Focus on the intended purpose of digital health applications

Category: product liability, product safety Industry: healthcare Author: Year:
Miriam Schuh

The Digital Care Act and the Digital Health Applications Ordinance form the legal basis for inclusion of health apps in statutory standard coverage. The right of people with statutory health insurance to receive care in the form of digital health applications is defined in Book V of the Social Code.

Coverage of digital health applications

This right applies only to those digital health applications which are included in the directory kept by the Federal Institute for Drugs and Medical Devices (BfArM). In general, only digital applications and health apps which meet the definition of Class I and IIa medical devices in accordance with Regulation (EU) 2017/745, the Medical Devices Regulation, as well as Class I medical devices with certificates in accordance with Directive 93/42/EEC, the Medical Devices Directive (cf. 2nd MDR Corrigendum: deadline extended until 2024), are eligible for inclusion.

In submitting their application for inclusion of their health apps in the directory, manufacturers must attach documentation establishing that their apps

  • meet the requirements for medical devices in terms of safety, effectiveness and quality;
  • meet the requirements for data protection so as to ensure data security according to the latest technological standards; and
  • have positive effects on care.

Positive effects on care

The term "positive effects on care" is defined in § 8 of the Digital Health Applications Ordinance. According to this definition, positive effects on care consist of either "medical benefits or procedural and structural improvements of relevance for patient care." "Medical benefit" refers to the relevant effect on the patient, particularly in terms of improving the patient's medical condition, shortening the duration of the illness, extending the life of the patient or improving the patient's quality of life. Relevant procedural and structural improvements in patient care relate to medical actions to provide patients with support and processes for interactions between patients and medical care providers in connection with the identification, monitoring, treatment or mitigation of illnesses or the identification, treatment, mitigation or compensation of injuries or disabilities. Such effects are to be explained by the manufacturer in accordance with § 9 of the Ordinance. It is also of decisive importance for the positive effects on care postulated by the manufacturer to be consistent with the intended purpose in accordance with applicable provisions of medical devices law and with the functions and content of the digital health application, as well as the manufacturer's published statements in that regard.

Relevance of the intended purpose

Precise specification of the intended purpose is of decisive importance for manufacturers of health apps/digital health applications. The manufacturer itself has it in its power to "make" a simple "wellness" or lifestyle app into a true health app with the character of a medical device by specifying its product's diagnostic or therapeutic benefits.  Only "true" medical devices have a chance for inclusion in the directory of digital health applications. At the same time, the intended purpose claimed by the manufacturer must conform to the positive effect on care: deviations may be treated by BfArM as a k.o. criterion in the application procedure. Finally, it should be kept in mind that all of the manufacturer's statements concerning the intended purpose should be consistent. The Digital Health Applications Ordinance explicitly stresses this point, noting that the content of all "the manufacturer's published statements" must be consistent. In particular, it is necessary to examine both analog and digital marketing materials and publications for consistency: consistency in the manufacturer's statements increases the chances of successful inclusion in the directory of digital health applications and of statutory health insurance coverage while at the same time minimizing risks in product liability law arising from "euphemistic" marketing statements, which ultimately prove untrue in many cases.

[September 2020]