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Digital health: Present conundrum, future hope or hype?

      Coming together is a beginning.Keeping together is progress.Working together is success.Henry Ford
      In this issue of HeartRhythm the newly formed Digital Health Working Group clarifies the existing state of the art concerning digital health and addresses the significant opportunities and challenges associated with integrating the advanced diagnostic improvements incorporated in cardiovascular implantable electronic devices (CIEDs) and wearable cardiac devices into existing health care systems.
      • Slotwiner D.J.
      • Tarakji K.G.
      • Al-Khatib S.M.
      Transparent sharing of digital health data: A call to action.
      In the foreseeable future health-based digital applications will become routine at multiple levels within the health care system, guiding individuals through novel pathways while bridging the outpatient and inpatient treatment sectors.
      • Ganeshan R.
      • Enriquez A.D.
      • Freeman J.V.
      Remote monitoring of implantable cardiac devices: current state and future directions.
      These monitors will generate and transmit automatically data obtained from many biological signals. This information will be incorporated into advanced data management algorithms that will then be used to detect the onset of disease, assess disease progression, and identify opportunities for improved treatment.
      Unfortunately, the rapid technical advances in monitoring incorporated into CIEDs and wearable devices has exceeded the ability of most existing health care systems to incorporate the available information into their organizational systems in a clinically advantageous manner. Therefore, actualization of the potential inherent in these technological improvements to improve health care outcomes at a lower cost will necessitate collaborative efforts among the 5 major affected stakeholder groups (patients, providers, industry, regulators, and payers). Because many of the early digital health initiatives have taken place in the arrhythmia world, the specialty of cardiac electrophysiology is poised to lead the charge by establishing high foundational standards of excellence in this new arena.
      Maximizing patient outcomes and assuaging patient concerns about the clinical implications associated with information derived from these devices constitute the most important patient goal. The concerns relevant for CIED patients typically differ from those of patients with wearable devices. While some CIED patients want timely access to all of their device data, others only want their providers to craft effective care plans based upon that data. Accordingly, as the authors note, clinicians and health care systems should lead the effort to “democratize” data and institute full transparency by providing patients with regular, “nontechnical” summaries of device functionality and routine clinical observations via an electronic health record (EHR) patient portal.
      • Slotwiner D.
      • Varma N.
      • Akar J.G.
      • et al.
      HRS expert consensus statement on remote interrogation and monitoring for cardiovascular implantable electronic devices.
      In addition, they should put into place robust patient communication processes about important digitally identified items that might impact health outcomes (eg, new-onset atrial fibrillation, an excessively rapid ventricular response to atrial fibrillation, ventricular tachycardia therapies, data suggesting worsening heart failure, etc). Wearable devices, available in the retail marketplace without a physician prescription or recommendation, afford patients a great opportunity to take a more active role in managing their medical conditions. However, the exclusion of the traditional heath care system from the information generated by these devices carries significant risk for individuals with critical health observations. This concern might result in deleterious outcomes if patients respond incorrectly to clinically insignificant or erroneous device data or if untrained clinicians misinterpret the data. Accordingly, qualified clinicians should be included as integral members of digital data management programs to optimize health outcomes and minimize health risks.
      • Agarwal S.
      • LeFevre A.E.
      • Lee J.
      • et al.
      WHO mHealth Technical Evidence Review Group
      Guidelines for reporting of health interventions using mobile phones: mobile health (mHealth) evidence reporting and assessment (mERA) checklist.
      As the only liaison between the manufacturer and the patient, the provider is faced with 3 major challenges: satisfying patient needs, dealing with the vast amount of generated data, and constructing effective care plans. Clinicians must demonstrate a commitment to the maintenance of robust physician-patient relationships by working with both CIED patients and patients using wearable devices to determine the specific components that will be shared and the timelines and methods by which that information will be made available. While progress in deep machine learning and artificial intelligence has significant potential to improve efficiency and augment accuracy, the role of the clinician in orchestrating patient-focused care delivery will remain paramount.
      Industry, regulatory bodies, and payers all play important roles in furthering the innovation trajectory and encouraging the development of the requisite support systems. Device and EHR manufacturers must coordinate efforts to overcome in a cost-effective manner the existing technical and operational hurdles that limit interoperability. Device manufactures must continue to develop innovations to augment arrhythmia detection accuracy and make false-positive transmissions a distant memory. Regulatory bodies will need to work with clinicians and industry engineers to minimize the risk of cybersecurity breaches and maximize device function and safety. Governmental and private payers must adopt effective reimbursement schemas for both existing and evolving health care delivery systems.
      The availability of rapidly evolving, digitally enhanced monitoring options places patients, scientists, clinicians, industry, health care executives, regulators, and payers on the threshold of a paradigm shift in health care delivery with significant potential to enhance patient outcomes and involve patients more constructively and proactively in their care. In proposing a potential roadmap for the future, the Digital Health Working Group has thrown down the gauntlet, challenging electrophysiologists everywhere and the Heart Rhythm Society to lead the way. To meet this challenge we must encourage researchers and industry partners to seek continuous improvement so that previously unimagined potentialities become routine; convince providers and patients of the importance of embracing digital health technology while establishing realistic expectations; engage clinicians and institutional leaders to maximize operational structures by developing best practice models that will consistently put patients in touch with clinically relevant data and recommendations in a timely manner; work with device manufacturers, EHR vendors, and regulatory officials to protect patient privacy, safeguard their security, and maximize interoperability; and push payers to establish globally effective reimbursement schemas. If we pick up this gauntlet and provide effective leadership, engaging proactively and collaboratively with all of the stakeholders, we will be taking small but significant steps toward creating this “brave new world” and advancing the Heart Rhythm Society vision of working “to end death and suffering due to heart rhythm disorders.”

      References

        • Slotwiner D.J.
        • Tarakji K.G.
        • Al-Khatib S.M.
        Transparent sharing of digital health data: A call to action.
        Heart Rhythm. 2019; 16: e95-e106
        • Ganeshan R.
        • Enriquez A.D.
        • Freeman J.V.
        Remote monitoring of implantable cardiac devices: current state and future directions.
        Curr Opin Cardiol. 2018; 30: 20-30
        • Slotwiner 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-e100
        • Agarwal S.
        • LeFevre A.E.
        • Lee J.
        • et al.
        • WHO mHealth Technical Evidence Review Group
        Guidelines for reporting of health interventions using mobile phones: mobile health (mHealth) evidence reporting and assessment (mERA) checklist.
        BMJ. 2016; 352: i1174