What does application-related performance measurement mean?

The objective of the Act to Accelerate the Digitisation of the Healthcare System (Digital Act - DigiG) is to accelerate digitisation in the healthcare system and to simplify everyday treatment for doctors and patients through digital solutions, thereby making them more widely usable.

A central element of the law is the introduction of the personal health record (ePA), which is intended to promote the exchange and use of health data in order to provide targeted support for healthcare. In addition, the electronic prescription (e-prescription) will be established as a binding standard and digital health applications (DiGA) - including those with a higher risk class (RK IIb) - are to become an integral part of care. The DigiG aims to improve the integration of digital applications into everyday healthcare in order to maximise the benefits for patients and healthcare professionals. It is also intended to facilitate research with health data in order to make Germany more competitive internationally in the field of medical research. This also includes the notification of the application-accompanying performance measurement of manufacturers of DiGA to the Federal Institute for Drugs and Medical Devices (BfArM), which is to publish this data in aggregated form.

Data collection accompanying the use of medicinal products

Under certain circumstances (§35a SGB V), data collection accompanying the use of new medicinal products is already used if only limited meaningful data is available at the time of authorisation and a special authorisation is granted. Patients should therefore have faster access to medicines, but manufacturers are obliged to provide better data on benefits and harms. The Federal Joint Committee (G-BA) or the Institute for Quality and Efficiency in Healthcare (IQWiG) must develop a concept for implementing this data collection within 6 months. The concept contains details on how long and to what extent data should be collected, which questions the data collection should answer and which methods should be used to collect and analyse the data. This is subsequently decided in a group of experts. According to this, either a study must be conducted or a registry must be used to collect data. This data is evaluated every one and a half years at the latest in order to assess the potential additional benefit.

Performance measurement accompanying the use of a DiGA

DiGA manufacturers are obliged to carry out an application-accompanying performance measurement (AbEM) of all their DiGAs (Section 139e (13) SGB V).

From 1 January 2026, the BfArM will publish the results of the performance measurement of digital health applications in the DiGA Directory. Manufacturers must submit anonymised and summarised data,

• the duration and frequency of use,
• patient satisfaction and
• health status of the patients during use.

Scientifically valid and validated endpoints must be selected and recorded for this purpose. The Federal Ministry of Health may regulate details of the data to be transmitted, the methods of performance measurement and publication without the approval of the Bundesrat. Similarly, the proportion of performance-related price components should be at least 20% of the remuneration amount for already negotiated remuneration amounts (Section 134 (1) SGB V).

It is expected that the AbEM will comply with basic requirements for clinical studies, such as a clear research question and a pre-specified analysis plan. The extent to which established standards (e.g. Enhancing the QUAlity and Transparency Of health Research, EQUATOR or Consolidated Standards of Reporting Trials, CONSORT) are expected for reporting is not presented transparently. As the data is published by the BfArM, this implies a high level of standardisation and quality control, possibly even with guidelines for implementation.

In a nutshell

Differences and similarities between application-based outcome measures and clinical studies

• AbEM is conducted as part of the regular use of digital health applications (DiGA) in healthcare practice.
• Data is collected on the frequency and duration of use, patient satisfaction and the self-reported health status of patients.
• Data is collected continuously during the use of the DiGA, not during a fixed study period.
• Clinical studies follow a predetermined clinical investigation plan with defined inclusion and exclusion criteria, interventions and endpoints.
• There is no protocol for AbEM; data is collected as part of normal use.
• Clinical studies are subject to authorisation and/or consultation, AbEM is not.
• Clinical studies and AbEM should both be scientifically sound and comply with regulatory requirements.

Differences and similarities between application-accompanying outcome measures and traditional observational studies (AWB)

• AWB are non-interventional studies that collect findings from regular treatment with approved products (drugs, medical devices, incl. in vitro diagnostics, DiGA or DiPA).
• AbEM focusses specifically on DiGA and their use.
• AWB are subject to counselling, AbEM are not
• Both observe procedures, diagnostics and/or treatments under real conditions.
• AWB and AbEM can be used for price negotiations, provided that scientific standards are adhered to.
• AWBs may be suitable for the inclusion of a medical device as an aid (§33 SGB V), data from an AbEM may be suitable for the price negotiations of a DiGA.
• AWBs often have a limited observation period, whereas AbEMs are continuous.

As experts in digital clinical studies and DiGA evidence generation, MEDIACC GmbH sees AbEM as an important instrument for continuous evaluation and as an element of additional quality assurance of DiGA. Clear and transparent quality standards and methods for AbEM to minimise bias through selection or references to control groups must be communicated by the BfArM so that meaningful results are subsequently recognised.

(as of March 2024)

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