The intended purpose is the basis for all further steps. It answers the following questions, among others:
In this article on the medical purpose and intended use, you will learn how to document this information in a legally compliant and sufficiently complete manner.
If you know the intended purpose, you know whether your product can be a DiGA. You can also use it to estimate how large the market is and what reimbursement forms may be available.
You can estimate reimbursement rates and volumes if the product is likely reimbursable as a DiGA.
Once you have a project plan and an initial expense estimate, you can calculate expected revenues and profitability.
Before manufacturers begin the development of a DiGA, they should identify project risks. These include:
Providers of alternative forms of diagnosing and therapy count as indirect competition.
The requirements for this proof are high. It is often not possible to prove the expected benefit with the necessary statistical significance.
Many young companies underestimate the challenges of software development and building a business, as well as the regulatory requirements.
At the same time, they regularly overestimate the acceptance of DiGAs by physicians and patients.
Based on the intended purpose, manufacturers must check whether the product actually counts as a medical device.
If this is the case, you must determine the class of the medical device.
Read more here about class I software medical devices
For DiGA, essential regulatory requirements typically include the following:
Most DiGA manufacturers will also be affected by the EU Data Act.
Many changes to the Social Code, among others, were introduced via the Digital Care Act DVG and the Digital Care Modernization Act DVPMG.
Please also note
The DiGAV requires evidence of positive health care effects. The regulation defines these as.
Either [a] medical benefit or patient-relevant structural and procedural improvements in care. (DGV)
To be able to prove positive health care effects, the manufacturers must first specify the performance and acceptance criteria ("claims") (as quantitatively as possible). This sounds trivial. But this is precisely where manufacturers regularly make mistakes. For example, the claims are
Once these claims are specified, manufacturers must decide whether to seek direct listing or only provisional listing in the DiGA directory. The latter gives manufacturers an additional year to complete the clinical study, but no certainty of final acceptance.
One advantage of the "trial year" is that the statutory health insurance funds (SHI) must already reimburse the DiGA, and the manufacturer is allowed to determine the price itself. Negotiations with the SHI funds do not take place until after the trial year. In this way, the expensive study can be at least partially counter-financed.
Subsequently, the study has to be planned and the evaluation concept including the study design has to be defined.
Manufacturers should contact the BfArM at the latest at the end of this third step (as described in step 7).
A prerequisite for the DiGA main study is a pilot study with systematic data evaluation.
The Johner Institute assists DiGA manufacturers in designing the study so that manufacturers can simultaneously meet both the requirements for this evidence under DiGAV and the clinical evaluations and inspections under MDR without undue burden.
Feel free to contact us to find out more.
Two areas of law require DiGA manufacturers to have management systems in place:
The requirements for these management systems overlap greatly, as the following examples show. Both require:
These similarities are also reflected in the standard operating procedures (SOPs):
QMS according to 13485 | ISMS according to 27001 |
quality management manual | (x) |
quality objectives | (x) |
organisational chart, definition of roles | x |
SOP management review / SOP performance measurement | x |
SOP analysis of data / SOP performance measurement | x |
SOP control of documents and records | x |
SOP CAPA (incl. ISMS) | x |
SOP internal and external audits | x |
SOP reporting of incidents and recalls EU | (x) |
SOP IT infrastructure | x |
SOP computer system validation | x |
SOP recruiting and training | x |
SOP purchasing and supplier management | x |
SOP software development | x |
SOP support, feedback handling, complaint handling | (x) |
Therefore, DiGA manufacturers should not establish two isolated but one integrated management system and have it audited and certified together.
Especially for DiGA manufacturers, the Johner Institute has designed templates for an integrated management system. Interested? Then contact us right away.
As of 2024, manufacturers are not only required to have a certified IT security management system but also data security and data protection certification.
DiGA manufacturers create technical documentation in accordance with the specifications of their own quality system. In this way, they provide evidence that their products meet the regulatory requirements for medical devices.
This article on technical documentation provides you with an overview of the typical content and structure of technical documentation.
The technical documentation of DiGAs differs little from that of other medical devices:
However, certification of the management system is not proof of the IT security of the products. Penetration tests are an important and mandatory component of this proof.
The Johner Institute performs penetration tests for DiGA manufacturers. Read more about this offer here.
So far, Johner Institute's security experts have always identified vulnerabilities in the backend infrastructures or the products themselves (e.g., apps).
However, penetration tests do not replace other measures, such as adherence to coding guidelines and threat modeling. Instead, they complement these measures.
See also the article on security and data protection at DiGA.
Proof of the positive health care effects is provided - as described in the study plan (see above) - by collecting the (clinical) data within the framework of corresponding "comparative studies", as required by the DiGAV in § 10 (only available in German).
If the manufacturers want to go into trials first, they start with a systematic data evaluation or pilot study. This should already correspond to the main study in all essential study details. Only the number of cases may be somewhat smaller. The manufacturers then submit the outputs of the pilot study together with the evaluation concept when submitting the application.
The manufacturers must register the study with the BfArM.
The DiGAV even obliges the manufacturers to publish the outputs in full on the Internet.
The Johner Institute advises DiGA manufacturers to benefit from the BfArM's offer of consultation and not to wait until the application is submitted before contacting the authority. A good time for an initial consultation is toward the end of the third step.
To ensure the best possible coordination with the authority, manufacturers should prepare the interview and their documents well:
Manufacturers should assemble their own expert group (product, regulatory, study design/statistics, medical) to sit opposite the BfArM expert group.
To facilitate the most efficient and effective interview, manufacturers should at least
If all previous steps have been successfully completed, the DiGA manufacturers may submit the application. For this purpose, the BfArM has provided a completion-guide (only available in German).
Further details on the costs and the contents of the applications are provided in this article on the DiGAV.
The BfArM's tips for applicants are also helpful.
Germany was one of the first countries to create the possibility of reimbursing digital health applications. However, the hurdles for this are high.
In particular, demonstrating positive health care effects through studies (along with or in addition to clinical evaluation and clinical investigation, if applicable) is challenging for many DiGA manufacturers.
Following the seven steps outlined in this article should make it easier to overcome the hurdles.
The Johner Institute safely guides DiGA manufacturers through the entire process: from the initial idea to the inclusion in the DiGA Directory. Get in touch right away.