Advertisement

Transparent sharing of digital health data: A call to action

      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

      Keywords

      Abbreviations:

      CIED (cardiovascular implantable electronic device), EHR (electronic health record), FDA (U.S. Food and Drug Administration), IMDRF (International Medical Device Regulators Forum), RWIs (relationships with industry and other entities)
      To read this article in full you will need to make a payment
      Subscribe to Heart Rhythm
      Already a print subscriber? Claim online access
      Already an online subscriber? Sign in
      Institutional Access: Sign in to ScienceDirect

      References

      1. FDA. Digital health.
        (Available at:)
      2. U.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.

        • Federal Communications Commission
        Telehealth, telemedicine and telecare: what’s what?.
        (Available at:)
        • Turakhia M.P.
        Moving from big data to deep learning-the case of atrial fibrillation.
        JAMA Cardiol. 2018; 3: 371-372
        • Dorn S.D.
        Digital health: hope, hype, and Amara’s Law.
        Gastroenterology. 2015; 149: 516-520
      3. SNOMED.
        (Available at:)
        http://www.snomed.org
        Date accessed: March 26, 2019
        • LOINC
        LOINC from Regenstrief.
        (Available at:)
        https://loinc.org
        Date accessed: March 26, 2019
      4. HL7 International.
        (Available at:)
        http://www.hl7.org
        Date accessed: March 26, 2019
      5. IEEE. IEEE.org.
        (Available at:)
        https://www.ieee.org/
        Date accessed: March 26, 2019
        • IHE
        Integrating the Healthcare Enterprise International.
        (Available at:)
        https://www.ihe.net/%09
        Date accessed: March 26, 2019
        • Campos H.
        10 Years with an implantable cardiac device and *almost* no data access.
        Quantified Self Public Health, 2018 (Available at:) (Accessed January 17, 2019)
        • Nash I.S.
        It’s my heart why not my data?.
        Circulation. 2018; 137: 4-6
        • Wilkoff 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-e86
        • 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
        • Varma 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: 697-703
        • Varma N.
        • Stambler B.
        • Chun S.
        Detection of atrial fibrillation by implanted devices with wireless data transmission capability.
        Pacing Clin Electrophysiol. 2005; 28: S133-S136
        • Crossley G.H.
        • Chen J.
        • Choucair W.
        • et al.
        Clinical benefits of remote versus transtelephonic monitoring of implanted pacemakers.
        J Am Coll Cardiol. 2009; 54: 2012-2019
        • Al-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: 545-550
        • Cronin 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: 1947-1951
        • Schoenfeld M.H.
        • Compton S.J.
        • Mead R.H.
        • et al.
        Remote monitoring of implantable cardioverter defibrillators: a prospective analysis.
        Pacing Clin Electrophysiol. 2004; 27: 757-763
        • Cheung C.C.
        • Krahn A.D.
        • Andrade J.G.
        The emerging role of wearable technologies in detection of arrhythmia.
        Can J Cardiol. 2018; 34: 1083-1087
        • FDA
        Apple Inc. Class II.
        (Available at:)
        • FDA
        Guidances with Digital Health Content.
        (Available at:)
        • IMDRF SaMD Working Group
        Software as a medical device (SaMD): key definitions.
        (Available at:)
      6. Digital Health Software Precertification (Pre-Cert) Program. Available at: https://www.fda.gov/medical-devices/digital-health/digital-health-software-precertification-pre-cert-program. Accessed March 26, 2019.

        • Lye C.T.
        • Forman H.P.
        • Daniel J.G.
        • Krumholz H.M.
        The 21st Century Cures Act and electronic health records one year later: will patients see the benefits?.
        J Am Med Inform Assoc. 2018; 25: 1218-1220
        • FDA
        Classify your medical device.
        (Available at:)
        • Tarakji K.G.
        • Vives C.A.
        • Patel A.S.
        • Fagan D.H.
        • Sims J.J.
        • Varma N.
        Success of pacemaker remote monitoring using app-based technology: does patient age matter?.
        Pacing Clin Electrophysiol. 2018; 41: 1329-1335
        • Delbanco T.
        • Walker J.
        • Bell S.K.
        • et al.
        Inviting patients to read their doctors’ notes: a quasi-experimental study and a look ahead.
        Ann Intern Med. 2012; 157: 461-470
        • Fossa A.J.
        • Bell S.K.
        • DesRoches C.
        OpenNotes and shared decision making: a growing practice in clinical transparency and how it can support patient-centered care.
        J Am Med Inform Assoc. 2018; 25: 1153-1159