The new article describes the approach to be followed by the applicants when presenting sufficient evidence demonstrating the proper performance of their products when used for the intended purpose.

medical device regulations in Germany

In particular, the article addresses the matters related to the positive care effect.

The German regulating authority of healthcare products (BfArM) has published a guidance document dedicated to the fast-track process for digital health applications (DiGA) intended to be marketed and used in the country.

The document provides an overview of the applicable regulatory requirements, as well as additional clarifications and recommendations to be taken into consideration by medical device manufacturers (software developers) to ensure compliance thereto.

The authority also acknowledges the rapid technological development and reserves the right to make changes to the present guidance and recommendations provided therein, should these changes be reasonably necessary to reflect the new information becoming available to the authority or relevant amendments to the underlying legislation.

Positive Care Effects: Key Points

First of all, the document describes the concept of the “positive care effects” (pVE) introduced under the Digital Healthcare Act (DVG). 

This term covers two main aspects: medical benefits (mN) and patient-relevant structural and procedural improvements (pSVV). 

According to the guidance, the distinction between these two is vitally important as they form the basis of the evidence required for the inclusion of DiGA into the statutory healthcare system.

Medical Benefit (mN)

When discussing medical benefits, the authority refers to tangible improvements in patient health outcomes as a result of using DiGA.

These benefits are not merely theoretical but must be demonstrated through measurable changes in health status, illness duration, survival rates, or quality of life.

The burden of proof lies with the manufacturer, who should demonstrate through patient-relevant endpoints that their DiGA can positively impact the quality of life or other factors.

Patient-relevant Structural and Procedural Improvements (pSVV)

The pSVV aspect broadens the scope of care beyond direct health outcomes. It recognizes that DiGA may significantly enhance the healthcare experience by streamlining processes and empowering patients.

These improvements must be patient-centered, aiming to aid in disease detection, treatment, and management, or in mitigating the impacts of injuries and disabilities. 

The DiGAV outlines several key areas where DiGA can manifest pVE, including but not limited to:

  • Coordination of Treatment Processes
    DiGA can play a pivotal role in coordinating care among providers and patients, customizing therapies to meet immediate needs, and enabling more efficient communication among all the parties involved.

  • Alignment with Guidelines and Standards
    Recognized guidelines and standards guide both healthcare providers and patients. DiGA can translate such guidelines into actionable, daily routines that align with recognized care standards.

  • Adherence
    The concept of adherence underscores the necessity of patient engagement in the therapy process. DiGA can support patients in integrating healthcare into their daily lives, thereby improving adherence to treatment plans.

  • Facilitating Access to Care
    DiGA can enhance access to healthcare services, making them more accessible regardless of geographical or socioeconomic barriers.

  • Patient Safety
    DiGA can extend the quality and safety measures from clinical settings into patients’ homes, providing better risk management and error reduction in treatment application.

  • Health Literacy
    DiGA can address the challenge of health literacy by providing tailored health information that patients can easily understand and apply to enhance therapy outcomes.

  • Patient Sovereignty
    By fostering patient engagement and autonomy, DiGA can contribute to improved health outcomes and quality of life, enabling patients to play an active role in their health decisions.

  • Coping with Daily Challenges
    DiGA can assist in managing daily challenges posed by illnesses, such as early warning of symptoms or facilitating care from a distance.

Reducing Burdens of Therapy
By streamlining treatment processes, DiGA can alleviate the physical, psychological, and time burdens associated with therapy for patients and their relatives.

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Special Considerations

The authority additionally emphasizes the importance of taking into consideration the recent legislative developments, such as the Participation Strengthening Act, which introduced new requirements for DiGA provided by pension insurance providers.

These requirements extend beyond pVE to include evidence of maintaining work capacity.

The Role of Studies and Publication

To establish the efficacy of DiGA in providing pVE, comprehensive studies that meet general requirements are to be used. 

These studies must be designed to capture patient-relevant outcomes effectively. Furthermore, the full disclosure of study results is required to ensure transparency and integrity in the evaluation process.

Provisional Admission and Specific Study Requirements

The pathway for DiGA to enter the healthcare market may begin with provisional admission, which allows for real-world testing and data collection.

Such admission requires a study design that is robust, replicable, and scientifically sound, tailored to the specific type of DiGA and the pVE it is intended to demonstrate.


In summary, the present document describes in detail the concept of positive care effect and outlines its key components.

By the guidance, the authority explains the approach to be applied by medical device manufacturers (software developers) when demonstrating the positive impact their products are supposed to have on patients’ lives and well-being.

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