[From idea to standard care-a field report]

Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz. 2018 Mar;61(3):298-303. doi: 10.1007/s00103-018-2693-3.
[Article in German]

Abstract

Digital health products and services have started to fundamentally change healthcare and prevention. Products intended for a medical use require CE-marking and potentially certification (ISO 13485) of the company. Startups play an important role in the development of new digital products and services. Two startups share their experience with these processes. Becoming a part of standard care and hence being reimbursed is a challenge for startups. For this reason, startups pursue alternative sources of income, too. The statutory health insurance's procedures for assessing new products and services are perceived as long. Startups are required to provide evidence of the benefit of their product at an early stage in the procedure. This requires time-consuming and costly studies. Startups would therefore appreciate support in generating this evidence, e. g. through adequate procedures for testing.

Keywords: Digital Health; Digitization; Market access; Medical devices; Startups.

MeSH terms

  • Certification / legislation & jurisprudence
  • Certification / standards
  • Consumer Product Safety / legislation & jurisprudence*
  • Consumer Product Safety / standards
  • Germany
  • Health Care Sector / legislation & jurisprudence*
  • Health Care Sector / standards
  • Humans
  • National Health Programs / legislation & jurisprudence*
  • National Health Programs / standards
  • Standard of Care / legislation & jurisprudence
  • Standard of Care / standards
  • Telemedicine / legislation & jurisprudence*
  • Telemedicine / standards