What Makes a Quality Health App—Developing a Global Research-Based Health App Quality Assessment Framework for CEN-ISO/TS 82304-2: Delphi Study

Petra Hoogendoorn   ¹ , MSc ;   Anke Versluis   ¹ , PhD ;   Sanne van Kampen   ¹ , PhD ;   Charles McCay   ² , BA ;   Matt Leahy   ³ , DipHE ;   Marlou Bijlsma   ^{4 †} , MSc ;   Stefano Bonacina   ⁵ , PhD ;   Tobias Bonten   ¹ , PhD ;   Marie-José Bonthuis   ⁶ , LLM ;   Anouk Butterlin   ⁷ , BBSc ;   Koen Cobbaert   ^{8, 9} , MSc ;   Thea Duijnhoven   ¹⁰ , MSc ;   Cynthia Hallensleben   ¹ , RNC ;   Stuart Harrison   ¹¹ , CEng ;   Mark Hastenteufel   ¹² , PhD ;   Terhi Holappa   ^{13, 14} , MSc ;   Ben Kokx   ¹⁵ ;   Birgit Morlion   ¹⁶ , PhD ;   Norbert Pauli   ¹⁷ , PhD ;   Frank Ploeg   ^{18, 19} ;   Mark Salmon   ²⁰ , MBA ;   Kyma Schnoor   ¹ , MSc ;   Mary Sharp   ²¹ , MA ;   Pier Angelo Sottile   ^{13, 22, 23} , MSc ;   Alpo Värri   ^{13, 24} , EngD ;   Patricia Williams   ²⁵ , PhD ;   Georg Heidenreich   ^{26, 27, 28} , EngD ;   Nicholas Oughtibridge   ^{26, 27, 29} , BSc ;   Robert Stegwee   ¹³ , PhD ;   Niels H Chavannes   ¹ , PhD

¹ National eHealth Living Lab, Department of Public Health and Primary Care, Leiden University Medical Center, Leiden, Netherlands

² Ramsey Systems Ltd, Shrewsbury, United Kingdom

³ Assessment Team, ORCHA Health Ltd, Liverpool, United Kingdom

⁴ Healthcare, Royal Netherlands Standardization Institute, Delft, Netherlands

⁵ Health Informatics Centre, Department of Learning, Informatics, Management and Ethics, Karolinska Institutet, Stockholm, Sweden

⁶ Privacy1 B.V., Groningen, Netherlands

⁷ Projects, Accessibility Foundation, Utrecht, Netherlands

⁸ European Coordination Committee of the Radiological, Electromedical and Healthcare IT Industry, Brussels, Belgium

⁹ Quality, Standards and Regulations, Innovation and Strategy, Philips Belgium Commercial N.V., Brussels, Belgium

¹⁰ Understandable Information and Digital Healthcare, Pharos - Dutch Center of Expertise on Health Disparities, Utrecht, Netherlands

¹¹ ETHOS Ltd, Exeter, United Kingdom

¹² Institute for Software Technology and Data Communication, Hochschule Mannheim, Mannheim, Germany

¹³ Technical Committee 251 Health informatics, European Committee for Standardization, Brussels, Belgium

¹⁴ USBIMED, Oulu, Finland

¹⁵ Product Security, Group Security, Philips Electronics Nederland B.V., Best, Netherlands

¹⁶ Unit eHealth, Well-Being and Ageing, Directorate‑General for Communications Networks, Content and Technology, European Commission, Luxembourg, Luxembourg

¹⁷ Draeger Integrated System Management, Drägerwerk AG & Co. KGaA, Lübeck, Germany

¹⁸ Mobile Health Work Group, Health Level Seven, Brussels, Belgium

¹⁹ Enterprise Architecture, University Medical Center Groningen, Groningen, Netherlands

²⁰ Science, Evidence and Analytics Directorate, National Institute for Health and Care Excellence, Manchester, United Kingdom

²¹ School of Computer Science and Statistics, Trinity College, Dublin, Ireland

²² Technical Committee 527 Health informatics, Ente Italiano di Normazione, Milan, Italy

²³ Mexedia S.p.A. SB, Rome, Italy

²⁴ Faculty of Medicine and Health Technology, Tampere University, Tampere, Finland

²⁵ Flinders Digital Health Research Center, College of Science and Engineering, Flinders University, Adelaide, Australia

²⁶ Technical Committee 215 Health informatics, International Organization for Standardization, Geneva, Switzerland

²⁷ Subcommittee 62A Common aspects of medical equipment, software, and systems, International Electronical Commission, Geneva, Switzerland

²⁸ Healthcare IT Standards, Siemens Healthcare GmbH, Erlangen, Germany

²⁹ NHS Transformation, NHS England, Leeds, United Kingdom

†deceased