Health Apps in the Area of Conflict Between State Regulation and IT Architectures

Abstract

Abstract“Data protection is for healthy people” (Original quote translated from German) (Rohrer, B. (2016). „Datenschutz ist was für Gesunde“. https://www.deutsche-apotheker-zeitung.de/news/artikel/2016/09/13/jens-spahn-philosophiert-ueber-die-zukunft-der-versorgung. Accessed 21 April 2020.)—with this statement, Health Minister Jens Spahn has already attracted attention several times, but also identified data security as the “achilles heel for acceptance in the digitization of the healthcare system” (Beerheide 2019a). Reconciling the two statements is likely to be just as difficult as making health apps secure and data protection friendly while at the same time ensuring that they are accepted as a means of treatment by all the players involved.Based on the current developments in Germany—Digital Supply Act, (Digitale Versorgung Gesetz (DVG) in German) Medical Device Regulation, (Medizinproduktegesetz (MPG) in German) health apps on prescription—the involvement of the player app provider, patient, doctor or hospital and social health insurance in the medical consultation process and obstacles in the implementation are shown. The question arises whether more digitization in this context (e.g. Big Data, AI) means that data protection is weakened.The aim is to model the cause and effect chain for motivating the players. Critical factors for the successful introduction and implementation of health apps are identified.The goal was achieved by carrying out a qualitative content analysis for current scientific articles and online sources from 2018 until today. This resulted in the following priority categories: IT security in medical practices and hospitals IT security and data protection in health apps Regulatory requirements and test methods for health apps Interoperability of existing IT infrastructures at medical practices and hospitals The following conclusions can be drawn from this:The use of health apps should optimize healthcare from the point of view of quality and efficiency as well as legal requirements. This is currently taking place under conditions that casts doubt on the consistent implementation on the one hand and the acceptance by doctors, hospitals and app providers on the other. Support measures are needed to bring about harmonization and standardization.KeywordsHealth appsMedical appsDiGADigital Supply Act (DVG)Patient Data Protection Act (PDSG)Digitization of healthcare systemCause and effect chain