Challenges and Alternatives to Evaluation Methods and Regulation Approaches for Medical Apps as Mobile Medical Devices: International and Multidisciplinary Focus Group Discussion

Laura Maaß   ^{1, 2, 3} , PhD ;   Robert Hrynyschyn   ^{2, 4} , MSc ;   Martin Lange   ⁵ , Prof Dr ;   Alexandra Löwe   ⁵ , Dipl ;   Kathrin Burdenski   ⁶ , MA ;   Kaley Butten   ⁷ , PhD ;   Sebastian Vorberg   ^{8, 9} , LLM ;   Mariam Hachem   ^{10, 11} , MPH ;   Aldo Gorga   ¹² , MD ;   Vittorio Grieco   ¹³ , MD ;   Vincenzo Restivo   ¹⁴ , Prof Dr ;   Giuseppe Vella   ¹⁵ , MD ;   Marlien Varnfield   ⁷ , PhD ;   Felix Holl   ^{2, 16} , PhD

¹ University of Bremen, SOCIUM - Research Center on Inequality and Social Policy, Department of Health, Long Term Care and Pensions, Bremen, Germany

² Leibniz ScienceCampus Digital Public Health, Bremen, Germany

³ Digital Health Section, European Public Health Association (EUPHA), Utrecht, Netherlands

⁴ Charité – Universitätsmedizin Berlin, corporate member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Institute of Health and Nursing Science, Institute of Health and Nursing Science, Berlin, Germany

⁵ Department of Fitness & Health, IST University of Applied Sciences, Düsseldorf, Germany

⁶ School of Sport, Exercise and Health Sciences, Loughborough University, Loughborough, United Kingdom

⁷ Australian eHealth Research Centre (CSIRO), Brisbane, Australia

⁸ QuR.digital - Vorberg.law, Hamburg, Germany

⁹ Bundesverband Internetmedizin eV, Hamburg, Germany

¹⁰ Department of Medicine, Austin Health, Faculty of Dentistry, Medicine and Health Sciences, University of Melbourne, Melbourne, Australia

¹¹ Australian Centre for Accelerating Diabetes Innovations, Faculty of Dentistry, Medicine and Health Sciences, University of Melbourne, Melbourne, Australia

¹² Department of Sciences of Public Health and Pediatrics, University of Turin, Turin, Italy

¹³ Department of Medical, Surgical Sciences and Advanced Technologies “GF Ingrassia”, University of Catania, Catania, Italy

¹⁴ School of Medicine, University of Enna, Enna, Italy

¹⁵ Department of Health Promotion, Maternal and Infant Care, Internal Medicine and Medical Specialties (PROMISE) “G. D’Alessandro”, University of Palermo, Palermo, Italy

¹⁶ DigiHealth Institute, Neu-Ulm University of Applied Sciences, Neu-Ulm, Germany