATION:ClinicalTrials.gov Identifier: NCT04276441.

Abstract Development and maintenance of physical capabilities is an essential part of combat readiness in the military. This readiness requires continuous training and is therefore compromised by injury. Because Service Members (SMs) must be physically and cognitively prepared to conduct multifaceted operations in support of strategic objectives, and because the Department of Defense’s (DoD) non-deployable rate and annual costs associated with treating SMs continue to rise at an alarming rate, finding a far-reaching and efficient solution to prevent such injuries is a high priority. Compression garments (CGs) have become increasingly popular over the past decade in human performance applications, and reportedly facilitate post-exercise recovery by reducing muscle soreness, increasing blood lactate removal, and increasing perception of recovery, but the evidence is mixed, at best. In the current study we explored whether CG use, and duration of use, improves recovery and mitigates muscle soreness effectively in an elite Marine training course. In order to test this, we subjected Service Members to fatiguing exercise and then measured subjective and objective recovery and soreness using participant reports and grip and leg strength over a 72-hour recovery period. Findings from this study suggest that wearing CGs for post training recovery showed significant and moderate positive effects on subjective soreness, fatigue, and perceived level of recovery. We did not find statistically significant effects on physical performance while testing grip or leg strength. These findings suggest that CG may be a beneficial strategy for military training environments to accelerate muscle recovery after high-intensity exercise, without adverse effects to the wearer or negative impact on military training.

Reconnaissance Marine training is deliberately difficult, to assure that graduates have the capabilities required to function successfully in the high-risk military occupational specialty. The majority of training attrition is due to voluntary withdrawal and previous research has identified certain predictive factors such as demographics, mental status, and physical performance. While some characteristics of training attrition have been identified, there is still a lack of understanding related to an individual's profile that is more apt to complete Recon training. Retrospective survey data was analyzed from 3,438 trainees within the Reconnaissance Training Company. Surveys were related to trainees' military recruitment history and other military experience, prior life experience, athletic experience, self-identified personality characteristics and motivations, and reasons for voluntary withdrawal if applicable, as well as physical performance metrics. Various demographic factors, self-reported hobbies, motivations, aquatic experience, and physical performance were associated with success in Recon Marine training courses. Subjects who voluntarily withdrew from training most commonly cited mental stress and aquatic rigor as the reason and less commonly cited reasons were physical and family reasons. These results could potentially increase training success, but more research is needed to understand the relationships between the observed trainee characteristics and success in elite warfighter training.

The role of US Special Operations Forces (SOF) globally has expanded greatly in the past 20 years, leaving SOF serving multiple deployments with little time or ability to recover in between. Currently, assessments of the health and human performance capabilities of these individuals are episodic, precluding an accurate assessment of physical and mental load over time, and leading to high rates of acute and chronic injury to the mind and body. The collection of personal health-related continuous datasets has recently been made feasible with the advancement of digital technologies. These comprehensive data allow for improved assessment, and consequently better results, partly due to the warfighters' real-time access to their data. Such information allows Soldiers to engage in their own health optimization. This article describes a research platform that allows for collection of data via a custom-made secure mobile application that extends the type, scope, and frequency of data collection beyond what is feasible during an in-person encounter. By digitizing existing assessments and by incorporating additional physical, neurocognitive, psychological, and lifestyle assessments, the platform provides individuals with the ability to better understand their mental and physical load, as well as reserve. The results of this interactive exchange may help to preserve the health of users as well as the stability and readiness of units.

OBJECTIVES The aim of this study was to determine whether patients with heart failure with reduced ejection fraction (HFrEF) due to nonischemic etiology eligible for cardiac resynchronization therapy (CRT) benefit from an implantable cardioverter-defibrillator (ICD). BACKGROUND It is uncertain whether CRT with an ICD (CRT-D) compared to without an ICD (CRT-P) is associated with a survival benefit in patients with nonischemic etiologies of HFrEF. METHODS Analyses of the COMPANION (Comparison of Medical Therapy, Pacing, and Defibrillation in Heart Failure) trial were performed, using Cox proportional hazards modeling stratified by HFrEF etiology of nonischemic cardiomyopathy (NICM) or ischemic cardiomyopathy (ICM). The primary outcome was all-cause mortality (ACM), and secondary outcomes were the combination of cardiovascular mortality or heart failure hospitalization and sudden cardiac death. RESULTS Among patients randomized to CRT (n = 1,212), 236 (19.5%) died, 131 and 105 in the CRT-P and CRT-D arms, respectively. The unadjusted and adjusted hazard ratios (HRs) for CRT-D versus CRT-P were both 0.84 (95% confidence interval [CI]: 0.65 to 1.09) for ACM, with a significant device-etiology interaction (p(interaction) = 0.015 adjusted; p(interaction) = 0.040 unadjusted). In patients with NICM (n = 555), CRT-D versus CRT-P was associated with reduced ACM (adjusted HR: 0.54; 95% CI: 0.34 to 0.86), while patients with ICM (n = 657) did not exhibit a between-device reduction in ACM (adjusted HR: 1.05; 95% CI: 0.77 to 1.44). The effects of CRT-D versus CRT-P on sudden cardiac death (advantage CRT-D) and cardiovascular mortality or heart failure hospitalization (no difference between CRT-P and CRT-D) were similar between the 2 HFrEF etiologies. CONCLUSIONS COMPANION patients with NICM exhibited a decrease in ACM associated with CRT-D but not CRT-P treatment, whereas patients with ICM did not. (C) 2021 The Authors. Published by Elsevier on behalf of the American College of Cardiology Foundation.

Abstract The recent partnership of NFL’s Next Gen Stats with Amazon Web Services has created a buzz among media and fans, yet the full scope and utility of digital biosensors has yet to be determined. We review current uses of Global Positioning System technology and digital biosensors in the NFL and discuss the future role of this technology in injury prevention. A complete literature review was conducted, along with review of the NFL web site and news outlet articles, to obtain a comprehensive assessment of all prior and current uses of biosensor technology in the NFL. Limited data exist on successful injury prevention and return to play, and utilization of this emerging technology has mostly been for fan experience. While ethical and legal challenges exist, the integration of digital biosensor and GPS technology in the NFL has enormous potential and is an invaluable tool in the comprehensive assessment of player health.

BACKGROUND:The success of vaccination efforts to curb the COVID-19 pandemic will require broad public uptake of immunization and highlights the importance of understanding factors associated with willingness to receive a vaccine.METHODS:U.S. adults aged 65 and older enrolled in the HeartlineTM clinical study were invited to complete a COVID-19 vaccine assessment through the HeartlineTM mobile application between November 6-20, 2020. Factors associated with willingness to receive a COVID-19 vaccine were evaluated using an ordered logistic regression as well as a Random Forest classification algorithm.RESULTS:Among 9,106 study participants, 81.3% (n = 7402) responded and had available demographic data. The majority (91.3%) reported a willingness to be vaccinated. Factors most strongly associated with vaccine willingness were beliefs about the safety and efficacy of COVID-19 vaccines and vaccines in general. Women and Black or African American respondents reported lower willingness to vaccinate. Among those less willing to get vaccinated, 66.2% said that they would talk with their health provider before making a decision. During the study, positive results from the first COVID-19 vaccine outcome study were released; vaccine willingness increased after this report.CONCLUSIONS:Even among older adults at high-risk for COVID-19 complications who are participating in a longitudinal clinical study, 1 in 11 reported lack of willingness to receive COVID-19 vaccine in November 2020. Variability in vaccine willingness by gender, race, education, and income suggests the potential for uneven vaccine uptake. Education by health providers directed toward assuaging concerns about vaccine safety and efficacy can help improve vaccine acceptance among those less willing.TRIAL REGISTRATION:Clinicaltrials.gov NCT04276441.

In December 2019, the novel COVID-19 virus spread from a cluster of pneumonia cases in Wuhan, China, to every corner of the globe, creating a worldwide pandemic pushing hospital systems past capacity and bringing economies worldwide to a halt. The COVID-19 pandemic is unique in comparison to prior coronavirus epidemics in its superior ability to be spread by asymptomatic and presymptomatic patients, allowing the virus to silently evade traditional symptoms-based screening approaches. Countries have implemented cutting-edge digital solutions to enhance traditional contact-tracing methodologies in combination with novel testing strategies to combat the virus, with variable levels of success. Despite having one of the most advanced and expensive health care systems in the world, the United States (U.S.) response is arguably one of the world's largest failures, as it leads the globe in case number as well as deaths. Until a successful vaccine can be broadly distributed, it is imperative that the U.S. curb the viral spread by rapidly developing a framework implementing both enhanced tracing and testing strategies balancing the needs of public health while respecting individual liberties. This review will explore the role of technology-augmented contact-based surveillance in tracking the outbreak in select countries in comparison to the current U.S. approach. It will evaluate barriers in the U.S. to implementing similar technologies, focusing on privacy concerns and a lack of unified testing and tracing strategy. Finally, it will explore strategies for rapidly scaling testing in a cost-effective manner.

Introduction: Adolescents with heart disease report difficulty in communication about their health as a major inhibiting factor in their care. MHealth technologies collect health data in daily life and enable health data sharing between the provider and patient. The adolescent population has a high level of engagement with mobile devices and a willingness to use them for health-related activities. Hypothesis: We hypothesized that our novel gamified mHealth platform Heart Hero can engage adolescent patients in the collection of cardiac health data in their daily life. Methods: We designed the research app using ResearchKit to collect continuous physiological data from the Apple Watch and daily survey data on well-being, stress, medical adherence, and cardiac symptoms. Patients were provided the app, iPhone, and Apple Watch and enrolled for 27 days. A final in-app survey was provided to assess feedback. We enrolled 28 patients total who were scheduled for outpatient cardiopulmonary exercise testing. Results: Mean age was 14.3 years old (SD +/-3.08) with a 1:1 M:F ratio. 61% of patients were ≥ 15 years of age. 94% of patients completed the final survey. Subjects on average completed 64% (SEM +/-5) of the daily quizzes with an average daily adherence of over 50% wearing the watch. 100% reported they liked using the watch and app, and 89% would like to continue wearing the Apple Watch. 53% reported the study encouraged them to exercise more while 21% reported encouragement to walk more. Fig 1 demonstrates A) Apple Watch and b) daily survey data collected from a patient throughout the study. Conclusions: In conclusion, Heart Hero is a mHealth platform which can successfully be used to collect continuous health data from the adolescent population with high engagement characterized by adherence and positive patient feedback. Adherence to the app was notably superior to the initial 5 ResearchKit applications enrolling adult patients.

HomeCirculation: Arrhythmia and ElectrophysiologyVol. 13, No. 8Rates of Adoption and Outcomes After Firmware Updates for Food and Drug Administration Cybersecurity Safety Advisories Free AccessReview ArticlePDF/EPUBAboutView PDFView EPUBSections ToolsAdd to favoritesDownload citationsTrack citationsPermissions ShareShare onFacebookTwitterLinked InMendeleyReddit Jump toFree AccessReview ArticlePDF/EPUBRates of Adoption and Outcomes After Firmware Updates for Food and Drug Administration Cybersecurity Safety Advisories Leslie A. Saxon, MD, Niraj Varma, MD, PhD, Laurence M. Epstein, MD, Leonard I. Ganz, MD and Andrew E. Epstein, MD Leslie A. SaxonLeslie A. Saxon Correspondence to: Leslie A. Saxon, MD, USC Center for Body Computing, 12015 Waterfront Dr, Los Angeles, CA 90094. Email E-mail Address: [email protected] https://orcid.org/0000-0002-0127-368X Department of Medicine, University of Southern California, Keck School of Medicine, Los Angeles (L.A.S.). , Niraj VarmaNiraj Varma https://orcid.org/0000-0003-2296-2596 Department of Medicine, Cleveland Clinic, OH (N.V.). , Laurence M. EpsteinLaurence M. Epstein Northwell Health, Manhasset, NY (L.M.E.). , Leonard I. GanzLeonard I. Ganz Heritage Valley Health System, Beaver, PA (L.I.G.). and Andrew E. EpsteinAndrew E. Epstein https://orcid.org/0000-0003-0433-8802 Department of Medicine, University of Pennsylvania, Philadelphia (A.E.E.). Originally published6 Jul 2020https://doi.org/10.1161/CIRCEP.120.008364Circulation: Arrhythmia and Electrophysiology. 2020;13:e008364Other version(s) of this articleYou are viewing the most recent version of this article. Previous versions: July 7, 2020: Ahead of Print In response to Food and Drug Administration (FDA) Cybersecurity Safety Advisories affecting over 1 500 000 patients implanted globally with pacemakers (490 209 US patients) and implantable cardioverter-defibrillators (ICDs; 357 647 US patients) and related equipment, Abbott released 2 cybersecurity firmware updates between August 2017 and April 2018 for impacted pacemakers and ICDs.1,2 We previously reported on firmware update rates, complications, and predictors of upgrades in a subset of affected US patients with pacemakers.3 Firmware update adoption, requiring a clinic visit, was low, as were complications. Subsequently, in 2018 to 2019, FDA cybersecurity advisories have also impacted over 16 000 programmers and 600 000 ICDs manufactured by Medtronic and mitigations for those have also been FDA approved.1,4Before identification of these vulnerabilities, clinical and patient communities had little experience implementing device firmware updates. There was a paucity of published research and clinical experience defining the safety of performing these updates in large numbers of patients implanted over a multiyear interval with numerous device types and models.3,5 Lack of outcomes data, combined with the absence of any documented instance of actual cybersecurity intrusion to these devices or peripheral products that support device connectivity (programmer, home communicator, database, communication protocols), render the assessment of the risk-benefit of updating an individual's device less than straightforward. Abbott Cybersecurity Medical Advisory Board expected update rates to be the highest in the affected ICD subpopulation also impacted by an October 2016 advisory for premature battery depletion because the cybersecurity firmware update also included a new battery performance alert that impacted over 175 000 US patients.1 Through a number of communications, including an FDA-convened Patient Engagement Advisory Committee meeting in September 2019, the FDA has indicated that it would like the mitigating firmware updates performed in greater numbers of patients impacted by these cybersecurity advisories.6,7 On November 22, 2019, Abbott released a clinical update reporting a 25% overall upgrade rate for affected pacemakers and ICDs associated with an aggregate complication rate of 0.032%.8 The update recommended that clinicians update more devices and indicated that Abbott will provide field support to accomplish these at scale. In January of 2020, Medtronic announced a firmware mitigation for ICDs that will automatically update firmware in impacted patients at clinic visits.4This update to our prior publication provides further detail on mitigation adoption rates for the entirety of the US patient population with implanted cardiac rhythm management devices falling under FDA cybersecurity advisories from any device manufacturer.3 We also provide limited data on known cybersecurity mitigation adoption outside of the United States. We report a unique complication resulting from introducing firmware to already implanted devices and discuss how evolving FDA policies toward firmware mitigation adoption will increasingly determine how and when updates occur.6,7 Institutional review board approval was not required for this study.Table 1 lists the characteristics of US patients with affected devices that are active on Abbott Merlin.net database as of March 1, 2020. To better understand associations predictive of receiving a firmware upgrade, we performed a multivariate regression analysis. Compared with patients <50 years of age, those >80 years of age were less likely to receive the upgrade, and men versus women had greater rates of upgrades. Upgrade rates varied according to the US region and date of implant. Resynchronization devices were less likely to receive the upgrade as were pacemaker-dependent patients. Those ICD patients additionally falling under with the battery advisory were upgraded more frequently. The number of advisory patients followed in clinic was a significant predictor of firmware upgrade adoption, particularly for pacemakers that were more often upgraded in smaller size clinics. Overall, only 24% of devices (68 215/290 244) for all groups and 22% of devices not impacted by the battery advisory (52 435/238 327) were upgraded.Table 1. Predictors of Cybersecurity Firmware Upgrade Rates in US PatientsPatient and Device CharacteristicsPacemakerICDOdds Ratio (95% CI)P ValueOdds Ratio (95% CI)P ValueAge, y (<50 vs) >50–≤801.02 (0.93–1.12)0.6441.04 (0.98–1.11)0.157 >800.87 (0.80–0.95)0.0030.87 (0.82–0.93)<0.001Sex Male1.11 (1.08–1.14)<0.0011.06 (1.03–1.10)<0.001Region (Midwest vs) Northeast0.71 (0.68–0.74)<0.0010.92 (0.88–0.96)<0.001 Southeast1.02 (0.98–1.06)0.2741.14 (1.10–1.19)<0.001 Southwest1.17 (1.12–1.22)<0.0011.17 (1.11–1.23)<0.001 West0.68 (0.65–0.71)<0.0011.07 (1.01–1.12)0.012Time from implant, y (<3 vs) 3–70.79 (0.77–0.82)<0.0011.01 (0.97–1.06)0.488 >70.68 (0.65–0.71)<0.0010.94 (0.89–1.01)0.084Device type (CRT vs) Single chamber ventricular1.32 (1.23–1.41)<0.0011.24 (1.19–1.29)<0.001 Dual chamber1.33 (1.26–1.40)<0.0011.23 (1.18–1.28)<0.001ICD early battery depletion advisory YesNA1.80 (1.73–1.87)<0.001Pacemaker dependent Yes0.65 (0.63–0.68)<0.0010.92 (0.88–0.96)<0.001Clinic size (<50 vs) 50–2500.89 (0.81–0.97)0.0060.94 (0.86–1.04)0.237 250–5000.87 (0.80–0.95)0.0020.93 (0.84–1.02)0.125 500–10000.76 (0.70–0.82)<0.0010.73 (0.67–0.80)<0.001 1000–25000.74 (0.68–0.81)<0.0010.78 (0.71–0.86)<0.001 2500–50000.77 (0.71–0.84)<0.0010.86 (0.79–0.95)0.003 >50000.78 (0.71–0.86)<0.0011.01 (0.91–1.12)0.821CRT indicates cardiac resynchronization therapy; ICD, implantable cardioverter-defibrillator; and NA, not available.Table 2 lists the date of the FDA cybersecurity advisories, type of advisory, and the number of devices impacted by manufacturer. Mitigation FDA approval dates, overall firmware upgrade adoption rates, and known complications are provided (Product Security at Medtronic, Alexander Kent, PhD, MBA, email communication, March 2020). For Abbott devices, the home communicator cybersecurity vulnerabilites were mitigated with an automatic software patch that was updated using the Merlin network link, and adoption rates were ≈100%. For the entire patient cohort with impacted pacemakers and ICDs, US and global adoption rate has remained at 24% to 35% with a low rate of complications. Most reported complications for pacemakers and ICDs were symptoms (transient palpitations, dizziness, or syncope) that resulted from the temporary change in pacing mode (to ventricular demand pacing) or transient loss of programmer telemetry while performing the upgrade (pacemaker: 107/220 500, 0.050%; ICD: 21/196 700, 0.01%). Globally, a total of 9 pacemakers (9/220 500) and 8 ICDs (8/196 700, 0.004%) required replacement as a result of performing the firmware upgrade due to irreversible reversion to backup pacing mode with loss of defibrillation therapy (ICDs). Analysis of the returned ICD pulse generators found that in 7 cases, the cause was related to a capacitor bond failure that was exposed only with extended telemetry as required by the upgrade. The failure mechanism was an isolated component failure in the remaining ICD. A programmer-based test has been recently FDA approved that can be performed prior the firmware upgrade to identify ICD devices at risk for the capacitor bond failure. A total of 256 ICDs were susceptible to loss of radiofrequency telemetry after receiving a firmware update, and this has since been mitigated with a software patch. For Medtronic programmers, the initial mitigation response to the cybersecurity advisory was to take the programmers off the network. The network connection was subsequently enhanced with more cybersecurity protections, provided to the programmers using a flash drive, so that programmers can now be secured from potential cyber intrusion when connected to the network. Medtronic ICDs are currently being upgraded. The update is being provided to impacted patients automatically when their device is interrogated with the programmer during a clinic follow-up. Medtronic is introducing the updates in phased approach expects all updates to be completed by the beginning of 2021. There are 9% or 55 000 ICDs under this advisory that cannot receive the update due to design or safety constraints.Table 2. Connected Cardiac Rhythm Management Device FDA Cybersecurity Safety Communications MitigationsDateManufacturerRadiofrequency Enabled Device(s)Number of Devices ImpactedSoftware/Firmware FDA Approved Mitigation DateUpdate Adoption Rate, %Upgrade Complications, %US/Outside USUS/Outside USWorld WideJanuary 9, 2017St. Jude Medical/AbbottHome communicators374 219/2487January 9, 2017, software patch to home communicators99/95None knownPacemakers, ICDs490 209/323 200 pacemakersAugust 29, 2017, firmware update to pacemakers24/25Symptoms, 0.05%Replacement, 0.004%*357 647/382 404 ICDsApril 17, 2018, firmware updates to ICDs†25/35Symptoms, 0.01%Replacement, 0.004%‡Potential loss of radiofrequency telemetry,§ 0.13%October 11, 2018MedtronicProgrammers that download software from Medtronic SDN Technology16 896/not providedOctober 5, 2018, software to block programmers from accessing Medtronic SDN100None knownJanuary 30, 2020, restored network connectivity with enhanced cybersecurity96None knownMarch 21, 2019MedtronicHome communicators, ICDs605 000/not providedJanuary 30, 2020, automatic firmware update to 55% of impacted ICDs requires programmer interaction to updateExpected to be 91 early 2021∥None known, firmware patch loaded to unused memory in ICD, no existing function impactedFDA indicates Food and Drug Administration; ICD, implantable cardioverter-defibrillator; SDN, software-defined networking; and US, the United States.* Eight due to backup mode pacing, 1 elective replacement, 2 US, 7 outside US.† Also contained battery alert for ICDs impacted under premature battery FDA advisory.‡ Seven known mechanism, 1 unknown failure mechanism, 2 US, 6 outside US.§ Software patch available, total ICDs at risk 256, 41 US, 15 outside US.∥ Nine percent of devices cannot be upgraded due to age of device (older).Since the 2017 Abbott advisories, advisories identifying cybersecurity vulnerabilities in pacemakers and ICDs with the potential for exploits have increased, including 2 additional FDA advisories issued for another major manufacturer, Medtronic's connected communication products and implantable defibrillators and in the past 14 months.1 FDA pre- and postmarket guidance has also evolved with the cybersecurity research community, along with device manufactures and the clinical community increasingly engaged in public and private dialogue to coordinate disclosers and provide guidance to both the clinical and patient communities about the risk/benefits of cybersecurity mitigations, such as firmware upgrades.1–8 The ability to leverage connected device databases and continuously assess for cybersecurity vulnerabilities or exploits and to report on the safety of cybersecurity firmware upgrades is critical to enhancing patient safety. In the case of Abbott's vulnerabilities, while complication rates associated with firmware updates are exceedingly low, it is now better appreciated that exposing dormant failure mechanisms, such as the ICD capacitor bond issue reported here, can occur and needs to be considered, as well as mitigated. It is also possible that a firmware update may corrupt an otherwise functional device, causing a random component failure, which was also documented as causal in one ICD.8 Thus far, similar to our prior publication, reporting on updates to a subset of affected pacemaker patients, the majority of the clinical and patient community has not elected to perform or receive updates for potential cybersecurity vulnerabilities.3 Our findings of age, sex, and region update adoption rates, while statistically significant, are not clinically significant because overall update rates are small. The willingness to update younger devices or ICD devices also receiving a battery depletion alert is understandable. Pacemaker-dependent status was clearly recognized as a risk factor and impacted the decision-making process not to update. That seems justifiable in light of the small number of devices that required replacement due to nonprogrammability and backup mode pacing. Smaller volume clinics updating more often may reflect the practices of a smaller number of clinicians than larger clinics. At any rate, we feel that deferring an update is a justifiable decision as there have been no reported cybersecurity breaches impacting the devices included in any of the FDA advisories issued to date. A recent report, in a smaller number of Abbott impacted pacemaker and ICD patients from Canada, reported marked differences in mitigation update adoption rates between pacemakers and ICDs. This was due to increasing and incremental clinical familiarity and comfort with performing the updates as experience and education surrounding these issues evolved.5 In the case of the Medtronic ICD mitigations, occurring 3 years after the first Abbott advisories, the FDA approved an automatic update mitigation that supports FDA's stated intent that cybersecurity updates should be automatic.7 In many instances, this will happen without involving a discussion or decision process on the part of the patient or clinician. From a safety standpoint, the Medtronic ICD updates will likely be associated with less risk of complications, because the updates do not require the devices to revert to backup modes to receive the update. This is because the update is uploaded to unused memory on the device that is segregated from other device functions. Nonetheless, automating cybersecurity updates without processes in place for determining safety or for alerting patients or clinicians that updates have been delivered may also be associated with, as yet, unknown risks. As physicians, we routinely make risk-benefit decisions with our patients. Governmental mandates and automated upgrades remove both physicians and patients from the shared decision-making process as it relates to cybersecurity risks. In this scenario, in the event of an unintended complication, it is possible that neither the clinician nor the patient would have an awareness of the issue, and that would definitely be a disadvantage in terms of making the best clinical determination of what needed to be done. Newer generation devices and communication protocols may render cybersecurity advisory events less frequent as cybersecurity integration is considered an essential aspect of device design.The data will not be made available to researchers as they are proprietary to the manufacturer and were specifically queried for the purposes of examining the response to the firmware update advisory.Nonstandard Abbreviations and AcronymsFDAFood and Drug AdministrationICDimplantable cardioverter-defibrillatorSources of FundingAbbott supported the data query of the remote monitoring database with Abbott personnel.DisclosuresAll authors are paid members of the Abbott Cybersecurity Medical Advisory Board.FootnotesFor Sources of Funding and Disclosures, see page 872.Correspondence to: Leslie A. Saxon, MD, USC Center for Body Computing, 12015 Waterfront Dr, Los Angeles, CA 90094. Email [email protected]eduReferences1. U.S. Food & Drug Administration. Cybersecurity.2020. https://www.fda.gov/medical-devices/digital-health/cybersecurity#safety. Accessed March 24, 2020.Google Scholar2. U.S. Food & Drug Administration. U.S. Food & Drug Administration: Digital Health.2019https://www.fda.gov/medical-devices/digital-health. Accessed March 24, 2020.Google Scholar3. Saxon LA, Varma N, Epstein LM, Ganz LI, Epstein AE. Factors influencing the decision to proceed to firmware upgrades to implanted pacemakers for cybersecurity risk mitigation.Circulation. 2018; 138:1274–1276. doi: 10.1161/CIRCULATIONAHA.118.034781LinkGoogle Scholar4. Alexander B, Neira V, Campbell D, Crystal E, Simpson C, Enriquez A, Chacko S, Abdollah H, Redfearn D, Baranchuk A. Implantable cardioverter-defibrillator-cybersecurity.Circ Arrhythm Electrophysiol. 2020; 13:e008261. doi: 10.1161/CIRCEP.119.008261LinkGoogle Scholar5. U.S. Food & Drug Administration. September 10, 2019: Patient Engagement Advisory Committee Meeting Announcement.2019. https://www.fda.gov/advisory-committees/patient-engagement-advisory-committee/september-10-2019-patient-engagement-advisory-committee-meeting-announcement-09102019-09102019. Accessed March 24, 2020.Google Scholar6. Abbott. Product Advisories Archive.2020. https://www.cardiovascular.abbott/us/en/hcp/resources/product/advisories.html. Accessed March 24, 2020.Google Scholar7. Medtronic. Security Bulletins - Conexus Telemetry and Monitoring Accessories.2020. https://global.medtronic.com/xg-en/product-security/security-bulletins/conexus.html. Accessed March 24, 2020.Google Scholar8. Paulsen JE, Hazelett MB, Schwartz SB. CIED cybersecurity risks in an increasingly connected world.Circulation. 2018; 138:1181–1183. doi: 10.1161/CIRCULATIONAHA.118.035021LinkGoogle Scholar Previous Back to top Next FiguresReferencesRelatedDetailsCited By Qian X, Channels C, Gaeta S, Wish M, Matthews B, Atwater B and Kumar V (2022) Radiofrequency remote monitor software patch update without cybersecurity implantable cardioverter-defibrillator firmware update increases the risk of inappropriate implantable cardioverter-defibrillator therapies, HeartRhythm Case Reports, 10.1016/j.hrcr.2021.12.016, 8:2, (69-72), Online publication date: 1-Feb-2022. Giansanti D and Gulino R (2021) The Cybersecurity and the Care Robots: A Viewpoint on the Open Problems and the Perspectives, Healthcare, 10.3390/healthcare9121653, 9:12, (1653) August 2020Vol 13, Issue 8 Advertisement Article InformationMetrics © 2020 American Heart Association, Inc.https://doi.org/10.1161/CIRCEP.120.008364PMID: 32631098 Originally publishedJuly 6, 2020 Keywordsdefibrillators, implantableambulatory carerisk assessmentcomputer securityaccidental fallsPDF download Advertisement SubjectsCatheter Ablation and Implantable Cardioverter-DefibrillatorComplicationsQuality and Outcomes

Background Specialized training for elite US military units is associated with high attrition due to intense psychological and physical demands. The need to graduate more service members without degrading performance standards necessitates the identification of factors to predict success or failure in targeted training interventions. Objective The aim of this study was to continuously quantify the mental and physical status of trainees of an elite military unit to identify novel predictors of success in training. Methods A total of 3 consecutive classes of a specialized training course were provided with an Apple iPhone, Watch, and specially designed mobile app. Baseline personality assessments and continuous daily measures of mental status, physical pain, heart rate, activity, sleep, hydration, and nutrition were collected from the app and Watch data. Results A total of 115 trainees enrolled and completed the study (100% male; age: mean 22 years, SD 4 years) and 64 (55.7%) successfully graduated. Most training withdrawals (27/115, 23.5%) occurred by day 7 (mean 5.5 days, SD 3.4 days; range 1-22 days). Extraversion, positive affect personality traits, and daily psychological profiles were associated with course completion; key psychological factors could predict withdrawals 1-2 days in advance (P=.009). Conclusions Gathering accurate and continuous mental and physical status data during elite military training is possible with early predictors of withdrawal providing an opportunity for intervention.

Despite the promise of remote patient monitoring (RPM), this technology remained underutilized secondary to a lack of data transparency and systems issues until the COVID-19 pandemic ushered in a new era of telehealth and virtual solutions out of necessity. This review will explore the data supporting the use of RPM via both implantable and wearable devices in the field of cardiology and the role of home monitoring using RPM in the era of COVID-19. RPM using implantable cardiac devices is a safe alternative to in-person only visits which leads to enhanced patient satisfaction and improved clinical outcomes. Consumer-grade wearable sensors have drastically expanded RPM capabilities from just the sickest cardiac patients to the entire population aiding in early diagnosis and real-time disease management. Home monitoring enabled by automated alert systems tailored specifically to the needs of the patient by the provider will be the cornerstone of a more continuous, patent-centric healthcare model.

OBJECTIVES This study tested the hypothesis that the extent of left ventricular (LV) eccentric structural remodeling in heart failure with reduced ejection fraction (HFrEF) is directly associated with clinical event responses to cardiac resynchronization therapy (CRT). BACKGROUND Whether the severity of LV structural remodeling influences CRT treatment effects is unknown. METHODS COMPANION (Comparison of Medical Therapy, Pacing and Defibrillation in Heart Failure) trial data were analyzed retrospectively. Left ventricular internal dimensions at end diastole indexed by body surface area (LVEDDI) were measured pre-randomization by 2-dimensional echocardiography. LVEDDI values were stratified around the median value of 35 mm/m(2), and CRT (including CRT-P [CRT with only pacing capability] and/or CRT-D [CRT with an implantable defibrillator]) treatment effects were assessed and compared by LVEDDI group. Patients assigned to these treatments were compared to those undergoing optimal pharmacologic therapy (OPT) for the outcomes of all-cause mortality (ACM) or ACM and heart-failure hospitalization (ACM/HFH). RESULTS In the LVEDDI >= 35 mm/m(2) group (n = 614), CRT vs. OPT was associated with a lower ACM/HFH hazard ratio (HR) (HR: 0.53; 95% confidence interval [CI]: 0.40 to 0.70; p < 0.001), whereas in the LVEDDI <35 mm/m(2) group, the CRT vs. OPT ACM/HFH hazard ratio was not statistically significant (HR: 0.80; 95% CI: 0.59 to 1.08; p = 0.15). For ACM alone, in the LVEDDI >= 35 mm/m(2) group, the hazard ratio for CRT-P was 0.59 (95% CI: 0.39 to 0.90; p = 0.012) and for CRT-D 0.50 (95% CI: 0.32 to 0.77; p = 0.002). Neither of the CRT groups showed a statistically significant reduction in ACM in the LVEDDI <35 mm/m(2) group. CONCLUSIONS Larger versus smaller LVEDDIs are associated with a reduction in ACM with CRT-P or CRT-D treatment, and with a more effective reduction in ACM/HFH for the combined CRT treatment groups. (C) 2019 by the American College of Cardiology Foundation.

Advisors: Mintu P. Turakhia, MD, MAS, FHRS, Jill Schaeffer, MSN, CRNP, FHRS, CEPS, CCDS, G. Stuart Mendenhall, MD, FHRS, Gerhard Hindricks, MD, Sanjiv M. Narayan, MD, PhD, FHRS, Elizabeth E. Davenport, BA, RN, Nassir F. Marrouche, MD, FHRS This HRS Needs Assessment is in the category of the Heart Rhythm Society (HRS) documents delineating a future direction of research, technology development, or health care policy and adheres to the following requirements set forth by the HRS:1.There are no clinical practice recommendations.2.The Chair (and Vice-Chair) of the document is free of any relationships with industry and other entities (RWIs).3.The remainder of the writing committee may have RWIs, with no dollar limit, but may not have relevant stock, stock options, equity, or royalties or be employed by industry.4.The writing committee is encouraged to gain information from advisors. Advisors must be physicians or health care providers who are not able to serve as writing committee members because they have relevant stock, stock options, equity, royalties, or other relationships that may be determined to create conflict of interest. Advisors cannot be employed by industry and do not participate in writing.5.The writing committee uses industry forums to engage representatives of industry, the U.S. Food and Drug Administration, or other third-party organizations in a dialogue to provide an exchange of information.6.A full disclosure of RWIs for each writing committee member and each advisor is provided in Appendix 1. Tools of digital health are empowering individuals to assume a central role both in maintaining health and in detecting and managing chronic diseases. Patients, the public at large, health care providers, and other stakeholders are using digital health to reduce inefficiencies, improve access, reduce cost, increase quality, and make medicine more personalized for patients.1FDA. Digital health.https://www.fda.gov/medicaldevices/digitalhealth/Date accessed: January 17, 2019Google Scholar As a result, there is a growing awareness and increasing expectation by patients and the public for access to transparent and secure health care data. The U.S. Department of Veterans Affairs recently announced that veterans will soon be able to access an aggregated view of their allergies, conditions, immunizations, lab results, medications, procedures, and vitals in the Health application on their iPhone (Apple, Inc, Cupertino, CA).2U.S. Department of Veterans Affairs. VA to provide capability for veterans to access their VA health data on Apple iPhones. Available at: https://www.va.gov/opa/pressrel/pressrelease.cfm?id=5199. Accessed March 26, 2019.Google Scholar It is inevitable that this trend will accelerate and that patients will soon have transparent access to all their medical data, possibly in real time. Heart rhythm care professionals and patients routinely depend upon digital health data obtained by cardiovascular implantable electronic devices (CIEDs), medical-grade ambulatory cardiac monitors, and, most recently, consumer personal biometric monitoring devices. Yet the data typically reside either exclusively with the health care team, or, in the case of consumer devices, with the patient. If we are to realize the transformative opportunity of digital health, it will be necessary to ensure that all stakeholders, particularly patients, have complete, transparent, and secure access to their data. This document focuses on digital health and cardiac electrophysiology, outlining the present state and future vision of key stakeholder groups. It also is meant to serve as a call to action to heart rhythm professionals to join in leading this transformation. The document is organized into sections representing the constituents involved in the digital health transformation: patients and caregivers, clinicians, research, industry, and regulatory agencies. Additionally, we present our thoughts on adoption of digital health tools by clinical providers. In order to inform the writing group, a 1-day Think Tank was held in August 2018 to convene patients, clinicians, and industry leadership from Abbott, Biosense Webster, BIOTRONIK, Boston Scientific, iRhythm, Janssen, Medtronic, and Preventice Solutions. Representatives from the U.S. Food and Drug Administration (FDA) did not attend the Think Tank but participated in discussions with the writing group and were able to provide a global regulatory perspective through the FDA division that studies global regulatory policy. Digital health can be defined as the convergence between health care and emerging digital technologies that acquire, collect, manipulate, and share health data.1FDA. Digital health.https://www.fda.gov/medicaldevices/digitalhealth/Date accessed: January 17, 2019Google Scholar, 3Federal Communications CommissionTelehealth, telemedicine and telecare: what's what?.https://www.fcc.gov/general/telehealth-telemedicine-and-telecare-whats-whatDate accessed: March 26, 2019Google Scholar, 4Turakhia M.P. Moving from big data to deep learning-the case of atrial fibrillation.JAMA Cardiol. 2018; 3: 371-372Crossref PubMed Scopus (7) Google Scholar Many terms have been employed to refer to the various aspects of the digital health revolution, such as mHealth (mobile health), wireless health, big data, quantified self and self-tracking, wearable computing, telehealth, body computing, precision medicine, and personalized medicine. Digital health may be divided into technologies that are physician-facing (ie, electronic medical records, medical websites, CIEDs, medical-grade wearable heart monitors), patient/consumer-facing (ie, self-monitoring with consumer wearable devices, Internet searches), or centered on patient-physician communication (ie, telehealth, patient portals).5Dorn S.D. Digital health: hope, hype, and Amara's Law.Gastroenterology. 2015; 149: 516-520Abstract Full Text Full Text PDF PubMed Scopus (17) Google Scholar The data generated by physician-facing technology, such as CIEDs and medical-grade wearable cardiac monitors, reside within the traditional closed-loop medical establishment infrastructure, whereas data generated from patient/consumer-facing technologies reside primarily with the individual, to be shared as needed with health care providers to assist in interpreting and developing treatment plans. Therefore, the challenges of sharing digital health data from CIEDs and medical-grade wearable cardiac monitors vs patient/consumer-facing devices are fundamentally different. Cardiac electrophysiology, by nature of the technology central to arrhythmia diagnosis and management, is among the first domains of medicine to face both the opportunity and the challenges of sharing and managing patient data under this new paradigm. Many important questions related to the new consumer wearable technology, such as privacy, security, and reimbursement, are beyond the scope of this document's charge and will need to be addressed in subsequent forums. Digital health tools generate many types of data; therefore, it is necessary to specify which types of data this document is referring to as we advocate for transparent and secure access by patients and their health care providers. We define these to be clinically relevant data that are patient-specific and could be useful to either the patient or their health care provider for the purposes of evaluating and managing an individual patient's health. This may include, for example, physiologic data recorded by the patient, battery status of an implantable CIED, or recordings from a wearable medical-grade heart monitor. This would not include proprietary data used by the manufacturer to assess product performance or other proprietary algorithms that are not available to the health care team. Sharing and organizing digital health data, whether obtained from CIEDs or from medical-grade or consumer wearable devices, is a subject of critical importance to patients and the health care team. The data categories, regardless of device manufacturer, are often identical. However, for CIEDs and now for the emerging consumer wearable devices, each manufacturer develops proprietary terminology and communication protocols, isolating the granular data in digital silos, thereby limiting the findings to be communicated as an image file. Patients and health care providers expect the data to be securely and readily available and interoperable with electronic health records (EHRs), smart phones, and other digital platforms for research, cataloging, and sharing. There are numerous potential solutions to this challenge, beginning with the creation of a single nomenclature or data standard developed in partnership with the appropriate standards development organization, such as the Regenstrief Institute's Systematized Nomenclature of Medicine Clinical Terms (SNOMED CT),6SNOMED.http://www.snomed.orgDate accessed: March 26, 2019Google Scholar Logical Observation Identifiers Names and Codes (LOINC),7LOINCLOINC from Regenstrief.https://loinc.orgDate accessed: March 26, 2019Google Scholar Health Level Seven International (HL7),8HL7 International.http://www.hl7.orgDate accessed: March 26, 2019Google Scholar the Institute of Electrical and Electronics Engineers (IEEE),9IEEE. IEEE.org.https://www.ieee.org/Date accessed: March 26, 2019Google Scholar and Integrating the Healthcare Enterprise (IHE).10IHEIntegrating the Healthcare Enterprise International.https://www.ihe.net/%09Date accessed: March 26, 2019Google Scholar Achieving interoperability or liquidity of the data requires a coalition and cooperation of industry, clinicians, informaticians, EHRs, and health information technology vendors. The writing committee sought to understand what types of data patients want to access, as well as how and when. The patient perspective was sought through 3 avenues: (1) the Digital Health Think Tank, which was held in August 2018 and included 2 patient representatives, 1 with implantable CIED and 1 with extensive experience using a consumer wearable device; (2) the participation of an arrhythmia patient, who we will refer to as DM, on the document writing group who is also an experienced patient advocate with a large social media following of arrhythmia patients who have CIEDs and/or experience with consumer wearable digital health products; (3) a survey of DM's online social media followers (of which a small number responded) with CIEDs, inquiring if they wished to have access to data from their device and, if so, what type of data. In 2007, I learned that my implantable defibrillator could and would be monitored remotely. I was very excited and I asked the doctor, what is the URL for the patient website? He said, there is no patient website. The sad reality is that to date, some things really haven't changed.∼Hugo Campos11Campos H. 10 Years with an implantable cardiac device and *almost* no data access. Quantified Self Public Health, 2018https://medium.com/quantified-self-public-health/hugo-campos-10-years-with-an-implatable-cardiac-device-and-almost-no-data-access-71018b39b938Google Scholar This quote from a patient with an implantable defibrillator represents the perspective of a small and vocal group of patients with CIEDs who have been advocating for full and unrestricted access to all clinically relevant data from their implantable device. This aligns with the request of 1 of the participants of the Think Tank, Dr Ira Nash.12Nash I.S. It's my heart why not my data?.Circulation. 2018; 137: 4-6Crossref PubMed Scopus (4) Google Scholar As a patient and cardiologist, Dr Nash was surprised to learn he could not have direct access to data from his implantable loop recorder. This is not the view expressed by the majority of patients with CIEDs when asked either informally, at the Think Tank, or through the survey conducted to inform this writing group. The survey conducted by DM of her social media followers asked the following 5 questions: age, gender, type of CIED, what information does your doctor share with you about your device, and what information would you like your doctor to share with you about your device. Fifty-two respondents completed the informal survey. Average age was 62 years (range 26–89 years), 65% were female. Six patients reported having an implantable defibrillator, 23 an implantable pacemaker, and 21 an implantable loop recorder. Recognizing the limitations of this self-selected population, who are already engaged in social media and therefore not representative of most CIED patients, the responses are still valuable and align with the experience of the writing group when inquiring from their patients what type of information they presently receive and what they would like to receive. Most patients reported receiving very little information about their CIED, with data limited to battery longevity, and only receiving it at in-office follow-up appointments. A few stated that they received monthly reports from their health care team through their patient portal that included arrhythmias recorded, other physiologic trends such as heart rate, and information about the device, including battery status. In response to the question "What information would you like your doctor to share with you?" the responses were remarkably consistent: a log of arrhythmia episodes, information that they could use to determine if their condition was changing, and an expressed desire to receive reports on the status of their device at regular predefined intervals. Additionally, the contents of the report should be expressed in nontechnical language that they could understand, and should include battery status, a summary of any arrhythmias detected, and any physiologic data recorded, such as heart rate trends. Patients explained that they want this information in order to better understand their chronic disease and to determine if their symptoms corresponded to any abnormal heart rhythms recorded by their device. Some indicated that they had become frustrated with an inability to access these data, which led them to purchase consumer wearable devices such as the Kardia device or Apple Watch in order to attempt to record on their own and have access to their arrhythmia data. The patients we engaged recognized that they are a self-selected group with greater interest in receiving data than the majority of patients. Therefore, they advised that given the wide range of patients' desires for more or less information from their CIED, the best approach at the present time is for the health care team to have a conversation with the patient to understand how much and what type of information the individual would like to know. The vocal minority of patients who want access to all of the clinical data from their CIED also would like to be able to access their data at the same time they become available to their health care team and through the same servers.11Campos H. 10 Years with an implantable cardiac device and *almost* no data access. Quantified Self Public Health, 2018https://medium.com/quantified-self-public-health/hugo-campos-10-years-with-an-implatable-cardiac-device-and-almost-no-data-access-71018b39b938Google Scholar, 12Nash I.S. It's my heart why not my data?.Circulation. 2018; 137: 4-6Crossref PubMed Scopus (4) Google Scholar However, most patients accept the paradigm of the existing health care infrastructure, which appoints the patient's health care team as the sole group to have direct access to their data, which can then be shared via the electronic medical record patient portal once the clinician has reviewed and interpreted the information. Both patient groups agree that having direct access to basic data about their CIED, such as battery status, estimated longevity, and overall status of the device function, is important. A practical approach for the immediate future suggested by patients at the Digital Health Think Tank is for teams to post basic data at a minimum on the patient portal as soon as the clinical team has reviewed it. Consumer wearable devices capable of recording heart rate trends, beat-to-beat intervals, and single-lead electrocardiograms are rapidly being employed by patients with known or suspected arrhythmias. Two types of population using such devices are individuals at high risk or those who use them for early detection and prevention purposes and patients already diagnosed or suspected to have an arrhythmia. A common scenario is to employ these devices for patients with known or suspected arrhythmias, either to make an initial diagnosis or to assist in managing the arrhythmia after it has been detected. Individual patient interest in employing these tools varies dramatically, often based upon their comfort with digital technology. Once patients use this technology, they often find themselves forced to figure out how to share the data with their clinical provider. Providers must make accommodations for these patients, such as providing e-mail access, since EHR portals typically do not accommodate attachment of digital health data. The patient perspective of these tools will need to be assessed as these technologies mature. The perspective of the cardiac electrophysiology clinical team was assessed through discussions with the Heart Rhythm Society's Digital Health Working Group, which includes clinical cardiac electrophysiologists and allied professionals, a subset of whom comprise the writing group for this document. There was unanimous agreement among the clinicians of the working group that both patients and health care team beyond the electrophysiology service should have full access to data obtained from CIEDs, medical-grade ambulatory cardiac monitors, and consumer wearable devices in a timely and secure manner. Although the electrophysiology team manages abnormal findings detected by CIEDs and medical-grade ambulatory cardiac monitors, many of the findings are also of significance to general cardiologists and primary care physicians managing those patients. Ensuring clear and timely sharing of this information with these individuals is important. Equally important is sharing this information with the patient. Clinicians recognize that patients have the right to access their health records, and data from CIEDs and medical-grade ambulatory cardiac monitors are not different. However, how much data from devices should be shared with patients is an important consideration. Many believe that all data that clinicians have access to should be made accessible to patients. However, even these advocates acknowledge that patients have considerable variance in their desire of how much data they would like to access. Clinicians advocate that in an ideal scenario patients should have access to all of their data, but that the data should be organized in layers in a format that is comprehensible to the lay public. A quick-view summary should be available to patients, with appropriate explanations. Full disclosure of the entire data should also be available, permitting the patient to share the information with other health care providers if they choose. Patients, health care providers, and industry should collaborate to determine the most effective patient-facing format for presenting the data. The writing group recommends that stakeholders develop a consensus regarding which data elements should be included in the high-level summary presentation and implement consistent reporting of these in the summary for all patients with a particular type of device (ie, pacemaker, defibrillator, event monitor, etc), regardless of manufacturer. While CIEDs have been in clinical use for decades, their follow-up was only recently revolutionized through the advent of remote monitoring.13Wilkoff B.L. Fauchier L. Stiles M.K. et al.2015 HRS/EHRA/APHRS/SOLAECE expert consensus statement on optimal implantable cardioverter-defibrillator programming and testing.Heart Rhythm. 2016; 13: e50-e86Abstract Full Text Full Text PDF PubMed Scopus (160) Google Scholar, 14Slotwiner D. Varma N. Akar J.G. et al.HRS expert consensus statement on remote interrogation and monitoring for cardiovascular implantable electronic devices.Heart Rhythm. 2015; 12: e69-e100Abstract Full Text Full Text PDF PubMed Scopus (365) Google Scholar Remote monitoring has been shown to improve patient outcomes through the prompt detection and management of arrhythmias and device-related issues.15Varma N. Pavri B.B. Stambler B. Michalski J. Same-day discovery of implantable cardioverter defibrillator dysfunction in the TRUST remote monitoring trial: influence of contrasting messaging systems.Europace. 2013; 15: 697-703Crossref PubMed Scopus (35) Google Scholar, 16Varma N. Stambler B. Chun S. Detection of atrial fibrillation by implanted devices with wireless data transmission capability.Pacing Clin Electrophysiol. 2005; 28: S133-S136Crossref PubMed Scopus (107) Google Scholar, 17Crossley G.H. Chen J. Choucair W. et al.Clinical benefits of remote versus transtelephonic monitoring of implanted pacemakers.J Am Coll Cardiol. 2009; 54: 2012-2019Crossref PubMed Scopus (161) Google Scholar, 18Al-Khatib S.M. Piccini J.P. Knight D. Stewart M. Clapp-Channing N. Sanders G.D. Remote monitoring of implantable cardioverter defibrillators versus quarterly device interrogations in clinic: results from a randomized pilot clinical trial.J Cardiovasc Electrophysiol. 2010; 21: 545-550Crossref PubMed Scopus (88) Google Scholar, 19Cronin E.M. Ching E.A. Varma N. Martin D.O. Wilkoff B.L. Lindsay B.D. Remote monitoring of cardiovascular devices: a time and activity analysis.Heart Rhythm. 2012; 9: 1947-1951Abstract Full Text Full Text PDF PubMed Scopus (69) Google Scholar, 20Schoenfeld M.H. Compton S.J. Mead R.H. et al.Remote monitoring of implantable cardioverter defibrillators: a prospective analysis.Pacing Clin Electrophysiol. 2004; 27: 757-763Crossref PubMed Scopus (171) Google Scholar It also has enabled a reduction in the frequency of office encounters for routine device checks. While this is convenient for patients and improves efficiency for the office practice, it leaves a potential gap in communication of information between the patient and clinician. Based upon the Digital Health Working Group's experience as well as the findings from DM's survey of CIED patients, we know that most practices do not share data received through remote transmission with patients. Therefore, there is a need to ensure that remote transmission reports are made available through patient portals in a format that is comprehensible to patients. This can be accomplished by creating timely patient-centric and user-friendly brief reports for patients that include the basic information that most, if not all, patients are interested in. Such information, according to patients who participated in the Think Tank and DM's survey, includes an acknowledgement that the transmission was received, battery status, the overall function of the device and leads, whether arrhythmias were detected, and if the transmission has been reviewed and verified by a clinician. Because developing and implementing a template for such reports at a given site may take time, an initial step is for clinicians to make the data available to patients through the EHR patient portals. However, this should not be considered an acceptable long-term solution. Data from medical-grade wearable cardiac monitors should be available to patients in a similar format: a high-level summary with explanations understandable to the patient, with the ability to access the full data set if the patient wishes. Consumer products are typically initiated by individual patients and the flow of data are now reversed: from patient to their clinical team. Therefore, expectations should be set between the clinician and the patient or consumer regarding how to communicate and transmit the data into the clinical practice, how frequently they will transmit, and over what period of time. Generally, clinicians are unable to review tens or hundreds of tracings generated by consumer products a week, and reimbursement structures are not fully implemented. Clinicians can help educate patients about what features/data of the wearables will be useful. For example, knowing a patient's heart rate every minute of the day has not been shown to provide any benefit. Instead, patients should pay attention to measures that are likely to impact outcomes, such as documenting their heart rhythm at times when they are experiencing symptoms such as palpitations. Also, educating patients about the inaccuracies of rate and rhythm determinations by wearables is critically important.21Cheung C.C. Krahn A.D. Andrade J.G. The emerging role of wearable technologies in detection of arrhythmia.Can J Cardiol. 2018; 34: 1083-1087Abstract Full Text Full Text PDF PubMed Scopus (61) Google Scholar For example, fast heart rates detected by a wearable device may be due to an arrhythmia, but they could also be due to artifact or double counting of heart beats. Finally, patients will need assistance learning about the features of the different consumer products available and guidance identifying which device might be most appropriate for their individual use. Consumer wearable devices remain relatively untested and the regulatory paradigm (covered later in this document) is unfamiliar to most clinicians. Physicians are accustomed to receiving data from rigorously tested medical-grade diagnostic equipment, typically after prescribing or ordering the test for a specific indication. Clinical studies will be needed to assess and validate the data and to guide both the public and clinicians in utilizing the technologies effectively. There will be numerous opportunities for research in relation to digital health. Many of these opportunities involve how patients use and interact with their data and whether their interaction with these data informs self-management and impacts outcomes. Such outcomes may include time to diagnosis and treatment of identifiable issues, overdiagnosis and/or treatment that may have adverse consequences, or patient satisfaction and quality of life. Related research areas include how patients' use of their data affects practice workflows and whether it burdens or unburdens health care providers. Data obtained by digital health tools, which enable more continuous measures of patient status, may lead to new clinical trial endpoints that could accelerate discovery. Important issues of patient privacy, ethical use of data, and the question of bias in digital health studies will need to be considered as these studies are designed and the data acquired. Digital health tools will challenge the traditional care models by providing the opportunity for data to be communicated from the patient to the provider between routine office visits. This will facilitate a more collaborative relationship between the patient and provider and will likely require frequent but brief interactions rather than the intermittent and lengthy encounters during which much of the time is devoted to administrative tasks of little value to the patient. The greatest research opportunity, however, relates to how digital health can be embedded in multicenter clinical trials and other types of prospective research studies to monitor patients for certain outcomes or to interact with patients. This is particularly pertinent to clinical trials that are patient-centric, where patient involvement could extend to patient-reported outcomes and handling of digital health data. Not only will this be innovative and paradigm changing, but the embedding of digital health in research will likely enhance efficiencies and reduce burden and need for resources. Most clinicians recognize that regulatory approval of a CIED in the United States indicates that a device has been demonstrated to be safe and effective for its labeled indication by rigorous clinical trials and bench testing data. But regulatory oversight of digital health products such as consumer wearable devices is less well understood. As clinicians begin to use data acquired by these devices to make clinical decisions, it becomes important to understand the regulatory model for this emerging group of devices. The FDA's regulatory paradigm for medical devices is based on the degree of control necessary to assure that a device is safe and effective. This generally correlates with how critical the device function is for sustaining or supporting life. Devices with higher risk have more regulatory controls placed on them while devices with lower risk have fewer controls. Devices that fall into the highest category of risk (class III) typically are essential for sustaining or supporting life and require a Premarket Approval Application; examples include devices such as implantable cardioverter-defibrillators and pacemakers. This typically involves data from a randomized controlled clinical trial and performance testing of the device in the intended population. Moderate-risk devices (class II) require a Premarket Notification 510(k) application, which requires that a device demonstrate that it is substantially equivalent to a legally marketed device. This may or may not involve clinical evaluation as well as performance testing. Examples of class II devices include implantable and wearable loop recorders and intracardiac mapping catheters. Most medical devices are considered class II devices. The lowest-risk devices (class I) typically do not require a regulatory review prior to marketing the device. Examples include elastic bandages and tongue depressors. Although there have been updates to the device regulations since they were first published in 1976, the technological advances to devices have outpaced these updates. Consumer electronics have enabled new paradigms for health care. Software applications themselves now can be

Since its introduction in 2015, the Apple Watch (Apple Inc., Cupertino, CA, USA) has been purchased by an estimated 60 million consumers and boasts algorithms cleared by the United States Food and Drug Administration able to detect bradycardia, tachycardia, and atrial fibrillation, with the newest version of the device also allowing for real-time electrocardiogram acquisition. This case offers potentially the first demonstration of an Apple Watch correctly detecting atrial fibrillation with an implantable cardioverter-defibrillator confirming the accuracy of the detection from stored electrograms.

We are in the midst of a revolution in medicine. As new diagnostic consumer devices emerge every day, the natural order of disease detection is shifting, and the clinical implications are profound. In the novel study by Reed et al. – the first of its kind in the UK – we see the immense power of smartphone-based event recorders in augmenting traditional care models [[1]Reed et al.Multi-centre randomized controlled trial of a smartphone-based event recorder alongside standard care versus standard care for patients presenting to the Emergency Department with palpitations and pre-syncope: the IPED (Investigation of Palpitations in the ED) study.Trials. 2019; https://doi.org/10.1016/j.eclinm.2019.02.005Summary Full Text Full Text PDF PubMed Scopus (22) Google Scholar]. Their study reinforces the new truth that these devices not only accurately detect disease, but also do so more quickly, more cost-effectively, and at a grander scale. Though set in the Emergency Department, it introduces a paradigm that can be applied across specialties and workflows. Its findings foreshadow significant implications in clinical resource allocation. Consequently, it raises a fundamental question at the core of medicine — who shall have the power to make diagnoses? We have seen an unprecedented number of health monitoring devices emerge and embed themselves into the fabric of medicine. The Apple Watch alone – which now has FDA-approved ECG sensors and algorithms – is rumored to have sold 50+ million units and is expected to sell another 30+ million in 2019 [[2]Hall Zac Apple watch business to grow 40% YOY in 2019 with 33M units shipped, UBS predicts.https://9to5mac.com/2018/10/31/apple-watch-sales-5/Date: 31 Oct, 2018Google Scholar]. There are now medical-grade activity trackers, sleep monitors, glucose monitors, ECG monitors, and as of early 2019, wrist-worn continuous blood pressure monitors like the Omron HeartGuide [[3]Omron HeartGuide.https://omronhealthcare.com/products/heartguide-wearable-blood-pressure-monitor-bp8000m/Google Scholar]. With so many devices in the consumer space, they are destined to become an integral component of the doctor-patient conversation. And we are starting to witness the benefits. They are, without a doubt, fundamentally changing the way we diagnose disease by promoting virtual diagnosis outside of the traditional brick-and-mortar clinic. Instead of waiting for a clinic visit for diagnosis, patients are coming with a diagnosis in hand. And the chance of them being correct is becoming increasingly higher. With the AliveCor Kardia, a new diagnosis of Atrial Fibrillation is backed by a 96.6% sensitivity and 94% specificity chance of being right. As discussed by Reed et al., this leads to tremendous healthcare savings. In their study, it reduced the time-to-disease-detection by 78%. It increased cost-efficiency by eliminating expensive work ups (i.e. expensive Holter monitors) and reduced costs by 67% [[1]Reed et al.Multi-centre randomized controlled trial of a smartphone-based event recorder alongside standard care versus standard care for patients presenting to the Emergency Department with palpitations and pre-syncope: the IPED (Investigation of Palpitations in the ED) study.Trials. 2019; https://doi.org/10.1016/j.eclinm.2019.02.005Summary Full Text Full Text PDF PubMed Scopus (22) Google Scholar]. In the ED, where time and efficiency are essential, these devices are invaluable. This efficiency also goes beyond the ED and promotes new virtual care models to replace inefficient traditional outpatient clinic models. It eliminates the need for standard routine appointments where patients inevitably find themselves asymptomatic. Instead, it allows patients to schedule visits only when they know something is awry. And if appointments are reserved for active patients, then it allows specialists to focus on those who require immediate assistance, thus liberating specialists' time and valuable appointment slots. It has the power to elevate the sacred doctor-patient discussion to greater heights. Device data introduces concrete objective information into the discussion. Device sensors and apps bring context to symptoms and unveil new insights into what we were doing or where we were when the device detected an arrhythmia. Lastly, these platforms promote new opportunities in patient education. When a device detects atrial fibrillation for the first time, there is an opportunity for innovations like the Virtual Doctor avatar – a mobile-based virtual reality doctor developed by the USC Center for Body Computing – to explain the diagnosis and use artificial intelligence to answer FAQs about the disease [[4]Virtual care clinic.https://www.uscbodycomputing.org/virtual-care-clinicGoogle Scholar]. This helps patients become better informed prior to their appointment, and it elevates the subsequent doctor-patient conversation to a higher plane. The stage is set for a new natural order in the way we diagnose disease. However, we must ensure that these new clinical work flows are implemented safely. In a world that is increasingly virtual, data privacy is of the utmost importance. New ethical standards must be implemented to bring Hippocrates into the 21st century, as exemplified by the recent multidisciplinary effort to develop Stanford's “Guiding Principles for Ethics in Digital Health” [[5]Statement of guiding principles for ethics in digital health.https://library.stanford.edu/digitalhealthethics/guiding-principlesGoogle Scholar]. True to the core of medicine, patients and their safety must come first. As these devices and virtual care models become universally adopted, they will define a new universal truth. In the way social media redefined the way we view each other, these devices will define a new way to view our health. There is a proverb amongst Millennials — “If it's not on Instagram, did it really even happen?”. Then devices like the Apple Watch will set a new standard of truth in Medicine — “If it didn't capture the arrhythmia, did it really even happen?” This is a cultural revolution. The sacred power of diagnosis now lies in the literal hands of the everyman. Nothing to declare. The authors acknowledge the efforts of Cynthia Romero in preparing the manuscript. Multi-centre Randomised Controlled Trial of a Smartphone-based Event Recorder Alongside Standard Care Versus Standard Care for Patients Presenting to the Emergency Department with Palpitations and Pre-syncope: The IPED (Investigation of Palpitations in the ED) studyUse of a smartphone-based event recorder increased the number of patients in whom an ECG was captured during symptoms over five-fold to more than 55% at 90 days. This safe, non-invasive and easy to use device should be considered part of on-going care to all patients presenting acutely with unexplained palpitations or pre-syncope. Full-Text PDF Open Access