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08.09.2020

Without DiGA it won’t do ...

... But digital health applications (DiGA short for “Digitale Gesundheitsanwendungen”) need guidance, monitoring and development to help others! The experts at seleon are well versed in the jungle of laws, guidelines and manufacturer specifications and can navigate you.

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The regular grab for or glance at your smartphone shows that almost nothing works without digital apps. And this does not only affect young people. The current tense situation due to the pandemic situation is bringing the advantages of digital innovation in the medical sector to light. A visit to the doctor is no longer necessary because you can talk to the doctor via smartphone or PC; health apps on the smartphone collect health-related data, evaluate it and forward it to the doctor for further treatment. The digital devices are motivator, evaluator and tipster in one. They do not replace communication between patients and doctors, but they make it easier, save time, ways and costs, in short: the digital change in medicine is unstoppable. 

Soon, even doctors will be able to prescribe apps on prescription, with the cost of these being covered by health insurance.

In order to strengthen digitisation in medicine, the German Federal Government has introduced some new legal regulations:

  • Law for better coverage through digitisation and innovation (“Gesetz für eine bessere Versorgung durch Digitalisierung und Innovation“)
    (Digital Supply Act - Digitale Versorgungs Gesetz - DVG) came into force on 19 December 2019
    The Digital Supply Act in the Federal Law Gazette
     
  • Regulation on the procedure and requirements for testing the eligibility of digital health applications for reimbursement by the statutory health insurance scheme (“Verordnung über das Verfahren und die Anforderungen zur Prüfung der Erstattungsfähigkeit digitaler Gesundheitsanwendungen in der gesetzlichen Krankenversicherung”)
     (Digital Health Applications Regulation - Digitale-Gesundheitsanwendungen-Verordnung - DiGAV)
    Digital Health Applications Ordinance (DiGAV) in the Federal Law Gazette

 

What changes will DVG and DiGAV bring for medical device manufacturers?

  • Insured persons are entitled to a Digital Health Application (DiGA). A new procedure will be established at BfArM, in the course of which BfArM will test the respective DiGA for safety, functional capability, quality, data security and data protection. Subsequently, the DiGA will be made available online in a corresponding directory for one year, where it can be prescribed by doctors and reimbursed by the statutory health insurance. The manufacturer has one year to prove that the DiGA improves patient care. This will enable patients to use the health apps/-DiGA more quickly and with less bureaucracy.
     
  • In the future, health insurance funds will be able to promote the development of digital innovations in a needs-based and patient-oriented manner, using up to two percent of their financial reserves for this purpose when acquiring investment assets, e.g. by specifically promoting an idea or by participating in health-innovative capital funds. The innovation fund available at https://innovationsfonds.g-ba.de/ will be continued and further developed.

The health insurance funds may inform insured persons who so wish about innovative care offers.

  • The IT security of doctors in private practice is strengthened. Certified service providers can support the practices in implementing the IT security standards.
     
  • Networking of the health care system: In future, the exchange of information between the insured and various health care service providers is to be easier, faster and based on international standards.
     
  • The DiGAV ensures that high quality DiGAs are quickly supplied and thus generate added value for the insured.

BfArM has developed a fast-track procedure for digital health applications (DiGA) according to § 139e SGB V, which is intended to serve as a guideline for manufacturers, service providers and users. The milestones of the implementation of the Fast-Track procedure are as follows (source BfArM).

 

Which medical digital applications belong to DiGA?

A DiGA is a medical device of risk class I or IIa (according to MDR or, within the framework of the transitional provisions, according to MDD), which has the following characteristics:

  • Digital technologies are the main function of DiGA.
  • The DiGA is not only used to read out or control a device; the medical purpose must be essentially achieved by the main digital function.
  • The DiGA supports the detection, monitoring, treatment or alleviation of diseases or the detection, treatment, alleviation or compensation of injuries or disabilities.
  • The DiGA does not serve primary prevention.
  • The DiGA is used by the patients or by the service provider and patients together.
  • Applications that are only used by the doctor to treat patients are not a DiGA.

A DiGA can include not only software but also devices, sensors (and other hardware such as wearables). The main function must remain predominantly digital. The hardware must be necessary to achieve the purpose of the DiGA and may not be a privately financed object of daily life (e.g. a gymnastics mat for the implementation of the DiGA exercises). However, the DiGA can, for example, obtain data from a Smartwatch via a standard interface if this has been taken into account in the conformity assessment and has been positively assessed.

The DiGA can also be combined with services that include consultation, coaching or private medical services. However, these services are not reimbursed by the statutory health insurance. The positive care effect of a DiGA must be proven without the use of such additional services.

The DiGA manufacturer can offer additional optional services and functions (e.g. connection to a social network, appointment bookings or apps/device connections). However, these may not have any medical purpose or influence on the medical purpose, may not endanger or change the positive effects of care, must be segregated and may not impair the DiGA even in the event of an error, and must be separately labelled. The extra costs are borne by the user.

Primary preventive digital applications cannot be included in the DiGA directory because primary prevention is aimed at the general population and serves to prevent the development of diseases (i.e. for the population not [yet] sick). However, a DiGA that prevents the worsening of a disease state or avoids secondary diseases is summarised under the term "treatment" and belongs in the DiGA directory. The prerequisite for this is: there is a risk factor in the sense of a disease that can be coded as a diagnosis.

 

Who is eligible to apply?

The procedure for including a DiGA in the BfArM's DiGA directory is initiated upon application by the manufacturer of the medical device in accordance with the applicable medical device regulations or by third parties on behalf of the manufacturer with the latter's authorisation in written or electronic form.

 

What are the contents of the application?

§ Section 139e, paragraph 2, sentence 2 of Book V of the German Social Code lists the contents of the application. These include proof that the DiGA meets the requirements for safety, functional capability and quality of the medical device and for data protection, that data security is ensured in accordance with the state of the art and that it has positive effects on supply. In addition, the manufacturer must list many other details listed in § 2 of the DiGAV and fill in Appendices 1 and 2 of the DiGAV and enclose them with the application.

 

What are the positive supply effects and how are they demonstrated?

Positive supply effects within the meaning of the DiGAV are either

  • a medical benefit, with a patient-relevant effect, in particular in terms of an improvement in health status, a reduction in the duration of disease, a prolongation of survival or an improvement in quality of life; or 
     
  • patient-relevant structural and procedural improvements in care in the context of detecting, monitoring, treating or alleviating disease or detecting, treating, alleviating or compensating for injury or disability, are aimed at supporting patients' health-related activities or integrating the processes between patients and care providers. They include in particular the areas of coordination of treatment processes, facilitating access to care, patient safety, aligning treatment with guidelines and recognised standards, etc. (§ 8 DiGAV).

The applicant states the positive supply effect of DiGA to be proven and the patient group for which the positive supply effect is to be proven. The positive supply effect postulated by the DiGA manufacturer must be consistent with the intended purpose as well as with the functions, contents and statements on DiGA published by the manufacturer.

The manufacturer shall submit a comparative study, alternatively a prospective comparative study or quantitative, comparative studies to prove the stated positive health care effects (§ 10 DiGAV). The chosen methodological approach must be appropriate to the positive supply effect to be proven.

The retrospective and prospective comparative studies must have been conducted in Germany, registered in a public study register and published in full (including negative results) on the Internet within 12 months of completion of the study (personal data, company secrets, etc. may be blacked out). Study reports must be prepared in accordance with the relevant internationally recognised standards for the presentation and reporting of studies.

 

Here we show you how the process works. (source BfArM)

The entire application procedure for the inclusion of a DiGA in the DiGA directory at BfArM is carried out exclusively via the application portal at BfArM (currently not yet online, but to be put into service by mid-September 2020).

Following a formal examination of the documents for completeness and, if necessary, additional claims by BfArm, the actual examination of the application begins. Once the processing period begins, the BfArM has a maximum of three months to evaluate the application and to inform the applicant by letter whether his DiGA will be included in the DiGA directory for testing or finally or whether the application will be rejected.

If a DiGA is provisionally included in the DiGA directory, the manufacturer has twelve months (trial phase) to prove the positive supply effects. The manufacturer can also extend the trial phase once for up to twelve months.

Within three months after the end of the trial period the BfArM will issue a decision as to whether the DiGA concerned will finally be included in the DiGA register. If BfArM rejects the inclusion, BfArM will delete the DiGA from the list. The manufacturer may submit a new application at the earliest twelve months after the negative decision, providing new evidence of positive supply effects. A repeated provisional inclusion in the DiGA register for testing purposes is not permitted.

The manufacturer is obliged to notify the BfArM of any significant changes to the DiGA after its inclusion in the directory. If the information that is publicly accessible online in the directory changes, the manufacturer is also obliged to update it.

Illustration of the process (source BfArM)

 

What are the costs for applicants?

Details of the fees to be paid can be found in § 139e of Book 5 of the Social Security Code (SGB V). In general, these amount to three to four-digit amounts:

  • Final admission of a DiGA: 3,000 to 9,900 euros.
  • Final admission of a tested DiGA: 1,500 to 6,600 euros.
  • Extension of the trial period by up to twelve months: EUR 1 500 to 4 900.
  • Deletion of a DiGA on request: 200 Euro.
  • Processing of a notification of major changes: 1,500 to 4,900 euros.
  • Change to the information published in the directory: 300 to 1 000 euros.
  • Advising of a DiGA manufacturer: 250 to 5,000 euros (excluding minor general oral, written or electronic information).

 

Other changes that DGV and DiGAV will bring about:

  • Telematics infrastructure is being expanded. A compulsory digital network for the health sector will be created and a nationwide introduction of electronic patient files (elektronische Patientenakte - ePA) will be defined. Pharmacies are to be connected to the telematics infrastructure (TI) by the end of September 2020 and hospitals by 1 January 2021 (midwives, physiotherapists, care and rehabilitation facilities on a voluntary basis). Doctors who do not wish to be connected have to pay an increased fee deduction of 2.5% since 1 March 2020.
     
  • Video consultation hours are becoming an everyday occurrence. Doctors are allowed to provide information on their website on video consultation hours and hold them accordingly.
     
  • The administrative process is simplified by digitisation and ensures less paperwork. In addition to the electronic certificate of incapacity to work and the e-prescription, all other initiated services (e.g. doctor's letters) can also be prescribed electronically.
     
  • For better knowledge in health research, the accounting data available at the health insurance companies are summarised pseudo-anonymised by the Research Data Centre and made available to research in anonymised form. Regulations on data transparency are being further developed.
     
  • All insured persons participate in digitisation. The health insurance funds will be obliged to make offers to their insured persons to promote digital health literacy. If they wish, the insured can learn how to use the digital processes and applications, e.g. by using health apps or the electronic patient card.
     
  • The future of electronic patient cards is still uncertain. Much still needs to be adapted in SGB V in terms of data protection and further comprehensive regulations regarding the patient card need to be defined. There will be a separate law for this.
    The electronic patient card will nevertheless be introduced on 1 January 2021.

 

Please note that all details and listings do not claim to be complete, are without guarantee and are for information purposes only.

Every product is unique – the mandatory tasks and measures for entering the market need to be specified individually. seleon advises you on your individual questions without any obligation.

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