On December 19, 2019, the Digital Health Care Act (DVG) came into force. The “app on prescription” is thus anchored in the health care system and guarantees legally insured persons an entitlement to a supply of digital health applications (DiGA). These are prescribed by doctors and psychotherapists for appropriate indications and reimbursed by the statutory health insurance funds (SHI). Patients can have a DiGA approved directly by their statutory health insurer, even without a doctor’s prescription, if they can provide evidence of a confirmed diagnosis.
So what exactly is a DiGA?
According to the DVG, a DiGA is a Class I or IIa medical device whose main function is based on digital technologies. This main function is to
Detection, monitoring, mitigation or treatment of diseases or
or
Detection, mitigation, treatment, or compensation of injury or disability through digital technologies.
Additionally, it should be noted that the DiGA is not for primary prevention and must also be usable by patient:s independently, or by provider and patient together. This means that applications that are only used by doctors to treat patients (“practice equipment”) are not included. DiGAs are therefore “digital assistants” in the hands of patients.
And how does a technology-based medical device become a DiGA?
Since May 2020, it has been possible for manufacturers of technology-based medical devices to apply for inclusion of their product in the DiGA directory using the fast-track procedure. The application is submitted to the Federal Institute for Drugs and Medical Devices (BfArM), which reviews it within 3 months. Accordingly, the first DiGAs are now expected to hit the market in August.
The review by the BfArM is based on a strictly regulated list of criteria.
Among other things, the following are tested:
- the manufacturer’s specifications regarding the required product properties. These relate to safety, functional capability, quality, data protection and data security.
- In addition, the manufacturer must provide evidence of a positive supply effect, through a comparative study.
If all criteria are met, the device is included in the DiGA directory. The DiGA can now be prescribed and reimbursed.
If there is not yet sufficient evidence for a positive supply effect, while all other criteria are fulfilled, a provisional inclusion follows. Manufacturers will then be granted a 12-month trial period, during which proof of efficacy must be provided by a comparative study. If the trial period is successfully completed, inclusion in the final DiGA directory follows.
Required product features, data protection & security
In addition to the required product properties such as functional suitability and quality, DiGAs are tested in particular to determine whether they are geared to the realities of users’ lives. In other words, is the DiGA realistically usable in everyday life and does it lead to acceptance among users? At the same time, the user’s abilities and needs should not be neglected. In addition, manufacturers guarantee the technical functionality, user-friendliness and further development of their product on a permanent basis.
Data protection and security concerns the guarantee of and compliance with the general data protection regulations (DSGVO), the Federal Data Protection Act (BDSG), and the Digital Health Applications Ordinance (DiGAV). Requirements for DiGA are thus strictly regulated and far exceed the data security of conventional “wellness & health apps”. The processing of personal data is limited to the specific purpose and only with the consent of the user:in. Data is neither processed nor passed on for advertising purposes. The only exception to the disclosure of data is when it comes to billing and reimbursement with the GKV. However, this is strictly prescribed and regulated by the BfArM. Furthermore, all persons working for a manufacturer are subject to a duty of confidentiality.
Positive supply effect
The positive health care effect results from the medical benefit, as well as patient-relevant procedural and structural improvements in health care.
Medical benefits are defined as:
Improvement in health status, improvement in quality of life, reduction in the duration of illness, and extension of life.
Procedural and structural improvements include:
Reduction in disease-related burden, increase in health literacy, and improvement in care delivery.
In summary: The Fast Track process is the first to define a comprehensive set of requirements for DiGA. The focus is particularly on user-friendliness, performance, data protection, information security, and must have a positive care effect. In other words, a DiGA must above all be easy to use, secure and useful.
What changes for me as a practitioner? And how do I prescribe a DiGA?
The aim is to avoid additional work and costs for the use and prescription of a DiGA. If the use of DiGA results in additional services for panel physicians, physicians and psychotherapists will receive additional remuneration. (Other service providers such as physiotherapists and occupational therapists are excluded). In addition, the aim is to have the prescription of DiGA take place via the primary system and to integrate it into already known processes, more precisely the model 16 form (note: psychotherapists can apply for the model 16 form at their panel doctors’ association).
The prescription for a DiGA should then be handed out on a paper prescription, as is usual for a prescription for medicines. The patient submits this to his or her SHI (by mail or via the electronic portal of the respective SHI) and then receives a 16-digit prescription code. With this prescription code, the patient can register within the app, which was previously downloaded independently via the popular app stores (Apple App Store & Google Play). This procedure is intended, among other things, to ensure pseudonymous use of DiGA and data economy.
How will I, as a practitioner, be informed about the offers and respective changes?
The DiGA directory of the BfArM lists all approved digital health applications with information. The aim is to achieve maximum transparency. The DiGA directory will provide clear information on the requirements to be met by manufacturers, as well as comprehensive information on the features and performance of the product. This will ensure that users, physicians, psychotherapists and health insurance companies can make well-informed decisions regarding the use of DiGA.
In addition, manufacturers are obliged to provide information material via their application website and are also authorized to send this proactively to practitioners, as long as this takes place within the framework of the provisions of the Therapeutic Products Advertising Act.
