Requirements for design and function of blood pressure measuring devices used for the management of hypertension: Consensus Statement by the European Society of Hypertension Working Group on Blood Pressure Monitoring and Cardiovascular Variability and STRIDE BP

aHypertension Center STRIDE-7, National and Kapodistrian University of Athens, School of Medicine, Third Department of Medicine, Sotiria Hospital, Athens, Greece

bDepartment of Medicine and Surgery, University of Milano-Bicocca, Milan, Italy; Istituto Auxologico Italiano, IRCCS, Department of Cardiology, San Luca Hospital, Milan, Italy

cSchool of Population Health, University of New South Wales, The George Institute for Global Health, Sydney, Australia

dDepartment of Hygiene and Public Health, Teikyo University School of Medicine, Tokyo, Japan

eFoundation-Medical Research Institutes, Geneva, Switzerland

fDepartment of Internal Medicine, Hospital Mutua Terrassa, University of Barcelona, Catalonia, Spain

gStroke and Hypertension Unit, Connolly Hospital, Dublin, Ireland

h2nd Department of Internal Medicine, Medical Faculty of Charles University & University Hospital, Pilsen, Czech Republic

iNeuropharmacology Laboratory, Baker Heart and Diabetes Institute, Monash University, Melbourne, Australia

jDivision of Cardiovascular Medicine, Department of Medicine, Jichi Medical University School of Medicine, Tochigi, Japan

kUniversity of Milano-Bicocca, Milan, Italy

lDepartment of Clinical Therapeutics, National and Kapodistrian University of Athens, School of Medicine, Athens, Greece

mNuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK

nCardiovascular & Hormonal Research Laboratory, Department of Cardiology and Kolling Institute, Royal North Shore Hospital, Macquarie University, Sydney, Australia

oSchool of Public Health, University of Alabama at Birmingham, Birmingham, Alabama, USA

pNational Institute for Health and Welfare, and Department of Medicine, University of Turku and Turku University Hospital, Turku, Finland

qClinical Research Unit, Italian Institute of Telemedicine, Varese, Italy

rCardiovascular Prevention and Research Unit, Department of Pathophysiology, Medical School, National and Kapodistrian University of Athens, Athens, Greece

sCardiology Ubi, Cittadella Town Hospital, Cittadella, Italy

tMenzies Institute for Medical Research, University of Tasmania, Hobart, Australia

uDepartment of Women and Children's Health, School of Life Course Sciences, FoLSM, Kings College London, UK

vColumbia Hypertension Center and Lab, Department of Medicine, Columbia University Irving Medical Center, New York, New York, USA

wDiagnosis and Therapeutic Center, Hotel Dieu Hospital, Paris, France

xThe Shanghai Institute of Hypertension, Ruijin Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China

yThe Conway Institute, University College Dublin, Ireland

zStudium Patavinum, Department of Medicine, University of Padova, Padua, Italy

Correspondence to George S. Stergiou, MD, PhD, FRCP, Hypertension Center STRIDE-7, National and Kapodistrian University of Athens, School of Medicine, Third Department of Medicine, Sotiria Hospital, 152 Mesogion Avenue, Athens 11527, Greece. Tel: +30 2107763117; fax: +30 2107719981; e-mail: [email protected]

Abbreviations: AAMI, Association for the Advancement of Medical Instrumentation; ABPM, ambulatory blood pressure monitoring; BP, blood pressure; ESH, European Society of Hypertension; HBPM, home blood pressure monitoring; ISO, International Standardization Organization; SaMD, Software as a Medical Device; SDKs, Software Developer Kits; STRIDE, Science and Technology for Regional Innovation and Development in Europe

Received 16 May, 2023

Accepted 16 May, 2023

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