JACC Focus Seminar: Future Technology of Cardiovascular Care
JACC Review Topic of the Week
Using Digital Health Technology to Better Generate Evidence and Deliver Evidence-Based Care

https://doi.org/10.1016/j.jacc.2018.03.523Get rights and content
Under an Elsevier user license
open archive

Abstract

As we enter the information age of health care, digital health technologies offer significant opportunities to optimize both clinical care delivery and clinical research. Despite their potential, the use of such information technologies in clinical care and research faces major data quality, privacy, and regulatory concerns. In hopes of addressing both the promise and challenges facing digital health technologies in the transformation of health care, we convened a think tank meeting with academic, industry, and regulatory representatives in December 2016 in Washington, DC. In this paper, we summarize the proceedings of the think tank meeting and aim to delineate a framework for appropriately using digital health technologies in healthcare delivery and research.

Key Words

clinical trial conduct
digital health technology
healthcare delivery
think tank meeting

Abbreviations and Acronyms

CTTI
Clinical Trials Transformation Initiative
EHR
electronic health records
FDA
U.S. Food and Drug Administration
FD&C
Federal Food, Drug, and Cosmetics Act
HITECH
Health Information Technology for Economic and Clinical Health Act
RCT
randomized clinical trial

Cited by (0)

This manuscript was funded internally by the Duke Clinical Research Institute (Durham, North Carolina). Funding support for the think tank meeting was provided through registration fees from Amgen, AstraZeneca, Bayer AG, Janssen Pharmaceutical Companies of Johnson & Johnson, MyoKardia, Sanofi, St. Jude Medical, Medtronic, and Qualcomm Life. No government funds were used for this meeting. Dr. Sharma has received research grant support from the American Heart Association (AHA) Strategically Focused Research Network–Heart Failure (16SFRN30180010), Alberta Innovates Health Solution Clinician Scientist fellowship, the European Society of Cardiology Young Investigator research grant, Roche Diagnostics and the Canadian Cardiovascular Society Bayer Vascular award, BMS-Pfizer, and Takeda. Dr. Harrington has a research relationship with Apple (Apple Watch Study); has received consulting fees from Amgen, Bayer, Gilead, Merck, MyoKardia, and The Medicines Company; has received fees for consulting and educational programs from WebMD; has received grant funding from AstraZeneca, Bristol-Myers Squibb, CSL Limited, GlaxoSmithKline, Janssen, Merck, Novartis, Portola, Sanofi, and The Medicines Company; holds equity in Element Science and Scanadu; and holds an unpaid seat on the board of directors of the AHA. Dr. McClellan has received personal fees from Johnson & Johnson. Dr. Turakhia has received research support from Amazon, AstraZeneca, Bristol-Myers Squibb, Medtronic, the AHA, Apple, Janssen, Cardiva Medical, and Boehringer Ingelheim; and holds equity in iBeat, AliveCor, Metrica Health, Zipline Medical, and CyberHeart; has received consulting fees from Abbott, Medtronic, iRhythm, Precision Health and Boehringer Ingelheim; and has received honoraria for presentations from Medscape. Dr. Steinhubl has received grant support from the National Institutes of Health/National Center for Advancing Translational Sciences grant UL1TR001114 and a grant from the Qualcomm Foundation; and has served as a medical advisor for DynoSense, EasyG, Spry Health, and FocusMotion. Dr. Mault is an employee of Qualcomm Life. Dr. Majmudar has received consulting fees from AliveCor, HUINNO, MC10, and Nokia; holds ownership in BioFourmis, Cardiogram, and HiLabs; and has conducted personal research with Echosense. Dr. Majmudar has received research grants from GE Healthcare. Dr. Roessig is a full-time employee of Bayer AG, Wuppertal, Germany. Dr. Chandross is a full-time employee of Sanofi. Dr. Green has an equity stake in MyoKardia. Mr. Patel owns shares in Boston Scientific. Dr. Hamer is an employee of Amgen Inc.; and owns Amgen shares. Dr. Olgin has received research support from ZOLL and the National Institutes of Health. Dr. Roe has received research grants from AstraZeneca, Eli Lilly & Co., Janssen Pharmaceuticals, Sanofi, Daiichi-Sankyo, Ferring Pharmaceuticals, and The Familial Hypercholesterolemia Foundation; speaker honoraria from Amgen and Bristol-Myers Squibb; and consultant/advisory board fees from AstraZeneca, Eli Lilly & Co., Daiichi-Sankyo, Amgen, PriMed, Myokardia, Boehringer Ingelheim, and Merck & Co. Dr. Peterson has received grants from Amgen Inc.; grants and personal fees from AstraZeneca, Merck & Co., and Sanofi; and has served as a consultant for SignalPath. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.

Listen to this manuscript's audio summary by JACC Editor-in-Chief Dr. Valentin Fuster.